NATIONAL IMMUNIZATION PROGRAM

ABCs OF
CHILDHOOD
VACCINES

Immunization
NATIONAL IMMUNIZATION PROGRAM

VACCINE SAFETY

Immunization
VACCINE SAFETY

Terms To Remember
• Pre-Clinical Studies: First tests of a vaccine,
conducted on animals
• Clinical trials: Initial human studies done in 3 phases
to test safety, doses, and effectiveness of a vaccine
• Adverse Reactions: Negative ways people react to
vaccines
• Biologics License Approval: FDA approval of the
vaccine and of the manufacturing plant where the
vaccine is made
• Post-Licensure Monitoring: FDA tracking of a vaccine after it
is approved
• Vaccine Lot: Each separate manufacturing run of a vaccine
• VAERS: Vaccine Adverse Event Reporting System, a federal
program that compiles reports from up to 200,000 healthcare
providers and members of the public annually

Immunization
VACCINE SAFETY

Creating Vaccines: Safety And Effectiveness Go

Hand In Hand.
• It takes a long time to develop a single vaccine
—usually 10 years or more.
• Why? Because vaccines must be proven
safe and effective before ever reaching
the public.

Immunization
VACCINE SAFETY

Vaccines Start With Research…

Research…And More Research.
• In the laboratory, scientists look for clues
about how a bacterium or virus causes a
disease, because making a vaccine starts
with finding the cause.
• Every human being has a genetic code—
the thing that makes us unique—and so do
viruses and bacteria.
• When scientists learn the code for a
disease, they can identify the points where
a vaccine could make antibodies to fight off
viruses or bacteria.
• Computer models and lab tests help
predict how the vaccine will affect the
human immune system.

Immunization
VACCINE SAFETY

After Research, Testing Starts

(But Not On People).
• Once a prototype vaccine is created, the first
studies are conducted in animals (these are
called “pre-clinical studies”).

• Animals are used because their immune

systems are similar to those of humans. Tests
on animals help predict the effect on people.

• These tests help to make sure a vaccine has

no major side effects. If it does, it’s time to
start over!

Immunization
VACCINE SAFETY

I
Four Phases Of Clinical Trials On People:
Phase I Involves Animal Testing.
• By now, years may have passed since
scientists first started research. But the work p
is just beginning.

• A vaccine that’s been proven safe on animals

has
•
goes through four phases of trials on people.

In Phase I, anywhere from 20 to 100 volunteers

e
receive the vaccine.

• The first phase is limited to just a few people,

because scientists are triple-checking for safety,
looking for serious side effects.

Immunization
VACCINE SAFETY

Phase II Trials Are Long

II
And Complicated.
• Hundreds of volunteers take part in Phase II trials.
p
• These trials might take a few months, or they might
last for years. has
• Safety, safety, safety—that’s still being studied
in Phase II. e
• Phase II tests also explore how the human immune
system responds to the vaccine.

Immunization
VACCINE SAFETY

Phase II Also Finds The Precise Dose.

• Now the vaccine is fine-tuned. Phase II trials set

(1) the most effective use of the vaccine,
(2) the best dose for effectiveness and safety, and
(3) the right number of doses.
• Adverse reactions are recorded. Local reactions
include redness and swelling where the vaccine is
given. General bodily reactions, such as fever or
muscle aches, are also tracked.
• Some Phase II volunteers do not get the vaccine being tested.
Instead, they get either an already-licensed vaccine or another
harmless substance (placebo).
• Placebos and controlled testing enable researchers to compare
reactions in an immunized person with reactions in someone who
isn’t immunized with the vaccine under study.

Immunization
VACCINE SAFETY

Now It’s On To Phase III,

III
(And That’s The Longest One Of All).
• Phase III trials may last several years. A few
hundred to tens of thousands volunteers may be
p
has
involved.
• Some volunteers receive another already-licensed

e
vaccine instead of the vaccine under study.
• That way, researchers can compare one vaccine to
another for adverse effects—anything from a sore arm
to a serious reaction.
• If everything about the proposed vaccine checks out
for safety and effectiveness in Phase III, the
manufacturer applies for a license from the Food and
Drug Administration (FDA).

Immunization
VACCINE SAFETY

One License Won’t Do—There Have To Be Two.

• During the application phase, the FDA
reviews everything: clinical trial results,
product labeling, the manufacturing plant
itself, and the manufacturing protocols.

• A biologic license is the license the FDA

gives for the vaccine itself and for the
manufacturing plant where the vaccine is
made.

Immunization
VACCINE SAFETY

Phase IV Tracks Vaccines After Licensing.

• A license can be recommended or refused. This decision is made

after an FDA team of specialists (microbiologists, chemists,
biostatisticians, and medical officers) assess the safety data from the
vaccine trials.

• If a license is issued,
post-licensure monitoring
takes place.
• Monitoring is the continual tracking
of tens of thousands of people
who have been immunized
with the vaccine under study.
• Post-licensure monitoring
gives valuable information
about the vaccine’s long-term
safety and effectiveness.
Immunization
VACCINE SAFETY

Every Lot Of Vaccine is Tested

and Sampled.
• After a vaccine is approved and in
production, samples of each lot (separate
manufacturing run) of a vaccine must be
submitted to the FDA before it can be
released for use.
• Each lot must be tested for safety, potency,
and purity to assure uniformity in every dose
of vaccine given.
• Why test each lot? Because vaccines are
very sensitive. Changes in temperature
during the manufacturing process, for
example, can make them lose strength.

Immunization
VACCINE SAFETY

Vaccine Safety Datalink (VSD)

• In 1990, the CDC started its Vaccine Safety

Datalink project—VSD for short.

• Eight large health maintenance organizations

(HMOs) joined with the CDC to help keep an eye
on vaccine safety.

• Since its beginning in 1990, VSD has collected

safety statistics on more than 7 million people who
have received vaccines. These statistics are a
powerful tool for assuring safety.

Immunization
VACCINE SAFETY

Vaccine Adverse Event Reporting System (VAERS)

• Sometimes, rare side effects and delayed

reactions don’t show up in clinical trials.

• So, once a vaccine is released to the

public, data on effects and reactions are
gathered continually.

• To make the gathering of information about

potential side effects as complete as possible,
the CDC and the FDA started a national system
called the Vaccine Adverse Event Reporting
System (VAERS) in 1990.

Immunization
VACCINE SAFETY

Vaccine Adverse Event Reporting System (VAERS)

• Anyone can report to VAERS. More than

200,000 healthcare providers get reporting
forms from VAERS to remind them to
note reactions and enter them into the
system.

• You can get information about VAERS

and submit VAERS reports at this website:
www.fda.gov/cber/vaers/vaers.htm

Immunization
VACCINE SAFETY

Clinical Immunization Safety Assessment Centers

(CISA)
• In 2001 the Clinical Immunization
Safety Assessment Centers
(CISA) were started.

• These Centers serve as an expert

resource on vaccine adverse
events for parents, patients, and
healthcare providers.

Immunization
VACCINE SAFETY

Clinical Immunization Safety Assessment Centers

(CISA)
• Prior to the CISA network there were no
coordinated facilities in the United States
that investigated, evaluated, and managed
vaccine adverse events for individual
patients.

• CISA Centers work together

with CDC to systematically
assess individual cases that
have been reported to the
Vaccine Adverse Reporting
System (VAERS).

Immunization
VACCINE SAFETY

Vaccine Additives

• Tiny amounts of three types of substances

may be added to vaccines.
• Preservatives keep bacteria or fungus from
growing, which could otherwise give vaccine
recipients serious infections. Adjuvants
• Stabilizers help the vaccine keep its correct
chemical composition even if conditions Stabilizers
(such as temperature) change dramatically. Preservatives
• Adjuvants boost the vaccine’s ability to
provide an immune response.
• All additives are within the safety margins
established by federal agencies.
• Some additives can cause redness and
soreness on the skin where the vaccination
has been given.
Immunization
VACCINE SAFETY

All Additives Are Disclosed,

And You Should Talk About Them.
• Every vaccine comes with a package
insert listing every ingredient, including
every additive.
• The insert lists every known adverse
reaction ever reported, no matter
how minor.
• If you wonder just what’s in a vaccine,
or are worried about allergic reactions,
ask your doctor for a copy of the insert.
• And if you have any other questions or
concerns, talk with your doctor.

Immunization
VACCINE SAFETY

Key Facts

• As we’ve seen, vaccines are created

slowly and carefully. Research, lab
tests, and tests on human volunteers
take years for each vaccine.
• At every step, safety and effectiveness
are checked, double-checked and
triple-checked.
• Even after a vaccine is licensed, the
FDA and the CDC keep gathering
information on adverse events and
overall vaccine safety.

Immunization
VACCINE SAFETY

Additional Resources

• Centers for Disease Control and Prevention website:

www.cdc.gov. Click “Vaccines & Immunizations,” then click “NIP Home
Page” in the right column or go directly to www.cdc.gov/nip
• National Immunization Hotline: 1-800-232-2522
• Parent’s Guide to Childhood Immunization: Publication available
online at www.cdc.gov/nip/publications/
• For information on vaccine testing and licensing: www.fda.gov
• For information about local health care resources: www.naccho.gov or
look under “public health” in the blue pages of your local phone book
• For information on children’s health insurance: www.insurekidsnow.gov
• Additional ABCs of Childhood Vaccines slide shows cover the following
topics: Risks of Not Vaccinating; How Vaccines Work; Natural Immunity;
Primary Vaccinations

Immunization
Immunization