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What Parents Need to Know*

Prepared for the American Council on Science and Health
by Kathleen Meister, M.S.

Project Coordinator
Gilbert L. Ross, M.D.
Medical Director, ACSH

Elizabeth M. Whelan, Sc.D., M.P.H.

Art Director
Yelena Ponirovskaya

September 2003


1995 Broadway, 2nd Floor, New York, NY 10023-5860
Tel. (212) 362-7044 • Fax (212) 362-4919
URL: • E-mail:

* based on ACSH’s special report The Promise of Vaccines: The Science and the
Controversy, by David R. Smith, M.D., President, Texas Tech University Health
Sciences Center, Lubbock, Texas

Dale J. Chodos, M.D. Donald A. Henderson, M.D., M.P.H.

Kalamazoo, Mich. Johns Hopkins Bloomberg School
of Public Health
William H. Foege, M.D., M.P.H. Baltimore, Md.
Rollins School of Public Health
Emory University Paul Offit, M.D.
Atlanta, Ga. Children’s Hospital of Philadelphia

Vincent A. Fulginiti, M.D. Edgar J. Schoen, M.D.

University of Colorado Kaiser Permanente Medical Center
The Children’s Hospital Oakland, Cal.

Bruce G. Gellin, M.D., M.P.H. Ekhard E. Ziegler, M.D.

Vanderbilt University School of College of Medicine
Medicine University of Iowa
Nashville, Tenn.

Robert Heimer, Ph.D.

Yale School of Public Health
New Haven, Conn.

ACSH accepts unrestricted grants on the condition that it is solely responsible for the
conduct of its research and the dissemination of its work to the public. The organization
does not perform proprietary research, nor does it accept support from individual corpo-
rations for specific research projects. All contributions to ACSH—a publicly funded
organization under Section 501(c)(3) of the Internal Revenue Code—are tax deductible.

Individual copies of this report are available at a cost of $5.00. Reduced prices for 10 or
more copies are available upon request.

Copyright © 2003 by American Council on Science and Health, Inc.

This book may not be reproduced in whole or in part, by mimeograph or any other
means, without permission.
Table of Contents
Introduction 5
Routine Childhood Immunization and Disease Rates 6
The Diseases that Childhood Vaccines Prevent 7
Diphtheria 7
Tetanus 8
Wooping Cough 9
Polio 9
Measles 10
Mumps 10
Rubella 10
Chickenpox 11
Hepatitis B 11
Hib (Haemophilus Influenzae Type B) Disease 12
Pneumococcal Disease 12
Hepatitis A 12
Myths about Immunizations 13
Balancing Risks and Benefits 15
How Vaccine Safety Is Evaluated 16
Specific Concerns about Vaccine Safety 18
SIDS (Sudden Infant Death Syndrome) 18
MMR Vaccine and Autism 19
Multiple Sclerosis 19
Type 1 Diabetes 20
Influenza Vaccines and Guillain-Barré Syndrome 20
Thimerosal 20
The Future of Vaccines 21

Tables and Figures

Table 1: Recommended Childhood and Adolescent
Immunization Schedule, 2003 6
Table 2: Universally Recommended Childhood Vaccinations 7
Table 3: Comparison of Maximum and Recent Morbidity
from Vaccine-Preventable Diseases and Vaccine
Adverse Events, United States, 1999 8
Figure 1: Incidence of Invasive Hib Disease Among
Children <5 Years of Age, 1987-1997 14
If you asked a group of parents to list their greatest concerns
about their children’s futures, you would get a variety of answers. Some
parents would say that the quality of their children’s education is the
most important issue. Others might mention economic uncertainty, the
impact of new technology, or concerns about crime and violence. It’s
unlikely, though, that any of the parents would say that their greatest
fear is that their children will die of an infectious disease before reach-
ing adulthood. Yet if you had asked the same question a century ago,
infectious diseases would have been at the top of every parent’s list –
and for good reason. At the beginning of the twentieth century, 16 out
of every 100 children died of infectious diseases before reaching the age
of five. Epidemics of highly contagious diseases such as diphtheria,
polio, and whooping cough routinely killed large numbers of children
and left others with permanent disabilities.
Today’s parents no longer fear these diseases. Some parents, how-
ever, have come to fear the vaccines that prevent them. Other parents
have become careless about having their children immunized because
they don’t realize that protection against infectious diseases is still
important. The very success of vaccines has made it difficult for people
to appreciate the true impact of immunization on children’s health.
When contagious diseases such as measles and whooping cough were
still common, people could easily understand why it was important to
vaccinate their children against them. Modern parents often lack this
This report from the American Council on Science and Health
(ACSH) – based upon a special report written for ACSH by Dr. David
R. Smith, President of the Texas Tech Medical Center, a pediatrician
and vaccine expert – summarizes the evidence on both the benefits and
the potential risks of vaccines, with an emphasis on the vaccines used in
routine childhood immunization. The report addresses some of the com-
mon myths about vaccines and discusses some vaccine safety issues that
have recently been in the news.

Routine Childhood Immunization and Disease Rates
Current guidelines call for children to receive routine immuniza-
tions against 11 diseases (12 in some parts of the country): diphtheria,
tetanus, pertussis (whooping cough), polio, measles, mumps, rubella
(German measles), chickenpox (varicella), hepatitis B, Haemophilus
influenzae type B disease (Hib), pneumococcal disease, and (in some
parts of the country) hepatitis A. Table 1 shows the current schedule for
immunization against these diseases, and Table 2 lists the recommended
vaccines all infants, toddlers and children should get.
Routine childhood immunization has dramatically reduced the
number of cases of vaccine-preventable diseases. Table 3 compares the
maximum number of cases of various diseases that occurred in the U.S.
each year before vaccines were introduced with the number of cases
occurring in 1999. For all of the diseases listed, immunization has led
to a decrease in the number of people who develop the disease of at
least 97 percent.

This schedule indicates the recommended ages for routine administration of currently licensed childhood
vaccines, as of December 1, 2002, for children through age 18 years. Any dose not given at the recom-
mended age should be given at any subsequent visit when indicated and feasible. Indicates age groups that
warrant special effort to administer those vaccines not previously given. Additional vaccines may be
licensed and recommended during the year. Licensed combination vaccines may be used whenever any
components of the combination are indicated and the vaccine’s other components are not contraindicated.
Providers should consult the manufacturers' package inserts for detailed recommendations.

Vaccinations: What Parents Need to Know

Population Vaccination Dosage

All young children Measles, mumps, rubella 2 doses
Diphtheria-tetanus toxoid
and pertussis vaccine 4 doses
Poliomyelitis 4 doses
Haemophilus influenzae
type b 4 doses
Hepatitis B 3 dose
Varicella 3 doses
PCV7 4 doses
Hepatitis A (in selected
areas) 2 doses
Previously unvac- Hepatitis B 3 doses
cinated or partially Varicella If no previous history of
vaccinated adolescents varicella, 1 dose for chil-
dren aged < 12 years, 2
doses for children aged
≥ 13 years
Mumps, measles, 2 doses, total
rubella if not vaccinated during
previous 5 years, 1
combined booster during
ages 11-16 years

The Diseases that Childhood Vaccines Prevent

Many of the diseases that vaccines prevent have become so unfa-
miliar that parents may not realize why it’s important to protect children
against them. To understand why immunization is necessary, it’s helpful
to know something about these diseases and about the impact that they
had on America’s children before vaccines were developed. The
descriptions that follow are not pleasant, but they provide a necessary
perspective on the importance of immunization.

Most Americans alive today have never seen a case of diphtheria.
Our great-grandparents, however, were terrified of it. Diphtheria is a

Disease Maximum 1999* Percentage
Cases (Year) Change
Diphtheria 206,939 (1921) 1 -99.99
Measles 894,134 (1941) 86 -99.99
Mumps 152,209 (1968) 352 -99.76
Pertussis 265,269 (1934) 6,031 -97.63
Polio (wild) 21,269 (1952) 0 -100.00
Rubella 57,686 (1969) 238 -99.58
Cong. Rubella
Synd. 20,000* (1964–5) 3 -99.98
Tetanus 1,560* (1948) 33 -97.88
Invasive HIB
Disease 20,000* (1984) 33 -99.83

Total 1639,066 6,777 -99.58

Vaccine Adverse
Events 0* 11,827**
Provisional totals of reported cases to the CDC.
* Estimated because no national reporting existed in the prevaccine era.
** Adverse events after vaccines against diseases shown on table = 5,296

very serious disease caused by a kind of germ called a bacterium. It can

cause a thick membrane to form in the throat, making it difficult or even
impossible for a child to swallow or breathe. The diphtheria bacterium
also produces a toxin (poison), which can cause serious complications,
including heart and nerve damage. About 10 percent of all cases of
diphtheria are fatal. Before immunization began, diphtheria was a major
cause of illness and death in U.S. children. For example, in 1921,
206,000 cases of diphtheria and 15,520 deaths were reported.

Unlike the other vaccine-preventable diseases, tetanus is not spread
from person to person. Instead, it enters the body through breaks in the
skin. Deep puncture wounds are especially likely to become infected

Vaccinations: What Parents Need to Know
with the tetanus bacterium.
Inside the body, the bacterium
produces a toxin (poison) that How Vaccines Wo r k
causes severe muscle spasms Vaccines work by priming
(contractions). Approximately the body’s immune system to
30 percent of all cases of respond quickly and effectively
tetanus are fatal. People who to a particular disease-causing
survive tetanus may be left virus or bacterium. A vaccine
with lasting impairments in may consist of a live but weak-
speech, memory, and mental ened disease agent, a killed
function. In the 1920s, before disease agent, or a specific
component of the disease virus
immunization became avail-
or bacterium. The vaccine does
able, there were more than not cause the disease, but it
1,000 cases of tetanus each tricks the immune system into
year in the U.S. Today, there producing antibodies or
are only about 40 cases a year. immune cells that are capable
of responding to the real dis-
Whooping Cough ease agent. If, at some later
Whooping cough (also time, the immunized person is
called “pertussis”) is a nasty, exposed to the disease-caus-
prolonged illness in which ing virus or bacterium, the
body’s defenses will be ready
children may have severe
to fight off the invader.
coughing spells for many
weeks. The spells can make it
difficult for a child to eat,
drink, or even breathe.
Although whooping cough is a miserable experience for any child, it is
especially serious in infants, who may develop pneumonia, dehydration,
seizures, and brain damage. Before immunization became available,
between 150,000 and 260,000 cases of this disease were reported each
year, with up to 9,000 deaths. Whooping cough still occurs today, with
over 7,000 cases reported in 1999. It still causes some deaths, especially
in young infants. Between 1990 and 1996, 57 people died from whoop-
ing cough in the U.S.; 49 of them were under the age of 6 months.

Before a vaccine became available in 1955, polio was one of the
most dreaded childhood diseases. In just a few days, this disease could
permanently cripple a previously healthy child. Polio is caused by a
virus that lives in the throat and intestinal tract. Sometimes, this virus
causes a disease so mild that the person who catches it never realizes

that it’s polio. In other cases, however, polio causes paralysis that can
lead to permanent physical disability or death. Before immunization, an
average of 16,000 cases of paralytic polio were reported in the U.S.
each year, and about 1,800 people per year died of this disease. There
were no reported cases in the U.S. in 1999.

Before measles vaccine became available in 1963, practically
everyone in the U.S. got this extremely contagious disease. At least half
a million cases of measles were officially reported each year, and
experts believe that the total number of cases was approximately 3 to 4
million annually. For the majority of children who contract measles, the
disease is relatively mild, with a fever, a rash, and symptoms resem-
bling those of a cold. Some children, however, become seriously ill.
About one in five children with measles need to be hospitalized, one in
20 develops pneumonia, and one in 1,000 develops encephalitis (an
inflammation of the brain that can cause convulsions and lead to perma-
nent deafness or brain damage). During each of the 10 years just before
the development of measles vaccine, about 1,000 Americans developed
permanent brain damage or deafness as a result of measles, and over
500 died of the disease. Worldwide, measles still kills almost a million
people each year, primarily in developing countries where immuniza-
tion is not readily available. But in the U.S. in 1999, there were only
about 100 cases reported.

Before a vaccine became available, mumps was a common child-
hood disease. Most cases of this disease are mild, with fever, headache,
and swelling of the cheeks and jaw, caused by inflammation of the sali-
vary glands. In some instances, though, mumps can lead to serious
complications. About one child in every 10 who get mumps also gets
meningitis, and about one in every four adult men or teenage boys who
get mumps develops a painful swelling of the testicles. In rare cases,
mumps can cause deafness, encephalitis (brain inflammation), or male
sterility. One case in 10,000 is fatal. While at its peak there were well
over 100,000 cases, in 1999 only 350 were reported.

Rubella (also called “German measles” and “three-day measles”)
is almost always a mild illness in children. It causes a slight fever that
lasts a day or so and a rash that lasts for two or three days. Rubella can

Vaccinations: What Parents Need to Know
be disastrous, however, to unborn babies. If a woman gets rubella dur-
ing the early months of her pregnancy, there is at least an 80 percent
chance that her baby will be born with serious, permanent health prob-
lems, such as heart defects, blindness, deafness, or mental retardation.
This condition is called congenital rubella syndrome (CRS). In 1964-65,
before rubella vaccine was widely available in the U.S., more than 12
million Americans developed rubella during a major epidemic, and
20,000 infants were born with CRS. About 11,600 of these children
were deaf, 3,580 were blind, and 1,800 were mentally retarded. In 1999,
however, less than 100 such cases were reported.

Chickenpox (also called “varicella”) is a very common and very
contagious disease. Prior to the availability of chickenpox vaccine, prac-
tically everyone contracted chickenpox, for a total of about 4 million
cases per year. Most cases of
chickenpox are mild, with an What About Yo u ?
itchy rash and sometimes a
fever. In rare cases, however, Immunization isn’t just for
chickenpox can be serious. children. It can also play an
important role in protecting
About one child out of 500
adults against infectious dis-
(and one adult in 50) who gets eases. Unfortunately, though,
chickenpox must be hospital- many adults don’t get the
ized. Of 100,000 children who "shots" that they need.
get chickenpox, one will die of All adults should have a
the disease. In infants, the tetanus-diphtheria booster shot
death rate is higher – about every ten years. Older people
four in 100,000. Prior to should also receive a single
immunization, there were immunization against pneumo-
about 100 deaths from chick- coccal disease and an annual
flu shot. Some adults may need
enpox in the U.S. each year.
additional immunizations, espe-
While these numbers are much cially if they are members of
lower now, there are not yet groups at high risk for a partic-
exact statistics available on ular disease. For example, peo-
recent infection and complica- ple who have multiple sex part-
tion rates since vaccination has ners should be immunized
been widely used. against hepatitis B.
Have you had all your
Hepatitis B shots? If you’re not sure,
Hepatitis B is a liver dis- check with your doctor.
ease caused by a virus. Some

people who develop this disease recover completely, but others develop
a long-term (chronic) hepatitis B infection. People with chronic hepati-
tis B often carry the virus in their blood for the rest of their lives. They
can infect other people, and they may develop severe liver problems,
such as cirrhosis or liver cancer, as a result of their prolonged infection.
It is also important to diagnose hepatitis B in pregnancy, so that the
newborn can be given protective immunization to prevent mother-to-
child transmission. Of the 1.25 million people in the U.S. who have
chronic hepatitis B infection, about 4,000-5,000 die from related liver
diseases each year.

Hib (Haemophilus influenzae Type B) Disease

Despite its name, Haemophilus influenzae type B does not cause
influenza. But it does cause other serious illnesses, including meningi-
tis, in infants and young children. Before a vaccine became available in
the early 1990s, there were approximately 20,000 cases of Hib diseases
each year; approximately two-thirds were meningitis, and the other one-
third were other conditions such as pneumonia, bacteremia (bacterial
infection of the bloodstream), or epiglottitis (a severe throat infection
that can cause death from suffocation). Meningitis due to Hib caused
600 deaths each year, and many children who survived the disease were
left with permanent problems, such as deafness, seizures, or mental
retardation. In 1999, there were under 80 such cases.

Pneumococcal Disease
Like Hib, the pneumococcus bacterium can cause meningitis and
other severe illnesses, including pneumonia and blood infections. The
groups at highest risk for pneumococcal disease are elderly people and
very young children. Each year in the U.S., about 16,500 children under
the age of five develop pneumococcal disease, including approximately
1,000 who develop meningitis. About 200 children die. A vaccine
against the pneumococcal bacterium has long been available for adults,
but that vaccine doesn’t work well in children. Very recently, a new
type of pneumococcal vaccine that does work in children has become
available, and it is now recommended as one of the routine immuniza-
tions for all children under the age of two.

Hepatitis A
Like hepatitis B, hepatitis A is a liver disease. Hepatitis A is the
most common type of hepatitis reported in the U.S., with an estimated
125,000 cases each year. Unlike hepatitis B, hepatitis A does not cause

Vaccinations: What Parents Need to Know
long-term infection. However, it can be a serious or even fatal disease.
About 100 Americans die from liver failure due to hepatitis A each year.
A vaccine against hepatitis A is available for children age two years and
older. It is recommended as part of the routine immunizations for chil-
dren in the Western states, where rates of this disease are highest, and
for members of certain other high-risk communities.

Myths about Immunizations

People sometimes believe that childhood infectious diseases are
things of the past, and that vaccination is no longer necessary. This is a
myth. The viruses and bacteria that cause vaccine-preventable diseases
still exist and cause disease. If immunization rates are allowed to
decrease, these now-rare diseases will come back.
This happened in the U.S. a little more than a decade ago. Due to
a combination of parental apathy and increasing abuse of “philosophi-
cal” and religious exemptions from vaccination, during the late 1980s,
measles vaccination rates decreased. As a result, in 1989-91, a large out-
break of measles occurred, with more than 43,000 cases and more than
100 deaths. Only a few hundred cases would have been expected. The
decreased coverage rate for measles led to an increased susceptibility
for the entire community, and the epidemic resulted, striking mainly
unvaccinated infants in the inner cities.
Other industrialized nations have had similar experiences. For
example, levels of immunization against pertussis (whooping cough)
dropped in both the United Kingdom and Japan during the 1970s.
Within a few years, large outbreaks of pertussis occurred in both coun-
tries, with more than 100,000 cases and 36 deaths in the U.K. and more
than 13,000 cases and 41 deaths in Japan.
Pertussis and measles aren’t the only vaccine-preventable diseases
that won’t disappear. Tetanus is also here to stay. The bacterium that
causes this disease is widespread in the environment. It’s found in soil
and street dust, and it’s resistant to heat and chemicals. Although tetanus
is a very rare disease, immunization is still necessary, and it probably
always will be.
Even diseases that are virtually unknown in the U.S.—such as
polio or diphtheria – could return if they were reintroduced into this
country by travelers from other parts of the world. (Infectious disease
experts like to point out that even the most exotic diseases are only a
plane ride away.) In 1994, polio was introduced into Canada from India,
but it didn’t spread in the North American population because immu-

nization levels were high. In the early 1990s, a major outbreak of diph-
theria occurred in the countries of the former Soviet Union, with more
than 150,000 cases and 5,000 deaths. This epidemic was caused by a
breakdown in public health services, with an accompanying decrease in
immunization rates. If diphtheria immunization were discontinued in
the U.S., a similar situation could occur here.
Another myth about vaccines is that they aren’t needed because
improvements in sanitation and nutrition had caused disease rates to
drop even before vaccines were introduced. While it is true that general
improvements in living conditions have helped to reduce disease rates,
immunizations have caused an additional, sustained reduction in dis-
ease. Moreover, such reductions are just as evident for vaccines intro-
duced in recent decades, when high standards of sanitation and nutrition
were well established, as they were for vaccines introduced in earlier
times. The experience with Hib disease, illustrated in Figure 1, is a
good example. The rate of Hib disease dropped dramatically after
immunization was introduced in the late 1980s, and it remained low
throughout the 1990s. Yet standards of hygiene in the mid-1990s were
not appreciably different from those that existed a decade earlier.
A third myth is that parents who choose religious or philosophical
exemptions from routine childhood vaccinations are risking only their
children’s health, not anyone else’s. The truth is that these people are
risking the health of other members of their families and communities
as well. When the proportion of a population that is immunized against
a disease is high, the spread of the disease through the community may

* Rate per 100,000 children <5 years of age, estimated

Vaccinations: What Parents Need to Know
stop, even though some individuals are not immunized. This phenome-
non is called community immunity. If coverage falls to a level where
transmission of the disease agent resumes, community immunity is lost,
and people who are not immune to the disease are put at risk. Thus,
children who don’t receive their routine vaccines endanger others. The
people who are put at risk include those too young to have been immu-
nized, those who cannot receive the vaccine for medical reasons (e.g.,
people who are severely allergic to vaccine components), and people
who received the vaccine but did not respond to it. (Vaccines are not
100 percent effective; a small percentage of people who receive a vac-
cine do not develop immunity.)

Balancing Risks and Benefits

Like all pharmaceutical products, vaccines can produce side effects. The
most common side effects are minor ones: soreness at the injection site
or low-grade fever. Serious side effects from immunizations are very
When evaluating the safety of a vaccine, it’s necessary to consider
both the risk of side effects and the benefits of immunization. Or, to put
it another way, the risks associated with receiving the vaccine should be
compared with the risks associated with not receiving it. For all of the
vaccines recommended today, the risks associated with the vaccine are
far lower than the risks associated with not receiving it and therefore
remaining susceptible to the disease.
For example, approximately one out of every 30,000 people who
receives MMR (measles-mumps-rubella) vaccine develops thrombocy-
topenia (an abnormally low platelet count). This condition is temporary
and usually causes no major problems, but in some instances it leads to
abnormal bleeding. Two of the diseases that the vaccine protects
against, measles and rubella, can also cause thrombocytopenia, and the
risk of this complication is much greater during the actual illness than it
is after vaccination. If MMR vaccination were discontinued, practically
everyone would get measles and many people would also get rubella.
The number of people who would develop thrombocytopenia as a result
of these diseases would be far greater than the number who currently
develop it as a result of immunization.
Official decisions about what vaccines to use are based on careful
considerations of risks and benefits. A recent change in polio vaccina-
tion recommendations in the U.S. was based on just this sort of evalua-
tion. There are two kinds of polio vaccine: oral polio vaccine (OPV)

and inactivated polio vaccine (IPV). Both protect against polio, but
OPV is more effective in preventing the spread of the disease from one
person to another. OPV has an important disadvantage, however. In
extremely rare instances (about 1 in 2.4 million), OPV actually causes
polio. IPV, which is made from a killed virus, cannot cause polio. For
many years, practically all American children received OPV. However,
since the risk of getting polio in the U.S. is now extremely low, experts
believe that the use of OPV is no longer worth the slight risk associated
with it. As of January 2000, official guidelines in the U.S. call for the
use of IPV, except in very limited circumstances. In some other parts of
the world, however, where the risk of polio is much higher, OPV is still
the preferred vaccine.

How Vaccine Safety Is Evaluated

The safety of vaccines is monitored both before and after they go
on the market. Like all drugs, vaccines must be approved and licensed
by the Food and Drug Administration (FDA) before they can be sold.
The FDA requires new vaccines to be evaluated for safety and efficacy
in laboratory studies and in three different phases of clinical trials in
human volunteers. The clinical trials, which typically involve several
thousand or more people, can identify common side effects of the vac-
cine and provide an estimate of how often these effects occur. Rare side
effects are not likely to be discovered, however, until after the vaccine
is marketed.
To identify rare side effects, FDA and the federal Centers for
Disease Control and Prevention (CDC) have set up a system called the
Vaccine Adverse Event Reporting System (VAERS), which collects
information from physicians, manufacturers, and others about any
unusual events that occurred after vaccination. If VAERS data or infor-
mation from other sources suggest that some type of risk may exist, for-
mal scientific studies are conducted to assess the potential risk.
It’s important to note that events that occur after vaccination are
not necessarily caused by vaccination. They may merely be coinci-
dences. For example, suppose you heard of a case in which an infant
received immunizations in the morning and then died of Sudden Infant
Death Syndrome (SIDS) later the same day. Would you think that the
immunizations had caused the death? Many people would. However,
the two events are not necessarily linked. Every year in the U.S., nearly
5,000 infants die of SIDS, usually between the ages of 1 and 4 months.
Practically all infants receive immunizations at least once during those

Vaccinations: What Parents Need to Know
months. By sheer coincidence, some of the infants who die of SIDS will
have received immunizations shortly before their deaths. In fact,
approximately 50 cases of SIDS (roughly 1 in 100) will occur each year
within 24 hours of vaccination by chance alone.
Individual case reports (such as the report that a physician would
submit to VAERS if an infant died of SIDS shortly after being immu-
nized) cannot distinguish
between coincidences and
cause-and-effect relationships. The Disease that
To make this distinction, scien- No Longer Exists
tists must conduct studies
involving large groups of peo- If you were born before
ple. Researchers compare the the 1970s, you almost certainly
experiences of groups who received a vaccine against
smallpox – one of the deadliest
received the vaccine with
diseases the world has ever
those of groups who did not. known. Today’s children, how-
They look at data from differ- ever, do not need to be immu-
ent time periods to see what nized against smallpox. Thanks
changes may have occurred to an extraordinary global
after a new vaccine was intro- immunization campaign, this
duced. They consider all the disease no longer exists in
alternative explanations for nature. It is the first – and so
any patterns that they observe. far the only – disease to be
Health officials then use the truly eradicated worldwide.
Health authorities hope, how-
data and analyses as the basis
ever, that smallpox won’t retain
for decisions about whether or its unique status much longer.
not to recommend the use of a A campaign to eradicate polio
particular vaccine. worldwide is now in progress
The recent experience and may reach its goal within
with rotavirus vaccine illus- the next few years.
trates the way that this system (Note: the necessity of
works. Rotavirus causes severe re-instituting large-scale small-
diarrhea in children and pox vaccination was consid-
accounts for more than ered recently, due to threats of
bioterrorist use of smallpox
500,000 physician visits and
virus as a weapon. Focused
50,000 hospitalizations in the vaccination of armed forces,
U.S. each year (and this dis- health-care workers, and first
ease is even more devastating responders was initiated in
in the underdeveloped world). early 2003 but suspended
In August 1998, a vaccine again a few months later.)
against this virus became

available, and doctors began to administer it to infants. Within the next
few months, VAERS received reports indicating that about 15 infants
had developed intussusception (a rare condition in which one segment
of the intestine telescopes into another, sometimes leading to intestinal
blockage) shortly after receiving rotavirus vaccine. Although the num-
ber of cases of intussusception was very small in comparison with the
number of infants who had received the vaccine, analysis of the VAERS
reports and other data suggested that the vaccine might indeed be asso-
ciated with an increase in the risk of this rare problem. Therefore, the
use of rotavirus vaccine was discontinued in the U.S. in October 1999
pending further study.

Specific Concerns about Vaccine Safety

Several concerns about safety aspects of various vaccines have
been raised in recent years. Three such issues have already been men-
tioned in this report: the basis for the recent change in the type of polio
vaccine recommended for U.S. children is discussed on page 16 the
relationship between MMR vaccine and thrombocytopenia is explained
on page 15; and the withdrawal of rotavirus vaccine is discussed in the
preceding section. The following sections summarize other vaccine
issues that have been in the news.

SIDS (Sudden Infant Death Syndrome)

As mentioned earlier in this report, since practically all infants
receive immunizations, it is inevitable that some of the infants who die
of SIDS will have received immunizations shortly before their deaths.
This is a matter of chance, not a cause-and-effect relationship. There is
no evidence that any vaccine actually causes or contributes to SIDS.
There is also no evidence that any vaccine protects against SIDS,
although a casual look at statistical data might seem to suggest other-
Between the years 1992 and 1996, routine childhood immuniza-
tion with hepatitis B vaccine was introduced in the U.S., and the pro-
portion of young children who received this vaccine increased dramati-
cally. During the same time period, the rate of SIDS dropped just as
dramatically. The similarity in the two time trends is striking, but it is
merely a coincidence. The real cause of the decrease in SIDS was a
campaign to teach parents to put infants to sleep on their backs, which
began in the early 1990s. The hepatitis B vaccine did not play a role.

Vaccinations: What Parents Need to Know
MMR Vaccine and Autism
A great deal of public attention has recently focused on the sus-
pected link between the MMR (measles-mumps-rubella) vaccine and
autism. (Autism is a developmental disorder characterized by impaired
communication and social interaction, with repetitive activities that fur-
ther restrict social interactions. It is estimated to occur in about two of
every 1,000 children.) This concern was first raised in 1998, when
British researchers published a study that seemed to show an associa-
tion. That initial study, however, was based on only 12 children.
Subsequent studies of much larger groups of children have not con-
firmed an association and have not demonstrated the patterns of change
that would be expected if MMR and autism were truly linked. For
example, a larger British study showed that the number of cases of
autism had been increasing since 1979, with no jump after the introduc-
tion of MMR vaccine in 1988. A study in California showed that the
MMR vaccination rate had increased there for several years and then
leveled off, while autism rates increased steadily during the same years.
If MMR and autism were linked, one would expect that the rates of vac-
cine coverage and autism would parallel one another. But in these and
other studies, that pattern has not been observed.
Several other recent studies have confirmed the lack of any associ-
ation between autism and MMR vaccine. MMR is usually given
between the ages of 12 and 15 months. Symptoms of autism often
become evident just a few months later, when parents or professionals
notice that a child’s language development is not proceeding normally.
For this reason, it is likely that some children will be diagnosed with
autism shortly after receiving MMR vaccine. There is no scientific evi-
dence to support the notion that the vaccine causes the disorder.

Multiple Sclerosis
Several reports in medical journals have described individual cases
in which a patient developed symptoms of multiple sclerosis (MS)
shortly after immunization. These reports have raised concerns that vac-
cines (especially hepatitis B vaccine) might be linked to this disease.
Individual case reports cannot distinguish between coincidences and
cause-and-effect relationships, however. Studies of larger groups of peo-
ple have not detected any association between immunization and the
onset of MS.
The cases in which individuals developed symptoms of MS shortly
after receiving hepatitis B vaccine are almost certainly coincidental. In
recent years, physicians have encouraged young adults, especially those

who have risk factors for hepatitis B, to be vaccinated against this dis-
ease. Young adulthood is the time when MS is most often diagnosed.
Thus, simply by coincidence, some young people who receive hepatitis
B vaccine may develop MS shortly thereafter.

Type 1 Diabetes
The cause of type 1 diabetes (the type that often begins in childhood) is
not known. A variety of possible causal factors have been suggested,
including immunizations. However, analyses of the relationship of vac-
cinations to type 1 diabetes in humans have not found any causal link.

Influenza Vaccines and Guillain-Barré Syndrome

The swine flu vaccine administered during 1976-77 was associated
with a significant increase in the risk of Guillain-Barré syndrome (a
rare neurological complication involving paralysis that is usually
reversible). Other influenza vaccines, however, have not been associat-
ed with a similar risk. Outside of 1976, the increased risk for Guillain-
Barré syndrome associated with influenza vaccination has been no
greater than one case per million individuals vaccinated. This is much
less than the risk of developing a serious complication from influenza

Thimerosal is a preservative that has been included in some vac-
cines since the 1930s to help prevent bacterial contamination. Concerns
have been raised about the use of thimerosal because it contains mercu-
ry. There is no evidence, however, that thimerosal has caused any
health problems in children. Problems have not been found even in pre-
mature infants (who would be at highest risk because they would
receive the most thimerosal in relation to their body weight).
Nevertheless, despite the absence of scientific evidence linking
thimerosal to any disease, because the overall exposure of children to
mercury is a public health concern, it was decided in 1999 to switch to
vaccines that do not contain thimerosal preservative. As of 2002,
thimerosal has been removed from commonly administered pediatric
vaccines. (For diphtheria-tetanus-pertussis, hepatitis B, and Hib vac-
cines, this reflects a change; the measles-mumps-rubella, chickenpox,
inactivated polio, and pneumococcal vaccines never contained
In the unlikely event that parents discover that the preservative-
free version of a vaccine is not yet available from their health care

Vaccinations: What Parents Need to Know
provider, or if a child needs to receive a special type of vaccine that is
not available in a preservative-free formulation (e.g., influenza vaccine
for certain children with chronic diseases), they should not delay or
refuse the vaccination. The very real risk of disease associated with fail-
ure to immunize far outweighs the purely theoretical risk associated
with exposure to thimerosal preservative.

The Future of Va c c i n e s
Immunization is one of the most effective weapons in the modern
medical arsenal. This approach to disease prevention is likely to become
even more important in the future, as new technologies allow more and
better vaccines to be developed. Experts have projected that the number
of vaccines in widespread use will triple in the next 20 years. New vac-
cines may be especially helpful in the fight against diseases caused by
bacteria that have developed resistance to antibiotics.
Vaccines have done more to protect children against death and disability
from infectious diseases than any other public health intervention.
However, the war against these diseases is not over. Worldwide, it is
estimated that over two million children die annually from infectious
diseases that could have been prevented by immunization. Even in the
U.S., several hundred children a year die from vaccine-preventable dis-
eases. To prevent these tragedies and keep infectious diseases under
control, parents and health care professionals should make every effort
to ensure that all children receive the proper immunizations, both for
their own protection and for the protection of the community as a


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College Park, MD Allison A. Muller, Pharm.D J. D. Robinson, M.D. University of Texas, Houston
Lillian Langseth, Dr.P.H. The Children’s Hospital of Philadelphia Georgetown University School of Medicine
Robert D. Steele, Ph.D.
Lyda Associates, Inc. Pennsylvania State University
The opinions expressed in ACSH publications do not necessarily represent the views of all ACSH Directors and Advisors.
ACSH Directors and Advisors serve without compensation.