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



 
 
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Old December 15th 03, 10:41 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 anaphylctic=
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 ony 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=
=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 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
 




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