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misc.kids FAQ on Childhood Vaccinations, Part 1/4



 
 
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Old February 16th 04, 09:58 AM
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Default misc.kids FAQ on Childhood Vaccinations, Part 1/4

Archive-name: misc-kids/vaccinations/part1
Posting-Frequency: monthly
Last-Modified: October 23, 1999


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Collection maintained by: Lynn Gazis-Sax )=20

To contribute to this collection, please send e-mail to the address given a=
bove, and ask me to add your comments to the FAQ
file on vaccination. Please try to be as concise as possible, as these FAQ =
files tend to be quite long as it is. And, unless
otherwise requested, your name and e-mail address will remain in the file, =
so that interested readers may follow-up directly for
more information/discussion.=20

Copyright 1994-1999, Lynn Gazis-Sax. All rights reserved. Use and copying o=
f this information are permitted as long as (1)
no fees or compensation are charged for use, copies or access to this infor=
mation, and (2) this copyright notice is included
intact.=20

For a list of other FAQ topics, ftp to the pub/usenet/misc.kids directory o=
f rtfm.mit.edu, look for the FAQ File Index posted to
misc.kids weekly, or tune in to misc.kids.info.
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[NOTE: this is information collected from many sources and while I have str=
ived to be accurate and complete, I cannot
guarantee that I have succeeded. This is not medical advice. For that, see =
your doctor or other health care provider.]=20

[This version is updated to reflect the approval of the chicken pox and hep=
atitis A vaccines by the FDA, the approval of an
acellular pertussis vaccine for all shots, the approval of IPV for all poli=
o shots, the rise and fall of the new rotavirus vaccine,
new information about adverse events, and new information about vaccine res=
earch. ]
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Contents=20

Section 1. Introduction and General Information
Q1.1 What is vaccination?
Q1.2 What are active and passive vaccination?
Q1.3 What is herd immunity?
Q1.4 How effective is vaccination at producing immunity?
Q1.5 What are some of the risks of vaccination?
Q1.6 What are some contraindications to vaccinations?
Q1.7 How common are the diseases vaccinated against?
Q1.8 What percentage of children are vaccinated?
Q1.9 What are some sources of further information about vaccinations?

Section 2. The recommended vaccination schedule and official organizations
Q2.1 What is the recommended vaccination schedule in the US for infants?
Q2.2 What is the recommended vaccination schedule in the US for older child=
ren who were not vaccinated in infancy?
Q2.3 What is the recommended vaccination schedule in the US for adults?
Q2.4 Who determines this schedule?
Q2.5 What other US government organizations are concerned with vaccinations=
?
Q2.5.1 What is the National Vaccine Injury Compensation Program (VICP)?
Q2.5.2 What vaccines are covered?
Q2.5.3 Who may file a claim?
Q2.5.4 Who can I contact to get more information about the Program? Q2.5.5 =
What is VAERS?
Q2.5.6 Who can report to VAERS?
Q2.5.7 What events should be reported to VAERS?
Q2.5.8 Are all events reported to VAERS caused by vaccinations?
Q2.5.9 How can I get rapid information on VAERS, such as how to file a repo=
rt?
Q2.5.10 Have there been any comprehensive scientific studies on adverse eve=
nts following immunization?
Q2.5.11 Are VAERS data available to the public?
Q2.6 What vaccination schedules are used in other countries?
Q2.7 What international bodies are concerned with vaccinations?

Section 3. Specific vaccines
Section 3a. DTP (diptheria, tetanus, and pertussis) and DT
Q3a.1 What is diptheria, and what are the risks of the disease?
Q3a.2 How common was diptheria before routine vaccination, and how common i=
s it now?
Q3a.3 How effective is the diptheria vaccine?
Q3a.4 How long does the diptheria vaccine last?
Q3a.5 What is pertussis, and what are the risks of the disease?
Q3a.6 How common was pertussis before routine vaccination, and how common i=
s it now?
Q3a.7 How effective is the whole cell pertussis vaccine?
Q3a.8 How long does the pertussis vaccine last?
Q3a.9 What is tetanus, and what are the risks of the disease?
Q3a.10 How common was tetanus before routine vaccination, and how common is=
it now?
Q3a.11 How effective is the tetanus vaccine?
Q3a.12 How long does the tetanus vaccine last?
Q3a.13 What are some of the risks of the DTP vaccine?
Q3a.14 Did SIDS disappear in Japan after the Japanese changed their pertuss=
is vaccination policy in 1975?
Q3a.15 When is the DTP vaccine contraindicated?
Q3a.16 What are the advantages and disadvantages of the new acellular pertu=
ssis vaccine?
Q3a.17 What are some of the risks of the DT (diptheria and tetanus) vaccine=
?
Q3a.18 When is the DT vaccine contraindicated?
Q3a.19 Under what circumstances is tetanus toxoid given to pregnant women?=
=20

Section 3b. Polio
Q3b.1 What is polio, and what are the risks of the disease?
Q3b.2 How common was polio before routine vaccination, and how common is it=
now?
Q3b.3 How effective is the polio vaccine?
Q3b.4 How long does the polio vaccine last?
Q3b.5 What is the difference between oral polio vaccine (OPV) and inactivat=
ed polio vaccine (IPV)?
Q3b.6 I've heard that it is possible to contract polio from handling the di=
apers of recently immunized infants. How long after
receiving the vaccine does the child's excrement continue to contain the vi=
rus?
Q3b.7 What are some other risks of the polio vaccine?
Q3b.8 When is the polio vaccine contraindicated?
Q3b.9 Isn't it true that wild polio has been eliminated in the US?
Q3b.10 Why are we still vaccinating for polio, then?

Section 3c. MMR (measles, mumps, and rubella)
Q3c.1 What is measles, and what are the risks of the disease?
Q3c.2 How common was measles before routine vaccination, and how common is =
it now?
Q3c.3 How effective is the measles vaccine?
Q3c.4 How long does the measles vaccine last?
Q3c.5 What are some of the risks of the measles vaccine?
Q3c.6 What is mumps, and what are the risks of the disease?
Q3c.7 How common was mumps before routine vaccination, and how common is it=
now?
Q3c.8 How effective is the mumps vaccine?
Q3c.9 How long does the mumps vaccine last?
Q3c.10 What are some of the risks of the mumps vaccine?
Q3c.11 What is rubella, and what are the risks of the disease?
Q3c.12 How common was rubella before routine vaccination, and how common is=
it now?
Q3c.13 How effective is the rubella vaccine?
Q3c.14 How long does the rubella vaccine last?
Q3c.15 What are the pros and cons of vaccinating all infants for rubella ve=
rsus vaccinating females only at puberty?
Q3c.16 What are some of the risks of the rubella vaccine?
Q3c.17 When is the MMR vaccine contraindicated?

Section 3d. HiB (Hemophilus influenze B)
Q3d.1 What is hemophilus influenze B, and what are the risks of the disease=
?=20
Q3d.2 How common was HiB before routine vaccination, and how common is it n=
ow?
Q3d.3 How effective is the HiB vaccine?
Q3d.4 How long does the HiB vaccine last?
Q3d.5 What are some of the risks of the HiB vaccine?
Q3d.6 When is the HiB vaccine contraindicated?
Q3d.7 What about rifampin prophylaxis?

Section 3e. Hepatitis B gamma globulin and hepatitis B vaccine
Q3e.1 What is hepatitis B, and what are the risks of the disease?
Q3e.2 How common is hepatitis B?
Q3e.3 What is hepatitis B gamma globulin, and when is it given?
Q3e.4 How long does the immunity provided by hepatitis B gamma globulin las=
t?
Q3e.5 What are the risks and contraindications of hepatitis B gamma globuli=
n?=20
Q3e.6 How effective is the hepatitis B vaccine?
Q3e.7 How long does the hepatitis B vaccine last?
Q3e.8 What are some of the risks of the hepatitis B vaccine?
Q3e.9 When is the hepatitis B vaccine contraindicated?
Q3e.10 Why did the ACIP and AAP change their recommendation about the hepat=
itis B vaccine?
Q3e.11 Does vaccination for hepatitis B affect one's ability to donate bloo=
d?
Q3e.12 Do people who have showed up positive on the blood banks' tests for =
hepatitis B exposure still need to be
vaccinated?
Q3e.13 I will be travelling to an area where hepatitis B shots are recommen=
ded, but I have less than six months before I leave.
Is there an accelerated schedule for hepatitis B vaccination?

Section 3f. Influenza
Q3f.1 What is influenza, and what are the risks of the disease?
Q3f.2 How common is influenza?
Q3f.3 How effective is the influenza vaccine?
Q3f.4 How long does the influenza vaccine last?
Q3f.5 What are some of the risks of the influenza vaccine?
Q3f.6 When is the influenza vaccine recommended?
Q3f.7 When is the influenza vaccine contraindicated?
Q3f.8 Is it OK to be vaccinated for influenza during pregnancy?

Section 3g. Pneumococcal vaccine
Q3g.1 What is pneumococcal disease, and what are the risks of the disease?=
=20
Q3g.2 How common is pneumococcal disease?
Q3g.3 How effective is the pneumococcal vaccine?
Q3g.4 How long does the pneumococcal vaccine last?
Q3g.5 What are some of the risks of the pneumococcal vaccine?
Q3g.6 When is the pneumococcal vaccine recommended?
Q3g.7 When is the pneumococcal vaccine contraindicated?

Section 3h. Meningococcal vaccine
Q3h.1 What is meningococcal disease, and what are the risks of the disease?=
=20
Q3h.2 How common is meningococcal disease?
Q3h.3 How effective is the meningococcal vaccine?
Q3h.4 How long does the meningococcal vaccine last?
Q3h.5 What are some of the risks of the meningococcal vaccine?
Q3h.6 When is the meningococcal vaccine recommended?
Q3h.7 When is the meningococcal vaccine contraindicated?

Section 3i. Varicella (chicken pox) vaccine
Q3i.1 What is chicken pox, and what are the risks of the disease?
Q3i.2 How common is chicken pox?
Q3i.3 What is Herpes Zoster?
Q3i.4 What is the current recommendation for the chicken pox vaccine be par=
t for children?
Q3i.5 What is the current recommendation for adults?
Q3i.6 How effective is the chicken pox vaccine?
Q3i.7 How long does the chicken pox vaccine last?
Q3i.8 What reactions have been reported following the chickenpox vaccine?
Q3i.9 Will a second dose be necessary in younger children?
Q3i.10 For which groups is the chicken pox vaccine especially recommended?
Q3i.11 When is the chicken pox vaccine contraindicated?
Q3i.12 Is there a gamma globulin for chicken pox?

Section 3j. BCG (tuberculosis) vaccine
Q3j.1 What is tuberculosis, and what are the risks of the disease?
Q3j.2 How common is tuberculosis?
Q3j.3 How effective is the BCG vaccine?
Q3j.4 How long does the BCG vaccine last?
Q3j.5 What are some of the risks of the BCG vaccine?
Q3j.6 When is the BCG vaccine recommended?
Q3j.7 When is the BCG vaccine contraindicated?
Q3j.8 What are some other methods of controlling tuberculosis?

Section 3k. Hepatitis A vaccine
Q3k.1 What is hepatitis A and what are the risks of the disease?
Q3k.2 How common is hepatitis A?
Q3k.3 Who is at risk for acquiring hepatitis A?
Q3k.4 Is there a vaccine to protect against hepatitis A?
Q3k.5 How is it to be administered?
Q3k.6 How effective is the vaccine?
Q3k.7 How long does immunity last?
Q3k.8 What are some of the risks of the vaccine?
Q3k.9 When is hepatitis A vaccine contraindicated?
Q3k.10 What groups at risk may be included in a recommendation to receive h=
epatitis A vaccination?
Q3k.11 Is it possible that hepatitis A vaccine (like hepatitis B vaccine) m=
ight eventually be recommended for routine
administration to children and adults?

Section 3l. Rotavirus vaccine
Q3l.1 What is rotavirus, and what are the risks of the disease?
Q3l.2 How common is rotavirus?
Q3l.3 What is the current status of the rotavirus vaccine?
Q3l.4 How effective is the rotavirus vaccine?
Q3l.5 Is the rotavirus vaccine effective for breastfeeding infants?
Q3l.6 How long does the rotavirus vaccine last?
Q3l.7 What is intussusception?
Q3l.8 What is the relationship between the rotavirus vaccine and intussusce=
ption?
Q3l.9 Why was a connection between the rotavirus vaccine and intussusceptio=
n not observed prior to FDA approval of the
vaccine?
Q3l.10 What other reactions have been reported following the rotavirus vacc=
ine?
Q3l.11 Can the rotavirus vaccine be effectively used in developing countrie=
s?
Q3l.12 When is the rotavirus vaccine contraindicated?=20

Section 3m. Other vaccines which are available
Q3m.1 What other vaccines are available and when are they given?

Section 3n. Vaccines under development
Q3n.1 What vaccines are currently under development?
Q3n.2 What other research is being done to improve vaccines?

Section 4. References

Section 5. Stories of Parents

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Section 1. Introduction and General Information
[This section last updated on September 25, 1999.]=20

Q1.1 What is vaccination?=20

The basic principle of vaccination is that a disease-causing agent is given=
to a person in a killed or weakened form (or in the
form of proteins genetically engineered to look like a disease-causing agen=
t), in order to stimulate the production of antibodies
to fight off the disease.=20

Q1.2 What are active and passive vaccination?=20

Active immunization involves trying to stimulate antibodies by giving a per=
son a killed or weakened form of a disease-causing
agent. Passive immunization involves giving a person antibodies from someon=
e who was infected with the disease (these are
called gamma globulins). Passive immunization doesn't last very long, but c=
an be useful for someone who expects to be
exposed to a disease (e.g. someone travelling to another country who takes =
hepatitis A gamma globulin right before leaving), or
to someone who has just been exposed to a disease. Most of the vaccinations=
discussed in this FAQ fall under the active
vaccination category.=20

Q1.3 What is herd immunity?=20

If a large enough percentage of a population is immune to a disease, their =
immunity protects the rest of the "herd."=20

Some discussion of this concept from misc.kids follows:=20

************************************************** ***********************
From: (Paula Burch)

| Paula Burch ) wrote:
| : If one child remains unvaccinated, but all other children are
| : vaccinated, the one child who does not get vaccinated is pretty safe
| : from getting the disease. If many children remain unvaccinated,
| : epidemics occur, and children die needlessly.

|
(Mark Dolson) writes:=20
| This is exactly what occured with measles in the 80's, BTW. Fewer
| vaccinated, and the incidence skyrocketed, with resulting complications
| of eye problems, etc, and even some deaths. I agree that people who
| let their children remain unvaccinated are riding on the backs of=20
| everyone that does vaccinate, and I resent it.

(Cerebus) writes:
| To be fair, most of the major outbreaks (as well as most of the
| serious complications) were and are on college campuses, and occurred *n=
ot*
| because of failure to vaccinate, but because the vaccine that was given
| to kids between '69-'76 turned out not to give total immunity. Many kid=
s
| who were vaccinated were victims of measles, before people became consci=
ous
| that it was necessary for many teens and young adults to be re-vaccinate=
d.
|
| I had measles my first year in college, after vaccination at the appropr=
iate
| age. After that outbreak my college began requiring re-vaccination. Bu=
t it
| is not technically correct to blame the measles outbreak on the failure =
of
| parents to vaccinate.

It's true that that's what happended in that case, but it's not true for
other cases, in which failure to vaccinate has been a major factor:

"The nation [U.S.] has experienced a marked increase in measles cases=20
during 1989 and 1990. Almost one half of all cases have occurred in
*unvaccinated* preschool children." (JAMA. 1991 Sep 18. 266(11). =20
P 1547-52.)

"Beginning in October, 1990, a large measles outbreak involving
predominantly *unvaccinated* preschool age children occurred in
Philadelphia. By June, 1991, 938 measles cases had been reported to
the Philadelphia Health Department. In addition to these cases, 486
cases and 6 measles-associated *deaths* occurred between November 4,
1990, and March 24, 1991, among members of 2 Philadelphia church
groups that do not accept vaccination." (Pediatr-Infect-Dis-J. 1993 Apr=
..=20
12(4). P 288-92.)

"In 1989 and 1990 the United States experienced a measles epidemic with=
=20
more than 18,000 and 27,000 reported cases. Nearly half of all persons
with measles were *unvaccinated* preschool children under 5 years of age=
.."=20
(Am-J-Public-Health. 1993 Jun. 83(6). P 862-7.)

Measles is bad, but I'm more concerned myself about pertussis (whooping cou=
gh):

"From 1980 through 1989, 27,826 cases of pertussis were reported to
the Centers for Disease Control....Infants less than 2 months of age=20
had the highest reported rates of pertussis-associated hospitalization=
=20
(82%), pneumonia (25%), seizures (4%), encephalopathy (1%), and *death*=
=20
(1%)." (Clin-Infect-Dis. 1992 Mar. 14(3). P 708-19.) [Many of these=
=20
infants would not have caught the disease if enough older children were=
=20
appropriately vaccinated.]

"Two large *epidemics* of pertussis occurred in Britain during 1977-79
and 1981-83." (Commun-Dis-Rep-CDR-Rev. 1992 Dec 4. 2(13). P R155-6.)

This explains the herd immunity concept rather well:

"The epidemiology of whooping cough [pertussis] in Denmark is described =
=20
on the basis of the notified cases of the disease. The frequency of
whooping cough has decreased to approximately one sixteenth of the
previous level in children following the introduction of vaccination
for whooping cough in 1961....deaths from whooping cough still
occurred in the eighties, all of these among *unvaccinated* infants.
The risk of whooping cough in an *unvaccinated* child is approximately
one sixth of the risk prior to introduction of vaccination. In a
vaccinated child, the risk, as judged from the notified cases, is one
twentieth of the risk during the time prior to introduction of
vaccination. In all age groups "herd immunity" is considered to have
contributed considerably to the reduced incidence. The incidence in
Denmark is, however, high compared with the incidence in some other
industrialized countries. A vaccination programme with more numerous
whooping cough vaccinations...may be recommended on the basis of the=20
strategy aimed at keeping the incidence of whooping cough, and thus the=
=20
risk of exposure, as low as possible." (Ugeskr-Laeger. 1990 Feb 26. =20
152(9). P 597-604.)

Paula Burch

not speaking for Baylor College of Medicine
************************************************** ***********************

Q1.4 How effective is vaccination at producing immunity?=20

Vaccination does not always work. For one thing, vaccines can lose effectiv=
eness when they aren't stored properly. And even
if they are stored effectively, they will fail to stimulate immunity a cert=
ain percentage of the time. The effectiveness of vaccines
varies, depending on the vaccine. Effectiveness can also vary depending on =
the age, sex, and health of the recipient. Sometimes
different strains of a vaccine can have different effectiveness.=20

Vaccine effectiveness is measured in two ways. First, antibody levels are m=
easured after a vaccine is given. Second, people are
vaccinated and then followed to see whether they get the disease when they =
are exposed to it. Estimates of effectiveness can
vary in some cases depending on the level of antibodies which is considered=
as passing, and the criteria for measuring whether
someone has the disease (for instance, pertussis vaccine is more effective =
at preventing full-blown pertussis than at preventing a
mild cough). Also, some sources give estimates of field effectiveness which=
take into account difficulties in storing vaccines in
some areas; these estimates tend to be lower than estimates based on studie=
s of vaccination in the US or other developed
countries.=20

Estimates of effectiveness of individual vaccines are given in the section =
for each vaccine (and, where I have found variations in
estimates of effectiveness, I have noted that as well).=20

************************************************** ***********************
From=20J Thompson ):=20

In addition to all of the factors you mentioned which determine the variabi=
lity of response to a vaccine, another very important
factor is the genetic inheritance of every individual. To give an example I=
feel sure of, I'll use the Hepatitis B vaccine. A certain
small percentage of the population has no response at all to the recombinan=
t Hep B vaccine. This occurs because these people
lack the particular forms of major histocompatibility complex (MHC) protein=
s which are necessary to "present" the _single_
protein in the vaccine to the immune system. These people can make a good r=
esponse to the whole virus, but they have a
problem with the protein in the vaccine.=20

This also highlights the need for "herd immunity," since people who cannot =
make an immune response to a vaccine component
will _never_ have a good response to the vaccine, regardless of how often i=
t is given.
************************************************** ***********************

Q1.5 What are some of the risks of vaccination?=20

Again, these risks vary with the vaccine. However, there are some risks whi=
ch are common to several vaccines. People may be
allergic to a component of the vaccine, such as eggs or neomycin. Occasiona=
lly, these allergies can lead to anaphylactic shock
(doctors keep epinephrine on hand when giving vaccinations to guard against=
this risk). Vaccines can produce the same
symptoms as the disease (in a milder form, and with less frequent incidence=
of the risks associated with the disease). Live
vaccines in particular can be risky for people with weakened immune systems=
, who have less ability to resist even the
weakened form of the disease. Common minor adverse reactions include sorene=
ss or swelling at the injection site and fever.
Because of the latter, vaccinations are often postponed if the recipient al=
ready has a fever.=20

Another risk is the risk that the vaccination will wear off, and the recipi=
ent will get the disease later. Depending on the illness,
the disease could be either less or more harmful to adults. While this risk=
can be dealt with by giving boosters, it is worth
bearing in mind in setting vaccination policies and making vaccination dsci=
sions, because in some case getting the vaccine and
then *not* getting the booster might lead to increased risk.=20

Further information related to vaccination risks follows:=20

From=20Cyndy Brunken:

I posted this for Kathleen over on sci.med then I realized that=20
misc.kidders might also benefit from the info contained herein.
************************************************** ***************

DISCLAIMER: THIS MESSAGE IS BEING POSTED FOR KATHLEEN STRATTON BY
SOMEONE NOT AFFILIATED WITH THE MESSAGE. I have read-only access to
USENET and have followed the immunization discussions in the last few
weeks. I think some of the participants will have an interest in the
following information.

An Institute of Medicine (IOM) committee has concluded in a new report
that a causal relation exists between certain common childhood vaccines
and specific, but rare, health problems. The committee also determined
that there appears to be no causal relation between some of those same
vaccines and other specific health problems. The vaccines studied
include those used against tetanus, diphtheria, measles, mumps, polio,
hepatitis B, and Haemophilus influenzae type b (Hib). =20

The IOM is a private, non-profit organization that provides health
policy advice under a congressional charter granted to the National
Academy of Sciences. The IOM committee was NOT asked to assess risk-
benefit or cost-benefit relations. Rather, the task was to evaluate all
medical and scientific evidence bearing on the causal relation between
childhood vaccines and specific, serious health outcomes.

The report is entitled "Adverse Events Associated with Childhood
Vaccines: Evidence Bearing on Causality". A previous IOM committee
submitted a report in 1991 entitled "Adverse Effects of Pertussis and
Rubella Vaccines". Both reports were mandated by the U.S. Congress in
the 1986 National Childhood Vaccine Injury Act (P.L. 99-660). This law
addressed many aspects of childhood immunization. Notably, it
established a federal compensation program for those who have been
injured by mandated childhood vaccines.

The IOM committee reported that the evidence established a causal
relation between diphtheria, tetanus, measles-mumps-and-rubella, and
hepatitis B vaccines and anaphylaxis. The evidence established a causal
relation between measles-mumps-and rubella vaccine and thrombocytopenia;
between measles vaccine and death from measles infection (primarily in
immunocompromised individuals); between oral polio vaccine and death
from poliovirus infection (primarily in immunocompromised individuals);
and between the oral polio vaccine and poliomyelitis disease.

On the other hand, the committee found that the evidence favored
rejection of a causal relation between diphtheria and tetanus vaccines
and encephalopathy, infantile spasms, and SIDS. The committee found
similarly regarding certain Hib vaccines and increased susceptibility to
Hib disease. The committee investigated other serious health problems
and classified their relation to vaccines in three other categories: no
evidence, inadequate evidence to accept or reject a causal relation, and
evidence favors acceptance of a causal relation. The specific relations
are too numerous to list here. =20

The committee noted that in most cases it was impossible to calculate an
incidence rate or relative risk for these reactions, but that they were,
on the whole, extremely rare.

The final report will be available in late October or early November
from National Academy Press, 1-800-624-6242. It will cost approximately
$60.00. (The report on pertussis and rubella is still available) A few
prepublication copies of the Executive Summary of the new, 1993 report
are available from the project director at no cost on a first come-first
served basis. Anyone wishing specific information about this report can
email me, Kathleen Stratton, directly. I am the study director for this
project. My internet address is


************************************************** ***********************

More information on the findings of the expert committee of the Institute o=
f Medicine, along with a table showing in which
categories they have placed various adverse events, and modified ACIP recom=
mendations based on these findings, can be
found in (MMWR 1996;45[No. RR-12]), or
http://www.medscape.com/govmt/CDC/MM=
WR/1996/sep/rr4512/rr4512.html.
Between the publication of the 1993 report, and the publication of the 1996=
update, two other IOM committees had met, and
published findings concerning "concerning both the diphtheria and tetanus t=
oxoids and pertussis vaccine (DTP) and chronic
nervous system dysfunction ... and research strategies for vaccine-associat=
ed adverse events" (MMWR 1996;45[No.
RR-12]).=20

From=20Mike Dedek:

************************************************** ***********************
New England Journal of Medicine 1987; 316: 1283-1288, May 14, 1987,=20
"Compensating Children with Vaccine-Related Injuries", Iglehart, John K.

The federal immunization program, by virtually all economic, medical, an=
d
political measures, is a stunning success story because of its record of
protecting millions of children against the common infectious diseases of t=
he
young. But in recent years the program has come under a legal cloud that is
threatening its stability, slowing the development of new vaccines, and
sending vaccine prices sharply upward. To address these problems, Congress =
has
created a new federal program to compensate children who suffer vaccine-rel=
ated
injuries, but how it will be funded and whether it will achieve its goals r=
emain
open questions.

The legal cloud has formed because, even when the best vaccine products =
are
properly administered and used, vaccines pose minute risks to those who rec=
eive
them, and an increasing number of lawsuits are seeking damages on behalf of
injured persons. Dr. Louis Z. Cooper, representing the American Academy of
Pediatrics, testified before Congress on March 5 about the nature of these
risks. Cooper stated:

One case of polio-like disease will result from each 2.6 million doses =
of
oral polio vaccine OPV , and a serious, permanent neurological injury will
result from every 310,000 doses of DTP diphtheria, tetanus, and pertussis
vaccine . In extremely rare cases, an encephalitis or nerve deafness will
develop from MMR measles, mumps, and rubella vaccine . Approximately 75
vaccine-related injuries per year are the price we pay to protect the more =
than
3.8 million children born each year in this country.

For five years, Congress has struggled to fashion legislation that addre=
sses
he complex issues related to the compensation of children injured by vaccin=
es;
in the process, it has explored virtually every conceivable policy option.



************************************************** ***********************

Q1.6 What are some contraindications to vaccinations?=20

Contraindications vary with the vaccine, so contraindications for each spec=
ific vaccine are given in the appropriate sections.
Some common ones a allergy to some substance contained in the vaccine (s=
uch as eggs or thimerosal, a preservative used in
some vaccines), a weakened immune system (which may make attenuated live va=
ccines more risky), and pregnancy.=20

The allergies to worry about, in particular, are those with an anaphylactic=
or anaphylactoid reaction, e.g. hives, swelling of
mouth and throat, difficulty breathing, hypotension, or shock.=20

Breastfeeding is not a contraindication to vaccination. From Harrison's Int=
ernal Medicine, "Breastfed infants can be immunized
on a normal schedule. Breast feeding does not adversely affect the immunce =
response and is not a contraindication for any
vaccine. Breast-feeding mothers also may be vaccinated without any problem.=
" (British Medical Journal 1994; 309:1073-5
contains an article which confirms that breastfeeding will not interfere wi=
th vaccination, and provides references to a couple of
relevant studies.)=20

Q1.7 How common are the diseases vaccinated against?=20

I have extracted from table number 190, in _Statistical Abstracts of the Un=
ited States_, the following table, showing the
frequency, in the US, of some diseases for which vaccinations are either av=
ailable and diseases for which I knew a vaccine was
being developed or researched (obviously with more success in some cases th=
an in others). Table information extracted from:=20

No. 190. Specific Reportable Diseases - Cases Reported: 1970 to 1990

Disease 1970 1980 1983 1984 1985
AIDS (N/A) (N/A) 2,117 4,445 8,249
Chickenpox (1000) (N/A) 190.9 177.5 222.0 178.2
Diptheria 435 3 5 1 3
Hepatitis B (serum) (1000) 8.3 19.0 24.3 26.1 26.6
A (infectious) (1000) 56.8 29.1 21.5 22.0 23.2
Measles (1000) 47.4 13.5 1.5 2.6 2.8
Meningococcal infections 2,505 2,840 2,736 2,746 2,479 =20
Mumps (1000) 105.0 8.6 3.4 3.0 3.0
Pertussis (1000) 4.2 1.7 2.5 2.3 3.6
Plague 13 18 40 31 17
Poliomyelitis, acute 33 9 15 8 7
Rabies, animal 3,224 6,421 5,878 5,567 5,565
Rabies, human 3 _ 2 3 1
Rubella (1000) 56.6 3.9 1.0 1.0 0.6
Tetanus 148 95 91 74 83
Tuberculosis (1000) 37.1 27.7 23.8 22.3 22.2
Typhoid fever 346 510 507 390 402

Disease 1986 1987 1988 1989 1990
AIDS 13,166 21,070 31,001 33,722 41,595
Chickenpox (1000) 183.2 213.2 192.9 185.4 173.1
Diptheria _ 3 2 3 4
Hepatitis B (serum) (1000) 26.1 25.9 23.2 23.4 21.1
A (infectious) (1000) 23.4 25.3 28.5 35.8 31.4
Measles (1000) 6.3 3.7 3.4 18.2 27.8
Meningococcal infections 2,594 2,930 2,964 2,727 2,451
Mumps (1000) 7.8 12.8 4.9 5.7 5.3
Pertussis (1000) 4.2 2.8 3.5 4.2 4.6
Plague 10 12 15 4 2
Poliomyelitis, acute 8 6 9 5 7
Rabies, animal 5,504 4,658 4,651 4,724 4,826
Rabies, human _ 1 _ 1 1
Rubella (1000) 0.6 0.3 0.2 0.4 1.1
Tetanus 64 48 53 53 64
Tuberculosis (1000) 22.8 22.5 22.4 23.5 25.7
Typhoid fever 362 400 436 460 552

Measles: 45 million cases and around 1 million deaths estimated in developi=
ng countries in 1990. (Clements, Strassburg, Cutts,
and Torel)=20

Polio: 16,435 cases reported by 46 countries to the Expanded Programme on I=
mmunization in 1990, a 39% decrease from
1989 when 26,916 cases were reported. (Hull and Ward)=20

"Neonatal tetanus claimed the lives of over 433,000 infants in 1991. It is =
endemic in over 90 countries throughout the world."
(Whitman, Belgharbi, Gasse, Torel, Mattei, and Zoffman)=20

Pertussis (whooping cough): 659,973 cases reported in 1987. (Galazka)=20

The incidence of some of these diseases has changed significantly since the=
tables in this section. More up to date information
on worldwide incidence of vaccine preventable diseases can be found at http=
://www.who.org.=20

Q1.8 What percentage of children are vaccinated?=20

Some estimates of vaccination rates, from articles in World Health Statisti=
cs Quarterly, 45, 1992:=20

Measles: About 80% of the world's children aged less than 1 were reported t=
o have received measles vaccine (a dramatic
increase from 1983, when the figure was less than 20%). (Clements, Strassbu=
rg, Cutts, and Torel)=20

Polio: Estimated vaccination rate of 85% worldwide in 1990. This rate isn't=
equally distributed, though. The Western Pacific
Region had a coverage rate of 95%, and the South-East Asia Region 91%, but =
the Africa Region had a coverage rate of only
56%. (Hull and Ward)=20

DTP: Varies widely from country to country. The US, Canada, France, Norway,=
Poland, Australia, China were among the
countries with coverage rates over 80% in 1987-1989. (The article gives Yug=
oslavia as also being in this category, but in view
of the breakup of the country and the civil war there, I would suspect that=
level hasn't been maintained.) England, Spain,
Mexico, Turkey, and most of the countries in South America, as well as the =
Soviet Union (now defunct) were in the 50-80%
category. Sweden and many African countries had coverage rates of under 50%=
.. Coverage rates in the WHO regions were as
follows: Africa 57%, Americas 75%, Eastern Mediterranean 80%, South-East As=
ia 89%, Western Pacific 94%. (Galazka)=20

From=20_Statistical Abstracts of the United States, tables no. 189, Percent=
of Children Immunized Against Specific Diseases, by
Age Group: 1980 to 1985 (I am including the totals only, but the table also=
includes a breakdown by race)=20

Disease All Respondents =20
1 to 4 years old =20
1980 1984 1985=20
Diptheria-tetanus-pertussis 66.3 65.7 64.9
Polio 58.8 54.8 55.3
Measles 63.5 62.8 60.8
Rubella 63.5 60.9 58.9
Mumps 56.6 58.7 58.9

Disease All Respondents =20
5 to 14 years old
1980 1984 1985=20
Diptheria-tetanus-pertussis 74.0 73.8 73.7
Polio 70.0 70.2 69.7
Measles 71.0 73.5 71.5
Rubella 74.0 72.4 70.2
Mumps 63.2 70.9 71.6

Respondents consulting records, 1985 (29 percent of white and 15 percent of=
black or other respondents who consulted
records for some or all vaccination questions)=20

Disease 1 to 4 years 5 to 14 years

Diptheria-tetanus-pertussis 87.0 93.0
Polio 75.7 88.4
Measles 76.9 87.4
Rubella 73.8 85.3
Mumps 75.5 87.1

According to the California Morbidity for May 21, 1993, about one third of =
infants were found not to be vaccinated, and more
than half of all toddlers were behind schedule at their second birthday. Va=
ccination rates were lower among black and Hispanic
children. Only at school entry age did vaccination levels really rise, the =
result of school requirements. By 1990, more than 90%
of school age children were vaccinated. Immigration was cited as one factor=
keeping vaccination rates low.=20

The May 1, 1994 HICNet Medical News, citing MMWR, reports on vaccination co=
verage of 2 year old children in the US
from 1992-1993,=20

"Vaccination coverage increased for three vaccines from 1992 to 1993: for t=
hree or more doses of Hib, from 28.0% to 49.9%
(p less than 0.05); for three or more doses of poliomyelitis vaccine, from =
72.4% to 78.4% (p less than 0.05); and for three or
more doses of DTP/ diphtheria and tetanus toxoids (DT), from 83.0% to 87.2%=
(p greater than 0.05). Coverage with
measles-containing vaccine decreased from 82.5% to 80.8% (p greater than 0.=
05). Among 19-35-month-olds, 12.7% had
received three or more doses of Hep B.=20

From=201992 to 1993, the proportion of children who had received a combined=
series of four or more doses of DTP/DT, three
or more doses of polio vaccine, and one dose of MMR increased from 55.3% to=
64.8% (p less than 0.05), primarily because
of increased coverage with the fourth DTP/DT dose (from 59.0% to 71.1% [p l=
ess than 0.05])."=20

More details on these statistics in that issue of HICNet Medical News. For =
those who are interested, MMWR gives quarterly
updates of vaccination coverage in the US, evaluating progress toward the n=
ational goal of 90% coverage. These updates are
included in HICNet Medical News when they come out, and MMWR itself can als=
o be retrieved over the net. See the
reference section in section 3 of this FAQ for information on retrieving MM=
WR over the net. HiB and hepatitis B vaccination
coverage has been increasing (as is to be expected, since those are the mos=
t recently instituted vaccines). The March 5, 1995
HICNet includes an MMWR report which shows HiB coverage rising to a record =
high of 70.6% and Hep B coverage rising to
25.5% during the first quarter of 1994. However, a report in JAMA, cited in=
a summary in Journal Watch for Jan 15, 1995
(paper) or Feb 7, 1995 (electronic), "found that only 46 percent of white c=
hildren and only 34 percent of black children had
received adequate immunization by eight months of age (JAMA Oct 12, pp. 110=
5 and 1111)."=20

Q1.9 What are some sources of further information about vaccinations?=20

I don't have any addresses for information outside the US (except for the W=
HO book on travel vaccinations); if people
contribute them I'll add them.=20

Information on vaccinations is available from: The Academy of Pediatrics, C=
ommittee on Infectious Diseases, Evanston, Illinois
60204; Centers for Disease Control, Atlanta, Georgia 30333; Council on Envi=
ronmental Health, American Medical
Association, Chicago, Illinois 60610. The CDC also has a Voice/Fax Informat=
ion Service. To access the CDC Voice
Information System, telephone (404) 332-4555; to access the CDC Fax Informa=
tion System, telephone (404) 332-4565.
Their Web site is http://www.aap.org.=20

Not specific to vaccinations, but useful in general for the effects of drug=
s, illnesses, etc., during pregnancy is the UCSD
Teratogen Registry (1-800-532-3749). Another general source of information =
on illnesses is the National Foundation for
Infectious Diseases, 4733 Bethesda Ave., Suite 750, Bethesda, Maryland 2081=
4 (USA).=20

Critics of routine vaccination have set up their own information center; it=
is called the National Center for Information on
Vaccination and is based in Virginia. Their telephone number is 1-800-909-S=
HOT (for orders only) or 703-938-DPT3 and
their address is 512 W. Maple Ave. #206, Vienna VA 22180. Their web site ca=
n be found at
http://www.909shot.com/default.htm.=20

Information on travel vaccinations is available from _Health Information fo=
r International Travel_, published annually by the
Centers for Disease Control, and available from: Superintendent of Document=
s, US Government Printing Office, Washington,
DC 20402. This publication also has a lot of other information on health-re=
lated travel issues, and some information on the
regular childhood vaccinations as well (it also includes a table, for all v=
accinations, of which are contraindicated during
pregnancy). It is also available in some public libraries. The CDC informs =
all state and many city and county health departments
twice monthly about changing risks and requirements. Another source is _INT=
ERNATIONAL TRAVEL AND HEALTH:
Vaccination Requirements and Health Advice_, copies of which may be ordered=
from WHO Distribution and Sales,
CH-1211, Geneva 27, telephone (41 22) 791 2476; fax (41 22) 788 0401. (More=
sources of information about travel
vaccinations can be found in the section of this FAQ which covers them.)=20

The reference section of this FAQ lists the sources I used in putting toget=
her the FAQ. Some of the ones I used most heavily
include Harrison's Principles of Internal Medicine, The Merck Manual, _Taki=
ng Care of Your Child: A Parents' Guide to
Medical Care_, by Pantell, Fries, and Vickery, The Physician's Desk Referen=
ce, The American Hospital Formulary Service
Drug Information, and _The Wellness Encyclopedia_ From the editors of the U=
C Berkeley Wellness Letter, and, more
recently, http://www.medscape.com. Here is a list of other people's suggest=
ions (to which people are welcome to add):=20

Suggested by Heather Madrone:=20

Robert Mendelsohn _How to Raise a Healthy Child_ George Wootan _Take Charge=
of Your Child's Health_=20

Suggested by Roger Barr:=20

recommend books by Harris Coulter among others: Shot in the Dark (about DPT=
vaccinations) and another about violence in
society due to neurological damage caused by vaccinations (autoimmune respo=
nses leading to meningitis)=20

Suggested by John:=20

http://www.whale.to/vaccines.html=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 2. The recommended vaccination schedule
[This section last updated on October 23, 1999.]=20

Q2.1 What is the recommended vaccination schedule in the US for infants?=20

The following schedule is based on the schedule published on January 15, 19=
99, published in MMWR 48(01);8-16 and the
schedule on the AAP website as of August 1999.=20

Vaccine Recommended Age (or Range)

Hepatitis B Birth to 2 mos, 2-4 mos, 6-18 mos=20
DTaP 2 mos, 4 mos, 6 mos, 15-18 mos, 4-6 yrs
DT 11-12 yrs or 14-16 yrs, every ten years thereafter
HiB 2 mos, 4 mos, 6 mos, 12-15 mos
Polio (IPV) 2 mos, 4 mos, 6-18 mos, 4-6 yrs
MMR 12-15 mos, 4-6 yrs
Varicella 12-18 mos

Notes: (1) At 11-12 years, hepatitis B, MMR, and Varicella vaccines to be a=
ssessed and administered if necessary. (2)
Hepatitis B vaccine schedule in infants depends on the mother's hepatitis B=
surface antigen status; where this status is positive
or unknown, hepatitis B vaccination is recommended within 12 hours of birth=
, but where this status is negative, the vaccine may
be given at any time between birth and 2 months. (3) Three different Hib co=
njugate vaccines are licensed. Depending on which
is used, the dose at 6 months may or may not be required. (4) As of July, 1=
999, the AAP recommended a temporary delay
(until thimerosal-free Hepatitis B vaccine is available), for children of H=
epatitis B surface antigen negative mothers, in the first
shot, to six months. The CDC continues to recommend that the shot be given =
at from 2-6 months. As of September, 1999, a
hepatitis B vaccine without thimerosal has become available, so, as supplie=
s of this vaccine are distributed, the temporary delay
should come to an end. (5) In 1999, ACIP recommended hepatitis A vaccine fo=
r all children aged 2 years and older in the 11
Western states where incidence is especially high (at least 20 cases per 10=
0,000 people, twice the national average). These
states a Arizona, Alaska, California, Idaho, Nevada, New Mexico, Oklahom=
a, Oregon, South Dakota, Utah and
Washington.=20

There has been a difference of opinion about when the second dose of MMR sh=
ould be given. ACIP recommended 4-6 years,
but the AAP recommended at entry to middle or junior high school. Health au=
thorities in different states in the US have
adopted one or the other of these requirements. The advantage of giving the=
second dose at 4-6 years is that compliance may
be higher if it is made a requirement of entrance to public schools. The ad=
vantage of giving the second dose later is that it will
be closer in time to the age at which measles outbreaks have been occuring,=
and may increase immunity at that time. The AAP
and ACIP have since coordinated their recommendations and agreed on 4-6 yea=
rs.=20

This schedule is subject to change, and so, if you look at different medica=
l and childcare books, you may see slightly different
schedules. Recent changes include the addition of a new vaccine for haemoph=
ilus influenzae B, the addition of the hepatitis B
vaccine to the schedule, and the addition of a second dose of MMR at entry =
to primary or middle school, in response to an
increased incidence in measles among teenagers, and the addition of the chi=
cken pox vaccine to the schedule. The FDA
approved a couple of new vaccines in 1993: a combination of Haemophilus inf=
luenzae B vaccine and DTP vaccine, and a new
dosage for the hepatitis B vaccine. In 1992, a new acellular pertussis vacc=
ine was approved. In 1995, the varicella zoster
(chicken pox) vaccine was approved. On July 12, 1996, ACIP recommended that=
this vaccine be added to the schedule. The
newly approved hepatitis A vaccine was *not* added to the schedule; this va=
ccine was recommended only for people at
particular risk, such as travellers to countries where hepatitis A is more =
prevalent (more recently, it has been recommended in
states where hepatitis A is particularly prevalent). In 1996, an acellular =
pertussis vaccine was approved for the earlier shots in
the pertussis series (previously it had only been approved for the fourth a=
nd fifth shots), so that it is now the preferred vaccine
for all shots. As a result of progress in the global eradication of polio, =
in 1997, ACIP recommended that the first doses of polio
vaccine use the inactivated polio vaccine (IPV) rather than the oral polio =
vaccine (OPV). In January, 1999, the AAP
recommended that all doses use IPV, and on June 17, 1999, the ACIP followed=
suit (this new ACIP recommendation will
become effective on January 1, 2000).=20

Rotavirus vaccine was added to the schedule at 2, 4, and 6 months, after it=
s approval on August 31, 1998, but on July 7,
1999, this recommendation was suspended, pending collection of further data=
, based on early surveillance reports of
intussusception (a type of bowel obstruction), and on October 15, 1999, the=
vaccine was withdrawn from the market.=20

Q2.2 What is the recommended vaccination schedule in the US for older child=
ren who were not vaccinated in infancy?=20

Schedules for people not vaccinated in infancy can be found, among other pl=
aces, in the Merck Manual and in AMA Drug
Evaluations Annual. There are two schedules, one for children under 7, and =
one for people (children or adults) over 7. The
reason is that pertussis vaccine should not be given to anyone over 7. Pert=
ussis is a mild disease over the age of 7, but a serious
one for the very young. For that reason, the risks of the vaccine outweigh =
the risks of the disease after the age of 7. It is
possible that, with the availability of a less reactogenic acellular vaccin=
e, this recommendation may change, and pertussis
vaccine be give to older people as well, but such a change will not occur w=
ithout further study.=20

Q2.3 What is the recommended vaccination schedule in the US for adults?=20

If they haven't been vaccinated at all, see the answer to question 2.22.2. =
If they have been vaccinated, then a tetanus and
diptheria booster is recommended every ten years (or five years in case of =
a very dirty wound). People in certain high risk
groups are advised to get flu shots annually (see the section on the flu va=
ccine).=20

Q2.4 Who determines this schedule?=20

Two bodies set these schedules. They are the Immunization Practices Advisor=
y Committee (ACIP) of the Public Health
Service, and the American Academy of Pediatrics Committee on Infectious Dis=
eases. During 1994, these organizations were
part of a working group which included representatives from the American Ac=
ademy of Family Physicians which developed
one schedule to incorporate ACIP and AAP recommendations. A new schedule wa=
s been endorsed by these groups and
became effective January 1995. In modifications of the schedule since then,=
sometimes one group has differed slightly from the
other, but in time they reconcile their schedules.=20

Q2.5 What other US government organizations are concerned with vaccinations=
?=20

Q2.5.1 What is the National Vaccine Injury Compensation Program (VICP)?=20

[Note: Answers to this and the following several questions are extracted fr=
om a longer list of questions and answers put out by
the National Vaccine Injury Compensation Program (1-800-338-2382).]=20

The National Childhood Vaccine Injury Act of 1986 (the Act) established the=
VICP. This Program went into effect in October
1988 and is a Federal "no-fault" system designed to compensate those indivi=
duals, or families of individuals, who have been
injured by childhood vaccines, whether administered in the private or publi=
c sector. The Program is administered jointly by the
Court, the Department of Health and Human Services (HHS), and the Departmen=
t of Justice (DOJ).=20

Q2.5.2 What vaccines are covered?=20

Diphtheria, tetanus, pertussis (DTP, DT, TT, or Td), measles, mumps, rubell=
a (MMR or any components), and polio (OPV or
IPV).=20

Q2.5.3 Who may file a claim?=20

A claim may be made for any injury or death thought to be a result of a cov=
ered vaccine. These injuries may include, but are
not limited to: anaphylaxis, paralytic polio, seizure disorders, and enceph=
alopathy. The injured individual may file; or a parent,
legal guardian, or trustee may file on behalf of a child or an incapacitate=
d person.=20

Claims need to be filed within 36 months after the first symptoms appeared =
and show that effects have continued for at least 6
months (in the case of vaccine related injuried) or be filed within 24 mont=
hs of the death and within 48 months after the onset of
the vaccine-related injury from which the death occurred. The time for fili=
ng claims for injuries resulting from vaccines
administered prior to October 1, 1988, has expired.=20

The petitioner must either prove that the vaccine caused the injury or sign=
ificantly aggravated a preexisting condition, or the
petitioner must show that an injury on the Vaccine Injury Table occurred (m=
ost claims involve "Table Injuries" because it is
easier to demonstrate a Table Injury than to prove that the vaccine caused =
the condition). A modified Vaccine Injury Table is
effective for claims filed on or after March 10, 1995.=20

Q2.5.4 Who can I contact to get more information about the Program?=20

1. The toll-free number for the National Vaccine Injury Compensation Progra=
m is 1-800-338-2382 to obtain an information
packet detailing how to file a claim, criteria for eligibility, and the doc=
umentation required. For further information write to:
National Vaccine Injury Compensation Program, Parklawn Building, Room 8A-35=
, 5600 Fishers Lane, Rockville, Maryland
20857.=20

2. For information on the rules of the U.S. Court of Federal Claims, includ=
ing requirements for filing a petition, call
1-202-219-9657 or write to: U.S. Court of Federal Claims, 717 Madison Place=
, N.W., Washington, DC 20005.=20

Q2.5.5 What is VAERS?=20

[LG: Information about VAERS excerpted and summarized from material from VA=
ERS. This section last updated in 1994.]=20

The National Childhood Vaccine Injury Act (NCVIA) of 1986 mandated the repo=
rting of certain adverse events following
vaccination. This Act led to the establishment of the Vaccine Adverse Event=
Reporting System (VAERS) in November 1990
by the Department of Health and Human Services. VAERS provides a database m=
anagement system for the collection and
analysis of data from reports of adverse events following vaccination. VAER=
S is operated jointly by the Centers for Disease
Control and Prevention (CDC) and the Food and Drug Administration (FDA). Bo=
th the CDC and the FDA review data
reported to VAERS.=20

Between January 1, 1991 and December 31, 1994, VAERS has received approxima=
tely 45,000 reports. VAERS currently
receives approximately 800-1000 reports each month.=20

Q2.5.6 Who can report to VAERS?=20

Any one can report to VAERS. VAERS reports are usually submitted by health =
care providers, vaccine manufacturers, and
vaccine recipients (or their parents/guardians). Patients, parents, and gua=
rdians are encouraged to seek the help of a
health-care professional in reporting to VAERS.=20

Q2.5.7 What events should be reported to VAERS?=20

The NCVIA requires the reporting of any events in the Reportable Events Tab=
le which occur within the time period specified
and any event listed in the manufacturer's package insert as a contraindica=
tion to subsequent doses of the vaccine. A copy of
the Table can be obtained by calling 1-800-822-7967. Although NCVIA only re=
quires reporting of the events mentioned in
the Table, VAERS encourages all reporting of any clinically significant adv=
erse event occurring after the administration of any
vaccine licensed in the United States.=20

On average, about 17% of the reports reflect adverse events resulting in li=
fe-threatening illness, hospitalization, permanent
disability, extended hospital stay or death. The remaining 83% of the repor=
ts primarily describe events such as fever, local
reactions transient crying or mild irritability, and other less serious exp=
eriences.=20

Q2.5.8 Are all events reported to VAERS caused by vaccinations?=20

Again, VAERS accepts all reports of adverse events following vaccination, s=
o not all events reported to VAERS are caused
by vaccines. In fact, limitations such as differential reporting rates, sim=
ultaneous administration of different vaccine antigens,
temporal reporting bias and lack of background vaccination rate data genera=
lly prevent the determination of vaccine-event
causal associations using VAERS data.=20

Q2.5.9 How can I get rapid information on VAERS, such as how to file a repo=
rt?=20

There is a toll-free VAERS information line that is currently receiving ove=
r 650 calls per month.=20

A VAERS report form has been designed to facilitate and standardize the pro=
cess of reporting adverse events following
vaccination to VAERS. For a sample copy of the VAERS report form, see the l=
ast page of the 1995 Physician=FFs Desk
Reference (PDR) or page 34 of the 1994 Redbook.=20

Report forms can be obtained by calling VAERS at 1-800-822-7967. Xerox copi=
es of the PDR or Redbook forms may also
be used.=20

Q2.5.10 Have there been any comprehensive scientific studies on adverse eve=
nts following immunization?=20

Yes. In 1986, the US Congress mandated the Institute of Medicine to conduct=
a scientific review of the possible adverse
events following commonly used childhood vaccines. The Institute convened a=
n expert panel to implement this mandate and has
published two reports on its findings. Both reports concluded that adverse =
events caused by vaccines are rare.=20

1. Howson, et al., Adverse Effects of Pertussis and Rubella
Vaccines.
Washington, DC: National Academy Press, 1991.
2. Stratton, et al., Adverse Events Associated with Childhood
Vaccines,
Evidence Bearing on Causality. Washington, DC: National Academy
Press, 1993.

Q2.5.11 Are VAERS data available to the public?=20

Yes. Once any identifying information is removed, VAERS data are made avail=
able to the public, for a fee, through the
National Technical Information Service (NTIS) at:=20

National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
(703-487-4650).

Q2.6 What vaccination schedules are used in other countries?=20

Routine vaccination is practiced in many countries, but specific schedules =
vary from country to country. The vaccine for
tuberculosis is given in some countries where tuberculosis is common, but i=
s not given in the US. Tetanus toxoid is given to
pregnant women in countries where neonatal tetanus is common. Some countrie=
s, like the US, vaccinate all infants against
rubella, while others choose instead to vaccinate adolescent girls (as of 1=
992 - I am not sure whether this is still true, as I know
that the UK, at least, has switched to infant vaccination since then). (Gal=
azka). When this FAQ was first written, there were
significant differences between countries in requirements and coverage for =
the pertussis vaccine, but, with the introduction of
the new acellular pertussis vaccine, countries which had increased the age =
of pertussis vaccination or made it optional have
returned it to their schedules.=20

There is also some variation in the schedules at which vaccines are given. =
For example, schedules for DTP vaccine include 2,
3, and 4 months, or 3, 4, and 5 months, or 3, 5-6, and 7-15 months, and boo=
ster doses are given in some countries at 12-14
months, and in some countries at 3-6 years (Galazka - two charts in this ar=
ticle give DTP schedules for various countries in
Europe and percentages of countries following different schedules in differ=
ent regions of the world).=20

People outside the US are advised to consult their doctors about the specif=
ics of vaccination schedules in their countries
(keeping vaccination schedules for all the countries represented in misc.ki=
ds current is probably too big a job for one FAQ
maintainer). http://www.who.org is also a good source for vaccination sched=
ules in various countries.=20

Q2.7 What international bodies are concerned with vaccinations?=20

The World Health Service Expanded Programme on Immunization works to increa=
se the percentage of the world's children
vaccinated against certain target diseases: poliomyelitis, measles, tubercu=
losis, diptheria, and tetanus. The WHO/UNDP
(United Nations Development Programme) Programme for Vaccine Development pr=
omoted research into new and improved
vaccines. The Children's Vaccine Initiative, founded in 1990 by UNICEF, UND=
P, the Rockefeller Institute, the World Bank,
and WHO, promoted new and better vaccines for the world's children, coopera=
ting with the Programme for Vaccine
Development and the EPI. (Hartveldt) WHO also has three centers which coope=
rate with organizations in 79 countries to
formulate the annual flu vaccine. (Ghendon)
  #2  
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Section 3f. Influenza
[This section last updated on October 23, 1999.]=20

Q3f.1 What is influenza, and what are the risks of the disease?=20

Influenza has a fairly high mortality rate among the elderly and the chroni=
cally ill. Complications include pneumonia, neurological
complications, myocardia, heart block, and peripheral vasoconstriction.=20

Q3f.2 How common is influenza?=20

Outbreaks of flu occur almost every year, generally in the winter, and can =
cause thousands to be hospitalized.=20

Q3f.3 How effective is the influenza vaccine?=20

About 70-80% in young, healthy adults. About 50% effective in adults over 6=
0. (For studies on older adults, see JAMA 1994
Dec 7, N Engl J Med 1994.) For a summary of recent studies showing benefits=
in elderly adults, young children in day care,
and healthy adults, see Journal Watch for January 1, 1996, Volume 16, Numbe=
r 1, "Top Medical Stories of 1995." Of
particular interest to parents is a study published in Arch Pediatr Adolesc=
Medicine, Oct 1995, 149:1113, in which children at
high risk for otitis media (ear infections) showed 32% fewer cases during t=
he flu season when they received the flu vaccine.=20

Note that influenza vaccine protects against influenza only, and not agains=
t other respiratory infections.=20

An intranasal flu vaccine has shown efficacy in trials and may be available=
within a year.=20

Q3f.4 How long does the influenza vaccine last?=20

It has to be repeated every year, as the strains of influenza vary from yea=
r to year.=20

Q3f.5 What are some of the risks of the influenza vaccine?=20

Public confidence in flu shots was reduced by the swine flu controversy of =
1976-1977. Of the nearly 48 million people who
were vaccinated that year, about 500 came down with a rare paralytic condit=
ion called Guillaine-Barre syndrome. This was
many more than could normally be expected to come down with this disease (t=
hough still a small percentage of all the
vaccinated people). After this year, there were changes to the vaccine, and=
medical sources (Berkeley, PDR) report that the
vaccine has not been clearly associated with Guillaine-Barr syndrome since =
that time.=20

Adverse reactions include local tenderness, and, infrequently, fever, "most=
often [affecting] people who have had no exposure
to the influenza virus antigens in the vaccine (e.g. small children)." (PDR=
) Allergic reactions also occur.=20

Q3f.6 When is the influenza vaccine recommended?=20

It is recommended for people who are over 65 and for people with various ch=
ronic illnesses, particularly those affecting the
lungs (including asthma) or the heart. Candidates among children include si=
milar groups to those for pneumococcal vaccine:
sickle cell, chronic renal and metabolic disease, diabetes, chronic pulmona=
ry disease, long-term aspirin therapy, and significant
cardiac disease (Catalana).=20

In the US, the rate of vaccination for influenza in the groups for whom the=
vaccine is recommended is only 20%. Among
children, the rate is 1-7% (Catalana).=20

The antiviral drugs amantadine and rimantadine are also effective against i=
nfluenza A, but not influenza B.=20

Q3f.7 When is the influenza vaccine contraindicated?=20

Egg allergy, hypersensitivity to thimerosal. Delay in case of an active neu=
rological disease or fever. (PDR) The AHFS gives the
same contraindications, but adds a history of Guillaine-Barre syndrome and =
bleeding disorders which would contraindicate
intramuscular injection.=20

Vaccine components capable of causing adverse reactions: chick embryo compo=
nents, formaldehyde, thimerosal (Travel
Medicine Advisor).=20

Q3f.8 Is it OK to be vaccinated for influenza during pregnancy?=20

It depends. When this topic has come up on misc.kids, people have reported =
different recommendations from their doctors.
And, when I consulted the PDR, I found the same result: the PDR says that t=
he risks of the vaccine (especially during the first
trimester) have to be weighed against the risks of a particular patient get=
ting the flu, and that "The clinical judgment of the
attending physician should prevail at all times in determining whether to a=
dminister the vaccine to a pregnant woman."=20

The CDC, in the October 8, 1999 issue of MMWR, recommended that "Pregnant w=
omen with high-risk medical conditions
should be vaccinated before the start of the influenza season regardless of=
their stage of pregnancy. Pregnant women without
high-risk medical conditions, but who will be in their second or third trim=
ester during the influenza season, are at elevated risk
of complications and should be vaccinated. Some experts prefer to vaccinate=
these women during the second trimester to
avoid a coincidental association with spontaneous abortion, which is common=
in the first trimester, and because exposures to
vaccines traditionally have been avoided during the first trimester. "=20

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Section 3g. Pneumococcal vaccine
[This section last updated September 18, 1999.]=20

Q3g.1 What is pneumococcal disease, and what are the risks of the disease?=
=20

It causes ear infections and sinusitis in children, and sometimes meningiti=
s and pneumonia.=20

Q3g.2 How common is pneumococcal disease?=20

From=20Nelson Textbook of Pediatrics, Behrman and Vaughn, eds.,14th edition=
,
1992:

------------------------------------------------------------------------
Pneumococcus (_Streptococcus pneumoniae_) is a normal inhabitant of the
upper respiratory tract (as many as 91% of children between 6 mo and 4
1/2 yr of age carry this bacterium at some time). Pneumococcus is the most
common cause of bacteremia (bacteria in the blood), bacterial pneumonia,
and bacterial otitis media (middle ear infections). Pneumococcus causes
25-30% of acute middle ear infections. It is also high on the list for
bacterial causes of meningitis. =20
------------------------------------------------------------------------

There has been recent evidence of antibiotic-resistant pneumococci (see JAM=
A 1994; 271:1831; and MMWR 1994; 43:23;
articles summarized in Journal Watch, January 15, 1995 in the paper edition=
and February 7, 1995 in the electronic edition).=20

Q3g.3 How effective is the pneumococcal vaccine?=20

It protects against 23 strains of pneumococcus, 85% of those which cause ea=
r infections and almost all of those which cause
pneumonia and meningitis. Harrison's Internal Medicine estimates its effect=
iveness at 60-80%.=20

Some recent articles discussing (and debating about) the effectiveness of p=
neumococcal vaccine can be found in Arch Intern
Med 1994 Dec; 154:373, 154:2666 and 154:2531; these articles and others are=
summarized in "Featu Does Pneumococcal
Vaccine Live Up to Its Reputation?" in the February 28, 1995 Journal Watch =
(electronic form) or Mar 1, 1995 Journal Watch
(print form). Other relevant articles are in the Annals of Internal Medicin=
e 1988;108:616-625 and the New England Journal of
Medicine for 11/21/91.=20

Q3g.4 How long does the pneumococcal vaccine last?=20

According to a chart I got from Kaiser, one dose is good for life, except f=
or immune suppressed or immunodeficient patients,
who should get a booster two years later. _Travel Medicine Advisor_ also sa=
ys that no booster is required. _AHFS Drug
Information_, however, says that antibodies are elevated at least five year=
s in healthy adults, but decline to prevaccination levels
after ten years in some.=20

The reason for the apparent conflict in recommendations is that allergic re=
actions are more common after the booster shots,
but, at the same time, the booster shots are useful for maintaining immunit=
y. For this reason, there has been some debate about
the booster shots; the most recent recommendation is "revaccination with pn=
eumococcal vaccine after six years in people with
high-risk chronic conditions" (Journal Watch for Oct 18, 1994). (An example=
is a person without a functioning spleen.) The
23-valent vaccine was introduced in 1993; prior to that the vaccine was onl=
y 14-valent.=20

Journal Watch for Oct 18, 1994 summarizes an article in the Archives of Int=
ernal Medicine (1994 Oct 10; 154:2209-14) on
pneumococcal boosters. "Antibody levels wane significantly within six years=
after vaccination, necessitating revaccination of
high-risk patients. This interesting study evaluated immunogenicity associa=
ted with revaccination." Shots of pneumococcal
vaccine were found to increase antibody levels "at least 1.4-fold in about =
55 percent" of both previously unvaccinated adults
and those who had been vaccinated 5.5 to 9 years previously.=20

Q3g.5 What are some of the risks of the pneumococcal vaccine?=20

Discomfort at injection in 30-40% of recipients, and fever in 5-20% of reci=
pients. (Catalana)=20

Q3g.6 When is the pneumococcal vaccine recommended?=20

It is recommended for children 2 or older who are at increased risk of pneu=
mococcal infection. Conditions which increase risk
of pneumoccoal infection include HIV positive status, functional or anatomi=
c asplenia, and sickle cell or other
hemoglobinopathies. It is also recommended for adults 65 or older and adult=
s with significant cardiovascular or pulmonary
disorders, splenic dysfunction, asplenia, Hodgkin's Disease, multiple myelo=
ma, cirrhosis, alcoholism, renal failure, CSF leaks,
or immunosuppressive conditions.=20

Work is underway now to develop and test a pneumococcal conjugate vaccine (=
analogous to the HiB conjugate vaccine) to
allow immunization of those younger than 24 months (which is the age group =
most affected by S. pneumoniae). This might open
up a new indication for pneumococcal vaccine: prevention of middle ear infe=
ctions. As of 1997, four different conjugate
pneumococcal vaccines for infants were in Phase II/III trials (Williams, 19=
97)=20

Q3g.7 When is the pneumococcal vaccine contraindicated?=20

It should not be given to children under 2. It also shouldn't be given to p=
eople who have already been vaccinated (except for
booster shots for those in the highest risk categories).=20

Vaccine components capable of causing adverse reactions: phenol, polysaccha=
rides, thimerosal (Travel Medicine Advisor).=20

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Section 3h. Meningococcal vaccine [This section last updated on September 1=
8, 1999.]

Q3h.1 What is meningococcal disease, and what are the risks of the disease?=
=20

Meningococcal disease is a rare disease which causes meningitis as well as =
widespread blood infection, leading to shock and
death.=20

Q3h.2 How common is meningococcal disease?=20

About 2,500 cases a year in the US, but tens of thousands annually in sub-S=
aharan Africa.=20

Q3h.3 How effective is the meningococcal vaccine?=20

The current vaccine not highly immunogenic in children under 2, or very lon=
g lasting, and it is children under 2 who have the
highest rate of the disease. Research is being done on conjugate vaccines w=
hich would produce a greater immune response.
Global cooperation would be needed to make these affordable in developing c=
ountries. (Williams, 1997)=20

Q3h.4 How long does the meningococcal vaccine last?=20

I don't have this information.=20

Q3h.5 What are some of the risks of the meningococcal vaccine?=20

Adverse reactions are infrequent and mild, mostly redness at the injection =
site for 1-2 days. Up to 2% of children vaccinated
will experience transient fever (Health Information for the International T=
raveller, 1992).=20

Q3h.6 When is the meningococcal vaccine recommended?=20

For children with certain types of immune disorders and during epidemic out=
breaks. It is also given to children travelling to
certain areas, and is required for pilgrims to Mecca for the annual Haj (as=
of 1992, according to the CDC).=20

Q3h.7 When is the meningococcal vaccine contraindicated?=20

I haven't found any, except pregnancy (when it should be given only in case=
of an outbreak).=20

Vaccine components capable of causing adverse reactions: phenol, polysaccha=
rides, thimerosal (Travel Medicine Advisor).=20

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Section 3i. Varicella (chicken pox) vaccine=20

[Note: The varicella section has been modified slightly and updated. Inform=
ation is from FDA press releases on 1/28/94 and
3/17/95 and and an article in Infectious Diseases in Children newsletter {v=
ol 8(2) February l995}. It has been further updated
based on the July 12, 1996 recommendation by ACIP. This section last update=
d on September 25, 1999. I have some
additional information on zoster which I will be merging into this section =
in my next update.]=20

Q3i.1 What is chicken pox, and what are the risks of the disease?=20

Varicella or chickenpox is a highly contagious disease caused by varicella =
zoster virus. Complications are rare in normal
children, but more common in children with immune deficiencies. The disease=
is somewhat more severe in adults, and can be
serious for newborns and pregnant women. Possible (infrequent) complication=
s include hemorrhagic varicella, encephalitis,
pneumonia, and bacterial skin infection. Possible complications in pregnanc=
y include premature birth and congenital varicella,
and mortality (of the infant, not the mother) is high. "It is estimated tha=
t there are about 9,600 chicken-pox related
hospitalizations annually, with 50 to 100 deaths." (FDA announcement, Janua=
ry 28, 1994) Another risk, unfortunately on the
increase, is invasive group A streptococcal infections, to which children i=
ll with varicella may be susceptible.=20

A study of the effects of congenital varicella and herpes zoster (Enders G;=
et al. Consequences of varicella and herpes zoster in
pregnancy: prospective study of 1739 cases. Lancet 1994 Jun 18; 343:1548-51=
.., summarized in Journal Watch Summaries for
July 1, 1994.) followed 1373 women with varicella and 366 women with herpes=
zoster acquired during the first 36 weeks of
pregnancy. Nine of the infants had congenital varicella syndrome, with defe=
cts ranging from "multisystem involvement to limb
hypoplasia and skin scars." There were no cases of congenital varicella syn=
drome among infants whose mothers had varicella
after 20 weeks or among those whose mothers received anti-varicella-zoster =
immunoglobulin after they were exposed.=20

Q3i.2 How common is chicken pox?=20

An estimated 3.7 million Americans are affected by chickenpox each year, wi=
th more than 90% of the cases occurring in
persons under 15 years of age. 33% of cases are estimated to occur in child=
ren ages 1 to 4, and 44% in children ages 5 to 9
(estimates from January 28, 1994 FDA announcement).=20

In tropical regions, chicken pox is less common, and many people may reach =
adulthood without immunity (adult immigrants
from tropical to temperate regions may therefore be at risk).=20

I do not have data on how varicella incidence has been affected by the avai=
lability of the vaccine, but vaccine coverage is still
(as of 1999) fairly low for this particular vaccine.=20

Q3i.3 What is Herpes Zoster?=20

Following chickenpox infection, the varicella zoster virus persists in a la=
tent form in sensory nerve ganglia without any signs of
illness. The virus can be reactivated causing herpes zoster or shingles, wh=
ich is a painful small blister-like rash in the distribution
of one or more sensory nerve roots. It is estimated that 15% of the populat=
ion will experience zoster during their lifetimes.
Zoster develops most frequently among the elderly and among individuals who=
are immunocompromised. Most people only
have one episode of herpes zoster; fewer than 4% will have repeated episode=
s. Postherpetic neuralgia is a common
complication; this complication is more common among the elderly (25-50% of=
those over 50 who have shingles, but only 10%
of all people who have shingles.=20

(Information on the effect of the vaccine on herpes zoster will be added to=
this FAQ later.)=20

Q3i.4 What is the current recommendation for the chicken pox vaccine be par=
t for children?=20

The chickenpox (varicella) vaccine was first licensed for use among high-ri=
sk children in several European countries in 1984, in
Japan in 1986, and in Korea in 1988. It has been used for healthy children =
in Japan and Korea since 1989. This vaccine was
licensed by FDA on March 17, l995. It is manufactured by Merck and Co. Inc.=
under the trade name "Varivax." On July 12,
1996, ACIP came out with its recommendations for the new vaccine. ACIP reco=
mmends that all children be routinely
vaccinated at 12-18 months of age. The American Academy of Pediatrics recom=
mends that it be given to everyone over the
age of one who is not already immune to chicken pox. Currently it is approv=
ed by the FDA for a single injection in children
ages 12 months to 12 years, and two injections 4-8 weeks apart for adolesce=
nts and adults--ages 13 and older-- who have
not contracted chickenpox. Since the vaccine has been shown to be safe and =
effective when given at the same time as measles,
mumps and rubella vaccines, it is likely many physicians will give it eithe=
r at the 12 or 15 month checkup. Research is underway
for development of a combination measles, mumps, rubella and varicella vacc=
ine to avoid the need for a second injection. It is
unknown when this product may become licensed.=20

Q3i.5 What is the current recommendation for adults?=20

************************************************** ***********************
[Contributed shortly before the vaccine was licensed.]
From=20J Thompson ):

I think it is almost guaranteed that adults will be able to get the
varicella vaccine. The only area where there is _no_ scientific controversy
over the wisdom of using this vaccine is in adults who are not immune.
Varicella in adults is a dangerous disease, sometimes leading to
hospitalization, and usually lasting two to three weeks.
************************************************** ***********************

ACIP recommends that people 13 years and older be assessed for varicella im=
mune status, and that those who are not immune
be vaccinated. Priority should be given to vaccinating those at highest ris=
k for exposure and for transmitting the disease. There
is an antibody titre which can be done on adults who are not sure whether t=
hey are immune to chicken pox.=20

Q3i.6 How effective is the chicken pox vaccine?=20

Clinical trials, which span a decade and involved more than 11,000 persons =
in the United States, indicate that it is 70-90
percent effective in preventing chickenpox. Studies also show that almost a=
ll of the vaccinated patients who got chickenpox had
a milder form of the disease.=20

Q3i.7 How long does the chicken pox vaccine last?=20

We don't know yet. It is estimated to last at least six years. (Lancet, Apr=
il 16, 1994) "Children immunized as long as six years
earlier continued to be well protected. . . . So far, the US data show pers=
istence of antibodies for three to four years after
immunization; data from Japan show persistence of antibodies for seven to 1=
0 years in healthy children." (Gershon)=20

Q3i.8 What reactions have been reported following the chickenpox vaccine?=
=20

Adverse reactions reported were mild and included redness, hardness and swe=
lling at the injection site, fatigue, malaise and
nausea. The vaccine has been used in Japan routinely for more than 10 years=
with no complications.=20

Q3i.9 Will a second dose be necessary in younger children?=20

The question of a "booster" dose remains uncertain at this point. The manuf=
acturer has agreed to perform postmarketing studies
to determine the long-term effects of the vaccine and whether there is a ne=
ed for a booster immunization.=20

Q3i.10 For which groups is the chicken pox vaccine especially recommended?=
=20

People with HIV, nephrosis, severe asthma, and similar chronic diseases, bu=
t especially leukemia. Conditions for vaccination of
leukemic children a remission for at least a year, off maintenance thera=
py for a week before and a week after getting the
vaccine, and cellular immunity intact. (Catalana)=20

Q3i.11 When is the chicken pox vaccine contraindicated?=20

************************************************** ***********************
From=20the April 1995 issue of Medical Sciences Bulletin, published by=20
Pharmaceutical Information Associates ) and=20
available by Email subscription as MSB-L.

Use of Varivax is contraindicated for patients who are hypersensitive to an=
y
component of the vaccine; those with a history of anaphylactoid reaction to
neomycin; those with active febrile infections, pregnancy, blood dyscrasias=
or
other malignancies, or primary or acquired immunodeficiency; and those
undergoing immunosuppressive therapy.
************************************************** ***********************

The July 12, 1996 ACIP recommendation lists, for the most part, the same gr=
oups, but adds people who have experienced an
anaphylactoid reaction to gelatin, and people who have a family history of =
congenital or hereditary immune deficiency in parents
or siblings (unless their own immune competence has been clinically substan=
tiated or confirmed by a laboratory). Pregnant
women should not be vaccinated, as the effect on the fetus is unknown.=20

Although no adverse reactions from taking aspirin after the vaccine have be=
en reported, it is recommended that people
receiving the varicella vaccine refrain from taking aspirin for 6 weeks aft=
erwards, because of the association between aspirin
and Reyes syndrome following varicella.=20

Q3i.12 Is there a gamma globulin for chicken pox?=20

Yes, but it is only available to people at especially high risk from chicke=
n pox. It needs to be given within 72 hours of exposure.
More common on misc.kids is the concern of adults who haven't had chicken p=
ox, but aren't otherwise at high risk from
exposure. The varicella immune globulin isn't likely to be available to the=
se people, but something else is available: acyclovir.
This antiviral drug will lessen the severity of chicken pox if it is given =
promptly, as soon as the rash first begins to appear.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3j. BCG (tuberculosis) vaccine
[This section last updated on September 25, 1999, based on the ACIP recomme=
ndation which was published in MMWR on
April 26, 1996, and which can be found at ftp://ftp.cdc.gov/pub/Publication=
s/mmwr/rr/rr4504.pdf]=20

Q3j.1 What is tuberculosis, and what are the risks of the disease?=20

Tuberculosis is a chronic bacterial infection that is spread by inhaling dr=
oplets sprayed into the air by someone infected with TB
(it can also be spread through unpasteurized milk). It isn't as contagious =
as a cold (you need to inhale a higher concentration of
the droplets to catch it). The disease most commonly affects the lungs, the=
bones of the spine or large joints, and the kidneys,
but can reach almost any organ of the body.=20

Q3j.2 How common is tuberculosis?=20

In 1930, mortality was 101.5 per 100,000 population in the US. It declined =
steadily, and in 1970 was 18.3 per 100,1000
population (Historical Statistics). 37.1 thousand cases were reported in 19=
70, and the number was down to 25.7 thousand in
1990 (Statistical Abstracts). Unfortunately, while that number represents a=
decrease from 1970, it represents an *increase*
from 1985. In 1985, after decades of decline, TB cases began to rise again =
in the US, and have continued to rise ever since. A
similar increase has occurred in several other industrialized countries (TB=
was never really brought under control in the Third
World). Moreover, new, multi-drug-resistant strains of TB have emerged. The=
AIDS epidemic has worsened the TB situation.
(Ryan) The percentage of cases of drug-resistant TB varies in different are=
as. A Morbidity and Mortality Weekly Report
article summarized in the June 15, 1994 HICN726 Medical News gives the inci=
dence overall in New Jersey as 5% of the
state's TB patients, the incidence in Jersey City as 13%, and the incidence=
in New York City as 19%.=20

A joint statement by ACIP and the Advisory Council for the Elimination of T=
uberculosis, published in MMWR, Volume 45,
No. RR-4, April 26, 1996 states that the incidence of TB declined through 1=
984, increased from 1985 through 1992, and
declined slightly in 1993 and 1994. 57% of the total number of TB cases wer=
e reported in five states: California, New York,
Florida, Illinois, and Texas. Overall incidence rates are twice as high for=
men as for women.=20

Q3j.3 How effective is the BCG vaccine?=20

The AHFS Drug Information, 1992 says that its effectiveness is unknown, "Di=
agnostic and clinical evidence has generally
demonstrated a reduction` in the incidence of tuberculosis." Tuberculin sen=
sitivity is highly variable, depending on the strain, and
the relationship between tuberculin sensitivity and immunity has not been a=
dequately studied.=20

_The Forgotten Plague_ says that results of research varied in different co=
untries. In Great Britain, a Medical Research Council
survey of 50,000 children showed an 80% reduction in the infection rate aft=
er vaccination, leading Great Britain to introduce
BCG vaccination of school children in the 1950s. In the US, the results wer=
e the opposite, so the US has not used the vaccine.

A New York Times article ("Tuberculosis Vaccine Found Surprisingly Effectiv=
e in Studies", New York Times, 03/02/94, P.
C14), recently reported that "A new statistical study by the Centers for Di=
sease Control and Prevention reports that the
vaccine, known as BCG, reduced the risk of full-fledged tuberculosis of the=
lung by 50 percent and death by 71 percent." A
study reported in J Infect Dis in August 1994 concluded that BCG vaccine is=
effective, but local reactions are common.=20

The joint ACIP and ACET report in the April 26, 1996 MMWR says that there a=
re different strains of BCG vaccine in use
worldwide, and they differ in their ability to induce an immune response to=
tuberculin. Reported rates of efficacy may also have
been affected by methods of vaccine administration and the characteristics =
and environment of the populations to which the
vaccine was given. Protective efficacy rates for different studies of diffe=
rent BCG strains have ranged from 0% to 80%. Two
recent meta-analyses of the published literature have attempted to calculat=
e summary estimates of efficacy. The first analyzed
data from 10 randomized clinical trials and 8 case-control studies since 19=
50. It estimated protective efficacy against meningeal
and miliary TB in children in clinical trials as 88%, and the efficacy in c=
ase-control studies as 75%. There was too much
variability in data on efficacy against pulmonary TB for them to come up wi=
th a summary efficacy rate. The second
meta-analysis reviewed 14 clinical trials and 12 case-control studies. They=
estimated the overall efficacy of the vaccine in
clinical trials to be 51%, with higher efficacy for children than for adult=
s.=20

Q3j.4 How long does the BCG vaccine last?=20

It is of limited duration (Ryan). _AHFS Drug Information_ says that several=
studies showed tuberculin sensitivity lasting 7-10
years.=20

Q3j.5 What are some of the risks of the BCG vaccine?=20

It rarely has serious side effects. (See _AHFS Drug Information_ for a list=
..) The most common reactions are local. More
severe local reactions include ulceration at the vaccination site, regional=
lymphadenitis with draining sinuses, and purulent
drainage at the puncture site. The most serious reaction is disseminated BC=
G infection; BCG osteitis of the epiphyses of the
long bones, particularly epiphyses of the legs, can occur from 4 months to =
2 years after vaccination. The rate varies from 0.01
cases per million vaccinees, in Japan, to 32.5 and 43.4 cases per million v=
accinees, in Sweden and Finland, respectively.
Reactions may be more frequent among people with symptomatic HIV infection.=
=20

************************************************** ***********************
From=20J Thompson ):

The main strategy of TB control in the US is monitoring those at risk o=
f
exposure to the disease for signs of TB infection. The main method used is
something called a "PPD" (which stands for purified protein derivative, i.e=
..
proteins purified from TB). A PPD is "placed" (injected subcutaneously) and
then the site of injection is monitored (usually at 48 hrs. after the
injection). Anyone who has mounted an immune response to a TB infection wil=
l
exhibit redness and swelling at the site of the PPD injection (the criterio=
n
for calling a "true positive" PPD is that the inflammation must be at least
10 mm. wide). Also, this reaction must take place at a 1-2 day delay to be
diagnostic for TB infection (anything sooner is allergy, not a sign of
infection).
OK, what does all this have to do with BCG? Well, BCG, since it is very
similar to TB, can cause a positive PPD. Thus, widespread immunization with
BCG makes it more difficult to screen for TB, since the screening will pull
up many people who are not infected. The reaction due to BCG drops over
time, but it is still a problem, so that (combined with the low
effectiveness) has ruled out BCG in the US. Of course, now that
drug-resistant strains are becoming more common, opinions might change...
************************************************** ***********************

Q3j.6 When is the BCG vaccine recommended?=20

BCG vaccine is given in developing countries because it is easy to administ=
er, inexpensive, and rarely has serious side effects.
Some industrialized countries (e.g. Great Britain, France, Scandinavia) hav=
e also used it, for vaccination of children in general
and of household contacts of people with TB. Others (e.g. the US, the Nethe=
rlands) have not.=20

Because of the low rate of new infections, the availability of low-cost iso=
niazid prophylaxis for people who are exposed, and
the availability of effective treatment which quickly make patients non-con=
tagious and cures them, the BCG vaccine hasn't been
considered necessary in the US. There might be some changes in these recomm=
endations with the increase in
multiple-drug-resistant strains (one misc.kids poster reports that her city=
college system is now requiring TB shots). In the
meantime, the FDA has approved a new combination tuberculosis drug, Rifater=
, which combines isoniazid, rifampin, and
pyrazinamide, in hopes of making it easier for patients to take their medic=
ation and thus increasing patient compliance (antibiotic
treatment which is discontinued too early increases the development of drug=
resistant TB strains).=20

In the US, the AAP, ACIP, and the American Thoracic Society recommend BCG f=
or infants and children intimately exposed
to TB that is "persistently untreated, ineffectively treated, or resistant =
to isoniazid and rifampin and who cannot be removed
from the source of exposure or placed on long-term preventive therapy." The=
AAP and ACIP also recommend it for children
in groups with a rate of new TB infections greater than 1% annually "and fo=
r whom the usual surveillance and treatment
programs have failed or are not feasible." (_AHFS Drug Information_) ACIP a=
lso recommends vaccination for children who
are continually exposed to a patient who is infected with a strain of TB wh=
ich is resistant to isoniazid and rifampin (MMWR,
April 26, 1996). It is recommended for travel only for people who will be i=
n a high risk environment for a long time without
access to TB skin testing. It is currently not recommended for health care =
workers (skin testing and isoniazid is considered to
be enough), but this recommendation is periodically reevaluated because of =
the incidence of TB in AIDS patients.=20

BCG also has some use against certain tumors (in particular, bladder cancer=
).=20

************************************************** ***********************
From=20J Thompson ):

The TB "shots" a poster on misc.kids referred to ("one misc.kids poster
reports that her city college system is now requiring TB shots") are most
likely PPD, not BCG. I believe that all schools receiving federal funding
(and I know that all schools I have attended) require either a PPD or the
(less accurate but easier to administer) "tine test" as part of the
pre-matriculation physical.
************************************************** ***********************

Q3j.7 When is the BCG vaccine contraindicated?=20

Hypersensitivity to the vaccine, positive TB skin test, recent smallpox vac=
cination, burn patients, various immune deficiencies or
immunosuppressive therapy (see _AHFS Drug Information_ for a list). In case=
of eczema or other skin disease, give it in a
different area of the skin. Although no harmful effects to the fetus are as=
sociated wtih BCG vaccination, its use is not
recommended during pregnancy.=20

Vaccine components capable of causing adverse reactions: Triton WR 1339 (Tr=
avel Medicine Advisor).=20

Q3j.8 What are some other methods of controlling tuberculosis?=20

Tuberculin skin screening and use of drugs such as isoniazid. Pasteurizatio=
n of milk and testing of cows for tuberculosis are also
useful.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3k. Hepatitis A=20

[Hepatitis A: The following was taken from an article in JAMA (March 22/29,=
l995--Vol 273 (12) 906-907) and information
from the *draft* hepatitis A vaccine recommendation which was, as of April =
l995, under consideration by the ACIP It has
since been updated based on the ACIP and AAP recommendations as of December=
1996, the CDC Vaccine Information
Statement on hepatitis A as of 8/25/98, and articles at Medscape. This sect=
ion last updated September 19, 1999.]=20

Q3k.1 What is hepatitis A and what are the risks of the disease?=20

There are several forms of hepatitis (infection of the liver) which cause j=
aundice, nausea and weakness. Hepatitis A is caused
by infection with hepatitis A virus (HAV) which is acquired primarily throu=
gh a fecal-oral route, most often from person to
person. It can also occur via ingestion of contaminated food or water. The =
illness consists of mild flu-like symptoms or severe
nausea lasting for weeks. Hepatitis A does not become chronic and is rarely=
fatal. In children under 6, most cases (70%) of
hepatitis A are asymptomatic, and if illness occurs, it is usually not acco=
mpanied by jaundice. Among older children and adults,
the illness is usually symptomatic, and jaundice occurs in 70% of cases. S=
ymptoms usually last for 2 months, but 10-15% of
people infected have illness or relapses for up to 6 months. 11-22% of peop=
le who have hepatitis A are hospitalized, and
hepatitis A is responsible for an estimated 100 deaths a year (these number=
s from the ACIP recommendation on hepatitis A -
the AAP recommendation gives similar, but not identical, numbers).=20

Hepatitis A should not be confused with hepatitis B, which is less contagio=
us but more serious. Hepatitis B becomes chronic in
5-10% of those infected. Complications include hepatic necrosis, cirrhosis =
of the liver, chronic active hepatitis, and
hepatocellular carcinoma.=20

Some sources of general information on hepatitis can be found in the hepati=
tis B section of this FAQ.=20

Q3k.2 How common is hepatitis A?=20

During the past several decades, the incidence of hepatitis A in the U.S. h=
as been cyclic, with nationwide epidemics occurring
every 10-15 years; the last occurred in l989. Between epidemics, hepatitis =
A continues to occur at relatively high levels.
Nationally, CDC estimates that around 75,000 cases occur annually. Children=
play an important role in HAV transmission,
with highest rates among those aged 5-14 years. Rates are substantially hig=
her, in the Western US states than in other US
regions. The highest rates of hepatitis A are among children 5-14 years of =
age. In the US, 33% of the population has evidence
of prior hepatitis A infection, as determined by a survey conducted from 19=
88-1991 (reported in the ACIP recommendation
for hepatitis A). Prevalence is generally higher among Native Americans and=
Mexican Americans. Hepatitis A is the most
common vaccine preventable illness among travelers. It can be avoided by av=
oiding contaminated food and drink, but many
travelers succumb to temptation, assume food at hotels is safe, buy from st=
reet vendors, etc. Incidence is 1.6 per 1000
person-months of travel among travelers to developing countries (including =
those who stay in luxury hotels), and 20 per 1000
among backpackers and others who eat and drink in poor hygienic conditions.=
Incidence is 0.05 to 0.10 per 1000
person-months of travel in Southern Europe. (JAMA Sept 21, 1994 p. 885)=20

Q3k.3 Who is at risk for acquiring hepatitis A?=20

International travelers and individuals residing in hepatitis A endemic are=
as are at risk for acquiring disease. Other risk groups
include homosexual men, injecting drug users, hemophilic patients, veterina=
ry workers and certain research occupations
working with infected animals (particularly people working with non-human p=
rimates). Workers at day care centers, institutions
for the developmentally disabled, food service establishments and healthcar=
e settings are also at some increased risk.=20

Q3k.4 Is there a vaccine to protect against hepatitis A?=20

Yes, the FDA licensed the hepatitis A vaccine for use in persons 2 years of=
age and older on February 22, l995. An ACIP
recommendation was published in the MMWR for December 27, 1996. The America=
n Academy of Pediatrics also published
a policy statement in December 1996. The vaccine has been in use in Europe =
since 1992.=20

Q3k.5 How is it to be administered?=20

According to the labeling, the vaccine is given in a two-dose schedule to a=
dults 18 years of age and older, the second dose
being given 6-12 months after the first. Children and adolescents 2-18 year=
s of age are given 3 doses. The second dose is
given 1 month after the first and the third dose 6-12 months later. It is a=
dministered by intramuscular injection in the deltoid
(upper arm), and can be given with other vaccines without loss of immunogen=
icity.=20

Q3k.6 How effective is the vaccine?=20

A single dose of the vaccine induced antibodies in 88% to 96% of subjects b=
y two weeks and in 97% to 100% by one month.
Completion of the full vaccine schedule is recommended to ensure high antib=
ody levels and long-term protection. Efficacy trials
in children and adolescents show it is 94% (or more) effective against ende=
mic hepatitis A virus.=20

According to the AAP recommendation for hepatitis A, on December, 1996: "Cl=
inical studies suggested a possible
herd-immunity effect if more than 80% of the estimated susceptible individu=
als were vaccinated. A single dose of Havrix in
Alaskan native villages with endemic HAV disease resulted in a dramatic dec=
rease in cases within 8 weeks of vaccination. A
similar abrupt decrease in HAV cases was observed after two doses of vaccin=
e in two Slovak Republic villages experiencing a
large community outbreak. In the Vaqta trial in New York State, no cases of=
clinical and confirmed hepatitis A occurred in
vaccine groups more than 21 days after the first dose, and the calculated p=
rotective efficacy was 100%. "=20

Q3k.7 How long does immunity last?=20

Firm data on long-term protection are limited because the vaccine was under=
investigation for only 4 years before being
approved in 1995. Estimates of antibody persistence derived from kinetic mo=
dels of antibody decline suggest that the
protective levels of anti-HAV could persist for at least 20 years.=20

Q3k.8 What are some of the risks of the vaccine?=20

Information on adverse events comes from prelicensure clinical studies worl=
dwide and reports following vaccine licensure in
Europe, the US, and Asia. No serious adverse events have been attributed to=
the vaccine. Side effects include soreness and
redness at the injection site, headache and fatigue. In very rare cases, th=
ere is a severe allergic reaction within a few minutes to
a few hours of the shot.=20

Q3k.9 When is hepatitis A vaccine contraindicated?=20

The vaccine should not be administered to persons with a history of hyperse=
nsitivity reactions to any of the vaccine
components, including alum or the preservative (2-phenoxyethanol). Because =
it is inactivated, no special precautions need be
taken when vaccinating immunocompromised individuals. The inactivation also=
means that they theoretical risk to a fetus is low,
but there are no data to determine the safety of the vaccine during pregnan=
cy. People mildly ill at the time of vaccination may
get the vaccine, but people moderately to severely ill should wait until th=
ey recover.=20

Q3k.10 What groups at risk are be included in a recommendation to receive h=
epatitis A vaccination?=20

ACIP recommends the vaccine for:=20

1. Persons 2 years of age or older traveling or working in countries with h=
igh or intermediate endemicity of infection. The
vaccine series should be started at least one month before travelling.=20

2. Persons living in communities with high rates of HAV infection; for exam=
ple, American Indian, Alaska Native, Pacific
Islander, and some religious communities.=20

3. Men who have sex with men.=20

4. People who use street drugs (injected or non-injected).=20

5. People who work with hepatitis A infected primates or with hepatitis A i=
n a research setting should be vaccinated. No other
groups have been shown to be at increased risk for hepatitis A due to occup=
ational exposure.=20

6. Persons with chronic liver disease.=20

7. Persons who use clotting factor concentrates.=20

8. Since people who work as food handlers can contract hepatitis A and pass=
the disease to others, they may be vaccinated in
areas where state and local health authorities determine such vaccination t=
o be cost effective.=20

The AAP recommends the vaccine for the first six of the groups listed above=
, and suggests consideration of potential use for
child care center staff and attendees, custodial care institutions, hospita=
l personnel, food handlers, and people with hemophilia.=20

In 1999, ACIP recommended hepatitis A vaccine for all children aged 2 years=
and older in the 11 Western states where
incidence is especially high (at least 20 cases per 100,000 people, twice t=
he national average). These states a Arizona,
Alaska, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dako=
ta, Utah and Washington.=20

Any healthy individual 2 years of older may receive hepatitis A vaccine at =
the discretion of the physician and patient or parent.=20

Q3k.11 Is it possible that hepatitis A vaccine (like hepatitis B vaccine) m=
ight eventually be recommended for routine
administration to children and adults?=20

Those in public health say that control of hepatitis A infection will be fa=
cilitated by the development of vaccines that combine
hepatitis A with other routine childhood immunizations. The CDC's draft sta=
tement notes the important role of children in
hepatitis A transmission, and that "it is likely that routine childhood vac=
cination will be the only way to significantly decrease
hepatitis A rates in the U.S."=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3l Rotavirus vaccine
[This section last updated on October 23, 1999.]=20

Q3l.1 What is rotavirus, and what are the risks of the disease?=20

Rotavirus is one of the major causes of gastroenteritis among infants and s=
mall children in most countries. Symptoms are fever,
vomiting, diarrhea, and dehydration, with vomiting and dehydration more com=
mon than with other diarrheas. The illness
normally lasts 3-9 days, and becomes chronic only in immunodeficient childr=
en.=20

Group A rotavirus is a major cause of infant mortality in many parts of the=
world. 873,000 infants and children under 5 die per
year of rotavirus in developing countries. Non-group A rotavirus is less fr=
equent, and is epidemic only in China. In tropical
climates, rotavirus infection occurs year round, while in temperate climate=
s it is seasonal. Rotavirus can survive for hours on
human hands and for days on inanimate surfaces, and resists common disinfec=
tants.=20

Rehydration therapy makes death infrequent in developed countries. On the o=
ther hand, it is one of the most common causes of
hospitalization among infants during the winter months. Cecil Textbook of M=
edicine estimates that it is responsible for 35-52%
of the cases acute diarrheal illness needing hospitalization in infants and=
young children, in US.=20

Q3l.2 How common is rotavirus?=20

The AAP Committee on Infections Diseases estimates that rotavirus is respon=
sible for 3 million cases of diarrhea, 50,000
hospitalizations, and 20 to 40 deaths each year in the United States.=20

Q3l.3 What is the current status of the rotavirus vaccine?=20

On October 15, 1999, Wyeth Lederle Vaccines announced that it has withdrawn=
its RotaShield vaccine from the market and
has requested the immediate return of all doses of the vaccine. The company=
's press release can be accessed at the web
address below. http://www.ahp.com/releases/wa_101599.htm=20

A brief history of the release and withdrawal of this vaccine follows.=20

After years of research (animal studies beginning in 1983, and human trials=
in 1987) into an effective rotavirus vaccine (with a
couple of candidates being rejected), a live, oral, tetravalent rotavirus v=
accine was approved by the FDA on August, 1998.
This vaccine is composes of one rhesus monkey virus, and three genetically =
engineered combinations of rhesus monkey and
human rotavirus. In the December, 1998 issue of Pediatrics, the AAP Committ=
ee on Infections Diseases recommended that
the vaccine be added to the standard vaccination schedule, with shots being=
given at 2, 4, and 6 months, with the understanding
that it might take time to incorporate the new vaccine into the schedule.=
=20

On July 18, 1999, US health officials recommended postponement of rotavirus=
vaccine. Shipments have temporarily been
suspended. The company which makes the vaccine is working with the CDC to i=
nvestigate reports of bowel obstruction among
infants who received the vaccine. An additional reason for postponement was=
the fact that the rotavirus season, in the US,
occurs during the winter, allowing several months for investigation of thes=
e adverse reactions, before a decision needed to be
made about whether the vaccine should be used prior to this year's rotaviru=
s season. Results of a case-control study were
expected to be available by October, 1999. Additional studies could continu=
e into next year. Further information from the
CDC about rotavirus vaccine and intussusception can be found at http://www.=
cdc.gov/nip/Q&A/genqa/Rotavirus.htm and at
http://www.cdc.gov/nip/news/rotavirus.htm.=20

Q3l.4 How effective is the rotavirus vaccine?=20

Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
retaining the answer to this question, in case it
should be later reintroduced in some form.=20

The rotavirus vaccine doesn't confer full immunity, but protects against se=
vere illness (this is also the case with natural immunity
from prior rotavirus infections). Trials by the manufacturer, used for FDA =
approval, showed the following results:=20

Trial 1: None of the infants receiving the vaccine got dehydrated, compared=
to 3% in the placebo group. 11% fewer in vaccine
group needed a visit to the doctor. 88% showed elevated IgA titers.=20

Trial 2: 9% of infants in placebo group saw a doctor for diarrhea and vomit=
ing, compared with 2% in vaccine group. None in
the vaccine group needed hospitalization.=20

Both trials were by the manufacturer, and not published in the medical lite=
rature at the time of approval.=20

A third trial, in Finland, showed similar results.=20

Q3l.5 Is the rotavirus vaccine effective for breastfeeding infants?=20

Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
retaining the answer to this question, in case it
should be later reintroduced in some form.=20

For infants receiving the full three doses, breastfeeding infants show the =
same level of immunity as formula-fed infants. For
infants receiving only one dose, immunity may be less among breastfed infan=
ts.=20

Q3l.6 How long does the rotavirus vaccine last?=20

Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
retaining the answer to this question, in case it
should be later reintroduced in some form.=20

Efficacy persisted for two years in US and Finnish trials. Since followup h=
as only been done for two years, it is not known
whether efficacy persists beyond that time.=20

Q3l.7 What is intussusception?=20

Intussusception is a bowel obstruction in which one segment of the bowel be=
comes enfolded within another segment.=20

Q3l.8 What is the relationship between the rotavirus vaccine and intussusce=
ption?=20

15 cases of intussusception, possibly associated with administration of the=
rotavirus vaccine, have been reported to VAERS.
These cases were analyzed in "Intussusception Among Recipients of Rotavirus=
Vaccine -- United States, 1998-1999,"
MMWR 48(27);577-581, 1999, Centers for Disease Control.=20

VAERS reports of intussusception were reviewed, and parents or guardians or=
health-care providers contacted by phone for
clinical and demographic data. Data on vaccine distribution was also obtain=
ed from the manufacturer.=20

13 of the 15 developed intussusception after the first dose, and 12 of the =
15 developed symptoms within a week of receiving
any dose. Intussusception confirmed radiologically in all. 8 needed surgica=
l reduction. All recovered. 14 were spontaneous
reports, and one was obtained through active postlicensure surveillance. Ac=
cording to the report, "The manufacturer had
distributed approximately 1.8 million doses of RRV-TV as of June 1, 1999, a=
nd estimated that 1.5 million doses (83%) had
been administered. Given this information, 14-16 intussusception cases amon=
g infants would be expected by chance alone
during the week following receipt of any dose of RRV-TV.=20

As part of a preliminary analysis of postlicensure adverse events, cases of=
intussusception during December 1, 1998-June 10,
1999 were identified in Northern California and Minnesota, and the rate in =
vaccinated and unvaccinated children was
compared. Vaccinated children showed a statistically higher incidence of in=
tussusception.=20

A further announcement by the FDA, made on September 14, 1999, reported tha=
t the number of cases of intussusception that
may be related to the rotavirus vaccine (15 as of July 7), is now up to 99,=
including two deaths. The FDA's Dr. Kathryn
Carbone, one of the initial reviewers of the rotavirus data, reported to a =
gathering of the FDA's Vaccines and Related
Biological Products Advisory Committee that all these cases are still under=
investigation, and it is not clear yet whether the two
deaths or the other cases were caused by the vaccine.=20

Further study is being done.=20

Q3l.9 Why was a connection between the rotavirus vaccine and intussusceptio=
n not observed prior to FDA approval of the
vaccine?=20

Approval by the FDA only requires trials on about 5,000-10,000 subjects. Ra=
re reactions to a new drug or vaccine will
therefore be unknown at the time of FDA approval.=20

Q3l.10 What other reactions have been reported following the rotavirus vacc=
ine?=20

Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
retaining the answer to this question, in case it
should be later reintroduced in some form.=20

Mild, fever, for usually less than 24 hours. Fever after the first dose is =
more common in older children, for which reason it is
recommended that the vaccination series be begun by the time a baby is six =
months old. All doses should be given by 12
months, because data regarding the safety and efficacy of vaccine administr=
ation to older children are not available.=20

Irritability, decreased appetite, and decreased activity, were reported mor=
e often than with the placebo for five days. Diarrhea
was not reported more often than with the placebo.=20

Q3l.11 Can the rotavirus vaccine be effectively used in developing countrie=
s?=20

Price may be the major barrier, as it is one of the more expensive vaccines=
(and not likely to get cheaper if any modified
version is reintroduced later).=20

Q3l.12 When is the rotavirus vaccine contraindicated?=20

Although the rotavirus vaccine has been withdrawn as of October, 1999, I am=
retaining the answer to this question, in case it
should be later reintroduced in some form.=20

The rotavirus vaccine should not be given in case of: Infants with hypersen=
sitivity to aminoglycoside antibiotics, amphotericin B,
or monosodium glutamate that are components of the vaccine, or an anaphylac=
tic reaction to a previous dose of the rotavirus
vaccine.=20

Until further data are available, this live-attenuated vaccine should not b=
e given to children who are immunosuppressed or
immunodeficient. Babies of women who are HIV-infected should not get the va=
ccine unless these babies have tested as
HIV-negative at the age of two months or older.=20

The rotavirus vaccine should be postponed in case of: Acute vomiting and di=
arrhea (efficacy is uncertain in this case).
Moderate or severe fever.=20

The rotavirus vaccine may be given in case of: Breastfeeding, premature bir=
th, and low grade fever. The vaccine can be given
at same time as DTaP or DTP, HiB, hepatitis B, or IPV/OPV, and there is no =
need to adjust the timing for antibody-containing
blood products. Infants living with people known or suspected to be immunoc=
ompromised may be immunized.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3m. Other vaccines which are available
[This section last updated September 17, 1999.]=20

Q3m.1 What other vaccines are available and when are they given?=20

Other vaccines available include vaccines for cholera, Japanese encephaliti=
s, typhoid, yellow fever, rabies, plague, Lyme
disease, and anthrax. _Travel Medicine Advisor_ also mentions a vaccine for=
typhus, but, according to the 1996-1997 edition
of the CDC Yellow Book (CDC Health Information for International Travel), "=
production of this vaccine has been
discontinued in the US and there are no plans for commercial production of =
a new vaccine." Since other countries may offer
typhus vaccination (though, to the best of my knowledge, it is not required=
for travel to any country), I am drawing information
for this vaccine from a German web site. Immune globulins are also availabl=
e for a variety of diseases.=20

For more information on these other vaccines, check the _American Hospital =
Formulary Service Drug Information_ (a better
source than the PDR in this case) and _Health Information for Travelers_, w=
hich is put out by the CDC every year (vaccination
and booster schedules for all of these vaccines can be found there, as can =
information on where these diseases are common
and what vaccination requirements various countries have for entrance). The=
latter can be purchased from the Superintendent
of Documents, U.S. Government Printing Office, Washington, D.C. 20402, and =
most local health departments have a copy
which can be consulted, sometimes by telephone. It can also be found in som=
e public libraries. The CDC also has a
Worldwide Web site which can be accessed for travel information: http://www=
..cdc.gov/. The International Association for
Medical Assistance to Travellers (IAMAT), which has affiliated institutions=
in over 115 countries, puts out a _World
Immunization Chart_. The address of the U.S. affiliate is IAMAT, 736 Center=
Street, Lewiston, N.Y. 14092. The World
Health Organization produces a publication on international travel; it is c=
alled _INTERNATIONAL TRAVEL AND
HEALTH: Vaccination Requirements and Health Advice_, and copies may be orde=
red from WHO Distribution and Sales,
CH-1211, Geneva 27, telephone (41 22) 791 2476; fax (41 22) 788 0401. The p=
rice is 15 Swiss Francs; in developing
countries: 10.50 Swiss Francs. Further information about rabies can be foun=
d in books on mountaineering and spelunking (the
one I consulted is _Medicine for Mountaineering_, by James A. Wilkerson, M.=
D.). Hepatitis B, hepatitis A, and
meningococcus vaccines are given for travel, so people interested in travel=
vaccinations may want to check the sections of this
FAQ dealing with those vaccines.=20

Anthrax vaccine, in the US, is mainly used by the military as a protection =
against biological warfare; small quantities are also
made available to people with an occupational exposure, such as veterinaria=
ns and lab workers. Since vaccines given by the
military to soldiers are outside the scope of a FAQ primarily concerned wit=
h vaccines which might be given to children, I will
not be discussing the anthrax vaccine further.=20

Cholera is an intestinal infection spread by contaminated food and water. C=
holera vaccination is about 25-50% effective in
reducing clinical illness for 3-6 months after vaccination (with the greate=
st protection during the first two months). (_Health
Information for Travellers_ gives the effectiveness as 50%, and AHFS Drug I=
nformation gives it as 25-50%.) Boosters are
every six months for travelers who will be staying for a long time in chole=
ra-endemic areas. Serious reactions are rare. Since
the effectiveness is so low, neither the CDC nor the WHO actually recommend=
s the vaccine, but some countries require it.
According to AHFS Drug Information, "_Cholera vaccine does not prevent tran=
smission of infection_, and should not be used
to manage contacts of imported cholera cases or to control the spread of in=
fection."=20

Vaccine components capable of causing adverse reactions: bacterial componen=
ts (Travel Medicine Advisor). The vaccine
should not be given to children under 6 months.=20

Japanese encephalitis B vaccine, licensed in 1993, is given to travelers "w=
ho expect to go beyond the usual tourist routes or to
spend extended time in rural areas in disease endemic regions" (Harrison's)=
Its efficacy is estimated at 80-90%. Anaphylactic
and severe delayed allergic reactions are common, so people who receive thi=
s vaccine should be observed for ten days.=20

Lyme disease vaccine, licensed on December 21, 1998, is licensed (as of Sep=
tember, 1999) only for people 15 years or older,
though that age limit may soon be eliminated. It is recommended for adults =
and older teens who spend lots of time outdoors in
Lyme-endemic areas. You should still protect yourself against ticks if usin=
g the vaccine, both because the vaccine isn't 100 per
cent effective and because ticks also carry other diseases. In a randomized=
, double-blind, multicenter trial involving 10,936
people living in the northeastern and upper north central United States, th=
e vaccine efficacy at preventing Lyme disease was
50% (MMWR, January 22, 1999 / 48(02);35-36,43). The duration of immunity is=
unknown. Side effects included local
reactions, transient myalgia or arthralgia, influenza-like illness, fever, =
and chills.=20

It is unlikely that your child will ever need a plague vaccination. The dis=
ease is found among rural rodents in some areas,
including the Western third of the US, but urban outbreaks are now rare. Va=
ccination is only recommended for people at
increased risk due to research or field activities in epizootic areas. An a=
lternative for people at increased risk is tetracycline
prophylaxis. _AHFS Drug Information_ gives the vaccine's effectiveness as 9=
0% for 6-12 months. Other measures for
avoiding plague in epizootic areas are getting rid of wild rodent food and =
shelter, defleaing dogs and cats weekly, avoiding sick
or dead rodents, and routine bacteriologic precautions in labs.=20

Vaccine components capable of causing adverse reactions: phenol, beef prote=
in, soya, casein (Travel Medicine Advisor).=20

Rabies, an almost universally fatal disease transmitted by saliva and brain=
tissue of infected animals, is rare in the US but more
common in some countries where pet vaccination is not common. Dogs are the =
main reservoir in developing countries, but all
animal bites should be evaluated. The most common animal vectors in the US =
are carnivorous small animals (such as skunks,
racoons, foxes, coyotes, and bobcats) and bats. There has been a recent inc=
rease in racoon rabies in the mid-Atlantic and
northeastern states of the US (MMWR 29 Apr 1994), and programs to institute=
oral rabies vaccination of racoons, foxes and
coyotes have been initiated in some state (similar programs have been used =
to control fox rabies in Canada and Europe). More
than 50% of rabies cases in the US come from exposure to rabid dogs outside=
the US. The disease is most commonly spread
by animal bites, but can also be caught through non-bute exposure, includin=
g contact between infected saliva or brain tissue and
pre-existing cuts, scratches, open wounds, or mucuous membranes. There are =
also cases of aerosolized transmission in medical
laboratories and caves inhabited by rabid bats, and transmission through co=
rnea transplants from people who had died of
undiagnosed (before the transplant) cases of rabies. The chance of infectio=
n is more likely in case of bite or non-bite exposure
to the head, neck, face, shoulders, or hands, than with similar exposure to=
the trunk or legs.=20

In case of exposure to rabies, the wound should be immediately and thorough=
ly cleaned with soap and water. "Although not
included in the ACIP recommendations, some clinicians also rinse the wound =
thoroughly with water or 0.9% sodium chloride
solution and then cleanse with a topical antiseptic (e.g. povidone-iodine).=
" (AHFS Drug Information 1992) It is also important
to promptly vaccinate anyone exposed to rabies (and give rabies immune glob=
ulin if the person has not been previously
vaccinated), as the disease is, for all practical purposes, always fatal on=
ce rabies symptoms begin to show up. (A few people
have recently survived after symptoms appeared, but they all had serious br=
ain damage.) Pre-exposure vaccination is given to
people who live in or visit rabies endemic areas and to people whose profes=
sions or activities put them at extra risk, such as lab
workers, veterinarians, and spelunkers. The highest travel risk is where do=
g rabies is still endemic.=20

There is some drug interference between chloroquine (an anti-malarial drug)=
and rabies vaccine, but intramuscular injection can
take care of the problem. Need for boosters depends on risk category, and r=
anges from regular tests of antibody levels every
six months, with vaccination when they drop, for rabies lab workers, to no =
pre-exposure vaccination for most people.
Post-exposure, unvaccinated people get rabies immune globulin and rabies va=
ccine, while previously vaccinated people get
rabies vaccine alone, in a smaller amount. Adverse effects include local re=
actions (30-74% of vaccinees) and mild systemic
reactions (e.g. headache, nausea, 5-40% of vaccinees). About 6% of vaccinee=
s have a reaction characterized by urticaria,
pruritis, and malaise. Rarely, anaphylactic shock may occur. Because rabies=
is so deadly, pregnancy is *not* a contraindication
to postexposure vaccination.=20

Vaccine components capable of causing adverse reactions: neomycin, phenol r=
ed, thimerosal (Travel Medicine Advisor).=20

The following posting from sci.med, by Achim Lohse, provides further inform=
ation about rabies vaccine (the side effect under
discussion is anaphylactic shock):=20

----------------------------Original message----------------------------
....

In Canada (at least as of two years ago) there is only one rabies
vaccine availble, and the manufacturer supplies it only in one-millitre
vials, with strict instructions to use the entire vial for one injection
only. At $60 + per vial, the series of three costs over $180. I was
fortunate to have a physician who had worked among fur trappers up north,
and had some familiarity with the vaccine. He informed me that if
injected _intra_dermally, a dose of only 0.1 millilitre is enough.
I confirmed this with the local public health nurse, who showed me that it
had been standard public health procedure in British Columbia for five
years to use the 10% dose intradermally (10 trappers would arrange to
share the contents of a standard vial).

Later investigation via Medline showed that this particular vaccine
human diploid cell (HDCV) is not only the most expensive to produce,
but may also have a significantly higher rate of side-effects when
compared to the much less expensive purified chick embryo vaccine.

I had a taste of physician non-acceptance when my physician was away
after administering the first in the series of three shots. He assumed
any of the other five doctors in the rural practice could and would complet=
e
the series. NOT! I was turned down flat by the two experienced doctors
on duty, and had to get my shot from the public health nurse.

Rabies antibodies (assuming the initial titres are adequate) are considered
to be reliably adequate for only three years, after which a booster is
required (and with the HDVC adverse reactions have most often been
experienced with the booster). The alternative is to get a Rabies titre
test, but I understand (anyone have figures?) that this is quite expensive,
and in Canada's health system, may simply not be available on demand in
some provinces (unless you can persuade a sympathetic public health officia=
l
of the need).

However, since it's unusual for people to get rabies and the
vaccine does work fine after exposure, it will probably not be
part of the usual childhood vaccines.

Mike K


As someone noted in a previous post, the urgency of treatment depends on
the proximity of the infection site to the brain. A report from a
researcher from pre-war Yugoslavia (Zagreb) indicated that there wolf
attacks resulting in bites to the face and neck have resulted in death,
due to inability to get the antibody titres high enough in time. One possib=
le
strategy to improve this situation (suggested to me by Richard Passwater's
book "Selenium as Food and Medicine") is to take a large dose of selenium
concurrent with or within a few hours of vaccination. He reports that this
has greatly increased antibody titres with other vaccines.

Finally, aside from the risk of not being able to get to treatment in time
after clear exposure, there is the very real danger of unnoticed infection,
expecially in children, by having a cut finger or lip, etc. come in contac=
t
with saliva from the tongue or coat of an infected animal. There is even
one reported instance of a spelunker dying after supposedly no other exposu=
re
than inhaling saliva droplets from rabid bats. Since unvaccinated victims
can't be treated successfully once symptoms appear, pre-vaccination is the
only available protection for this last type of exposure.

Achim


------------------------------------------------------------------------

From: Achim Lohse=20
Subject: rabies vaccine - update

Hi Lynn. I did a little more reasearch on rabies vaccine in the past two
days, and learned that the Canadian manufacturer - Connaught Labs, also
markets the vaccine in the U.S.. In fact, it markets two versions in the
U.S., both are human deploid cell vaccines (HDCV), but one, called
"Merieux" is marketed in a 0.1 ml format for intradermal injection. In
Canada, ironically, this form is not available, and only the 1 ml
intramuscular form is marketed (suggested retail about CDN$75 per vial).

I wasn't able to get any us prices, but was given a U.S. information number=
:

1-800-VACCINE , which of course, doesn't work from my (Canadian) calling ar=
ea.

I wasn't able to learn whether HDCV is the still the _only_ type of rabies
vaccine available in the U.S. (it is the only typpe in Canada).

Finally, I learned that there are two methods of testing rabies antibody ti=
tre
(to find out if you need a booster). The preferred one is the
neutralization assay type, in which diluted serum is mixed with infected
cell culture and checked for reaction. The titre is reported as the highes=
t
dilution ratio that provokes a reaction, with 1:32 being the minimal
acceptable titre. If titre is at 1:32, then retesting or boosting is
adviseable in a year to maintain adequate protection. I couldn't get
any details about the other method, called complement fixation, except that
the local expert considered it less reliable. BTW - for Alberta and
Saskatchewan (and possibly other Canadian provinces) all rabies titre testi=
ng
is done by the _Ontario_ Provincial Laboratory, so it's a slow and costly
undertaking.

regards,

Achim



------------------------------------------------------------------------

Smallpox vaccine is no longer given, because smallpox has been eliminated b=
y vaccination. The virus is currently kept in labs in
the US and Russia, just in case it is needed at some point (there has been =
talk of destroying the last samples, but the virus
recently got a reprieve). Since the elimination of smallpox is one of the m=
ajor triumphs of vaccination, which is mentioned in
many medical texts which I consulted as an argument in favor of vaccination=
, I'll also mention at this point that smallpox
mortality was 25-30%, that it infected 90% of the population at risk, and t=
hat there were 10-15 million cases worldwide as
recently as 1967. The last natural case was reported in 1977, and the last =
cases were reported in 1978, as a result of an
escape of the virus from a lab (the lab director committed suicide while un=
der quarantine). (Kiple) The only people who still
need to be vaccinated for smallpox are the people who work in the labs wher=
e the virus is kept.=20

Vaccine components capable of causing adverse reactions: polymyxin B, strep=
tomycin, chlortetracycline, neomycin, phenol,
brilliant green dye, glycerin (Travel Medicine Advisor).=20

Typhoid is spread by contaminated food and water. The vaccine protects 70-9=
0% of recipients. There are two forms of the
vaccine: oral (live), and parenteral (killed). The oral vaccine shouldn't b=
e given to immune-compromised people. Otherwise,
there are few adverse reactions, mostly local discomfort and sometimes feve=
r and malaise. Boosters are every three years for
parenteral and five years for oral vaccine.=20

Vaccine components capable of causing adverse reactions: phenol, bacterial =
components (Travel Medicine Advisor).=20

The following posting from sci.med gives further information on typhoid vac=
cine:=20

------------------------------------------------------------------------
From: "Mark A. Shelly"=20
Subject: Oral form of typhoid vaccine

A typhoid vaccination is recommended for a trip to Costa Rica. My family
doctor said that the last time she gave someone a prescription for the
vaccine they came back with an oral vaccine. Since then she hasn't been
able to find any information comparing the oral to the injectable form:
- efficacy
- scheduling (the injectable form requires 2 doses, the first a month
before the trip)
- side effects (she says that the injectable form tends to make you feel
sick, the oral form may be an improvement).


Oral typhoid vaccine is a live but weakened (attenuated) strain (Ty21a) of
the Salmonella germ that causes typhoid fever.

The oral vaccine is probably equal to the injected vaccine in efficacy, at
about 80%.

It is given orally on an empty stomach every other day for 4 doses (total
elapsed time 6 days). It must be kept refrigerated but not frozen, a signif=
icant
limitation to use in other countries. You can't be taking antibiotics at th=
e
same time.

It is very well tolerated. (The injected form has 80+% side effects). If yo=
u
have weakened immunity, or if you are too young to take pills, you shouldn'=
t
use this vaccine.

I almost never recommend the injected form of typhoid vaccine. Typhoid
vaccine is recommended for travel to areas with poor water supplies when
the trip is over 3 weeks and when your eating will be "high risk".

Hope this helps

Mark Shelly

------------------------------------------------------------------------

Typhus vaccine (not available in the US) is described by Andreas Kaunzner's=
travel medicine Web site
(
http://members.aol.com/reisemed/impfung/typhus.htm). According to this sit=
e, there are two different typhus vaccines on the
market in Germany. One is a live oral vaccine, which is given in three dose=
s, and gives protection for about three years, if one
stays in a region where typhus is endemic; otherwise its immunity lasts for=
about a year. The most common side effect, seen in
fewer than 1% of those receiving the vaccine, is stomach trouble. General s=
ymptoms such as fever and chills can appear, and
very seldom a rash. The other is a killed vaccine, which may be given to ad=
ults and children two years or older, and which
provides immunity for at least three years. Its side effects are described =
as "typical side effects of vaccinations" (local reactions,
fever, and allergic reactions) appearing only seldom. Kabel 1 Online has a =
chart of German travel vaccine recommendations
(http://www.kabel1.de/reise/1998/06/26/11/) which says that typhus vaccine =
is given for trips of more than three months. The
CDC, on the other hand, recommends hygiene and, in areas where tick typhus =
is endemic, tick removal and tick repellant;
typhus vaccine production has been discontinued in the US.=20

Yellow fever is a viral infection which is spread by mosquitos. Yellow feve=
r vaccine is a live vaccine which can be given only at
certain vaccination centers. Many countries require this vaccination for en=
try. A booster is needed every ten years.
Contraindications include egg allergy and immune deficiency. Reactions are =
mostly mild.=20

Vaccine components capable of causing adverse reactions: chick embryo compo=
nents (Travel Medicine Advisor).=20

Travelers may also want to take anti-malarial drugs, bring insect repellant=
containing N,N diethylmethylbenzamide, and avoid
unboiled water, raw vegetables, fruit they haven't peeled themselves, under=
cooked fish and shellfish, and food kept at room
temperature. Other sources of travel health information are _Fielding's Tra=
velers' Medical Companion_ and the US State
Department Citizen's Emergency Center, which provides information on a vari=
ety of foreign travel risks 24 hours a day at
202-647-5225. CDC Travelers' Health Section, 404-332-4559, and Immunization=
Alert, 203-487-0611, have up-to-date
information on vaccinations for international travel.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3n. Vaccines under development=20

[This section most recently updated on September 18, 1999. References inclu=
de the Report of the Technical Review Group
Meeting, 7-8 June 1998 WHO Global Program for Vaccines and Immunization Vac=
cine Research and Development
(http://www.who.org/gpv-documents/DocsPDF/www9845.pdf), a New England Journ=
al of Medicine editorial on malaria
vaccine development at http://www.nejm.org/content/1997/0336/0002/0128.asp,=
reports on AIDS vaccine research at
http://www.iapac.org/ and http://www.nih.gov/news/pr/may98/od-15a.htm, an I=
ntellihealth report on vaccine news for 1999
(http://www.intelihealth.com/IH/ihtIH?t=3D18784&p=3D~br,IHW|~st,408|~r,WSIH=
W000|~b,*|), Lon Morgan's Web site on
vaccine developments: http://fp1.cyberhighway.net/~lmorgan/developments/vac=
cine_development.htm, and National Institute of
Health information on clinical trials at http://www.niaid.nih.gov/.]=20

Q3n.1 What vaccines are currently under development?=20

New vaccines under development include vaccines for HIV (vaccines are being=
tested both to improve the immune response in
those already infected and to resist infection), respiratory syncytial viru=
s (Rathone), malaria, leprosy, gum disease, herpes,
shigella, dengue, cervical cancer, type I diabetes, and other illnesses, as=
well as an intranasal flu vaccine, new versions of the
pneumococcal, meningococcal, and TB vaccines. Harrison's Internal Medicine =
has a list of vaccines in human trial, and a list of
those toward which priority efforts are being targetted.=20

As of May, 1998, the National Institutes of Health had evaluated 23 vaccine=
candidates and 10 adjuvants (substances that
might enhance the effect of a vaccine) in 49 Phase I and Phase II clinical =
trials to determine the safety of the vaccine candidates
and their effect on the human immune system. These studies have been conduc=
ted with 2,900 volunteers. Despite all these
vaccine candidates, the variation of retroviruses and the virus transmissio=
n directly from cell to cell by fusion pose significant
obstacles. It's anyone's guess when (and if) an AIDS vaccine will be ready.=
Two articles which discuss AIDS vaccine
development are "Vaccine Against AIDS?" in the British medical journal Lanc=
et ((02/26/94) Vol. 343, No. 8896, P. 493) and
"AIDS Vaccine: Shooting Blanks or Loaded for Bear?" in Men's Fitness ((03/9=
4) Vol. 10, No. 3, P. 118). Information about
efforts to produce an AIDS vaccine is sometimes posted in sci.med.aids, and=
references, updates, and current information is
available by gophering to odie.niaid.nih.gov. If you have gopher, gopher od=
ie.niaid.nih.gov will get you there. The AIDS FAQ
(available from the pub/usenet/sci.med.aids directory of rtfm.mit.edu) desc=
ribes some other Internet resources with information
about AIDS.=20

When I wrote this section in 1994, I had, "The malaria vaccine has shown po=
sitive results in Phase I/II trials, which were
reported on February 18, 1994 issue in the British medical journal _Vaccine=
_ (volume 12 no. 4, pp 328-336; 1994). (A
report on an earlier trial can be found in the medical journal Lancet, volu=
me 341, pp 705-710; l993). More details can also be
found in a WHO press release kept on gopher.who.ch. The first results of Ph=
ase III trials are expected to be available in
October 1994." Unfortunately, the years since then have not seen as much pr=
ogress toward a malaria vaccine as was hoped. It
is known to be possible to induce immunity to malaria, as letting volunteer=
s be bit by irradiated mosquitos has done so. But
translating that into an effective vaccine has proved tricky. An editorial =
in The New England Journal of Medicine -- January 9,
1997 -- Vol. 336, No. 2 reported that, though one vaccine has shown efficac=
y, recent trials in malaria endemic areas couldn't
confirm that efficacy. An improved subunit vaccine reported in the same iss=
ue of NEJM, but needs to be tested in malaria
endemic areas. WHO has malaria vaccine as a high priority, and aims to have=
an effective and affordable vaccine within the
next decade.=20

Respiratory syncytial virus (RSV) is a major respiratory pathogen among inf=
ants and young children which results in an
"estimated 90,000 hospitalizations among infants in the US every winter" (W=
illiams, 1997). Trials have indicated that the
vaccine is safe and immunogenic (produces antibodies), but there are mixed =
results so far on efficacy.=20

Shigella is one of the leading causes of diarrhoeal illnesses. A shigella v=
accine is moving toward clinical trials soon.=20

The vaccine for periodontitis (gum disease) has shown some positive results=
in macaque monkeys (less bacterially induced
bone loss in the vaccinated monkeys), indicating that a human periodontitis=
vaccine is feasiable. Full-fledged clinical trials,
however, may be a decade away.=20

Q3n.2 What other research is being done to improve vaccines?=20

Research is being done to improve existing vaccines (such as the research w=
hich resulted in the new acellular pertussis
vaccine). This includes efforts to decrease the number of visits, the numbe=
r of doses, and the number of injections, to move
immunization as early in life as possible (including research into the valu=
e of giving vaccines to pregnant women to provide
protection to infants very early in life), to decrease adverse effects, to =
increase protection, and to increase thermal stability. One
area being explored is whether it is possible to combine more vaccines in a=
single shot. Micro-encapsulation is an attempt to
encase vaccines in microcapsules which will be released over time, mimickin=
g repeated injections. Trans-disease vaccinology is
an attempt, by genetic engineering, to create vaccines which protect agains=
t more than one disease. Efforts are also under way
to produce a heat-resistant polio vaccine. (Hartveldt) (There is also a Uni=
ted Press International article from 3/25/94, included
in the CDC AIDS Daily Summary for March 28, 1994, which discusses the effor=
t to make a vaccine which will be effective
against a variety of different viruses.)=20

A major vaccine safety problem is the widespread reuse of syringes in devel=
oping countries, due to scarcity, resale value, and
cultural resistance to waste. In response to this problem, monodose, dispos=
able vaccines, and solid, non-injected vaccines are
being looked at. Solid vaccines would also eliminate the cost of keeping va=
ccines cold (a major factor in vaccine delivery costs,
and reduce the cost of wasted vaccines. Other research on different vaccine=
delivery methods includes work on an intranasal
flu vaccine and on an aerosol measles vaccine.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
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=3D=3D=3D=3D
Section 4. References=20

AAP recommendations (found at http://www.aap.org).=20

ACIP recommendations (found at http://www.cdc.gov/nip)=20

AMA Drug Evaluations Annual, 1993.=20

The American Medical Association Family Medical Guide. Random House, New Yo=
rk. 1987.=20

The American Hospital Formulary Service Drug Information, 1992. Published b=
y the American Society of Hospital
Pharmacists.=20

Boughton, Clement R. "Varicella-zoster vaccine." The Medical Journal of Aus=
tralia. Vol. 159. 4 October 1993.=20

California Morbidity, a Biweekly Report from the Division of Communicable D=
isease Control, part of the State of California
Health and Welfare Agency. Issues from October 31, 1987, May 21, 1993, and =
November 19, 1993.=20

Catalana, Paul, MD. "The 'Other' Childhood Immunizations." Emergency Medici=
ne, October 15, 1992. Center for Disease
Control. _Health Information for International Travel_, 1992.=20

Center for Disease Control Vaccine Information Statements (found at http://=
www.cdc.gov/nip).=20

Clements, C. John, Strassburg, Marc, Cutts, Felicity T. and Torel, Carol. "=
The epidemiology of measles." In _World Health
Statistics Quarterly, Vol 45, No 2/3, 1992.=20

FDA. "Advisory Committee Discusses Chickenpox Vaccine." January 28, 1994. (=
Pulled off of fdabbs.fda.gov. Connect with
login bbs to find this and other FDA information.)=20

Fettner, Ann Giuici. _The Science of Viruses._ Quill. William Morrow, New Y=
ork, 1990.=20

Galazka, Artur. "Control of Pertussis in the World." In _World Health Stati=
stics Quarterly_, Vol 45, No 2/3, 1992.=20

Gershon, Anna A. "Varicella - Immunization Practices in Children." Hospital=
Practice. Sept. 15, 1990.=20

Ghendon, Y. "Influenza - its impact and control." In _World Health Statisti=
cs Quarterly, Vol 45, No 2/3, 1992.=20

Harrison's Principles of Internal Medicine, Eleventh Edition. McGraw Hill B=
ook Company, 1987.=20

Hartveldt, Frank. "The Children's Vaccine Initiative." World Health 46th ye=
ar, No. 2, March-April 1993.=20

Historical Statistics of the United States, Colonial Times to 1970. Bicente=
nnial Edition. US Department of Commerce, Bureau
of the Census.=20

Hull, Harry F. and Ward, Nicholas A. "Progress towards the global eradicati=
on of poliomyelitis." In _World Health Statistics
Quarterly, Vol 45, No 2/3, 1992.=20

Journal Watch, 9-1-93. "Infant HBV Vaccination: Doubts Remain."=20

Kiple, Kenneth E., Editor. _The Cambridge World History of Human Disease_.=
=20

The Lippincott Manual of Nursing Practice, Fourth Edition. 1986.=20

Mandell/Douglas/Bennett. Principles and Practice of Infectious Diseases, Th=
ird Edition, 1990.=20

The Medical Letter on Drugs and Therapeutics, Vol. 34 (Issue 875), July 24,=
1992.=20

The Merck Manual, Sixteenth Edition. Merck Research Laboratories, 1992.=20

Nossal, Sir Gustav. "Prospects for new vaccines." World Health 46th year, N=
o. 2, March-April 1993.=20

Onorato, Ida M., MD, Wassilak, Steven G. Md, Meade, Bruce, PhD. "Efficacy o=
f Whole-Cell Pertussis vaccine in Preschool
Children in the United States." JAMA, May 27, 1992, Vol. 267, No. 20.=20

Pantell, Robert H., MD, Fries, James F., MD, and Vickery, Donald M., MD. _T=
aking Care of Your Child: A Parents' Guide
to Medical Care._ Third Edition.=20

The Physician's Desk Reference, 1993.=20

Rathone, Mobeen H., MD. "Childhood Immunizations: An Update." Infections in=
Medicine, June 1992.=20

Ryan, Frank, M.D. _The Forgotten Plague: How the Battle Against Tuberculosi=
s Was Won - And Lost_. Little, Brown, and
Company, 1993.=20

Shapiro, Eugene D., MD "Editorial: Pertussis Vaccines: Seeking a Better Mou=
setrap." JAMA, May 27, 1992, Vol. 267, No.
20.=20

Smith, Alice Lorraine. Principles of Microbiology. The C. V. Mosby company.=
St. Louis, Toronto, and London, 1992.=20

Statistical Abstracts of the United States, 1992.=20

Travel Medicine Advisor. May 1993.=20

Trollfors, B. and others. "A Placebo-Controlled Trial of a Pertussis-Toxoid=
Vaccine." NEJM, Vol 333, Number 16, October
19, 1995.=20

University of California, Berkeley. _The Wellness Encyclopedia._ From the e=
ditors of the UC Berkeley Wellness Letter.
Houghton Mifflin Company, Boston, 1991.=20

Viral Hepatitis Prevention Board. Safety of hepatitis B vaccination program=
mes.
http://esoc-www.uia.ac.be/esoc/VHPB/statement.html=20

Whitman, Cynthia, Belgharbi, Lahevari, Gasse, Francois, Torel, Carol, Matte=
i, Vittoria, and Zoffman, Henrik. "Progress
towards the global elimination of poliomyelitis." In _World Health Statisti=
cs Quarterly, Vol 45, No 2/3, 1992.=20

WHO. The Work of WHO 1990-1991. Biennial Report of the Director General.=20

Wilkerson, James A., M.D. Medicine for Mountaineering, Third Edition. The M=
ountaineers, Seattle, Washington, 1985.=20

Williams, Amelia L., Ph.D. News and Perspectives: New Vaccines for Childhoo=
d Immunization. Drug Benefit Trends
9(3):10-11,15-22, 1997. (Found on Medscape.)=20

Wyngaarden/Smith/Bennett. Cecil Textbook of Medicine, 19th edition, 1992.=
=20

Electronic resources consulted:=20

American Association of Pediatrics Web site. http://www.aap.org=20

CDC AIDS DAILY SUMMARY (regularly posted on sci.med.aids)=20

CDC National Immunization Program Web site. http://www.cdc.gov/nip/=20

Degos, Francoise. Immunisation contre le virus de l'h=E9patite B : bilan de=
quinze ann=E9es de vaccination.
http://www.john-libbey-eurotext.fr/a...7/index.htm=20

fdabbs.fda.gov (login using name "bbs") (more recently, http://www.fda.gov)=
=20

gopher.who.ch (gopher gopher.who.ch, also:=20

telnet gopher.who.ch login:gopher) (more recently, http://www.who.org)=20

HICNet Medical News Digest (available from ET; regular=
ly posted to sci.med)=20

Immunization Action Coalition Web site.
http://www.immunize.org=20

Journal Watch Summaries (regularly posted to sci.med by =
m)=20

Le point sur la vaccination contre l'h=E9patite B
http://www.sante.gouv.fr/=
htm/pointsur/vaccins/effets_sec_hep_b.htm=20

Levy-Bruhl, Daniel et al. Comparaison entre les Risques de Premieres Attein=
tes Demyelinisantes Centrales Aigues et les
Benefices de la Vaccination Contre L'Hepathite B. http://www.rnsp-sante.fr/=
beh/1999/9909/index.html=20

Medscape http://www.medscape.com=20

Also available on the net is the Morbidity and Mortality Weekly Report (MMW=
R). It is available by Worldwide Web at:=20

http:/www.cdc.gov/; Go to publications and scientific data, then Morbidity =
and Mortality Weekly Report, OR=20

by gopher at Duke University.=20

Morgan, Lon. Immunization, Vaccines, Vaccination in the Modern World http:/=
/fp1.cyberhighway.net/~lmorgan/=20

Swiss Medical Weekly. http://www.smw.ch=20

A list of Internet and Bitnet Health Sciences resources, compiled by Lee Ha=
ncock, can be ftped from the pub/nic directory of
ftp.sura.net.=20
  #3  
Old February 16th 04, 09:58 AM
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Default misc.kids FAQ on Childhood Vaccinations, Part 4/4

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Last-Modified: September 25, 1999

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Section 5. Stories of Parents

The questions asked were as follows:

Now, the questions for parents (or parents to be) about vaccination. The
following questions refer both to the regular vaccinations which are
recommended for all children, and to any optional vaccinations which your
child may have gotten (such as hepatitis B or flu shots). (This list of
questions has been slightly modified from the first posting, to correct
a typing mistake which made some questions appear to be addressed only
to vaccinators.)

These first questions are meant for people anywhere on the spectrum
as far as what vaccinations they chose to give or not give their
children. What vaccines did you (will you) choose to give or not give
your children? What were your reasons for making the choices you did?
How did you go about making your decisions, and what resources did you
find helpful in getting the information you needed?

For parents who have vaccinated your children, do you have any advice for
parents who are about to have their children vaccinated about things they
should be prepared for?

For parents who have not given the recommended infant vaccinations, are
you planning to have your children vaccinated later? Why or why not?
In particular, would you vaccinate your daughter for rubella when she hits
puberty? Why or why not?

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From: Paula Burch

We choose to give our son all of his vaccinations as recommended by the
pediatrician. Vaccinations are one of the few true successes of modern
medicine, and despite some extremely small risks prevent far, far more
agony than they ever cause.=20

Some who would otherwise choose to have their children vaccinated cannot,
for odd medical reasons. These individuals depend absolutely on the rest
of the population's being vaccinated. Parents who elect to refuse
vaccination for their children, for no better reason than that they've
been listening to some quack, put not only themselves but these other
children in danger. When a child who cannot be vaccinated dies due to
infection from a child who could have been vaccinated but wasn't, the
parents of the latter child are morally though not legally guilty of the
dead child's murder. When only a small number of children are
unvaccinated, the risk is small, but when many elect to refuse
vaccinations, the risk of an epidemic becomes quite high, and in some
cases this has already been seen on a small scale.=20

Almost all problems blamed upon the pertussis vaccine actually have had
nothing to due with the vaccine, but were observed coincidentally in
children who would have had the problems even in the absence of the
vaccination.=20

In no case has our child shown any reaction at all to any of the
vaccinations he has received, through 18 months, except for pain
immediately after the injection. Even if he had shown some problem,
however, I would still be convinced of the necessity of the immunization.
A one in a million risk of a side effect is a whole lot better than a one
in twenty, or worse, chance of dying. It is my duty as a mother to do what
I can to improve my child's chances of good health, and it is extremely
clear that immunizations improve the odds tremendously.=20

At the turn of the century, no more than one or two out of five children
could be expected to survive to maturity. Vaccinations are one of the
primary reasons why our own children can expect to grow up.=20

Having said that, I saw no reason to give the hepatitis B vaccine to my
newborn. My peditrician gives it when the child is several months older,
which seemed preferable to me, as there was so little risk of exposure
before that time. The need for vaccination against hepatitis is much lower
than the need for immunization against the diseases of childhood, but, as
the hepatitis vaccine is genetically engineered, there is essentially zero
risk of ill effects, so I felt it was well worth getting.=20

Paula Burch


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From:
(Rayaz Jagani)

(It would be easier to answer/comment if the questions were
enumerated, I hope the following does not further confuse the issue)

I tend not to allow my child to be vaccinated.

My HMO (Kaiser Permanente), has not given me actual numbers of
efficacy/side effects over the life of an average person. I understand
that the definition of side effects is what happens within 6 weeks.
If the effects are known to be longer, why should side effects be of
shorter duration?

My wife, who is an M.D. thinks differently. Our son got all the
recommended shots. I had my fingers crossed.
He also got the works for our recent trip to India/Pakistan.
I don't think it worked as he did land up with stools etc.,
was prescribed some anti-biotic (Bactrin or something).

I dont take any shots when I visit that region; but then, I grew
up there, not that I was vaccinated regularly there :-)

About the hepatitis B shots, not enough is known. Also, should
babies be given this or more likely adolescents... if they are
becoming sexually active. Apparently, they do get some residual
effects from their infancy vaccines.

My conclusion is, that if you are looking for answers, a long
term view, and hard numbers, there is a lot of gray area.
All the numbers are based on samples, statistics, control groups,
duration of followup, etc. You decide what you want to bet on, in
this russian roulette.

There may also be a legal requirement in public schools, private
schools can probably do anything they wish. I think
you can get around public school limitations, however, you may
have to go to court.

You may wish to hunt the sci.med archives for more discussion;
I dont know how enlightening you will find it :-).
Below is an example:


EX:From:
(J. D. McDonald)
EX:Newsgroups: sci.med
EX:Subject: infant seizures after vaccination
EXate: Fri, 3 Sep 1993 13:52:43 GMT
[deleted rest of header]
EX:In article wri=
tes:
EX:Date: Thu, 2 Sep 1993 16:13:04 MST
EX:From:
EX:Subject: infant seizures after vaccination
EX:
EX:nnget 93245.161304
EX:In article ,
(Gordon Banks)=
says:
EX:
EX:
EX:Seizures and epilepsy are not uncommon in children. They often begin
EX:about the age that the child is vaccinated. No correlation has
EX:been shown between the vaccine and the development of epilepsy.
EX:It is likely just coicidence. The child needs a good pediatric
EX:neurologist. Denver is likely the only place in the State of
EX:COlorado that has one.
EX:
EX:--
EX:Given that a large portion of children are vaccinated; and that seizure=
s and
EX:epilepsy occur around the same time as vaccination; how could one possi=
ble say
EX:that no correlation has been shown. Where are the controls in this stud=
y?
EX:
EX:Certainly not every vaccinated child has seizures. And not every child =
will be
EX:allergic to milk, either. The fact that not every child has a reaction =
to
EX:vaccinations is no argument against the notion that they may cause reac=
tions
EX:in
EX:some. Unlike the milk allergy, where one can eliminate milk from the di=
et and
EX:see if the condition gets better, it is not possible to unvaccinate som=
eone.
EX:While the connection is not absolute, there are **NO** grounds for dism=
issing
EX:vaccinations as a possible source of health complications.
EX:
EX:
EX:There is NO reasonable doubt that vaccination with the pertussis vacine
EX:can cause permanent and serious neurological harm. That has been
EXroven again and again in court cases in the US. In fact, just this
EX:last week another child was awarded millions of dollars in damages
EX:after being brain-damaged by this vaccine. Note that one need=20
EX:not make any qualifications about that .. not "may have been", but
EX:"was". This is simply no longer debateable. It is only this one vaccine =
thaty
EX:does this. It is often given in combination with two other vaccines.
EX:If those are given alone, the vaccine is safe.
EX:
EX:The vaccine is still required in some places EVEN THOUGH it is known
EX:that it can cause SERIOUS harm to children.=20
EX:
EXoug McDonald=20

Best of luck.
--=20
Usual disclaimers/caveats apply.
It is impossible for a man to learn what he thinks he
already knows. -Epictetus

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From:


In article you write:
These first questions are meant for people anywhere on the spectrum
as far as what vaccinations they chose to give or not give their
children. What vaccines did you (will you) choose to give or not give=20
your children? =20


Morganne received 1 dose of DPT, 2 doses of DT, 3 doses of oral polio
and 1 dose of MMR. Matisse has received 1 dose of tetanus vaccine
and we plan to vaccinate her for polio. Both girls will receive
rubella vaccinations at puberty (if they show no immunity at that
time).

What were your reasons for making the choices you did? =20


I was undecided with Morganne but decided to vaccinate her anyway.
After she had severe reactions to the pertussis and MMR vaccines,
I did more reading and consulted with the doctor. We came up with
the following:

1) Additional doses of pertussis or MMR could be dangerous or deadly
for Morganne and were not advised for siblings, either.
2) The side effects of the diptheria, pertussis, measles, mumps
and rubella vaccines are a greater health risk to healthy
children than the diseases themselves.
3) There are concerns about vaccines wearing off. I would rather
my children contract mild illnesses (mumps, rubella, chicken pox,
measles) as children. I am haunted by the prospect of a population
of young women whose immunity to rubella may wear off just as
they begin to bear children.
4) The risks of tetanus and polio (and the safety of the vaccines)
are greater than the risks of the vaccines. So my children will
receive these vaccines.
5) The risk of rubella in a pregnant woman is very troublesome.
Therefore, I will delay this vaccine until puberty. This will
give them a chance to receive more effective immunity from the
natural disease and will also put them at lower risk for
reduced vaccine immunity in their childbearing years.

How did you go about making your decisions, and what resources did you=20
find helpful in getting the information you needed?


Our family doctor was very helpful. I also found the writings of
Robert Mendelsohn and George Wootan (both MDs) very helpful. Mothering
magazine was another good source of information. George Wootan's book
has an especially good section on the risks and benefits of the various
vaccines.

For parents who have vaccinated your children, do you have any advice for
parents who are about to have their children vaccinated about things they
should be prepared for?


Know what severe reactions to watch out for and take any unusual reactions
seriously. I didn't know until later that Morganne's reaction could
have resulted in brain damage or death. Report the reactions to your
doctor.

Prepare for mild illness for 1 week to 10 days after the vaccination.
It can and does happen.

For parents who have not given the recommended infant vaccinations, are
you planning to have your children vaccinated later? Why or why not?


I covered this above, but will summarize.

1) The effectiveness of some vaccines (particularly pertussis) is
questionable.
2) The incidence of diptheria is quite low and diptheria is now
treatable.
3) Measles, mumps, rubella and chickenpox are mild childhood diseases
with few side effects for healthy children. (These diseases are
dangerous for malnourished children, however).
4) Each vaccine carries certain risks.
5) The immunity conferred by a vaccine is generally shorter-lived and
less complete than the immunity conferred by the natural disease.

Note that we are choosing to vaccinate for polio and tetanus.

In particular, would you vaccinate your daughter for rubella when she hits=

=20
puberty? Why or why not?


Yes. Childhood rubella vaccinations seem short-sighted to me in light
of the tendency for the rubella vaccine to wear off. But young women
need immunity to rubella to protect their unconceived children.

(Please mail responses to this account. Your name will be included inthe
FAQ unless you specify otherwise.)

If anyone is interested in reviewing the FAQ when I have written a draft,=

=20
send me email (I have one person reviewing it already). I have found=20
some information about vaccinations in other countries, so I no longer=20
need that question answered, but if anyone on sci.med (or on misc.kids,=20
for that matter) can suggest good resources to check to keep this FAQ=20
current after I have written it, I'd welcome them (one thing I've noticed=

=20
in my research is that there are lots of changes happening).

Lynn Gazis-Sax






--=20
Heather Madrone
(WAS )

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From:
(Margaret T Kelliher)

Lynn,
Here's my 2 cents. Hope it's what you're looking for.
Margaret

We've given all recommended vaccinations so far (15 mos
and 4 years) We did delay certain of Colleen's shots=20
because she had a very rough neonatal period and we=20
couldn't see stressing her system more than necessary.

Why did we do this? All these things are a bet. Given
the relative rates of disease, and the seemingly bad
effects of these diseases, and the relatively low risks
of the shots, it seemed a good bet to take the shots.
(And it makes it easier to get into school and day care.)

I did a little reading (Parents, and a few articles my
doctor gave me at my request), but in large part, I=20
trusted my doctor, who has always answered my questions
to my satisfaction. With the hepatitis B, I also talked
to several other doctors: ob/gyn & pediatric neurologist
in particular, and read some articles on the subject.

Advice:=20

Give them tylenol immediately after the DPT shot.

For all shots, leave extra cuddle time in the schedule.
If nursing, try to make an opportunity to nurse the baby
immediately after the shot. Once they are verbal, prepare=20
them for it (but not too graphically).

Always ask questions about the shots effects and what to
look for. DPT especially; I believe that the first=20
adverse reaction is supposed to be somewhat mild; while
subsequent ones are more likely to be devastating. I would
not allow a second one if the first one raised a question.

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From:
(Carolyn Peterson)

Pertussis vaccine.

This vaccine is one that many parents worry about giving their children.
They do so for good reason. There is a lot of information out saying that
the vaccine could cause problems with their child's health. Who wouldn't
worry!

Unfortunately, the possibility of getting the illness and problems from the
illness does not seem to be publicized as much as the potential
complications from the vaccine are. Pertussis, or whooping cough, is still
present today and can easily be transmitted. The last booster for the
illness is given around 4-6 years, after that the illness isn't severe, so
boosters aren't given. Adults can have the disease and just think they
have a bad cold. It's a completely different story for infants.

Friends of ours came down with colds and a bad cough. They continued their
normal routine. Their 3 month old daughter also came down with the "cold".
The disease reached the pertussis stage while the mother and child were
thousands of miles from home. The baby had horrible coughing spells,
projectile vomiting and apnea attacks after the coughing. She was
hospitalized for 3 weeks, with 8 days of that in ICU due to whooping=20
cough (or pertussis).

Our 3 month old child and several other infants that age had all been
exposed to the disease at a play group. The infants received their second
vaccination early and were put on erythromycin for 10 days as a precaution.
That stuff is wicked for young children. After one day, our daughter
started screaming at the sight of the antibiotic bottle. It took two of us
to get the medicine down her and we were fortunate that she only needed two
doses a day. The only thing that gave us the strength to force her to
take the medicine was the knowledge that our friends' child was so ill many
miles away.

During this time, we learned that whooping cough is still quite active in
the United States. Countries that don't vaccinate against it have children
dying from the disease each year (I don't have the numbers any more.) The
immunization isn't complete until after the 3rd shot at six months. Even
then, there is a small chance they could come down with the disease. The
only other case of pertussis that our pediatrician had seen at the time was
from a child who had been vaccinated, but still came down with the disease.
--=20
Carolyn Peterson =20
=20

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From: Diane Lin

Our son has been given the full range of immunizations--polio, DPT
(diphtheria, pertussis, tetanus), MMR (measles, mumps, rubella),
Hib (meningitis), and Hepatitis-B. We made the decision to have our
son vaccinated for all of these because (a) we felt there was a moral duty
to have him vaccinated, both to escape the free-rider problem, and
to contribute to the herd immunity**, (b) the risk of serious side-effects
did not outweigh the benefits of immunization, and (c) the increased
numbers of children who are not immunized is steadily going up,
which increases the chances of an epidemic, and while most of the
diseases are fairly minor, we didn't see the point in exposing our son
unnecessarily. In making our decision, we spoke to our
pediatrician, other parents, and read the views expressed in misc.kids :-).

When our son got his first DPT shot, he cried for about 4 hours
afterwards, and I was at a loss to comfort him. After calling my
husband to come home, we were finally able to get a little bit of
Infant Tylenol into our son's system. That helped tremendously so
that he could nurse and be comforted. After that, we made sure we
gave him some Infant Tylenol just before he got his shots, to ease
the discomfort. Also, after his first MMR shot, I had forgotten
that some kids display symptoms of measles anywhere from a few days
to a week after the immunization. I didn't panic, but I wish I had
kept that in mind!

--=20
Diane C. Lin=09=09=09"The only rational way of educating
=09 is to be an example."
(Dylan's mom, 2-3/4 years)=09 -- Albert Einstein

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From:
(Joseph Karr O'Connor)
Subject: Immunization story

Dear Lynn Gazis-Sax,

I've been to your Web site and I have a story you might want to post the

Helpless Child Under Fire

When the subject of vaccinations first came up for my daughter, Siobhan, I
set out to gather information from friends. We had been in a group which
met to study what the birthing process was all about, and I began by asking
people in this group what they were doing about immunizations for their
children. My wife, Linda, does legal research for a living and she started
bringing home reams of research about vaccinations. Soon we could see it
was proper to call vaccinations off as long as possible. Siobhan has severe
developmental delays. Her only diagnosis is Infantile Encephalopathy, but
that's just a label to put on an as yet unexplained situation. She is
unable to communicate verbally and can't walk and she'll be 3 years old in
July. She looks to be moving toward walking but is not close at all to
speaking. She developed exactly backwards after a diagnosis of "failure to
thrive" early in the first year.

We resisted all minor and major efforts to get us to vaccinate her.
Receptionists would exclaim in horror or bewilderment: "She hasn't had her
shots?" Doctors would sniff loudly and bark condescendingly. At best it was
as if we were daft and had to be humored. At worst we were threatened with
child neglect. One doctor finally told us that in New York state (Ithaca,
New York, is where we lived 'till we moved back to California in January of
this year) all doctors are required by law to support vaccinating children
and if one is found not actively pushing vaccinations that their license to
practice is revoked immediately. I don't know how much of that is what I
made out of what I heard or what the doctor made out of what he understood
to be the facts, or a combination, but from my experience it might as well
be true. Even when you can see it in their eyes that they know something
different they lie right to your face and say it's OK, just do it, you'll
be glad, do it for the child, etc.

It's like when I go anywhere or do anything with my daughter and someone
wants to manipulate me into doing something I don't want to do and they
point at her and tell me to do it for her. I was at Midas Muffler the other
day and the first thing the mechanic pointed to was a hole in the catalytic
converter cover and he told me "Well, to do it right you'll have to replace
the whole thing" meaning the entire exhaust system. Considering I went in
to get only a tailpipe that was quite a leap. I argued with him, first by
pointing out that a 1/4 inch hole in the catalytic converter cover is not a
hole in the catalytic converter, and second with the fact that I didn't
want him to do it right, I just wanted him to fix the broken parts. This
got his dander up and he brought in the manager. The first thing the
manager did was point at Siobhan and say: "Don't you want to make it safe
for her?"

Even our neurologist, the head of a major pediatric neurology department in
a major hospital told us calmly to go ahead, there was no reason to delay,
there would be no side effects, etc. Finally, after many months of MRI/CAT
scans, blood tests, etc., the same neurologist proposed some tests to prove
or disprove the absence of two rare diseases... both of which would
contraindicate vaccinations! This, after he told us to go ahead with them!
When we took her in for a battery of tests and Linda stayed overnight with
her in the hospital, a young, idealistic, brainwashed resident in the unit
gave me a little lecture about vaccinating right there in the hall as I
held my daughter in my arms with a catheter in place to collect a 24 hour
urine sample--a sample they failed to collect properly so most of the
reason for our hospital stay was negated! Now... if they couldn't do a
urine sample properly, how can I expect them to manufacture a vaccine which
is safe? I told this young doctor-to-be that we were waiting for the test
results before proceeding, as the diseases we were testing for would
contraindicate vaccinations. She didn't hear me at all. I could see in her
eyes that she was looking at me like I was a bug. A bug that needed
squishing.

Finally, when Siobhan was two and a half years old, due to an outbreak of
Pertussus in our area, we decided to give her DTaP. The first shot seemed
to have no effect on Siobhan, but she was surprised when she was jabbed
with the needle, like she was surprised that anyone could willfully hurt
her. What a poor dear she is. We decided that perhaps our fears of the
immunizations were unfounded, and based on this we decided to go ahead with
all the rest of the shots. The second DTaP shot six weeks later sent her
immune system haywire, the third shot, killed Polio, brought her down so
low that her herpes infection took over and the fourth one, HIB, changed
her personality drastically. If it weren't for homepathic medicine and a
timely dose of a remedy she'd be a very sad little girl with no center...
way off balance.

I waited a long time before agreeing to immunizations and now I know it's
the wrong thing to do. We have never given her antibiotics even though
they've been prescribed several times, once by a doctor who told us she'd
have to either take them or she'd be ready for the hospital immediately.
(She was, at that moment, on the road to recovery, we just didn't know it
at the time.) She's never had an ear infection as far as I'm concerned. She
may have had some fluid buildup once or twice which the doctors described
as ear infections, but since doctors use the phrase "ear infection" all the
time it's difficult to tell if that was true. I credit her lack of ear
infections with the fact that we never give her a cold bottle, never let
her drink lying down, give her echinacea extract when she's sick, never
give her antibiotics--and didn't vaccinate her. If we're right about this
then following our own path has given us great rewards in that direction.
It seems to me we should follow our own counsel about the vaccinations.

Since the bureaucracy we are currently dealing with is demanding that we
continue the vaccinations in spite of the fact that there has been damage
from them we have determined that we must take a personal beliefs exemption
on behalf of Siobhan. We found that there is no one who can help us with
this. Linda did the legal research and wrote the letter. This is the first
draft, the second one was cleaned up and turned in. I have witheld the
names of the doctors involved, as I feel there is no need to make their
names public, which posting on the Internet tends to do;- We have not yet
heard from the program Siobhan is in, which is demanding the vaccinations,
whether or not this letter will be accepted by them as a personal beliefs
exemption.


TO WHOM IT MAY CONCERN:

This statement of personal beliefs is submitted to
comply with the requirements of the California
Health and Safety Code section 3385 and with 17
California Code of Regulations sections 6025 and =156051, to
document a personal beliefs exemption from
immunization on behalf of Siobhan O'Connor. The
undersigned, parents of Siobhan O'Connor, believe
that further immunizations are not in the best
interests of Siobhan, given the unknown etiology of
her neurological and physical problems, and the
reactions she has had to the immunizations she has
received. We also believe that the vaccinations she
received antidoted her homeopathic remedies,
compromising further her overall health and immune
response.

Siobhan is a 34 month old child with multiple
disabilties. She cannot walk or talk, is hypotonic
and ataxic. Siobhan's doctors in New York
recommended that we delay her immunizations
pending further knowledge of the origins and
progress of her developmental delays. Delays were
recommended by [name witheld] in 1992, by [name witheld]
in 1993, and by [name witheld], in fall of 1994.

There is still a question of whether Siobhan's immune function
is normal, and whether the underlying cause of her
condition presents contraindications for
immunization. [Name witheld] noted abnormally low
levels of some chemicals, and recommended
investigation of gamma globulin therapy as a way to
improve her immune functioning. However, given
that there was a pertussis outbreak in Ithaca, NY,
we went ahead with her first DTaP shot. Siobhan
showed no adverse reactions. Shortly after this, we
moved to California.

Siobhan received her second DTaP shot on
schedule. This shot produced swelling and fever,
severe diarrhea and Siobhan's emotional balance was
lost; she became a crying, whining, clingy child. The
next week she was given killed polio vaccine, and
the following week HiB. The HiB shot was
followed by 5 days of fevers of 105 degrees. By this
point she had had diarrhea for 3 weeks, and the
beginnings of a herpes outbreak. She went
backwards developmentally; for example, stopped
using her walker, would let her legs crumble beneath
her, stopped vocalizing and no longer used the two
words she had acquired. At the end of these three
weeks, we realized we had a child in serious trouble.
It occurred to us that the vaccines might have
caused reactions, and we sought medical advice.

Siobhan was seen by four doctors. Three of those
doctors believe that her health problems were clearly
related to the vaccines, and recommended that she
receive no further vaccines; one doctor felt that this
deterioration of her health could not be related to
the vaccines, that one was the doctor who administered
the shots. However, none of the three doctors
who told us to stop vaccinating Siobhan was willing
to write a note exempting her from the vaccines due
to fear of repercussions and investigations by state
licensing officials.

We are unwilling to sacrifice our daughter's health
due to public health concerns and pressures
unrelated to a concern for her individual health.
Siobhan's condition requires further study and
testing before her fitness for vaccinations can be
determined. Knowledge of whether she is reacting
to factors unrelated to the vaccination can be
established only after establishing a known,
identifiable cause for her condition. That her
condition is unknown cannot be the basis for a
presumption that the vaccines are safe for her at this
time, and we believe that her reactions to the
vaccines show that they are not. Due to the illnesses
described above, Siobhan's evaluation by [name witheld],
a developmental pediatrician, was delayed
twice. Having recently had this evalution by [name witheld]
she has been referred to genetics,orthopedic,
and neurologic clinics, where further
evaluations may establish the etiology of her
condition. It is our personal belief that only then can
the suitability of immunizations for our child be
ascertained.

We also believe that homeopathy and homeopathic
remedies have significantly improved the functioning
and emotional balance of Siobhan, allowing her to
progress developmentally, and that vaccines
antidoted these remedies. Siobhan is undergoing
homeopathic treatment to try and regain balance in
her intestinal tract and help her organs process the
toxins in the vaccines. She has suffered from
alternating diarrhea and constipation since receiving
the vaccines, and the constipation caused a painful
hemorrhoid. Siobhan is also suffering from a severe
diaper rash. She needs to recover her health, and it
is our personal belief, based on the deterioration of
her health, that further vaccination is inappropriate
and dangerous.

Sincerely,

Linda Karr O'Connor
Joseph Karr O'Connor

Addendum

We have since learned that the wording necessary for a personal beliefs
exemption from immunizations is available on the California School
Immunization Record, form PM 286 (3/89), 89 52111. The wording is quoted
he

"PERSONAL BELIEFS AFFIDAVIT TO BE SIGNED BY PARENT OR GUARDIAN -- IMMUNIZAT=
IONS

I hereby request exemption of the child, named on the front, from the
immunization requirements for school/child care center entry because these
immunizations are contrary to my beliefs. I understand that in case of an
outbreak of any one of these diseases, the child may be temporarily
excluded from school for his/her protection."

Since we turned in our letter, the school Siobhan is now attending has
stopped asking for proof of further vaccinations. We take it they are
satisfied that we are serious and/or they have cleared this with their
lawyer(s) and it meets their need to have complete records. Siobhan has a
new homeopath and is on a new remedy. Her rash is finally healing up after
weeks, she is balanced and making good progress. She has returned to the
developmental growth pattern we saw before the immunizations threw her off,
and is very, very happy!

Good luck to all those of you who are struggling with this issue, we hope
you make the right choices for your child. This is our story thus far. We
don't want to do anything but help Siobhan be the best person she can be,
get her the most help we can, and give her all the love we are able to
give. We are not crusaders for or against immunization, indeed, it may be
one of the most important advances in health care the human race has ever
made. Only time will tell. What we want most of all is for the pressure to
be taken off health care professionals so they can tell us the truth on
this issue. I have looked several doctors in the eye as they told me there
were no side effects, negligible side effects, etc., and caught them lying
as they were speaking. Please, if you administer immunizations and you know
something adverse about them up front, I must beg you not to lie outright.
The truth shall set us free. Let us make up our own minds about this issue.
Now that Congress has taken manufacturers off the hook for punitive damages
there is no way you can help your child after the fact if there is damage
from vaccines. Be sure you know what you're doing and don't take anyone's
word for it but your own.

~~~~~~~~~~~~~
Joseph Karr O'Connor
Santa Monica, California, USA


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From:
(ALF)
Subject: Vaccines

This is on my home page. "Stay tuned to this page. My
next story will be concerning "Are Vaccines Really Safe.?"
Moms, please do your research on the safety of vaccinations BEFORE YOU
VACCINATE YOUR BABY."

This is a very controversial topic. I hope I can give you enough info to
research and make up your own mind as to whether you should or shouldn't
vaccinate your child.

PLEASE GO TO A MEDICAL LIBRARY AND DO YOUR OWN RESEARCH. You will get so
much more out of this than you will believe from me. I start my research on
vaccine safety before my son was born so that when the time came for me to
decide I would make an informed decision and not let anyone sway me from my
decision based on facts and not heresy from a doctor, nurse, or my own
mother!

The most alarming stats came from the 3 in 1 shot called the dpt shot.
D=3DDiphtheria (epidemic disease affecting mainly the throat and air
passages) P=3DPertussis a.k.a. Whooping cough (infectious disease marked by
fits of convulsive coughing, followed by characteristic loud whoop or
indrawing of breath) T=3DTetanus (disease in which a virus causes spasms of
violent muscular contraction; a.k.a lockjaw)

The following is a disclaimer that is on all vaccine inserts: "As with any
vaccine, vaccination may not result in sero-conversion in all individuals".


Sero-conversion =3D vaccine may not necessarily result in blood antibodies,
and hence, nay not work in everyone.

What they don't give you are the stats on just how many times the vaccine
does work.
Example: 1989 Ohio, Pertussis outbreak. 82% of the children that contracted
the Pertussis were already fully vaccinated. The children that were
vaccinated against the Pertussis had just as bad a case as if they had not
been vaccinated at all. You hear all the time that "if you are vaccinated
and you come into contact with the virus you will either escape from
contracting the virus at all or you will have a lesser/easier case of the
virus than the person who isn't vaccinated at all." All of the research
that I could get my hands on proved that statement to be utterly false.

This is a hard statement for me to make due to the fact that I love my
child and I would never knowingly inflict any pain on that beautiful gift
from God. However, I can not knowingly give my child a vaccine knowing what
I know today.

Here are the facts:
1. Acquired immunity in childhood will last a lifetime. Most infectious
diseases contracted in childhood are not fatal and are fully recoverable.
Contract the same said infectious disease in adulthood and you might die.

2. Risk benefit analysis is for you to decide. THANK GOD. Our government
and the medical community would have you believe that your child can't
attend daycare or school without being vaccinated against everything known
to man and that is NOT TRUE. Fact: you can send your child to daycare and
school. Here is how.
A. Religious exemption,
B. Doctor's note exempting the child from vaccination,
C. Several states have statutes exempting mandatory vaccination.

3. No one knows how long vaccines last in the first place hence the
supposedly necessary evil of boosters. (This was a big WOW for me!) Note:
refer back to #1.

4. Time line for infants to receive vaccine is made up from several
recommendations based on lab results from pharmacuetical companies. Result
=3D the ultimate conflict of interest.

5. CDC maintains that all infectious diseases can be controlled by
vaccinating the entire population. I found No evidence to support their
claim. In fact the more I search the more I concluded that vaccines do not
work and in fact are responsible for the following; High/high fever
resulting in frying the brain causing sever seizures leading up to and
causing a stroke and eventually possibly death, ADD =3D Attention Deficit
Disorder, Hypertention/hypersensitivity, break down of the bodies own
immune system (draw your own conclusion from THAT), and the list goes own
on from the hugh side effects from vaccinations.

6. Fact: if the patient has a reaction (red swelling around shot area,
fever , fits of loud crying, etc.) discontinue remaing vaccination
schedule. The doctor will maintain and the CDC and AMA will maintain that
all babies and adults will have some sort of reaction to a shot. Your
pediatrician will continue with the shot schedule unless you ask to have
the shots discontinued. Also, ask the doctor to document your childs
reaction and forward the patient record to the CDC. I had a terrible time
getting any stats on low level reactions. High level reactions were no
problem. All of these reactions were recorded via emergency room visits and
the morgue. 602 deaths in 1994 were attributed to vaccines. 30,000 recorded
sever injuries from vaccines. Our government has a vaccine fund set up to
pay off survivors.

I could go on and on. I started asking a few questions on a couple of chat
lines and I was overwhelmed by the response. 95% of the responses were
solidly against vaccines.
One of the responses was from a lady in Dayton, Ohio - Kristine M. Severyn,
R. Ph., Ph.D., Director of "Ohio Parents for Vaccine Safety". She is your
best contact for up-to-date info on Vaccine Safety. Phone and fax513)
435-4750 Address: 251 W. Ridgeway Dr., Dayton, Ohio 45459.

7. Last but not least and definitely very important - New Chickenpox
vaccine called VARIVAX made by Merck and Co. will be used on our children
as if they were guinea pigs for company profits. Merck's own literature
states "The duration of protection is unknown at present and the need for
booster doses is not defined."

8. Post marketing studies of vaccines utilize the federal Vaccine Adverse
Events Reporting System (VAERS). The government that maintains this system
dismisses VAERS reports as "anecdotal".

Vaccine package insert is the place to start when doing your research.
Please obtain from doctor or pharmacist before you take your child in for
their "scheduled" vaccination. Several good books: "The Immunization
Resource Guide" reviews more than 60 books covering all aspects of
vaccinations, Several places on the internet.

The following site
http://wwwonder.cdc.gov/wonder/prevg...00238/body000=
8.htm
is published by the CDC and when you read this keep that in mind!


http://www.groupz.net/~CRSinc/ & http://www.groupz.net/~CRSinc/fff.html
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Date: Tue, 27 Oct 1998 14:46:16 -0500
From: bullard
To:
Subject: misc.kids FAQ on Childhood Vaccinations, Part 4/4

I'll be brief. I strongly believe that vaccinations are out there=20
to benefit our children. My son has cong. heart disease, and to do=20
nothing would be out of the question. Known fact~~ your child is=20
more at risk of disease if you do not vaccinate him/her. There isn't=20
anyone who can look into the future and determine whether or not
our children are going to be free of problems. If you do nothing,=20
when you can do something~~ then that is ignorance. You can't blame=20
yourself for something that may or may not happen. =20
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Date: Fri, 02 Apr 1999 21:06:38 -0800
From: Erin & Sam Viniegra
To:

Subject: vaccinations

I feel I need to share the tormenting decision I had to make regarding
my sons vaccinations, and the light I found at the end of the tunnel.
Let me begin by telling you that if the decision were completely up to
me, I probably wouldn't have done so. Although my husband (whos father
is a doctor) felt very strongly about doing so. We argued for quite
awhile over the matter. I believe in alternative medicines and had an
alternate plan brought to my attention. In the end he has been
vaccinated for most of them. The exception being Varicella (chicken
pox). We chose to wait to see if he got them on his own as a child, and
if not we may opt to do it later.
I have Kaiser and my doctor is still fighting me on the decisions we
have made. I chose to have him vaccinated for one thing at a time with
at least a two month period in between. I contacted National Homeopathic
Products (800)888-4066 in Madison, Wi and ordered several=20
pre-vaccination kits; one for each shot to be given. The theory behind
this is that giving them the homeopathics prior boosts their immune
systems preparing them for the shot. The homeopathics given after the
shot cleanses their systems of any toxins ( which are used in the base
of all vaccinations). This way I have felt more at ease, my husband is
satisfied, and my son has never had any discomfort, fever, and sometimes
he doesn't even cry when he gets the shot. I hope this helps someone
else who may be in the same position I was.

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=3D=3D=3D=3D
From: mstopp (Beth Topp)
[This story consists of excerpts from a much longer story
which is available at:
http://www.avn.org.au/robert_s.htm.
Since this FAQ is posted on Usenet, to keep the post length
short, I am excerpting from her story rather than including
it in full. - LG]

Am I writing to you because I would not be able to live with myself if=
I
didn't try to prevent other people from having to experience the same trage=
dy
that our family did this summer.

On May 28,1999 my 10 year old son and his 13 year old brother received =
the
first of three "mandatory" Hepatitis B vaccines. My 10 year old son
experienced mental, physical and personality deviations almost immediately.
Five days later the left side of his face was paralyzed followed shortly by=
his
left arm, then his abominable muscles and legs. He has been diagnosed with
Central Nervous System demylination/autoimmune disorder from serious advers=
e
reaction to Hepatitis B. The prognosis and severity of both are unknown.
There are no practice standards of treatment.

Our families story about the devastating effects of the Hep B vaccine law J=
une
1999


I could not imagine a more difficult task than describing how my son was be=
fore
the shot. With every word I feel that bright, curious, considerate, beautif=
ul
little boy getting farther away. My son is still here, but he=92s not the s=
ame.
He changed literally overnight. He had a thorough physical exam and our doc=
tor
said he was in great shape. A few minutes later the nurse gave him his firs=
t
"mandatory " Hepatitis B vaccine. The following morning he was different.
Different looking, different acting. I keep explaining this difference to a=
ll
the doctors.

I realize that it is hard to get past the fact that he is paralyzed on one
side, but that for us is only the tip of the iceberg. There is something el=
se
going on here. There is something really wrong with him. Mentally, physical=
ly,
and personality wise he is a different kid.

I can=92t expect a doctor who has never met him to realize what a dramatic
transformation this is because they have nothing to compare him to. I am ho=
ping
that my memories will be enough to help them understand how much of my chil=
d is
missing. I hope I can make them understand how special he is and help them =
find
some way to bring my little boy back to me. I=92m not asking for a miracle,=
but
just to understand what is happening to him, so maybe I can help fix it. I =
am
so desperate, I will try anything. If he was dead I could mourn him and if =
he
was missing I could look for him and if he had cancer I find the best docto=
rs
for treatment and comfort him. But he has turned into someone else and I do=
n=92t
know what I am supposed to do. I don=92t know how I am supposed to do it.

I enjoy my kids. With six of them there is never a dull moment. They are al=
l
good kids, but Robert was always the perfect child. If you asked the other =
kids
they=92d agree. He was the good one.

Since the day he was born, a perfect little angel with a halo of beautiful
white blonde hair and wise blue eyes. He was content. He didn=92t have coli=
c or
get fussy. He never showed any sign of a temper and was patient to a fault.=
He
was always so happy and agreeable. He was a natural athlete, nice, trying t=
o
please and very bright.

To say he was very bright doesn=92t seem to do justice to his intelligence.=
He
was a straight A student, every year and had scores of 100 percent on the s=
tate
tests. His fourth grade teacher encouraged me to sign him up for our local
college and he was accepted, but I decided a junior college wasn=92t the be=
st
place for a little boy to be a little boy. He went to the Gifted and Talent=
ed
Education Program.

Robert loved to think. He was so curious. He was always asking questions an=
d
loved to figure out brain teasers and word problems. His brothers nicknamed=
him
"Poindexter" and teased him because he would say "Well, actually..." everyt=
ime
he corrected you. And he was always right. But he never bragged. In fact to
Robert it wasn=92t any big deal. Even though he mastered most things immedi=
ately=20
he enjoyed practicing them as well. To keep himself challenged, he would ti=
me
himself and try to get his homework done in record times. I never had to te=
ll
him to do his homework, it was always done. Robert demanded so much of hims=
elf
that I never had to worry about him.

Robert was pleasant, calm, agreeable, mature, intelligent, athletic,
coordinated, focused, self-disciplined, responsible, considerate and so
fantastic every minute you had to remind yourself that he was there...never=
any
trouble. The day before this nightmare began I was on the phone talking to =
my
sister. I was catching her up on all the kids and I commented that I always
have something to talk about for everyone but Robert. Robert is always the
same, perfect as always. Nothing new. Straight A=92s, no trouble, no proble=
ms,
fantastic as always. She laughed and reminded me when Rob broke both his ar=
ms
all anyone talked about was his brother who hit him with the car. I told he=
r if
all the kids were as easy as Rob, I=92d have a lower phone bill because I=
=92d have=20
nothing to talk about.

You really would have to know Robert to understand how radical a change the=
re
was after the shot. He=92s not the same anymore in anyway. He=92s really ti=
cklish
now. And has no tolerance for pain. If you step on his toe he screams and f=
alls
down crying in agony. Then he jumps up and wants to attack whoever hurt him=
.. He
is mean to little kids. He argues and fights and demands that everything be
fair. He gets lost. He looks lost. He can=92t do basic subtraction. He can=
=92t
remember anything. He forgets what we did yesterday and doesn=92t have the
ability to think back and remember the last time he went to the bathroom. H=
e is
cold even when it is 90 degrees. He gets exhausted walking and gets noseble=
eds
alot. His face doesn=92t move on the left side. He can=92t even close his e=
ye or
blink. His face sometimes looks twisted tight and severe. Other times it lo=
oks
like it is sliding off his head. His mouth doesn=92t work so he drools, has
trouble swallowing., slurs words. and when he drinks it runs right down his
chin. The only thing he likes to eat is yogurt and does this weird thing wi=
th
the right side of his tongue licking the spoon. He eats by putting his face
down by the plate. =20

People stare at him constantly. This attention is really hard to take. He n=
ever
wanted to be the center of attention when he deserved it and he really does=
n=92t
want it now. That=92s hard for all of us to take.

He can=92t handle the simplest of tasks. It=92s things like putting items i=
n the
diaper bag to bring in the house. First he picked up everything and then pi=
cked
up the diaper bag. He wasn=92t able to get the zipper open because his hand=
s were
full. Instead of putting the stuff down and opening the zipper, he was stum=
ped.
He started to carry it all inside, but dropped a few things on the ground. =
He
was almost to the house when he decided to go back and get the stuff he
dropped. He then dropped more stuff when he tried to bend over. Finally he =
took
the empty bag in the house and made several trips back outside to get the
stuff. I put it in the bag and then went out side to shut the car door.
Afterwards he had to lay down and said he didn=92t know why he was so tired=
..
=
=20
We went to a block party at our local ice cream shop. They sold raffle tick=
ets
for all sorts of prizes donated by local merchants. Robert had three
consecutive tickets, 513, 514, and 515. They raffled off over 60 prizes in
between songs. My son stared at these three tickets for the entire evening.=
He
held them in his hand in front of his face. Everytime a number was called h=
e
would look at each of the three tickets. Even if the number was 247, he had=
to
look at each of the three tickets to see what the numbers were. Everyone el=
se
was talking, listening to the band and having fun except Robert. He stood i=
n
one spot and had to focus entirely on three consecutive numbers. After watc=
hing
him do this for over an hour, I asked him what his numbers were. He looked =
at
them and turned to tell me but couldn=92t. Then he showed me the tickets so=
I
could look for myself. It is awful to see him like this. My sweet, brillian=
t,
dynamic, little boy. My heart was breaking for him. It scared him and he se=
emed
to withdraw like a turtle into his shell. His shoulders slouched and his ch=
in
went to his chest and he wasn=92t there. I asked him what was wrong and he =
said
he was cold. We went to the car to get his jacket even though it was a
beautiful summer evening. He stumbled a few times on the way to the car so =
I
took him by the elbow to guide him. He put on his jacket with the collar up=
and
hid in it.

He seemed to feel a little better and I asked if he wanted something to eat=
..
The only thing he orders at this place is a corndog and rootbeer. He has li=
ved
here his entire life and that is all he has ever ordered, he loves it. His
brother wanted chili cheese fries so I gave Robert some money and he just s=
tood
there. I told him to go inside I would follow him in there. He stumbled on =
the
step and then barely had the strength to open the door. There was no line s=
o we
didn=92t wait at all to place the order. Robert stood at the counter lookin=
g
completely lost. When the girl asked him what he wanted he looked at me, bu=
t I
told him to go ahead and tell her what he wanted. He struggled and came up =
with
chili cheese fries. The girl asked if that was it and Rob just stared at he=
r.
Then he said "yes, I=92m not hungry". I said "I thought you said you were
hungry?" He said, "Yes, but I can share the fries". So I pushed a little mo=
re
by asking "Fries? What happen to your usual corndog and rootbeer." He looke=
d so
relieved as if I had rescued him, "That=92s right, I=92ll have a corndog an=
d a
large rootbeer." It was then that he realized there was something wrong wit=
h
him and others could tell. He was tucked back into his jacket before the gi=
rl
handed me our change.

I keep a log of what each day is like. Sometimes it seems that the harder t=
he
day the less I can write down. I suppose it is self preservation on my part=
to
avoid any thing that would put me over the edge. Some days I feel so close.
Especially when we have to interact with doctor=92s or the medical professi=
on.
The system makes them appear apathetic and detached. But I haven=92t met a =
single
doctor or nurse who wasn=92t truly affected by Robert=92s pathetic state. T=
hey are
sorry. That is the worst. I want them too fix him and they are sorry. We en=
ded
up in a urgent care bed after Robert collapsed during a doctors appointment=
..
The fourth doctor we saw asked me about his situation, then asked what he c=
ould
do for me. I almost lost it when I told him "How was I supposed to know? I=
=92m
not a doctor." He didn=92t get mad or walk away. He touched my arm and told=
me he
was sorry and wanted to do what he could. I couldn=92t get angry so I am sa=
d and
it just hurts.
=20
The same goes for everyone I=92ve called for information on what treatment =
is
available. I keep calling and reading and trying to find something on how t=
o
cure my son. I=92ve talked to doctors, experts, advocate, parents, and othe=
rs
like Robert. People are so kind. They listen, they care and then they say t=
hey
are sorry. And I wait...I keep waiting for them to continue. But they don=
=92t
continue. So I repeat myself and say my son was seriously injured by the He=
p B
Vaccine and I thought they might have information that could help us. Anyth=
ing
at all, please. They say they are sorry again. Some give me the name of a
lawyer or tell me about the compensation offered. I thought they said this
because the cure was expensive. All I am interested in is my son=92s health=
and
making sure he gets better. They listen as I go on and on. They are kind an=
d
they understand. They are sorry. Sorry doesn=92t bring him back. Compensati=
on
won=92t do it either. We need a doctor not a lawyer. So I keep searching an=
d
praying. I pray that if I ever receive a call from a desperate mother I wil=
l
have something to tell her besides sorry.

Please don=92t say you are sorry. Just bring Robert back.

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
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=3D=3D=3D=3D

  #4  
Old February 16th 04, 09:58 AM
[email protected]
external usenet poster
 
Posts: n/a
Default misc.kids FAQ on Childhood Vaccinations, Part 2/4

Archive-name: misc-kids/vaccinations/part2
Posting-Frequency: monthly
Last-Modified: October 23, 1999


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Section 3. Specific vaccines
---------------------------------------------------------------------------=
----
Section 3a. DTP (diptheria, pertussis, and tetanus) and DT
[Last updated October 2. 1999.]=20

Q3a.1 What is diptheria, and what are the risks of the disease?=20

Diptheria is a contagious disease affecting the nose, throat, and skin. Com=
plications include paralysis (about 20% of patients)
and heart damage (about 50%) (Pantell, Fries, and Vickery). The Merck manua=
l has a very long list of complications, mostly
involving the heart, and says that complications are likely if antitoxin is=
n't administered properly. The death rate was 35%
before antitoxin was available, and is now 10% (Harrison).=20

Q3a.2 How common was diptheria before routine vaccination, and how common i=
s it now?=20

In 1900, there were 40.3 deaths per 100,000 population from diptheria in th=
e US. There was a sharp decline in the number of
deaths per 100,000 both before and after routine vaccination was instituted=
in the 1940s, and in 1990 there were 4 cases of
diptheria reported in the US. (_Historical Statistics of the United States,=
Colonial Times to 1970_ and _Statistical Abstracts of
the United States_.=20

In Europe, there were large diptheria epidemics during and after World War =
II, with an estimated one million cases and 50 000
deaths in 1943 (source: WHO web page on diptheria, written March 1998,
http://www.who.org/gpv-dvacc/disease...theria_dis.htm). More recently, t=
here have been large epidemics in Russia and the
Newly Independent States.=20

Q3a.3 How effective is the diptheria vaccine?=20

"The fatality rate in immunized populations is one-tenth that in the unimmu=
nized population. Paralysis is 5 times and 'malignant'
disease 15 times less common in immune than in nonimmune individuals." (Har=
rison)=20

Q3a.4 How long does the diptheria vaccine last?=20

Ten years.=20

Q3a.5 What is pertussis, and what are the risks of the disease?=20

Pertussis, or whooping cough, is a very contagious disease of the respirato=
ry tract. Its attack rate in unvaccinated household
contacts is over 90% (PDR) or up to 90 and in some cases 100% (Harrison).=
=20

Pertussis is very serious in children under 2, with a mortality rate on abo=
ut 1 to 2%. (Merck) "Prior to the availability of a
vaccine, pertussis caused as many deaths as all other contagious disease _c=
ombined_." (Harrison, p. 607) Complications
include various lung complications (The Merck Manual has a long list of the=
se), cerebral complications, hemorrage into the
brain, eyes, skin, and mucuous membranes. In addition to killing, it can le=
ave surviving infants with lasting lung damage and
neurological diseases.=20

The mortality rate is higher in developing countries, partly because childr=
en in these countries contract pertussis at a younger
age (and mortality is higher at younger ages), and partly due to an associa=
tion with protein-energy malnutrition (Galazka). This
same article estimated that in the industrialized world, 0.04% of infected =
children die from pertussis and complications, usually
pneumonia "Among vaccine-preventable diseases, pertussis rivals measles and=
neonatal tentanus in importance and severity in
young children in developing countries and is third only to measles and neo=
natal tetanus as a cause of death. It is estimated that
pertussis is still causing some 340,000 deaths of children in the world eac=
h year." (Galazka)=20

Q3a.6 How common was pertussis before routine vaccination, and how common i=
s it now?=20

[Note: This section may be outdated, since the introduction of the new acel=
lular vaccine has caused changed in vaccination
schedules and vaccination coverage. More recent information on internationa=
l vaccine schedules and disease incidence may be
found at http://www.who.org.)=20

"Since immunization against pertussis (whooping cough) became widespread, t=
he number of reported cases and associated
mortality declined from about 120,000 cases and 1,100 deaths in 1950, to an=
annual rate of about 3,500 cases and 10
fatalities in recent years." (PDR) For unknown reasons, there has been an i=
ncrease in the US recently. "Over 6000 cases of
pertussis were reported in the U.S. in 1993, the highest number in 25 years=
.." (N Engl J Med 1994 Jul 7; 331:16-21,
summarized in Journal Watch for July 22, 1994.) There is also a recent repo=
rt (MMWR Nov 11, p. 807) of a strain of
pertussis resistant to erythromycin.=20

In some other countries, pertussis is more common (most of the following in=
formation is taken from Galazka). "Before the
introduction of widespread immunization of young children with pertussis va=
ccine, the incidence rates in Europe and the United
States were very high. The reported rates per 100,000 population ranged fro=
m 200-300 in England and Wales and Sweden,
to more than 1,000 in Denmark and Norway." (Galazka) Annual incidence in th=
e US and Canada before the introduction of
pertussis vaccine in the 1940s ranged from 98 to 210 per 100,000 population=
.. After the introduction and widespread use of
DTP vaccine, incidence declined dramatically in most countries, and this tr=
end continued for about 20 years. For example, in
England and Wales, more than 150,000 cases of pertussis were reported a yea=
r in the 1950s; by 1973, when vaccine
acceptance was over 80%, only about 2,400 cases were reported.=20

However, in the late 1970s and the 1980s, different trends began to appear =
in different European countries. In one group of
countries, reported incidence is between 10 and 100 per 100,000. This grou=
p includes Sweden and Italy, which don't
routinely give pertussis vaccine to infants. It also includes Germany, the =
former USSR, Ireland, Spain, and the United
Kingdom, where infants are routinely vaccinated, but coverage is less than =
80%. In Denmark, incidence is high despite high
coverage, but Denmark uses a different vaccination schedule from the other =
countries. Countries with a moderate reported
incidence (between 1 and 10 per 100,000) include Austria, Finland, Greece, =
Israel, Norway, the Netherlands, Portugal,
Romania, and Yugoslavia. Countries with a low incidence (less than 1 per 10=
0,000) include Hungary, Switzerland, Bulgaria,
Czechoslovakia, Poland, and Turkey.=20

Q3a.7 How effective is the whole cell pertussis vaccine?=20

It's one of the less effective childhood vaccinations. The PDR estimates it=
s effectiveness at 70-80%. It's effectiveness rating
depends on the severity of the cases of pertussis being observed. One study=
of 1797 households found the vaccine to be 64%
effective against a mild cough, 81% effective against a paroxysmal cough, a=
nd 95% effective against severe clinical illness.
"Requiring laboratory confirmation improved efficacy to 95 to 98% for cultu=
re-positive children and to 77% to 95% for
culture- or serology-confirmed cases, depending on disease severity. Vaccin=
e efficacy for typical paroxysmal cough increased
from 44% for one diptheria, tetanus, and pertussis vaccine to 80% for four =
or more doses." (Onorato, Wassilak, and Meade)
The variation in estimates of efficacy may be because the more severe cases=
were more likely to actually be pertussis, or it may
be that the vaccine protects better against severe pertussis than against a=
mild form of the disease. Note: these effectiveness
ratings are for the older, whole cell pertussis vaccine. For information on=
the effectiveness of the newer, acellular vaccines,
which is generally comparable to that of the older whole cell vaccines, see=
below.=20

Q3a.8 How long does the pertussis vaccine last?=20

It doesn't. According to _Harrison's Internal Medicine_, "the protection ..=
.. is transient, with minimal resistance being evident a
decade later." However, the critical years for pertussis immunity are when =
a child is young; the disease is not dangerous for
adults. With introduction of the new, less reactogenic acellular vaccine, i=
t is possible that boosters may eventually be given to
adults. (This estimate is for the older, whole cell vaccine, but the newer =
acellular vaccine is apparently at least as durable as the
whole cell one was.)=20

Q3a.9 What is tetanus, and what are the risks of the disease?=20

Tetanus is very dangerous. Even with antibiotics, mortality can be 40% or h=
igher (Pantell, Fries, and Vickery, Harrison).
Tetanus bacteria and its spores are everywhere. Because tetanus is so ubiqu=
itous, the only way to counter it is widespread
vaccination.=20

************************************************** ***********************
From=20J Thompson ):

The tetanus vaccine is actually against the tetanus toxin (a protein
called tetanospasmin), rather than the bacterium alone. The bacterium
doesn't really do much of significance, but the toxin it secretes can cause
muscular spasms. Thus, antibiotic therapy is rather pointless in preventing
the spasms, but it is given anyway. The administration of antitoxin (passiv=
e
immunity) is helpful. (see Harrison's, 13th ed., p. 635)
The vaccine consists of what is called "tetanus toxoid," which is simpl=
y
a purified version of the toxin, which has been treated to render it
ineffective as a toxin (but still immunogenic).
************************************************** ***********************

Q3a.10 How common was tetanus before routine vaccination, and how common is=
it now?=20

300,000 to 500,000 cases are reported worldwide, with a mortality of about =
45%. In the US, there are about 100 cases a
year, with a mortality of 40-60% (Harrison).=20

Q3a.11 How effective is the tetanus vaccine?=20

According to Taking Care of Your Child, "Tetanus is one of our best immuniz=
ations.... Of all the vaccines available, tetanus
comes closest to 100 percent effectiveness after the initial series of shot=
s."=20

Q3a.12 How long does the tetanus vaccine last?=20

Generally ten years. In the case of a really dirty wound, a booster is reco=
mmended if the person hasn't been vaccinated for
tetanus within the last five years.=20

Q3a.13 What are some of the risks of the DTP vaccine?=20

DTP, particularly in its earlier form (with the whole cell pertussis compon=
ent) is probably the most controversial of the
childhood vaccines, because of risks associated with its pertussis componen=
t. Anecdotal evidence has linked the vaccine with a
variety of problems, including convulsions, physical collapse, brain damage=
and SIDS. Supporters of the vaccine have argued
that these problems are common in any case at the age at which children are=
vaccinated for pertussis, and therefore are not
necessarily effects of the vaccine.=20

The association between DTP and SIDS has not been confirmed by further stud=
y (see Q1.5 for a study which found the
evidence to be against such an association). The story on brain damage is s=
omewhat different. Criticism of the pertussis vaccine
received some confirmation in 1976, when a large British study of all child=
ren 2 to 36 months old in Britain found that 1 in
310,000 doses resulted in permanent brain damage.=20

Critics argue that the rate of complications from the pertussis vaccine is =
too high, and the effectiveness too low. Some argue
that the decline in pertussis cases in this century has been an effect more=
of improved sanitation than of the pertussis vaccine.
The side effects of this vaccine have inspired groups critical of vaccinati=
on in several countries, including the US, where the
group Dissatisfied Parents Together (DPT) has lobbied Congress for changes =
to laws about vaccination and set up its own
vaccine information center.=20

Supporters of the pertussis vaccine differ in their response to the British=
study which linked pertussis to brain damage. Some
say that further analysis indicates that a link between the vaccine and bra=
in damage is not so clear. "Meticulous reexamination
of the data from this study led to the conclusion that the preliminary resu=
lts were due to a systematic bias that favored finding an
association between the vaccine and serious neurological sequelae. In fact,=
there was no valid evidence from the study that the
vaccine was associated with permanent neurological damage." (Shapiro)=20

Some smaller studies done since the British study didn't find a connection =
between DTP vaccine and neurological damage, and
a new study was just published in the Journal of the American Medical Assoc=
iation which finds no increased risk of serious
neurological illness. I haven't seen the article yet, so my information com=
es from the January 11, 1994 San Jose Mercury (from
the New York Times news service), which reports that the study is in the cu=
rrent (as of 1/11/94) issue of JAMA. According to
the article, "The federally financed study, the largest of its kind in the =
United States, involved 218,000 children up to 24 months
old in Oregon and Washington who were studied for a one-year period, beginn=
ing Aug. 1, 1987." However, the study is also
described as "not intended to give a definitive answer to the question of w=
hether whooping cough vaccine causes neurological
illness."=20

Others do not dispute the 1976 British study, but argue that a 1 in 310,000=
risk of brain damage is still much smaller than the
risk of actually getting pertussis. Supporters agree that it is important t=
o maintain high vaccination levels against pertussis, lest
we see a resurgence in the disease. In Great Britain, Japan, and Sweden, th=
ere were sharp increases in the number of cases of
pertussis when vaccination levels fell. Routine use was discontinued in Swe=
den as a result of reports of side effects, while
acceptance in Great Britain declined to 30% (Harrison), and vaccination dec=
lined in Japan as well. "Within two years, one
hundred thousand cases (with twenty-eight deaths) appeared in Great Britain=
and thirteen thousand cases (with forty-one
deaths) in Japan. Even in the US, the disease has by no means been wiped ou=
t; there are still about fifteen hundred to two
thousand cases (with four to ten deaths) each year. That is why virtually a=
ll health care authorities recommend that we keep
using this vaccine." (UC Berkeley)=20

ACIP considered the available data on brain damage in 1991, and concluded t=
hat "Subsequent studies have failed to provide
evidence to support a causal relation between DTP vaccination and either se=
rious acute neurologic illness or permanent
neurologic injury." It further noted that "The risk estimate from the NCES =
study of 1:330,000 for brain damage should no
longer be considered valid on the basis of continuing analysis of the NCES =
and other studies." (Staff, Diptheria, tetanus, and
pertussis: recommendations for vaccine use and other preventive measures, i=
n Recommendations of the Advisory Committee
on Immunization Practices (ACIP). Aug 8, 1991, CDC: Atlanta. p. 1-21.)=20

Known and non-controversial (i.e. everyone agrees that they occur) side eff=
ects of DTP vaccine include redness and
tenderness at the injection site, fever, drowsiness, fretfulness, vomiting,=
and convulsions. (A vaccine information pamphlet from
Kaiser gave the frequency as being 1 in 100 to 1 in 1000 for crying without=
stopping for three hours or longer, a temperature
of 105 F or greater, or an unusual, high-pitched cry, and 1 in 1,750 for co=
nvulsions, generally from high fever, or shock
collapse. I didn't see any frequencies in the PDR, other than describing th=
ese side effects as rare.) It is a good idea to give
acetaminophen to children being vaccinated for pertussis, to reduce the cha=
nce of fever and febrile convulsions.=20

From=20Mike Dedek:

************************************************** ***********************
American Journal of Diseases of Children 1992; 146: 173-176, February 1992,=
=20
"Pertussis outbreaks in Groups Claiming Religious Exemptions to Vaccination=
s",=20
Etkind, Lett, et. al.:

2% non-vaccinated students are monitored
:
Key measures in preventing pertussis are immunization and judicious use of
prophylactic antibiotics. Pertussis can be prevented in children by
immunization. Unfortunately, controversy over the safety of the pertussis
vaccine has reduced acceptance. Highly publicized accounts of reactions t=
o the
vaccine and a dramatic increase in the number of malpractice lawsuits have=
made
physicians and parents wary of using the diphtheria-tetanus toxoid and per=
tussis
vaccine. {n4-n6} This publicity may have caused overinterpretation of the
guidelines for medical contraindications. {n7} However, this overinterpret=
ation
creates its own risk for malpractice if a child given an inappropriate med=
ical
contraindication suffers damage due to disease.
************************************************** ***********************

Q3a.14 Did SIDS disappear in Japan after the Japanese changed their pertuss=
is vaccination policy in 1975?=20

This claim is examined at length by Lon Morgan, DC,DABCO in his Web site "A=
summary of JAPAN, SIDS, and
PERTUSSIS IMMUNIZATION" at http://fp1.cyberhighway.net/~lmorgan/fearmongers=
/japan_sids.htm. It turns out that what
went away, in 1975, when Japan increased the age at which it administered t=
he first dose of the vaccine from three months to
two years, was *claims of vaccine injuries* for SIDS. Japan had a compensat=
ion system for vaccine injuries, in which claims
were to be paid unless other causes were clearly provable. Under this syste=
m, 11 claims were paid for what was termed
Sudden Death, between 1970-1975 (this out of 25-30 million doses of pertuss=
is vaccine). After the vaccination age was
raised, no further claims were paid for Sudden Death related to vaccination=
.. Since SIDS occurs before 12 months of age, any
cases of SIDS can not be attributed to a vaccine which is given starting at=
24 months.=20

Japan has, however, kept statistics for SIDS, and these statistics showed t=
he numbers of SIDS cases *increasing*, rather than
decreasing, at the time that the age of the first pertussis vaccination was=
raised. Though the delay in age for the first pertussis
vaccination did not reduce the incidence of SIDS, it did result in a huge i=
ncrease in pertussis cases, peaking at 13,105 cases
and 41 deaths by 1979. For more details, and references, see Lon Morgan's s=
ite.=20

As a side note, recent vaccination rates for Japan, as listed in http://www=
..who.int/gpv-surv/country/japan.html, were, in 1996,
98% for polio, 100% for diptheria, pertussis, and tetanus, and 94% for meas=
les; the coverage for BCG in 1993 was 91%.=20

Q3a.15 When is the DTP vaccine contraindicated?=20

Hypersensitivity to a vaccine component, including thimerosal, a mercury de=
rivative. Defer vaccination in case of fever or acute
infection (but not nececcarily for a mild cold without a fever). A history =
of convulsions is generally a contraindication to
pertussis vaccination, but "The ACIP and AAP recognize certain circumstance=
s in which children with stable central nervous
system disorders, including well-controlled seizures or satisfactorily expl=
ained single seizures, may receive pertussis vaccine.
The ACIP and AAP do not consider a family history of seizures to be a contr=
aindication to pertussis vaccine." (PDR)=20

The following reactions to a previous dose are contraindications: An immedi=
ate anapylactic reaction. Encephalopathy occuring
within 7 days following DTP vaccination. Precautions include a fever of =
=3D 40.5 C (105 F) within 48 hours, collapse of
shocklike state within 48 hours, persistent inconsolable crying for more th=
an 3 hours within 48 hours, convulsions with or
without fever within 3 days. (These latter are precautions rather than cont=
raindications, because there might be circumstances,
such as a pertussis epidemic, where you would still want to give the vaccin=
e.)=20

Pertussis vaccine should not be given to anyone over seven years old (this =
may change, in time, with the new acellular vaccine,
but further study is needed first).=20

Vaccine components capable of causing adverse reactions: for diptheria, thi=
merosal and toxoid; for tetanus, thimerosal and
toxoid; for pertussis, bacterial components (Travel Medicine Advisor).=20

(Note: There is currently, as of 1999, a move toward replacing thimerosal i=
n vaccines, so the reference to thimerosal here may
shortly be out of date.)=20

Q3a.16 What are the advantages and disadvantages of the new acellular pertu=
ssis vaccine?=20

The big advantage is that the acellular vaccine has fewer side effects. The=
FDA initially held off on approving it for the earlier
shots (while approving it for the fourth and fifth shots), mainly due to re=
maining uncertainty as to whether it is as effective as the
whole cell vaccine. Reports from Japan indicated that it is, but a Swedish =
clinical trial indicated efficacy of 59% for one, and
64% for the other acellular vaccine. However, even this trial did show 90%=
efficacy against severe pertussis. (Shapiro) More
recent results in Sweden and Italy indicate it is both safe and effective. =
On July 31, 1996, the FDA licensed one acellular
pertussis vaccine for the inital three shots, and more followed. The Americ=
an Association of Pediatrics has issued guidelines for
the use of the new vaccine, which can be found at their web page, http://ww=
w.aap.org.=20

As of 7/14/95, results were available from two large European studies, invo=
lving 9,829 infants in Sweden and 15,601 infants in
Italy. The National Institute of Allergy and Infectious Disease (in the US)=
reported that "three similar experimental vaccines
effectively immunized 84% to 85% of the children in the trials, while resul=
ting in fewer side effects than current, widely used
versions." (Wall Street Journal, 7/14/95, p. A7A) A surprising result of th=
e studies was that whole cell pertussis vaccine
efficacy rates were lower than usual: "conventional vaccines provided prote=
ction for just 36% of children in Italy and 48% in
Sweden. In the US the conventional vaccine proves effective in 70% to 95% o=
f the children who are vaccinated." Officials
suggested that infants in these studies might have had a higher intensity o=
f exposure to the bacteria due to the lack of
widespread vaccination in those countries, and that might explain the lower=
efficacy. A fourth acellular vaccine provided
protection in 58% of the cases. The high efficacy and low side effects show=
n for the acellular pertussis vaccine in these studies
will likely lead to requests that the FDA also approve the acellular vaccin=
e for the earlier pertusis shots. More information on
recent study results can be found in NEJM, Vol. 333, Number 16, Oct. 19, 19=
95 (B. Trollfors and others).=20

From=20Mike Dedek:

This next one indicates there's a better vaccine that may soon become
available [Note: this vaccine is now available, and recommended for
all doses in the US and some industrialized countries]:

************************************************** ***********************
In Pediatrics 1992; 89; 882-887, May 1992, "Acellular Pertussis Vaccination
of 2-Month Old Infants in the United States", Pichichero, Francis, et. at.:

ABSTRACT: This is the first study in children from the United States that
evaluates the immunogenicity of and adverse reactions to the Connaught/Bike=
n
two-component acellular pertussis vaccine compared with whole-cell pertu=
ssis
vaccine when given as a primary immunization series at 2, 4, and 6 months o=
f
age. Three hundred eighty infants were studied; 285 received acellular
diphtheria-tetanus toxoids- pertussis (DTP (ADTP)) and 95 received whole-c=
ell
DTP (WDTP). Following the third dose, ADTP vaccination produced higher ant=
ibody
responses than WDTP to lymphocytosis-promoting factor (enzyme-linked
immunosorbent assay IgG geometric mean titer (GMT) =3D 131 vs 9 and Chinese
hamster ovary cell assay GMT =3D 273 vs 16) and to filamentous hemagglutini=
n (IgG
GMT =3D 73 vs 10) (all P .0001). Agglutinin responses were higher in WDT=
P
compared with ADTP recipients (GMT =3D 50 vs 37; P =3D .02). Local reactio=
ns were
fewer for all three doses following ADTP vaccination. Fever, irritability,
drowsiness, anorexia, vomiting, and unusual crying all occurred less freque=
ntly
in ADTP compared with WDTP recipients for one or more of the three doses. =
We
conclude that this two-component ADTP vaccine when given as a primary serie=
s
produces greater immunogenicity and fewer adverse effects than the currentl=
y
licensed WDTP vaccine.

....A large case-control study
in Britain (National Childhood Encephalopathy Study) estimated that permane=
nt
neurologic deficits may occur after its administration in 1 in 310000 doses
of WDTP. However, a reanalysis of this and similar studies recently has le=
d=20
to the widely held conclusion that a causal association between WDTP vaccin=
ation
and permanent brain damage has not been demonstrated....

************************************************** ***********************
Public Health Rep 1992; 107: 365-366, May 1992/June 1992, "FDA Approves New
Whooping Cough Vaccine"

The Food and Drug Administration (FDA) has licensed a new whooping co=
ugh
vaccine that may cause fewer side effects in children.

The new vaccine is being approved at this time only for the fourth an=
d
fifth shots. The current vaccine will continue to be used for the first t=
hree
shots. Additional research has been undertaken to ascertain whether it wi=
ll be
effective for preventing pertussis when used for primary inmunization --=
the
first three shots -- in infants.

The new vaccine is acellular, meaning that it is made from only part o=
f the
pertussis organism, as opposed to the whole organism from which the curre=
nt
vaccine is derived.

Whooping cough ( pertussis) is a highly contagious disease. As many as=
90
percent of nonimmune household contacts acquire the infection. Since rout=
ine
immunization against pertussis became common in the United States, the n=
umber
of reported cases of disease and deaths from it has declined from about 12=
0,000
cases with 1,100 deaths in 1950 to an annual average in recent years of ab=
out
3,500 cases with 10 fatalities.

The new vaccine appears to be as effective in older children as the cu=
rrent
vaccine and to cause fewer adverse reactions. It has been widely used in =
Japan
-- where it was developed -- with apparent success in children older than =
2
years. It will be combined with diphtheria and tetanus toxoids (DTP) and =
sold
under the brand name Acel-Imune.

Gerald Quinnan, MD, acting director of FDA's Center for Biologics, where=
the
vaccine was evaluated and licensed, said that the availability of an acell=
ular
vaccine is a significant step forward in infectious disease control.

The most common adverse reactions seen in clinical trials of the acellula=
r
pertussis vaccine included tenderness, redness, and swelling at the injec=
tion
site, fever, drowsiness, fretfulness, and vomiting.

The new pertussis vaccine component is produced by Takeda Chemical
Industries Ltd. of Osaka, Japan, and is combined with diphtheria and tetan=
us
toxoids manufactured by Lederle Laboratories of Wayne, NJ. Lederle will a=
lso
distribute the product in the United States. The vaccine is administered =
by
injection.

The approval of the new vaccine comes at a time when the Federal Govern=
ment
is emphasizing early childhood immunizations in the wake of the largest rep=
orted
measles outbreak in the nation in 20 years -- with more than 27,600 cases a=
nd 89
deaths reported in 1990.

The aim is to reach a goal of full immunization for 90 percent of childre=
n by
the time they are 2 years old.
************************************************** ***********************

As of September 1999, results are available from still more studies. Since =
1991, seven studies in Europe and Africa evaluated
the efficacy of eight DTaP vaccines given to infants. The vaccines were by =
different manufacturers, with varying number and
quantity of antigens. Number of doses varied (three in some, four in others=
), as did other aspects of the study design, such as
the case definition for pertussis and the laboratory method used to confirm=
the diagnosis. For this reason, the studies can't be
compared directly, but within the individual studies, the efficacy of whole=
cell vaccine can be compared with the efficacy of
acellular. Acellular was within the range expected for whole cell. Estimate=
s of efficacy ranged from 59% to 89%. More serious
adverse effects (fever over 105 F, persistent crying for more than three ho=
urs, hypotonic hyporesponsive episodes, and
seizures) happened less often with acellular. Really rare adverse events (e=
ncephalopathy and anaphylactic shock) were too rare
to show up in these studies. Acellular pertussis vaccines have also been us=
ed routinely since 1981 in Japan.=20

Despite the acellular vaccine's comparable efficacy and few adverse reactio=
ns, the whole cell pertussis vaccine retains one
advantage which ensures some continued use. It is cheaper, and more organiz=
ations know how to make it In developing
countries, where pertussis is a major killer, and money for vaccines in sho=
rt supply, it is not clear that the advantages of the
acellular vaccine justify the additional cost.=20

Q3a.17 What are some of the risks of the DT (diptheria and tetanus) vaccine=
?=20

Most of the risk in the DTP vaccine comes from its pertussis component; the=
diptheria and tetanus vaccines are quite safe.
Reactions to the diptheria vaccine are quite rare. Most reactions are local=
, limited to swelling at the injection site. The same is
true of the tetanus shot. "Severe local reactions can occur if too many sho=
ts are received; this phenomenon was frequently seen
in military recruits who received unneeded immunizations." (Pantell, Fries,=
and Vickery)=20

Q3a.18 When is the DT vaccine contraindicated?=20

Should be avoided during the first trimester of pregnancy. People who have =
had a reaction (which is very rare) should avoid it.=20

Vaccine components capable of causing adverse reactions: for diptheria, thi=
merosal and toxoid; for tetanus, thimerosal and
toxoid (Travel Medicine Advisor).=20

(Note: There is currently, as of 1999, a move toward replacing thimerosal i=
n vaccines, so the reference to thimerosal here may
shortly be out of date.)=20

Q3a.19 Under what circumstances is tetanus toxoid given to pregnant women?=
=20

Tetanus toxoid is given to pregnant women in countries where there is a hig=
h risk of neonatal tetanus (due to factors which
enhance the risk of cord contamination in these countries).=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3b. Polio
[This section last updated September 19, 1999.]

Q3b.1 What is polio, and what are the risks of the disease?=20

Polio is a contagious viral disease which crippled tens of thousands in the=
1950s, and killed more than a thousand a year.
Because it is a mild gastrointestinal illness in young children and a serio=
us paralytic illness in older people, it had an unusual
epidemiology, with more cases of paralytic polio turning up in wealthy area=
s and as sanitation improved. 80-90% of cases of
polio are the minor illness; the rest are paralytic poliomyelitis. In paral=
ytic poliomyelitis, 25% suffer permanent severe
disability, about 25% have mild disabilities, and 50% recover with no res=
idual paralysis. Mortality is 1 to 4%. "Recently, a
post poliomyelitis syndrome has been described, characterized by muscle fat=
igue and decreased endurance... The syndrome
occurs many years after an attack of paralytic poliomyelitis..." (Merck).=
=20

Q3b.2 How effective is the polio vaccine?=20

The Merck Manual and the Physician's Desk Reference give its effectiveness =
as 95%. An article in a WHO publication (Hull
and Ward) estimates effectiveness at 80%. (As with other WHO estimates, the=
lower effectiveness rating reflects an estimate
of effectiveness in the field in a variety of countries, including countrie=
s in the Third World. Polio vaccine effectiveness can
deteriorate if it is exposed to too much heat, which can happen in vaccinat=
ion programs in some countries.)=20

Q3b.3 How long does the polio vaccine last?=20

It provides lifelong immunity.=20

Q3b.4 What is the difference between oral polio vaccine (OPV) and inactivat=
ed polio vaccine (IPV)?=20

Oral polio vaccine provides better immunity, and was until recently usually=
the recommended form, "because induces intestinal
immunity, is simple to administer, is well accepted by patients, results in=
immunization of some contacts of vaccinated persons,
and has a record of having essentially eliminated disease associated with w=
ild poliovirus in this country." (PDR) However, it
carries a small risk of paralysis (see the answer to the next question for =
details).=20

Recently, with increased progress in worldwide eradication of polio, both A=
CIP and AAP have changed their recommendation
to IPV for all shots. OPV remains the vaccine of choice for countries where=
polio is still endemic, and for people who will be
shortly travelling to such countries.=20

Q3b.5 I've heard that it is possible to contract polio from handling the di=
apers of recently immunized infants. How long after
receiving the vaccine does the child's excrement continue to contain the vi=
rus?=20

************************************************** ***********************
From=20Caren Feldman:

Speaking of this, I know there has been mention in the past of contractin=

g
polio from handling diapers of recently immunized infants. Does anyone
know how long after receiving the vaccine the child's excrement continues=

to
contain the virus? The reason I ask is because sean got his polio booste=

r
and Rachel has only received the first vaccine in the series. The doctor=

's
office said she wain no danger of contracting poliofrom him since they do=

n't
come in contact with each other *that* closely. However, I have to be ex=

tra
careful after helping Sean clean up (he needs help sometimes) or handling=

his
underwear to make sure I wash my hands thoroughly. So, how long until I
can stop being paranoid about remembering to wash my hands after handling
the laundry? (I forgot to ask)
=20

The short answer is 6 weeks. But since you brought up the subject...here's =
what
I fond out about polio immunizations:

When I had read one poster's response that the live polio virus from feces
was actually weakened virus that would in fact help immunize unimmunized ki=
ds
they'd come in contact with it, naturally I didn't believe it. Well, not at
first. But I had enough doubts of my disbelief to start asking around, and =
came
up with some (at least to me) little known facts about polio and polio
immunizations. I am presenting it to misc.kids for everyone's edification.

Indeed, live virus from a recently immunized child's feces is weakened viru=
s
that health officials actually hope unimmunized kids come in contact with =
to
provide them with individual immunity and the general population with "herd=
"
immunity.

Now here's the tricky part. One of the attenuated strains used to make the
vaccine has a very low but existing back mutation rate, back to the "wild
type", i.e. back to "regular" polio. If the weakened virus the child has be=
en
given mutates back to wild-type polio, any adult with no immunity to it (or
an immunized adult for whom the immunization series did not "take") is
potentially at risk for full blown polio. Of course, people with weak immun=
e
systems may be at risk even from weakened virus. Steroid use may also caus=
e
the immune system to weaken (besides the usual anti-rejection drugs, HIV,
leukemia) and thus increase susceptibility for contracting the virus.

Polio in young children manifests itself as a mild gastrointestinal ailment=
..
Polio in older children and adults starts as a mild gastroenteritis but wit=
h
complications that may lead to paralysis. Before the advent of improved pub=
lic
sanitation, most young children were exposed to and probably contracted the
polio virus, so by adulthood, chances were everyone had immunity to it. It
was only when public sanitation improved to where exposure to the virus was
delayed until later childhood that polio epidemics became prevelant. Polio
outbreaks in the US were less frequent among poor children than among more=
=20
affluent families.

The CDC estimates the chances of getting polio from a first immunization (I
presume this means gastroenteritis symptoms in babies, not paralytic polio)
is one in half million. The chances of getting polio from subsequent
immunizations is 1 in 12 million. I assume the chances of secondarily
contracting polio from feces are even rarer.

These rare cases probably account for the supermarket tabloid (not to menti=
on
"60 Minutes") stories of adults catching polio from recently immunized kids
who'd been given oral vaccine. For those in the US, you will be glad to
hear that a federal compensation program exists, called the National Vaccin=
e
Injury Compensation Program, to help those stricken with paralytic polio as=
a
result of coming into contact with a recipient of the oral polio vaccine.


Thanks go to two posters on sci.med for answering my questions regarding th=
is
subject.
************************************************** ***********************

The 1993 Physician's Desk Reference confirms Caren Feldman's account, with =
two small modifications. First, it gives the time
when the virus is shed as 6-8 weeks, rather than six. Second, the CDC estim=
ates which she gives are the estimates for cases of
paralysis in *both* vaccine recipients and contacts of vaccine recipients c=
ombined, not for recipients alone.=20

Q3b.6 What are some other risks of the polio vaccine?=20

A small risk of anaphylactic shock.=20

Q3b.7 When is the polio vaccine contraindicated?=20

Because of the small risk of paralytic polio in recipients and contact of r=
ecipients of OPV, it should not be given to anyone who
is immune-compromised or who has immune-compromised family members. (The PD=
R has a really long list of immune
deficiencies involved, which you can check if you think anyone in your fami=
ly falls in this category.) In these cases, IPV should
be given instead. IPV is also recommended for adults who are at risk for po=
lio (such as unvaccinated adults travelling to an
area where polio is endemic). Both vaccines are contraindicated for people =
with an anaphylactic allergy to neomycin or
streptomycin.=20

Vaccine components capable of causing adverse reactions: for both OPV and I=
PV, streptomycin, neomycin, and phenol red;
for IPV, animal protein, formaldehyde, and polymyxin B (Travel Medicine Adv=
isor).=20

Q3b.8 Isn't it true that wild polio has been eliminated in the US?=20

From=20Mike Dedek:

************************************************** ***********************
From The Reuter Library Report, 2/26/93, "U.N. Warns on need for Polio=20

Immunisation" copyright 1993 Reuters:

The last outbreak of polio took place in the Netherlands 15 years ago. T=
he
virus was carried to Canada and the United States by infected people visit=
ing
their relatives, the WHO said. This caused the United States' last polio
outbreak which hit the Amish community in the state of Pennsylvania in 1=
979.

************************************************** ***********************
From The [London] Independent, 2/9/93, pg. 12, "Why child vaccines may be =

a
shot in the dark", by Tessa Thomas:

After numerous cases in which the ''live'' oral polio vaccination was
found to have caused the disease, the American government is considering
reintroducing the inactivated injectable version. In the UK, the Departmen=
t of
Health advocates the live version on the basis that it deactivates any wil=
d
polio virus that reaches the gut, preventing it being excreted into the
community, thus conferring community protection. The injectable vaccine ac=
ts
only on the bloodstream, protecting the individual but not breaking the ch=
ain of
infection. Lobbying by the Association of Parents of Vaccine Damaged Child=
ren
has prompted an acknowledgement by Virginia Bottomley, the Secretary of St=
ate
for Health, that the live vaccine is responsible for 50 per cent of recent=
new
cases of polio. Between 1978 and 1991 there were 42 cases of polio, 18 =
of
which followed vaccination and nine of which followed infection through co=
ntact
with the vaccinated child.

************************************************** ***********************
The Atlanta Journal and Constitution, 12/19/92, "Cases in Netherlands put
Americas at risk for polio", by Steve Sternberg, Section E; pg. 1

The last polio case in the Americas emerged on Aug. 23, 1991 in the remot=
e
Peruvian highlands village of Pichinaki...

************************************************** ***********************
UPI 12/10/92:

Except for a few rare vaccine-associated cases, there have been no cas=
es
of polio in the United States since 1986 when there was one imported ca=
se.
The current vaccine, Sutter said, is close to 100 percent effective in
preventing the disease.

************************************************** ***********************

MMWR's Summary of Notifiable Diseases, United States, 1997 (MMWR, November =
20, 1998 / 46(54);1-87) reports that
"Since 1980, a total of 147 cases have been reported, of which 139 were ass=
ociated with the use of OPV. The last imported
case was reported in 1993."=20

Q3b.9 Why are we still vaccinating for polio, then?=20

The AAP and ACIP continue to recommend vaccination for polio for several re=
asons. First, the risk of the disease is much
higher than the risk of the vaccine. Second, though there is no wild polio =
in the US *now*, with high levels of vaccination, there
is still polio elsewhere in the world. 148,000 cases were reported to WHO i=
n 1990. China reported 5,065 cases. The USSR
reported 337 cases. India reported 7,340. (Hull and Ward) There have been s=
everal outbreaks of polio in countries 2 or more
years after the last reported case of polio. Importation from polio endemic=
countries has led to outbreaks in Oman (1988-89
and 1993), Jordan (1991-92), Malaysia (1992), and the Netherlands (1992-93)=
(MMWR, reported in HICNet Medical
News on 15 August 1994). Wild poliovirus type 3 was isolated during January=
-February 1993 among members of a religious
community objecting to vaccination in Canada (although no actual cases of p=
arlytic polio occurred in Canada at this time).
There is a concern that if levels of vaccination were reduced in the US, po=
lio could be reintroduced, and we could see polio
epidemics here again.=20

Encouraged by the worldwide elimination of smallpox, WHO, in 1988, set a go=
al of eradicating polio from the world by 2000.
Since then, the number of cases in the world has declined dramatically (29,=
916 in 1989 and 16,435 in 1990), and the number
of countries reporting 0 cases has increased (74 countries in 1985 and 116 =
countries in 1990). As of 1993, the number of
cases worldwide has falled to 9714, and nearly 70 percent of all countries =
reported no cases. (Progress toward global
eradication of poliomyelitis, 1988-1993. MMWR 1994 Jul 15; 43:499-503. Summ=
arized in Journal Watch Summaries for July
22, 1994.) As of 1999, WHO reports still further progress, "In 1988, virus =
circulated widely on all continents except Australia.
By 1998, the Americas were polio-free (certification of eradication in 1994=
), transmission has been interrupted in the Western
Pacific Region of WHO, including China, and in the European Region, except =
for a small focus in south-east Turkey. As shown
below, only three major foci of transmission remain: South Asia (Afghanista=
n, Pakistan, India), West Africa (mainly Nigeria)
and Central Africa (mainly Democratic Republic of Congo)." So another facto=
r in the decision to continue vaccinating for polio
is the hope that it can be eliminated for good.=20

After much debate, the US has switched to IPV instead of OPV (IPV being les=
s effective, but lower in side effects). The
decision at first was to continue with OPV because it has been so successfu=
l, the rate of side effects is still considered very low,
and because of various advantages in producing immunity (see above). Accord=
ing to the 1993 PDR, "The choice of OPV as
the preferred poliovirus vaccine for primary administration to children in =
the United States has been made by the ACIP, the
Committee on Infectious Diseases of the American Academy of Pediatrics, and=
a special expert committee of the Institute of
Medicine, National Academy of Sciences." In 1995, though, that decision was=
changed, and the injected vaccine became
recommended for the first two polio shots. As progress toward worldwide pol=
io eradication continued, and as the change in
the vaccination schedule (from an oral to an injected form) did not result =
in any decline in vaccination coverage, ACIP and
AAP are now recommending IPV for all shots.=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3c. MMR (measles, mumps, and rubella)
[This section last updated on October 23, 1999.]=20

Q3c.1 What is measles, and what are the risks of the disease?=20

Measles is one of the most contagious infectious diseases. "A child can cat=
ch measles by breathing the air in a doctor's waiting
room two hours after an infected child has left." (Fettner) 90% of suscepti=
ble household contacts get the disease (Harrison).
Measles spreads very rapidly in unexposed populations. In 1951, it was intr=
oduced to Greenland by a recently arriaved visitor
who went to a dance as he was coming down with it, and in three months it s=
pread to more than 4000 cases and 72 deaths.
The attack rate was 999 cases per 1000 people. In 1875, measles was introdu=
ced to Fiji and killed 30 percent of the
population (Smith).=20

In areas where it was endemic, before the measles vaccine, measles epidemic=
s used to occur at regular intervals of two to three
years, usually in the spring, with small local outbreaks in intervening yea=
rs. Mortality is low in healthy, well-nourished children
unless complications ensue (Merck), but nevertheless there were 400 deaths =
a year before an improved measles vaccine was
introduced in 1966 (Pantell, Fries, and Vickery). Complications include bra=
in infection, pneumonia, convulsions, blindness,
various bacterial infections, encephalitis, and SSPE (a fatal complication =
which can occur years after a person has had
measles). Pregnant women who get measles have a 20% chance of miscarriage.=
=20

Worldwide, measles is one of the leading causes of childhood mortality. "Me=
asles has been called the greatest killer of children
in history." (Clements, Strassburg, Cutts, and Torel) In 1990, "45 million =
cases and around 1 million deaths were estimated to
occur in developing countries. Thus measles is still responsible for more d=
eaths than any other EPI target diseases. The true
number dying as a result of measles may be twice the estimated 1 million if=
the recently documented delayed effect of the
disease is taken into account." (Ibid.) Mortality is higher in developing c=
ountries due to a difference in the age at which most
people catch it (measles is a more dangerous disease in the very young), po=
orer nutrition, less availability of treatment for
bacterial chest infections, and other environmental factors. However, "Even=
in countries with adequate health care and healthy
child populations, the complication rate can reach 10%." (Ibid.)=20

More information on the incidence of measles complications is found in the =
answer to Q3c.2.=20

Q3c.2 How common was measles before routine vaccination, and how common is =
it now?=20

************************************************** ***********************
From=20Anthony C.:

I havent finished reading this thread so pardon if someone else has
already posted this information

Rates of complications of measles and measles immunization
Measles per 10^5 Vaccine per 10^5
Encephalomylelitis 50-400 .1
sspe .5-2.0 .05-.1
Pneumonia 3800-1000 =20
Seizures 500-1000 .02-19
Deaths 10-10000 .01

These statistics are worldwide, hence the variablility in numbers. The
higher rates of pneumonia and death represent figures collected from
India, Nambia, Nigeria, bangladesh and other countries with developing
health care industries.

As far as the number of people afflicted with measles in the US
Cases Deaths
1963 385,566 364 Inactivated measles type vaccine available
1964 458,093 421
1966 204,136 261 public health administration of vaccine
1967 62,705 81
1968 22,231 24
..
..hovers around 20-70,000
..
1977 57,345 15
1978 26,871 11
1979 13,597 6
1980 13,506 11
1981 3,032 2
1982 1,697 2
1983 1,497 4
1984 2,587 1
1985 2,822 4
1986 6,273 2
1987 3,588 2
1988 2,933 not available
1989 16,236 41
1990 26,520 97

iMajor foci of retransmission barring the complete elimination of measles:
1) unimmunized indigent, inner city youngsters.
2) illegal aliens.

I hope this is useful. My source is Zinsser microbiology, 20th edition
pages 1013-1015, joklik et al.
************************************************** ***********************

As the above table shows, there was a marked increase in measles incidence =
in the US from 1989 to 1991. This resulted in
more than 50,000 cases including 125 deaths (http://www.immunize.org/nslt.d=
/n21/paradx21.htm). Measles has been on the
decline again in the US since 1990 (MMWR Feb 4, 1994, p. 57). Colleges enfo=
rcing the requirement for a second measles
vaccine report fewer measles outbreaks than schools with no requirement (JA=
MA, Oct 12, 1994, p. 1127). (Both of these
citations from Journal Watch for Jan 15, 1995 - paper edition, or Feb 7, 19=
95 - electronic edition.) During 1998, a provisional
total of 100 measles cases was reported to the CDC, making for a record low=
, 28% lower than the 138 cases reported in
1997 (MMWR 48(34);749-753, 1999. Centers for Disease Control).=20

Q3c.3 How effective is the measles vaccine?=20

The Merck Manual and the Physician's Desk Reference estimate its effectiven=
ess at 95%. This estimate is based on studies of
the immunity induced by a series of vaccinations beginning at 15 months. An=
other article, estimating the immunity induced in
field conditions (including some Third World countries, which may have less=
reliable vaccine storage) by a series of injections
beginning at 9 months (the injections are started earlier in areas where me=
asles is widespread), estimated effectiveness as 85%
(Clements, Strassburg, Cutts, and Torel).=20

A recent article in Pediatric News (Imperio. Vaccine-Exempt At Higher Risk =
For Measles. Pediatric News 33(9):9, 1999.)
reported that "Individuals aged 5-19 years who were not vaccinated due to r=
eligious or philosophical exemptions were, on
average, 35 times more likely than vaccinated individuals to contract measl=
es, according to a population-based, retrospective
cohort study."=20

Q3c.4 How long does the measles vaccine last?=20

The Merck Manual describes it as "durable." The PDR says that all of the an=
tibody levels induced by MMR have been shown
to last up to 11 years without substantial decline, and "continued surveill=
ance will be necessary to determine further duration of
antibody persistance."=20

Q3c.5 What are some of the risks of the measles vaccine?=20

There is a small chance of complications similar to the complications of me=
asles (pneumonia, encephalitis, SSPE). Information
on the frequency of these complications is included in the answer to Q3c.2.=
There is some risk of anaphylaxis. This risk is low;
from the time that VAERS was instituted in 1990 till the publication of Upd=
ate: Vaccine Side Effects, Adverse Reactions,
Contraindications, and Precautions by ACIP in 1996, 70 million doses of MM=
R vaccine had been distributed in the US, and
only 33 cases of anaphylactic reactions had been reported to VAERS. It has =
been traditionally believed that this risk is mainly
for people allergic to eggs or neomycin. However, recent studies indicate t=
hat anaphylactic reactions are not associated with
egg allergies, but with some other component of the vaccine. There have bee=
n some case reports, in the US and Japan, of
anaphylactic reactions to the MMR vaccine in people with an anaphylactic se=
nsitivity to gelatin.=20

In rare instances, MMR vaccine can cause clinically apparent thrombocytopen=
ia within 2 months after vaccination. Passive
surveillance systems report an incidence of 1 case per 100,000 doses in Can=
ada and France, and 1 per million in the US.
Prospective studies have reported a range from 1 in 30,000 in Finland and G=
reat Britain to 1 in 40,000 in the US, with a
clustering of cases about 2-3 weeks after vaccination.=20

An article in the Feb 28, 1998 Lancet (based on 12 cases) about a possible =
association between inflammatory bowel disease,
autism, and MMR vaccine (Wakefield et al) raised concerns that the vaccine =
might increase the risk of autism. Wakefield and
his colleagues did not claim to have actually shown that the vaccine caused=
autism, but rather called for further investigation of
the question. An accompanying editorial in the same issue of Lancet express=
ed concerns about the validity of the study.=20

The article, and the public concern it raised, led to several further inves=
tigations of whether such an association existed. A
research letter in the May 2, 1998 issue of Lancet reported on a 14-year pr=
ospective study, in Finland, of children who had
experienced gastrointestinal symptoms after receiving the MMR vaccine. 31 c=
hildren (out of 3 million vaccine doses) reported
gastrointestinal symptoms; all recovered, and none developed autism. A Work=
ing Party on MMR Vaccine of the United
Kingdom=92s Committee on Safety of Medicines (1999) examined hundreds of re=
ports, collected by lawyers, of autism or
Crohn's disease (a gastrointestinal disease) and similar problems, after th=
e MMR vaccine, and concluded that there was no
causal relationship. A Swedish study (Gillberg and Heijbel 1998) found no d=
ifference in the prevalence of autism in children
born before the introduction of MMR vaccine in Sweden, and children born af=
ter. Wakefield and colleagues did laboratory
assays in patients with inflammatory bowel disease (the mechanism which the=
y had proposed for autism following the MMR
vaccine), and found them negative for measles virus (Chadwick 1998, Duclos =
1998, cited by the CDC at
http://www.cdc.gov/nip/vacsafe/vacci...cts/autism.htm).=20

Finally, a study in the June 12, 1999 issue of Lancet examined children bor=
n with autism since 1979 in eight North Thames
health districts, to look for changes in incidence or age at diagnosis sinc=
e the introduction of MMR vaccination in the UK in
1988. The study found a steady increase in cases of autism, with no sudden =
change in the trend after the introduction of the
MMR vaccine. Parents most frequently reported first noticing symptoms of au=
tism at around the age of 18 months, after the
MMR vaccine would have been received, but there was no difference in age at=
diagnosis between those vaccinated before and
after 18 months and those never vaccinated. Developmental regression (which=
occurred in about a third of the cases of autism)
was not clustered in the months after vaccination.=20

Q3c.6 What is mumps, and what are the risks of the disease?=20

Mumps is a viral disease which is less contagious than measles or chicken p=
ox. It causes swollen salivary glands. The most
common complication is swelling of the testes (in about 20 percent of males=
post puberty) and, less commonly, ovaries. Rarely,
it can lead to sterility. Other complications are meningitis (less common t=
han in measles) and acute pancreatitits. (A much longer
list of complications can be found in the Merck Manual.)=20

Q3c.7 How common was mumps before routine vaccination, and how common is it=
now?=20

105,00 cases were reported in 1970; by 1990 the rate of reported cases was =
down to 5,300.=20

Q3c.8 How effective is the mumps vaccine?=20

The Merck Manual estimates its effectiveness at 95%. The Physician's Desk R=
eference gives its effectiveness as 96%.
Switzerland has gotten lower efficacy rates, for mumps, out of its strain o=
f the MMR vaccine, and Swiss scientists have been
comparing the efficacy of different strains to improve this situation (Swis=
s Medical Weekly,
http://www.smw.ch/archive/1997/127-26-360-96.html and http://www.smw.ch/arc=
hive/1998/128-17-351-98.html).=20

Q3c.9 How long does the mumps vaccine last?=20

The Merck Manual describes it as "durable." "Mumps immunization provides pr=
otection through the blood serum antibodies for
at least 12 years, and possibly much longer." (Pantell, Fries, and Vickery)=
(See also Q3c.4 for the PDR's description of the
duration of all the MMR-induced antibodies.)=20

Q3c.10 What are some of the risks of the mumps vaccine?=20

"Rarely, side effects of mumps vaccination have been reported, including en=
cephalitis, seizures, nerve deafness, parotits,
purpura, rash, and prurittis." (Merck. Encephalitis and convulsions were al=
so on Merck's list of complications for mumps itself.)
According to ACIP's 1996 report on vaccine adverse reactions, "Aseptic meni=
ngitis has been epidemiologically associated
with receipt of the vaccine containing the Urabe strain of mumps virus, but=
not with the vaccine containing the Jeryl Lynn strain,
the latter of which is used in vaccine distributed in the United States." [=
MMWR 45(No. RR-12), 1996]=20

Q3c.11 What is rubella, and what are the risks of the disease?=20

Rubella is a mild illness, consisting of a mild fever and rash. Rare compli=
cations include ear infections and encephalitis, but the
real danger is to pregnant women. During the last rubella epidemic, in 1964=
, 20,000 children were born with birth defects
caused by rubella. Birth defects include deafness, cataracts, microcephaly,=
and mental retardation. Children born with
congenital rubella are als susceptible to rubella panencephalitis in their =
early teens.=20

Q3c.12 How common was rubella before routine vaccination, and how common is=
it now?=20

Before the development of the rubella vaccine, epidemics used to occur at i=
rregular intervals in the spring, with major epidemics
at 6 to 9 year intervals. (This means that one was just about due when the =
vaccine came out in 1969.) There have been no
major epidemics since 1969, but the number of cases of rubella and congenit=
al rubella syndrome increased starting in 1989
(Merck, also California Morbidity for November 19, 1993). (It was still a s=
mall fraction of the pre-vaccine number, though,
see table of disease frequencies in section 1.) "Serological surveys conduc=
ted in the late 1970s and the 1980s indicated that 10
to 25 percent of United States women of child-bearing age were shown to be =
susceptible to rubella." (California Morbidity,
November 19, 1993) It now appears to be declining again: "Following a resur=
gence of rubella and congenital rubella syndrome
(CRS) during 1989-1991, the reported number of rubella cases during 1992 an=
d 1993 was the lowest ever recorded."
(MMWR, cited in June 9, 1994 HICNet Medical News Digest.)=20

Q3c.13 How effective is the rubella vaccine?=20

The Merck Manual estimates its effectiveness at 95%. The Physician's Desk R=
eference gives its effectiveness as 99%.=20

Q3c.14 How long does the rubella vaccine last?=20

The Merck Manual describes it as "sustained." (See also Q3c.4 for the PDR's=
description of the duration of all the
MMR-induced antibodies.)=20

Another reference, from Heather Madrone:

************************************************** ***********************
D. M. Horstmann "Controlling Rubella: Problems and Perspectives"
_Annals of Internal Medicine_, vol. 83, no. 3, pg. 412

Horstmann found reduced antibody formation 3-5 years after administering
the vaccine and 25% of those tested showed no immunity to rubella at
all.
************************************************** ***********************

Q3c.15 What are the pros and cons of vaccinating all infants for rubella ve=
rsus vaccinating females only at puberty?=20

There is still some uncertainty about the most desirable rubella vaccinatio=
n policy. In 1969, when the vaccine came out, it was
decided to avert the expected epidemic by vaccinating all children over one=
year, so that they would not spread rubella to their
possible pregnant mothers - the first time one group of people was vaccinat=
ed to avoid having them spread a disease to a
different group of people. Supporters of this policy point out that the exp=
ected epidemic didn't occur. The possible
disadvantage is that we aren't sure how long the immunity lasts. Now that g=
eneration of children is old enough to have children,
and some of them may no longer be immune. In the past, 80% of the populatio=
n was immune due to having had rubella in
childhood.=20

Some countries follow a policy of vaccinating girls at puberty if they don'=
t have rubella antibodies (Pantell, Fries, and Vickery).
The disadvantage is that vaccine side effects are more common at this age. =
The most common is joint pain, which occurs in
10% of women who are vaccinated in adolescence or later. In some cases, it =
has lasted as long as 24 months. (Pantell, Fries,
and Vickery) The PDR describes this same side effect in somewhat milder ter=
ms, saying that it generally does not last very long
and "Even in older women (35-45 years), these reactions are generally well =
tolerated and rarely interfere with normal
activities." It does agree with Pantell, Fries, and Vickery that the incide=
nce of this side effect increases with age: 0-3% of
children and 12-20% of women have joint pain, and the pain is more marked a=
nd of longer duration in the adult women. A few
women (between 1 in 500 and 1 in 10,000) experience peripheral neuropathy (=
tingling hands). Another risk of vaccinating later
is the risk that a woman may be pregnant. So far, no connection with birth =
defects has been demonstrated, but women are
advised to avoid pregnancy for three months after getting the vaccination.=
=20

Current US policy is to vaccinate all children at 15 months, and give a boo=
ster during school years. Adult women are advised
to get an antibody test before becoming pregnant, and, if it comes up negat=
ive, get vaccinated and wait three months before
getting pregnant.=20

There has not been a rubella epidemic since 1964, either in countries which=
vaccinate all children at 15 months, or in countries
which vaccinate girls only at puberty.=20

Q3c.16 What are some of the risks of the rubella vaccine?=20

The PDR has a long list of possible adverse reactions (besides arthritis an=
d arthralgia, usually short-lived, see above). Most of
them are either mild or rare.=20

Q3c.17 When is the MMR vaccine contraindicated?=20

People with an anaphylactic or anaphylactoid allergy to eggs or neomycin sh=
ould not get the vaccine. Other allergies or chicken
or feather allergies are not a contraindication. Vaccination should be defe=
rred in case of fever. The PDR give active untreated
tuberculosis as a contraindication, but the AHFS says that there is no evid=
ence of a need to worry about TB. Both give immune
deficiency as a contraindication (see PDR for a long list of immune deficie=
ncies involved). Immune globulin preparation or
blood/blood product received in the preceding 3 months. The same contraindi=
cations apply individually to measles and mumps
vaccines, but the rubella vaccine can be given by itself to people with an =
anaphylactic egg allergy. The other contraindications
still apply to the rubella vaccine alone. (California Morbidity, October 31=
, 1987)=20

Vaccine components capable of causing adverse reactions: for mumps and meas=
les, chick fibroblast components; for mump,
measles, and rubella, neomycin (Travel Medicine Advisor).=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3d. HiB (Hemophilus influenze B)
[This section last updated September 19, 1999.]=20

Q3d.1 What is hemophilus influenze B, and what are the risks of the disease=
?=20

HiB is a bacteria which is one of the leading causes of meningitis in young=
children. About 60% of cases are meningitis. The
remaining 40% are cellulitis, epiglottis, pericarditis, pneumonia, sepsis, =
and septic arthritis. Mortality rate can be about 5%, and
there are neurologic sequelae in up to 38% of survivors.=20

Q3d.2 How common was HiB before routine vaccination, and how common is it n=
ow?=20

Before routine vaccination, about 12,000 cases a year in the US, with a cum=
ulative risk of 1 in 200 that a child would get the
disease by age 5. A vaccine was introduced in 1985. Since the introduction =
of the Hib conjugate vaccine in 1988, the
race-adjusted incidence of Hib among children less than 5, has declined fro=
m 41 cases per 100,000 in 1987 to two cases per
100,000 in 1993. (The incidence for people five or older remained stable. H=
ib is most serious in children under 5.) (A decline
of 95%, despite the fact that the National Health Interview Survey showed o=
nly 67% of children 12-23 months had received at
least one dose, and 36% three or more doses. This decline is attributed to =
the elimination of carriage, which reduces Hib
exposure even in unvaccinated children.) The CDC set a goal of eliminating =
Hib in the US by 1996. (HICN708 Medical
News, "[MMWR] Progress Elimination Haemophilus influenzae type b") As of Se=
ptember 1999, this goal wasn't met, but
there has been a significant decline; MMWR's "TABLE III. Provisional cases =
of selected notifiable diseases preventable by
vaccination, United States week ending September 11, 1999" records a cumula=
tive total for 1998 of 788 cases, and for 1999
of 820 cases, in the US.=20

Q3d.3 How effective is the HiB vaccine?=20

Estimates from different labs vary a lot. AHFS Drug Information, after noti=
ng this variability, and the uncertainty as to what
antibody level is adequate for protection, says that in one study, 75% of c=
hildren 18-23 months and 85% of children 24-29
months had serum anticapsular antibody levels of one microgram per millilit=
er or greater. The PDR lists numerous studies, with
results ranging from 100% efficacy to one study in which vaccinated childre=
n had more cases of HiB than the unvaccinated
group. With the exception of the latter study, all of the studies showed si=
gnificant positive results, often with efficacy estimates
over 90%.=20

According to a NY Times article of 12/18/90, HiB vaccine produces lower ant=
ibody response among Native Americans, but
the new conjugated vaccine seems to produce higher antibody response in Nat=
ive American children and may protect all
children at a younger age.=20

Q3d.4 How long does the HiB vaccine last?=20

The duration of immunity is unknown. However, the disease is only dangerous=
to very small children.=20

Q3d.5 What are some of the risks of the HiB vaccine?=20

In a study of 401 infants, fever occurred in 2%, and redness, warmth, or sw=
elling in 3.3%. All adverse reactions were
infrequent and transient. (PDR) The Institute of Medicine reported in 1994 =
that evidence favored rejection of a causal
relationship between early onset HiB disease and conjugate vaccines, but fa=
vored acceptance of a causal relationship between
early onset disease in children 18 months old or more whose first vaccinati=
on was with unconjugated PRP vaccine. [MMWR
45(No. RR-12), 1996]=20

Q3d.6 When is the HiB vaccine contraindicated?=20

Hypersensitivity to any component of the vaccine, including diptheria toxoi=
d and thimerosal in the multi-dose presentation.=20

Vaccine components capable of causing adverse reactions: phenol, bacterial =
polysaccharides, thimerosal (Travel Medicine
Advisor).=20

(Note: There is currently, as of 1999, a move toward replacing thimerosal i=
n vaccines, so the reference to thimerosal here may
shortly be out of date.)=20

Q3d.7 What about rifampin prophylaxis?=20

An alternative to HiB vaccination is rifampin prophylaxis, but it could be =
unwieldy to administer. AHFS Drug Information says
that it is "effective for eradicating nasopharyngeal carriage of HiB, but t=
he efficacy of the drug for prevention of secondary
disease has not been firmly established."=20

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3 D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D
Section 3e. Hepatitis B gamma globulin and hepatitis B vaccine
[This section last updated on September 15, 1999.]=20

Q3e.1 What is hepatitis B, and what are the risks of the disease?=20

There are several forms of hepatitis, infections of the liver which cause j=
aundice, nausea, and weakness. Hepatitis B is spread
mainly by contact with infected blood and by intimate contact with bodily f=
luids, such as in sexual intercourse and childbirth.
However, the hepatitis B virus is far more resilient than, for example, the=
AIDS virus, and the disease is not strictly a venereal
disease, and can be caught even by people who are not sexually active. Hepa=
titis B becomes chronic in 5-10% of those
infected. Complications include hepatic necrosis, cirrhosis of the liver, c=
hronic active hepatitis, and hepatocellular carcinoma.
Hepatitis B is endemic throughout the world, and a serious problem in group=
s at increased risk. Information about hepatitis B is
available by calling 1-800-HEP-B-873. Another source of information about h=
epatitis B and many other forms of liver disease
is:=20

American Liver Foundation
1425 Pompton Avenue
Cedar Grove, NJ 07009

A source on hepatitis B in particular is:=20

Hepatitis B Coalition
1537 Selby Ave #229
St Paul, MN 55104
(612) 647-9009

There is also a hepatitis mailing list, HEPV-L on =
U. A Web page on Diseases of the
Liver can be found at=20

http://cpmcnet.columbia.edu/dept/gi/disliv.html=20

A US government source of information on hepatitis is:=20

Hepatitis Branch
Mailstop G37
CDC
Atlanta, GA 30333
or call the CDC Automated Voice Information System at (404) 332-255=
3.

Hepatitis B should not be confused with hepatitis A, which is more contagio=
us but less serious. Hepatitis A is spread through
contaminated food and water. Symptoms can be mild flulike symptoms or sever=
e nausea lasting for weeks. Hepatitis A does
not become chronic and is rarely fatal. Other forms of hepatitis include he=
patitis C, hepatitis D, and hepatitis E, and hepatitis
(being a general term for inflammation of the liver) can also be caused by =
certain medications. Information on other kinds of
hepatitis can be obtained from the American Liver Foundation.=20

Q3e.2 How common is hepatitis B?=20

"The estimated lifetime risk of HBV infection in the United States varies f=
rom almost 100% for the highest risk groups to
approximately 5% for the population as a whole." (PDR) The CDC estimates ab=
out 0.75 - 1 million chronic carriers in the US,
and more than 170 million are estimated worldwide.=20

Q3e.3 What is hepatitis B gamma globulin, and when is it given?=20

It is given to people who have already been exposed to hepatitis B, to boos=
t their immunity. In particular, it is given to children
born to mothers with hepatitis B. It should be given as soon as possible af=
ter birth for the best results.=20

Q3e.4 How long does the immunity provided by hepatitis B gamma globulin las=
t?=20

Two months, maybe longer.=20

Q3e.5 What are the risks and contraindications of hepatitis B gamma globuli=
n?=20

No known contraindications. A couple of diseases (see PDR for more informat=
ion) are listed under precautions (a weaker
form of warning than contraindication - in the case of precautions gamma gl=
obulin may be given, but the extra risks of giving the
gamma globulin have to be weighed against the benefits). These diseases, th=
ough, aren't ones a newborn is likely to have, so
they would probably not apply in the case of giving it to the newborn of a =
mother infected with hepatitis B.=20

Q3e.6 How effective is the hepatitis B vaccine?=20

It varies depending on the age, sex, and general health of the recipient. A=
bout 96-100% in infants and children 19 and under,
94-99% in adults 20-39, 88-91% in adults 40 or older. May be lower in men t=
han women. Lower (only 64% in one study) in
hemodialysis patients. (AHFS Drug Information 1992) The PDR estimated 95-96=
% for infants, and agrees with AHFS about
the conditions which reduce effectiveness.=20

Q3e.7 How long does the hepatitis B vaccine last?=20

There is evidence that immunity lasts up to ten years, but beyond that, the=
duration is uncertain, and the need for booster doses
not defined. (My source for the duration is Journal Watch, 9/1/93.)=20

Q3e.8 What are some of the risks of the hepatitis B vaccine?=20

Hepatitis B has traditionally been considered one of the safest and least r=
eactogenic vaccines:=20

"During clinical studies involving over 10,000 individuals distributed over=
all age groups, no serious adverse reactions
attributable to vaccine administration were reported." (PDR, 1993) The most=
common adverse reactions were injection site
soreness (22%) and fatigue (14%). A longer list of adverse reactions can be=
found in the PDR. "Update: Vaccine Side Effects,
Adverse Reactions, Contraindications, and Precautions," published by ACIP i=
n 1996, reported that VAERS data showed a
low rate of anaphylaxis (approximately one event per 600,000 doses given).=
=20

More recently, controversy has been aroused by news reports, particularly i=
n France, of new or reactivated cases of multiple
sclerosis, and other demyelinating disorders, within two to three months fo=
llowing administration of hepatitis B vaccine. Critics
argue that the risk is too high for a vaccine routinely given to children n=
ot directly at much risk for hepatitis B. Supporters of
vaccination argue that, given the demonstrated risk of liver cancer and cir=
rhosis of the liver from hepatitis B, effective
vaccination programs should not be abandoned for a hypothetical risk that t=
he vaccine might in rare cases lead to multiple
sclerosis and other demyelinating diseases.=20

As is the case in other controversies about vaccination risks, part of the =
difficulty is assessing just what effect the hepatitis B
vaccine may have on demyelinating diseases. Multiple sclerosis is, in some =
countries, the most common neurological disease of
young adulthood. Though most commonly reported between 20 and 40, it can be=
reported at younger and older ages, and,
given near universal vaccination of pre-adolescents, some cases of MS are t=
o be expected, simply by chance, in proximity to
vaccination. Since the incidence of cases of multiple sclerosis attributed =
to the vaccine, in France and elsewhere, is less than the
number already expected for the age range in question, statistical analysis=
is required, to determine whether the risk of MS and
other demyelinating diseases is in fact higher in populations vaccinated fo=
r hepatitis B, and, if so, what the risk might be.=20

Several studies have been carried out, to date, to assess this risk, and mo=
re are ongoing.=20

ACIP reported, in 1996, that evidence was inadequate to establish or reject=
a causal relationship between hepatitis B vaccine
and demyelinating diseases of the central nervous system.=20

The French National Drug Surveillance Committee studied people who received=
more than 60 million doses of hepatitis B
vaccine between 1989 and 1997, and found that the prevalence of neurologica=
l disease, including MS, was actually lower in
this group than in the general population.=20

Three French studies, prompted by reports of MS, showed a slightly increase=
d relative risk in the vaccinated population, but
not one which was statistically significant. In response to this, the Frenc=
h government required a risk-benefit analysis. The
risk-benefit analysis did not attempt to determine whether the hepatitis B =
vaccine in fact causes MS or other demyelinating
diseases, but rather to use the largest possible risks which could be deriv=
ed from the studies which had been done, and weigh
these against the expected benefits of hepatitis B vaccine (with both being=
assessed in a statistical, quantititive fashion). This
study concluded that, though it isn't possible to determine yet whether the=
re is an association between the hepatitis B vaccine
and MS, the benefits of the vaccine for a given vaccinated pre-adolescent c=
ohort would clearly outweigh the risks.=20

In Canada, the Alberta Ministry of Health reported that a preliminary exami=
nation of hospital admission data between 1975
and 1995 suggests that the introduction of the hepatitis B vaccine in the m=
id-1980s has not been marked by an increase in the
incidence of multiple sclerosis.=20

The World Health Organization Viral Hepatitis Prevention Board (VHPB) assem=
bled experts, on September 28-30, 1998, to
review the epidemiology and current understanding of MS. This group examine=
d data on the epidemiology of hepatitis B, the
epidemiology of multiple sclerosis, from national reporting systems in the =
US, Italy, and Canada, from one active pediatric
surveillance system in Canada, from industry post-marketing surveillance an=
d clinical data, from published studies of hepatitis B
safety, and from preliminary reports of a small number of unpublished epide=
miological studies in the US, France, and the UK.
They tried to decide between three hypotheses for explaining the relationsh=
ip between the hepatitis B vaccine and MS: 1)
coincidence, 2) "triggering," in which an illness which would have occurred=
anyway was unmasked by the vaccine, or 3) a true
causal relationship.=20

Evidence for the hypothesis of coincidence included the lack of any statist=
ically significant association with MS to date, and the
fact that age and sex distributions of reported adverse events resemble age=
and sex distributions seen before the vaccine.
Evidence in support of an increased risk as precipitating factor was the fa=
ct that some studies showed slightly increased risk of
MS, though not to a statistically significant degree. Evidence against was =
that another study showed no increased risk. The
group concluded that the evidence for an association between the hepatitis =
B vaccine and MS was weak, and did not meet the
criterion for causality.=20

Response to this data has shown a rare divergence in public health policies=
.. The French National Network of Public Health,
while still recommending the vaccine as useful to pre-adolescents, conclude=
d that, because of differences in individual risk for
hepatitis B and for side effects of the vaccine and "the need for a medical=
consultation including the personal and family history,"
the vaccination program for pre-teens in the schools would be suspended. Th=
is suspension was announced on October 1,
1998. Public health departments in several other countries, along with the =
World Health Organization, criticized the French
government for making a decision based more on politics than on the actual =
risks, and reaffirmed existing vaccination policies.
The US Congress held hearings on the subject, while the CDC affirmed that "=
The scientific evidence to date does not support
hepatitis B vaccination causing MS or other demyelinating diseases." (http:=
//www.cdc.gov/nip/vacsafe/fs/qhepb.htm#7) Several
organizations concerned with hepatitis B and multiple sclerosis, in the US =
and Canada, came out with statements supporting
continued hepatitis B vaccination.=20

As I write this section of the FAQ, the CDC reports that at least six resea=
rch projects are underway, in the US, France, and
the UK, to examine what relationship, if any, exists between the hepatitis =
B vaccine and multiple sclerosis. In the meantime,
most countries are continuing to recommend universal hepatitis B vaccinatio=
n for infants and for pre-teens who have not
already been vaccinated.=20

Q3e.9 When is the hepatitis B vaccine contraindicated?=20

Sensitivity to yeast or any other component of the vaccine. Pregnancy is no=
t a contraindication to hepatitis B vaccination. A
previous anaphylactic response to the vaccine is a contraindication to furt=
her doses.=20

Vaccine components capable of causing adverse reactions: aluminum phosphate=
, thimerosal, and formaldehyde (Travel
Medicine Advisor). (Note, though, that as of September 1999, a thimerosal f=
ree hepatitis B vaccine is available.)=20

Q3e.10 Why did the ACIP and AAP change their recommendation about the hepat=
itis B vaccine?=20

Up until 1992, the recommendation was that hepatitis B vaccine be given onl=
y to people in high risk groups for hepatitis B:
people whose professions exposed them to blood, people at extra risk due to=
their sexual practices or intravenous drug use,
and certain populations (such as Southeast Asian immigrants) with a high in=
cidence of the disease. The chief reason was cost; it
was felt to be not cost-effective to vaccinate low-risk groups.=20

Unfortunately, this policy was not successful in checking the spread of hep=
atitis B. It proved difficult to identify high-risk
people, and high-risk people did not volunteer in large numbers to be vacci=
nated. For this reason, in 1992, the ACIP
recommendation was switched to vaccination of teens and adults in high-risk=
groups and universal vaccination of infants. The
AAP made a similar recommendation but would also like to extend hepatitis B=
vaccination to all adolescents, if possible.=20

The American Liver Foundation also supports hepatitis B vaccination of infa=
nts, and their pamphlet on the subject suggests a
variety of ways in which even young children could come in contact with the=
virus (through contact with blood, etc.). Though
young children are at low risk of catching hepatitis B, their risk of devel=
oping the chronic form of the disease if they do catch it
is higher than for adults.=20

The new policy was well-received internationally, and 30 countries now have=
universal infant HBV vaccination programs.
Many physicians remain skeptical, however, and a survey in North Carolina s=
howed one third of pediatricians and 20% of
family physicians supporting the new guidelines (Journal Watch, 9-1-93). (U=
pdate: Journal Watch for Jan 15, 1995/Feb 7,
1995 reports that this vaccine is gaining physician acceptance, citing Arch=
Pediatr Adolesc Med Sep 1994, p. 936)=20

Why the resistance? One reason is a reluctance to give low-risk infants yet=
another vaccination. Another is doubt about the
duration of HBV vaccine. There is evidence that it lasts up to 10 years, bu=
t we do not know yet whether it wears off beyond
that point. There is concern that infants vaccinated for HBV may lose immun=
ity during adolescence, when the risk of catching
the disease is greatest. An alternative would be to vaccinate all children =
at age 10 and give a booster at age 20. But compliance
would likely be lower at age 10 than in infancy. Hepatitis B vaccine is adm=
inistered in three shots over the course of six months,
and it would be difficult to get preteens to all come in for the full serie=
s. Also, 8% of hepatitis B infections occur before age 10,
and the deadly form is three times greater in children (NY Times, 3/3/93:B8=
). Boosters could be given later to infants
vaccinated for HBV if immunity proves to lapse.=20

Hepatitis B vaccine is also often recommended for travel purposes.=20

Q3e.11 Does vaccination for hepatitis B affect one's ability to donate bloo=
d?=20

************************************************** ***********************
From=20Gregory Froehlich, MD (from a posting to sci.med):

First, hepatitis B *antigen* is used to make Hep B vaccine. The
antigen is grown in yeast culture; formerly, it was purified from the
blood of people who were chronic hepatitis carriers. Antibodies are
used in the gamma globulin shots used for hepatitis A or for passive
immunization against hepatitis B if you're exposed.

The local blood bank does not specifically test for exposure to
hepatitis A (the kind you'd get from contaminated water). If a person
has an active hep A infection, it will be picked up by elevated liver
enzymes; if the person had such an infection in the past, it's over and
done with--hep A doesn't give you a chronic, subclinical infection.
Antibodies to hepatitis A should not preclude blood donation.

They check for chronic hep B carriers by testing for hep B surface
antigen. They test for recent hep B infection by testing for hep B
core antibody. This antibody does not carry disease, but rather
indicates that the person was recently infected and might or might not
still be infectious. They do not test for surface *antibody*, which
would indicate either (a) former hep B infection which was cleared, or
(b) immunization against hep B--in either case, not infectious. I've
got hep B surface antibody, because I was immunized; I can still donate
blood.

Blood banks also test for hepatitis C antibody; people with this
antibody can still be infectious.
************************************************** ***********************

Q3e.12 Do people who have showed up positive on the blood banks' tests for =
hepatitis B exposure still need to be
vaccinated?=20

It is still useful to be vaccinated, because some of the people who show up=
positive on the blood bank tests are false positive.=20

Q3e.13 I will be travelling to an area where hepatitis B shots are recommen=
ded, but I have less than six months before I leave.
Is there an accelerated schedule for hepatitis B vaccination?=20

_Travel Medicine Advisor_ lists an accelerated schedule, with 3 doses at 0,=
30, and 60 days. With this schedule, a fourth dose
is recommended at 12 months if there is still a risk for hepatitis B exposu=
re.=20

 




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