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

( Part1 - Part2 - Part3 - Part4 )
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Archive-name: misc-kids/vaccinations/part1
Posting-Frequency: monthly
Last-Modified: October 23, 1999

See reader questions & answers on this topic! - Help others by sharing your knowledge
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Collection maintained by: Lynn Gazis-Sax (lynng@alsirat.com)=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: pburch@cmb.bcm.tmc.edu (Paula Burch)

|> >Paula Burch (pburch@cmb.bcm.tmc.edu) 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.

|> dolson@ucsd.edu (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.

mblum@world.std.com (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
pburch@bcm.tmc.edu
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 (jet14@columbia.edu):=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 kstratto@nas.edu

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

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 are: 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=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=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 are: 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)

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