A r e p ort f rom

t h e A merican Academ y
of Microbiology

Adult
vaccines:
a Grown Up
Thing to Do

About ASM FAQs

The American Academy of Microbiology is the
honorific branch of the American Society for
Microbiology, a non-profit scientific society with
almost 40,000 members. Fellows of the AAM
have been elected by their peers in recognition
of their outstanding contributions to the field of
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Steering
Committee:
Nicola Klein,
M.D., Ph.D.
Kaiser
Permanente,
Vaccine Study
Center
Michael N.
Oxman, M.D.
Veterans
Administration
Medical Center
Stanley A.
Plotkin, M.D.
Vaxconsult, LLC
Gregory A.
Poland, M.D.
Mayo Clinic
College of
Medicine
Ann Reid
American
Academy of
Microbiology
Michael
IngersonMahar, Ph.D.
American
Academy of
Microbiology

PARTICIPANTS:
Roger
Baxter, M.D.
Kaiser
Permanente
Vaccine Study
Center
Michael D.
Decker,
M.D., Ph.D.
Sanofi Pasteur
Leonard
Friedland, M.D.
GlaxoSmithKline
Stanley A.
Gall, M.D.
University
of Louisville,
Department
of Obstetrics,
Gynecology and
Womens Health
Hayley
Gans, M.D.
Stanford
University
Medical Center
Pierce Gardner,
M.D.
Stony Brook
University School
of Medicine
Kevin P.
High, M.D.
Wake Forest
University,
Division of
Infectious
Disease
Wendy
Keitel, M.D.
Baylor College
of Medicine

Copyright 2012
American Academy
of Microbiology
1752 N Street, NW
Washington, DC 20036
www.asm.org

Written by
Michael Ingerson-Mahar
and Ann Reid

Martin G.
Myers, M.D.
Emeritus,
University of
Texas Medical
Branch
Alison
Naleway, Ph.D.
Kaiser
Permanente
Northwest,
The Center for
Health Research
Kristin L.
Nichol, M.D.
University of
Minnesota,
Research
Service (151)
Saad B.
Omer, Ph.D.
Emory
University,
Schools of
Public Health
& Medicine
and Emory
Vaccine Center
Jason L.
Schwartz,
M.B.E., A.M.
University of
Pennsylvania
Jonathan L.
Temte,
M.D., Ph.D.
University of
Wisconsin School
of Medicine and
Public Health,
Department of
Family Medicine

The world around us is filled with tiny microorganisms called microbes. Most of them are
harmless and many are even beneficial to us, but some microbescalled pathogensare
capable of making us sick. Our skin and mucous membranes keep a lot of these pathogens
out while our immune system is responsible for fighting off those that get inside us. The
human immune system has been ridding our bodies of pathogens for millions of years,
but only in the last century have scientists learned enough to help give us an additional
edge. Modern medicine has given us tools to aid our immune system in the fight against
pathogens. Drugs like antibiotics help eliminate pathogens after they make us sick, but only
vaccines are able to prepare our immune system so that many pathogens never make us
sick in the first place. Despite their benefits, many people do not know how vaccines work,
making some people uncomfortable and even mistrustful of vaccination. Also, many people
may not realize that vaccines are not just for children; adults can benefit too! This document
will tell you more about how vaccines work, why they are important, and how they can
protect adults. Take some time and look it overyour immune system will thank you.

1. What are vaccines and how

do they protect against disease?
A vaccine is a substance that teaches your immune
system to recognize a pathogen, protecting you against
a specific disease. To understand how this is possible, it
is important to know a little bit about how the immune
system works. The immune system can be summarized
as a defense network inside the body that reacts to
invasion by pathogens, microscopic organisms that can
make us sick. Our immune system protects us by recognizing pathogens and creating special tools to attack
and eliminate them. The next time you encounter that
same pathogen, your immune system will remember it
and fight it off more quickly. You may experience either
very mild symptoms or none at all.
In essence, vaccines mimic that initial attack. They trick
your immune system into thinking that you have been
infected by a pathogen. Included in every vaccine is

Adult Vaccines: A Grown Up Thing To Do

a component that looks like a specific pathogen to

your immune system. The immune system analyzes
the pathogen look-alike and learns to develop the tools
needed to combat it. In most cases, special memory
cells that are able to produce those tools persist in the
body for a long time, sometimes even for life. If an
exposure to the pathogen occurs after vaccination, the
immune system already has, or knows how to build,
the tools needed to fight it and can do so quickly. With
a blueprint for fighting the pathogen in place, many
pathogens will be killed or rendered harmless before
they have a chance to make us sick. Vaccines protect
against disease by preparing the immune system for
a pathogen ahead of time. In this respect, vaccines are
very natural, because they simply educate the bodys
own infection fighting system.

BOX 1: The parts list of a vaccine

Vaccines are not magic concoctions. They are made up
of only a few basic ingredients that each has a specific
purpose or reason for inclusion.

Antigens
The primary component in any vaccine is called the
antigen. The antigen is the pathogen look-alike that trains
your immune system to develop tools to protect against
that particular disease. You can think of the antigen as the
active ingredient of the vaccine. There are two main
types of vaccines defined by what type of material is used
as the antigen: live vaccines and not live vaccines.
Live vaccines employ a live pathogen that has been
weakened (or attenuated) as an antigen. To prepare these
types of antigens scientists isolate a pathogen and tame it
in the laboratory to the point that it is no longer capable of
causing disease. The weakened pathogen is then introduced
to the body by way of the vaccine. In its weakened state the
pathogen poses little threat to our body, but instead acts
like a training dummy to teach the immune system how to
fight the full-strength version of the pathogen.
Unlike live vaccines, not live vaccines employ either an
entire killed pathogen or a small part of it as an antigen.
Either way, it cannot cause disease on its own. When this
antigen is introduced into the body by the vaccine, the
immune system develops tools to recognize and destroy
it. If, in the future, the body is exposed to the whole
pathogen, the immune tools designed against the small
part will recognize the little piece of the pathogen it was
exposed to before and aggressively attack it, eliminating
the whole pathogen. Some not live vaccines use a
different strategy they prepare the immune system to
recognize the pathogens worst weapons. Many pathogens
produce powerful poisons, called toxins, that make us
sick. Scientists can isolate these toxins and render them
inactive in a laboratory. When these inactivated toxins
are introduced into our body in a vaccine, the immune
system creates tools to fight them. After vaccination, if
the pathogen invades our body and produces that toxin,
the immune system will already have the tools to fight
the toxin and the pathogen will be without its primary
weapon. Although these vaccines use slightly different
tactics to boost the immune system they are all considered
not live vaccines because they do not contain any live
pathogen. Not live vaccines may also be referred to as
inactivated vaccines, but dont be misled by the name;
they are excellent at protecting against disease.

Adjuvants
In some vaccines the antigen may be accompanied by
another component called an adjuvant. Adjuvants are
materials that increase the immune systems response to a
vaccine. Sometimes the inclusion of adjuvants in a vaccine
allows manufacturers to decrease the amount of antigen
needed in each dose of the vaccine. Adjuvants like aluminum
salts have been used in vaccines for over 70 years.

Preservatives
Vaccines may also contain preservatives, sometimes called
stabilizers, to ensure that the vaccine remains effective and
safe until it is ready to be used. Preservatives keep unwanted
microbes out of vaccines. Most people are familiar with
antibiotics, one commonly used preservative. Antibiotics
help keep unwanted bacteria out of vaccines. Formaldehyde
may also be used as a preservative in some vaccines. Low
levels of formaldehyde are poisonous to microbes but safe for
humans. In fact, small amounts of formaldehyde are produced
and metabolized naturally by our bodies. Regulatory agencies carefully monitor the levels of formaldehyde in vaccines
to be certain that they do not reach higher, harmful levels.
Thimerosal (sometimes called thiomersal) was used as a
preservative from the 1930s until 1999, when it was removed
from almost all vaccines. Thimerosal contains mercury, and its
inclusion in vaccines sparked fear among some members of
the public. Although scientific studies by many independent
groups showed that thimerosal was safe in the levels used in
vaccines, its use was discontinued out of concern that fear of
thimerosal would make people reluctant to get vaccinations.
Compounds called stabilizers are also sometimes added to
protect vaccines from the rigors of transport and make sure
that vaccine components dont break down before the vaccine
can be administered. Many stabilizers are sugars or amino
acids, compounds that are part of our everyday diet. Glycine is
one example of a stabilizer. It protects vaccines from damage
from light, heat, and humidity.

Trace materials and fluids

Vaccines also contain trace amounts of residual compounds.
These are mainly leftover ingredients from the manufacturing process. For example, the weakened pathogens used
in some vaccines are grown in chicken eggs, so it is not
uncommon to find trace amounts of egg protein in these
vaccines. Any residual compound used in the production of
the vaccine must be listed on the ingredients of a vaccine,
even if the compound is below detectable levels. Fluids
are added to vaccines so they can be given by injection or
inhalation. Generally, vaccine ingredients are suspended in a
mixture of water and salt, called saline.

A report from the American Academy of Microbiology

BOX 2: Edward Jenner the Father of

Immunology and the first vaccine
Edward Jenner was born in Gloucestershire, England
in 1749, a time when smallpox still claimed the lives of
millions of people in periodic epidemics and left millions
more with characteristic scars, or pock-marks. As a
young doctor Jenner became obsessed with finding
a way to prevent the horrible disease. Strangely, the
answer to his dilemma came from an unusual expression of the timesmooth as a milkmaids skinand
the hands of a woman named Sarah Nelmes.
Prevalence of polio (blue), measles (red), mumps (green), and
rubella (purple) in the US from 1950-2009, the black lines indicate
the introduction of a vaccine to protect against each disease.

Nelmes claimed that she was immune to smallpox because

she had contracted cowpox while working as a milkmaid.
Normally a disease of cattle, cowpox could spread to
humans that handled infected udders when milking cows.
Human infections were usually very mild and confined
to the hands, the area that was in contact with infected
udders. In 1796, Jenner set out to test Nelmes claim
and determine if cowpox infection could protect against
smallpox. He took material from a cowpox sore on Nelmes
hand and introduced it into the body of an eight year old
boy, James Phipps. A few months later Jenner exposed
Phipps to material taken from a fresh smallpox scab.
Nelmes was right! Normally exposing the boy to smallpox
would result in a reaction, if not the development of fullblown disease, but Phipps remained healthy, protected
from the pathogen that caused smallpox.
While vaccine development has certainly come a long
way since Jenners time, many of the principles are
unchanged. We know now that the pathogen that causes
cowpox is very similar to the pathogen that causes
smallpox in humans. When Jenner introduced the
cowpox pathogen into Phipps his immune system developed tools to fight it. So the cowpox virus acted as the
antigen in the vaccine. Because of the similarity between
the cowpox and smallpox viruses, when Phipps was later
exposed to the smallpox pathogen his immune system
already had tools to fight it off.
Jenners process was used to protect multitudes of
people against smallpox, saving millions of lives around
the world, and jump-starting the field of immunology.
In fact, the name vaccine dates back to Jenners
discovery. In Jenners honor, Louis Pasteur coined the
term vaccine from vaccinia, the name of the pathogen
that causes cowpox. Interestingly, Jenners discovery
explained why milkmaids skin was so smooth their
on-the-job exposure to vaccinia protected them from
smallpox, so milkmaids rarely suffered pockmark scars
from smallpox infections!

Adult Vaccines: A Grown Up Thing To Do

2. Why do we need vaccines?

Disease

Average U.S. Cases

(per year 20th century)

If you are younger than 50, you never had

% Decrease

Pre-vaccine 2010

to worry about polio or smallpox. Because

these diseases and others like them have been

Smallpox

29,005

100%

effectively eliminated from the United States,

Diphtheria

21,053

100%

we often take our increased life-span and

Whooping
cough

200,752

21,291

89%

relatively epidemic-free world for granted. The

Tetanus

580

99%

world without vaccination was very different.

Polio

16,316

100%

Measles

530,217

61

>99%

Mumps

162,344

2,528

98%

Rubella
(German
Measles)

47,745

>99%

The past offers insight into the harsh reality

of a world without vaccines. Parents watched
helplessly as their children were paralyzed by
polio. Smallpox killed millions and left millions
more with grotesquely disfiguring smallpox
scars. Diphtheria and whooping cough were
major causes of death among children. These
diseases and others like them were horrific but
unavoidable before vaccines were introduced.
Vaccines give our immune system the opportunity to
develop the tools to fight off a pathogen without having
to suffer the disease caused by the pathogen itself. In
this way vaccines are incredibly important to every
individuals health. There are still diseases, like polio
or measles, for which we have few treatment options.
In these cases the vaccine is the best, and sometimes
only, option for dealing with the disease.
Vaccines also save us money. Every year illness
imposes substantial costs in the form of doctors visits,
prescription drugs, and hospitalizations. Caring for
ailing individuals can place significant demands on
their families and friends. When illness is prevented by
vaccination, it saves money and the burden of sick days
and days spent at home caring for loved ones.
The benefits of vaccination are not limited to your
own health, but extend to those around you. Infectious
diseases are transmitted from one person to another,
so individuals are like links in a chain. Every vaccination breaks another link, helping to protect those who
cannot be vaccinated themselves. In this way vaccination of one person protects those around them from

A report from the American Academy of Microbiology

BOX 3: The eradication of

smallpox: a vaccine triumph
Smallpox was a devastating disease caused by the
viruses Variola major and Variola minor that plagued
humans for thousands of years; indeed smallpox scars
were found on an Egyptian mummy dating back to
10,000 BC. Characterized by the formation of raised
pustules all over the body, the disease was as deadly
as it was grotesque; Variola major killed about 30% of
those that it infected.1 Those that survived infection
were often left scarred and sometimes even blinded.
The loss of life exacted by smallpox was astronomical;
the World Health Organization (WHO) estimated that
smallpox was responsible for the deaths of nearly
500 million people in the 20th century alone. Edward
Jenner developed his smallpox vaccine in 1796, but
even in the mid-1900s vaccination levels were not high
enough to halt the spread of the viruses and there was
no effective treatment for smallpox once contracted.
Doctors in the mid-20th century were nearly as powerless to halt an infection as the ancient Egyptians.

disease, including their loved ones, co-workers, and

their community. No vaccine offers perfect protection.
The more often you are exposed to in infectious disease,
the more likely you are to become infected. When others
around you are vaccinated, you are less likely to be
exposed. This indirect protection, known as herd protection, relies on high vaccination rates and is particularly
important for the very young and very old. Even though
they are the most vulnerable to disease, these people
often cannot receive recommended vaccines because
they have a weakened or immature immune system.
Their protection depends on others. Another important aspect of herd protection is that unlike the U.S.,
some parts of the world do not have the resources to
vaccinate; in these countries the diseases of our past
are still the diseases of their present. Terrible infectious
diseases like diphtheria, measles, and polio are only a
short plane flight away from the U.S. These diseases
are not gone from the world; they are simply prevented
from spreading in the U.S. by high vaccination rates.
There have been many studies showing that if vaccines
were discontinued, pre-vaccine conditions would quickly
return. Choosing not to be vaccinated also affects those
around you. Even if you have no symptoms you can
still act as a carrier of a disease and can infect others
around you. This puts the elderly, people with weak-

Adult Vaccines: A Grown Up Thing To Do

The Variola viruses had one critical weaknessthey

could only reproduce in humans. If enough people
were immune to the viruses, they would have no
home, no way to replicate and smallpox would disappear forever. With the goal of eradication in mind,
public health officials from the WHO and other public
health organizations spearheaded massive worldwide
smallpox vaccination programs in the mid 1900s. The
last naturally occurring case of smallpox was recorded
on October 26, 1977. The protective power of the
vaccine and the diligence of public health workers had
paid off; the 12,000 year reign of smallpox was finally
ended. The greatest triumph of vaccination, the global
eradication of smallpox, was announced by the scientific community in 1979. Since that time people have
lived free of the fear of the devastating disease.

ened immune systems, and very young infants at risk

and is why medical personnel and care givers are so
strongly encouraged to be vaccinated. Many doctors
offices, especially those that treat infants, are now
asking parents before office or emergency room visits
to inform them about their childs immunization status,
in order to protect their other vulnerable patients from
potential exposure to the pathogens that unvaccinated
people could be carrying.

3. Arent vaccines only for children?

How about adults?
Is it too late to get vaccinated?
Vaccines are for everyone, not just children.
In fact, there are some vaccines that are
specifically recommended for adults. These
adult vaccines protect against diseases that
are more common in adults than children.
For example, shingles is a disease caused by the same
pathogen as chickenpox. The pathogen hides in nerve
cells for years and can reemerge in older adults to
cause shingles, so anyone who has ever had chickenpox is at risk. However, because shingles is rare in
children the vaccine is generally only recommended
for adults. Some vaccines protect against diseases that
can be more serious when contracted by adults. Adults
who develop chickenpox are more likely to suffer from
serious complications, including pneumonia. Arthritis
and inflammation of the brain are rare complications of
measles in children, but for unknown reasons are much
more common in adults suffering from measles. So if
you were not vaccinated against measles in childhood,
it is important to get the vaccine as an adult. Other
adult vaccines may actually be boosters of vaccines
that you received as a child. Although the immune
system uses memory cells to remember how to build
the tools to fight a pathogen, over time this memory
can fade. Booster vaccines refresh the immune
systems memory, so that it can continue to provide
protection against the disease.
The influenza vaccine (flu vaccine) is available for both
adults and children and is recommended to be given
once a year. In this case, its not that our immune
system forgets how to fight the influenza virus; rather,
the virus can change from year to year so we have to
retrain our immune system to fight it. Each years influenza vaccine may contain different antigens from the
previous years vaccine. The new antigens are specially
customized to train the immune system to fight this
years influenza viruses.

BOX 4: Is there anyone that

should not receive vaccines?
The benefits of vaccines vastly outweigh the risks for
almost everyone. But there are a few notable exceptions. Anyone who is allergic to any component of a
vaccine, or has had a serious adverse reaction after
vaccination or anyone that is immune compromised
should speak with a physician before being vaccinated.
Pregnancy is a particularly important time for vaccination; however women who are pregnant should not
receive live vaccines, but may receive non-live
vaccines. Two vaccines, influenza and combination
tetanus with whopping cough vaccine are specifically
recommended for pregnant women. Other non-live
vaccines such as pneumococcal vaccine and hepatitis
vaccines can be recommended if certain risk indications are present. Pregnant women should consult
with a physician regarding these vaccines.

Keeping up-to-date on vaccinations as an adult can help

you avoid contracting many of these diseases to begin
with. No one likes suffering from influenza, and it can
be very serious especially for the elderly, but it is just
one disease that adult vaccines can protect against.
Shingles and whooping cough vaccines are two other
examples of vaccines that can save you a lot of misery.
Shingles is characterized by an extremely painful rash,
particularly in older people. Severe cases of shingles
can result in permanent nerve damage, pain, and even
blindness. Whooping cough has been described as
the hundred day cough and sometimes can cause
coughing fits so powerful that they result in broken
ribs. Getting vaccinated reduces your risk of getting
shingles, measles, whooping cough, or influenza. To put

A report from the American Academy of Microbiology

BOX 5: Scientists play Cat and Mouse with influenza

The influenza vaccine stands out from other adult vaccines

as it is recommended to be given annually. But what makes
it special? The answer actually lies not in the vaccine, but
in the nature of the pathogen that causes the fluthe
influenza virus.
Influenza is not a single virus; there is a whole family of
influenza viruses. Although all the influenza viruses are
closely related, they look very different to our immune
system, and the tools that it builds to defeat one type of
influenza virus may not work against another. To make
matters worse individual members of the influenza virus
family change how they appear over time, so the tools
developed against one member of the influenza virus
family may not work against it the following year. Most
flu seasons there are one or two main types of influenza
virus causing infections in the U.S., but because vaccine
production takes a few months, scientists must guess
ahead of time which viruses will dominate each year. Most
of the time the scientists are right and the vaccine for
the year protects well against influenza, other times the
virus changes in unexpected ways and the vaccine is less
effective. This is why the influenza vaccine offers better
protection some years than others.
Health professionals agree that even partial protection from
influenza through vaccination is far better than no protec-

that risk in perspective, every year in the United States

over 40,000 adults die from diseases against which they
could have been vaccinated.
This number is particularly saddening because adult
vaccines are so effective in protecting against these
diseases. Its true that some vaccines are more effective
than others. The type of vaccine, the age of the recipient, and other factors can all alter the effectiveness of
a vaccine. But even if a vaccine is not 100% effective
at protecting you from contracting the disease, it is
likely to lessen the severity of the symptoms associated
with the disease. The shingles vaccine is an excellent
example; although some adults who have been immunized against shingles may still develop the disease,

Adult Vaccines: A Grown Up Thing To Do

tion at all. Although many people think of influenza as just

a nuisance, it can be far more serious. Most years, 5,000
to 40,000 people, generally older adults, die of influenza.2
Some years are far worse; the infamous 1918 influenza
outbreak killed over 50 million people worldwide.3 While
scientists generally think that a recurrence of such a deadly
influenza is unlikely (due to better nutrition and health,
availability of antibiotics to treat complications, and greater
understanding of the virus), the annual vaccine still represents your best chance at dodging influenza. Flu shots, and
the influenza vaccine delivered by nasal spray, are widely
available, and scientists agree that the benefits, even if they
are uncertain in any given year, far outweigh the risks.
So will this game of cat and mouse ever end? As scientists
learn more about the influenza virus they are becoming
better at correctly predicting which types will emerge each
year. New vaccine production techniques are reducing the
amount of time it takes to make a new vaccine so that the
prediction of what influenza virus will be circulating doesnt
have to be made so early. Scientists are also working on
new vaccines that will better protect against more, or even
all, types of influenza viruses. While scientists differ in their
opinion on whether there will ever be a universal influenza vaccine that protects against all types of influenza, we
can still hope that one day the yearly cat and mouse game
we play with influenza will be put to rest.

their symptoms are typically milder than those who

were not vaccinated.
Although it is generally never too late to be vaccinated,
most vaccines are designed to be given at specific
times. The Centers for Disease Control and Prevention
(CDC) maintains an adult immunization schedule with
vaccine recommendations for adults based on age,
occupation, and other risk factors. New vaccines are
constantly being developed. The CDC adult immunization schedule website (http://www.cdc.gov/vaccines/
recs/schedules/downloads/adult/mmwr-adult-schedule.
pdf) and your doctor are great references to stay up-todate on what vaccines are available for adults and
when they are recommended.

4. Are vaccines safe?

How do we know this?
In short, vaccines are extremely safe.
The chance of experiencing a serious side effect, like
an allergic reaction, after vaccination is less than one
in a million. That means that 999,999 people out of
a 1,000,000 do not suffer any serious adverse
effects after vaccination.4 To put this into
perspective, it is nearly as likely for someone
to suffer a severe allergic reaction to aspirin
as to a vaccine.5, 6
Vaccines are always safer than
contracting the diseases that they are
designed to protect against, but to say
that vaccines are completely harmless is
not true. Everything in life carries some
risk, even ordinary daily activities. For
example, in the U.S. each year 350 people
die from shower or bathtub related injuries, 200 choke to death while eating, and
100 are struck and killed by lightning while
outside during a storm.7 Vaccines can cause
side effects, but most are short-lived and
result in only very mild discomfort. Redness
and some swelling around the injection site are
some of the more common side effects of vaccines.
Serious side effects, like severe allergic reactions, are
exceedingly rare, far less common than serious slips
and falls in the shower.
So why do some people cringe at the thought of
vaccination and not at showering? The answer lies
in how we perceive risk. People are less comfortable
accepting risks with unfamiliar benefitseven if those
benefits are great. The benefits of showering are very
familiar and well worth the risk of a fall. The benefits
of protection against a disease that most people have
not experienced or even observed first hand are less
familiar. In this regard vaccines can be thought of as a
victim of their own success. Because vaccines protect
us from these diseases, many people are not familiar
with how horrific the diseases truly are.

If the blue circle represents everyone

who received a vaccine, then the black
point in the center represents the people
that would experience a severe allergic
reaction to the vaccine. Cant see the black
point? Its actually too small to print, but
even if it could be printed you would need
a very powerful microscope to see it.

A report from the American Academy of Microbiology

BOX 6: How VAERS works your

role in monitoring vaccine safety
Ensuring the safety of vaccines is a group effort.
Public and private researchers and scientists, the
FDA, and the CDC are just a few of the groups that
work to make sure vaccines are safe. The Vaccine
Adverse Event Reporting System (VAERS) allows
you to play a role in the process too. Researchers use
VAERS to track adverse health events experienced
by individuals after vaccination. These adverse
events may be caused by the vaccine (vaccine side
effects) or they just may be events that happened
by coincidence around the same time as the vaccine
was given. If you experience an adverse event
following a vaccination you should report it to VAERS
(http://vaers.hhs.gov/index). Each report, called
an anecdote, is reviewed by VAERS researchers.
Because side effects after vaccination are so rare,
separating chance events from vaccine side effects
requires review of many, many anecdotes and,
often the conducting of additional studies. Every
report logged in the system gives researchers a little
more information and allows them to make better
decisions on the safety of vaccines.

From concept to licensing

the life history of a vaccine
That vaccines are so safe is no accident. To understand
this, it is helpful to consider the path a potential vaccine
must take to be approved for use.
From their beginning as a twinkle in a researchers
eye to being stocked in your local physicians office,
vaccines may be the most heavily scrutinized of all
manmade goods. A new vaccines first challenge is the
manufacturers own in-house tests. New vaccines must
pass laboratory and animal tests meant to demonstrate their safety and effectiveness. If these tests are a
success the company can submit a request to the Food
and Drug Administration (FDA) to begin human testing.
The FDA carefully reviews all the preliminary data
submitted by the drug company and if those data are
satisfactory authorizes human clinical trials of a vaccine
in three phases. Phase I trials typically include 20-100
volunteers and test the vaccine for any serious side
effects; phase II trials involve hundreds of volunteers to
optimize vaccine dosing; finally phase III trials consist of

Adult Vaccines: A Grown Up Thing To Do

anywhere from hundreds to many thousands of volunteers who test the vaccine for safety and effectiveness.
During the final phases of clinical trials, FDA employees
also inspect the manufacturing process and production
facilities for the vaccine. Additional periodic inspections are conducted by the FDA even after a vaccine is
licensed to ensure that the manufacturing process has
remained the same. The three phases of clinical trials
and inspection can take many years to complete, and if
at any point in the trials the safety or effectiveness of the
vaccine is called into question the FDA can halt testing.
If a vaccine successfully makes it through all three
human trial stages, the manufacturer can submit an
application for a license for the vaccine. At this stage,
a diverse group of experts from the FDA reviews all
the data collected. The FDA may also ask a group of
non-FDA experts to review the data. During this time
the results of the clinical trials are also published and
made available for review by the entire scientific and
medical communities. Finally, the FDA will decide
whether to license the vaccine, request that more
studies be done, or deny the license. Because of this

rigorous process of review only the safest and most

effective vaccines are approved.
Even after it has been licensed, a vaccine continues to
be closely scrutinized. In the U.S. there are a number
of parallel systems in place to monitor the safety and
effectiveness of vaccines. The CDC and the FDA both
monitor vaccine safety through the Vaccine Adverse
Event Reporting System (VAERS). VAERS is a tool that
physicians, patients, and caregivers can use to report
adverse events that occur after a person is vaccinated. The system captures all adverse events that
are reported to it, and the CDC and FDA monitor the
reports for any suspicious trends that might point to
a rare but serious vaccine side effect. Other vaccine
safety monitoring services include the Vaccine Safety
Datalink (VSD) project and the Clinical Immunization
Safety Assessment (CISA) network. The VSD project is
a collaboration among ten large health care providers.
The Datalink tracks health records on over 9 million
individuals and provides this information to the CDC,
FDA, and scientists to compare health risks between
vaccinated and unvaccinated individuals. The Clinical
Immunization Safety Assessment (CISA) network is a
group of six academic medical centers that specialize
in evaluating the safety and efficacy of vaccines. CISA
conducts clinical research to monitor for and study any
adverse effects after vaccination.

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Recommending a vaccine for use

The CDC maintains recommended vaccination schedules for both adults and children. Only after a vaccine
has gone through the lengthy licensure process can it
become eligible to be included in the recommended
schedule of vaccines. The CDC is advised on vaccine
recommendation decisions by the Advisory Committee
on Immunization Practices (ACIP), a diverse group
of physicians, scientists, public health officials, and
consumer advocates. The ACIP was established in 1964
by the U.S. Surgeon General to consider the large
number of vaccines that were being developed at the
time and it has been in service ever since. It is made
up of 15 voting members and 30 nonvoting liaisons
from different government agencies and professional
associations like the American Medical Association and
the American Academy of Family Physicians. Voting
members are experts in their fields who are free of
conflicting ties to vaccine manufacturers or individual
vaccines. Despite their extensive expertise ACIP voting
members work on a volunteer basis; they are not paid
nor do they receive any financial benefits for their work
on the committee. In an effort to be transparent, all of
the meetings of the committee are open to the public
and available for viewing live in real time on the internet.
After each meeting the minutes are also made available
online. ACIP recommendations are the cornerstone of
the CDCs recommended immunization schedules.

A report from the American Academy of Microbiology

5. Can vaccines give you the disease that they

are designed to protect against?
Sometimes, so called live vaccines contain
a weakened pathogen and can cause you to
develop a very mild form of the disease itself.
This is an intended part of the vaccination
process. The yellow fever, varicella
(chickenpox), smallpox, typhoid, and
measles-mumps-rubella (MMR) vaccines
are examples of live vaccines that may
cause an extremely mild form of the
disease. In these cases, it is worth a little
discomfort to train your immune system
to fight the pathogens responsible for
these diseases because the benefits far
outweigh the temporary inconvenience.
Very rarely, when administered to someone whose
immune system is severely weakened, the attenuated
pathogen contained in the live vaccine can cause an
infection similar to the natural infection. This is why
anyone with a weakened immune system should
consult a physician before receiving any vaccine.
Not live vaccines will never cause the disease, even
a mild case, because they do not contain live diseasecausing pathogen. For example, the inactivated
influenza shot is a not live vaccine and thus cannot
give you influenza. So why do some people come
down with flu-like symptoms after vaccination? Influenza vaccines are generally given during flu season
which is prime time for all sorts of viruses that cause
upper respiratory infections. Influenza vaccines only
protect you from the influenza virus, not the dozens
of other viruses that can cause similar, but generally much milder symptoms. So, theres a reasonable
chance of getting a cold or some other flu-like illness
soon after getting the influenza vaccine. It doesnt help
that we call so many illnesses the flu that arent
caused by the influenza virus. For example, there is
absolutely no relationship between what most of us

Adult Vaccines: A Grown Up Thing To Do

call the
stomach flu and
influenza virus. Intestinal upsets are caused by an
entirely different set of viruses, so the influenza
vaccine will not protect you against stomach flu.
One additional point to note is that mild side effects of
the vaccine should not be confused with symptoms of
a disease. It is not uncommon to experience a slight
fever, fatigue, and aches after receiving a vaccine.
These side effects are an indication that the immune
system is responding to the vaccine, not symptoms of
the disease itself. Vaccines have protected people well
enough that many people have not seen first-hand
symptoms of many of these diseases so the confusion
is understandable. In almost every case these side
effects of the vaccine pale in comparison to the symptoms of the disease itself.

11

Getting vaccinated is a very safe and effective choice that any adult can make to help ensure
his or her health and the health of those around them. Vaccine recommendations are based
on the best science regarding safety, personal health, and the health of the public. Vaccines
have saved millions of lives and are perhaps the single greatest development in the war against
disease since the separation of sewage from drinking water. While the diseases that they
protect against may not be familiar to us in the U.S., they are still present, often only a short
plane ride away. Vaccines offer the best, and sometimes only, line of protection from these
diseases. The fact that we do not worry about these diseases is a testament to the tremendous
success of vaccine in the past. The future of vaccines is bright; each year scientists formulate
more innovative and effective vaccines. There are already vaccines that can help protect
against certain types of cancer and more are under development now. Scientists are also
working on new vaccines that could in time protect against killers like malaria, tuberculosis,
and HIV. Their efforts will help ensure that vaccines will save millions more lives in the future.

Learning more about adult vaccination

This document is meant to be a primer to understanding how vaccines work and why they are important,
but there is much more to learn. The best information on vaccination comes from the experts studying
them. If you would like to learn more about vaccines you can turn to any of the sources listed below.
They will provide reliable information, checked by scientists and researchers for accuracy.

Centers for Disease Control and Prevention (CDC)

www.cdc.gov/vaccines
CDC Adult Immunization Schedule
www.cdc.gov/vaccines/recs/schedules/downloads/adult/mmwr-adult-schedule.pdf
National Network of Immunization Information (NNii)
www.immunizationinfo.org
The Immunization Action Coalition (IAC)
www.immunize.org
The College of Physicians of Philadelphia
offers information about vaccine concepts and history
www.historyofvaccines.org
Johns Hopkins Institute for Vaccine Safety
www.vaccinesafety.edu

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A report from the American Academy of Microbiology

References
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Behbehani AM. The smallpox story: life and death of

an old disease. Microbiol Rev 1983; 47 (4): 455509.

Centers for Disease Control and Prevention. MMWR.

08/08/2008.

Taubenberger JK and Morens DM. 1918 Influenza:

the Mother of All Pandemics. CDC. 2006.

Myers M. and Pineda D. Do Vaccines Cause That?!:

A Guide for Evaluating Vaccine Safety Concerns.
Immunizations for Public Health 2008; 1819.

Kemp SF, Lockey RF, Wolf BL, Lieberman P.

Anaphylaxis. A review of 266 cases. Arch Intern Med.
1995; 155: 17491754.

 imons FE, et al. World Allergy Organization survey on

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global availability of essentials for the assessment and
management of anaphylaxis by allergy-immunology
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asthma & immunology 2010; 104 (5): 405412.

 tatistics derived from National Safety Councils

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Data on Accidents in the year 2000. Accessed at:
http://danger.mongabay.com/injury_odds.htm.

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