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ABCs OFCHILDHOODVACCINES
NATIONAL IMMUNIZATION PROGRAM
Immunization
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VACCINE SAFETY
NATIONAL IMMUNIZATION PROGRAM
Immunization
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VACCINE SAFETY
Immunization
Terms To Remember
Pre-Clinical Studies:First tests of a vaccine,
conducted on animals Clinical trials:Initialhuman studies done in 3 phases
to test safety, doses, and effectiveness of a vaccine
Adverse Reactions:Negative ways people react tovaccines
Biologics License Approval:FDA approval of the
vaccine and of the manufacturing plant where thevaccine is made
Post-Licensure Monitoring: FDA tracking of a vaccine after itis approved
Vaccine Lot: Each separate manufacturing run of a vaccine
VAERS: Vaccine Adverse Event Reporting System, a federalprogram that compiles reports from up to 200,000 healthcareproviders and members of the public annually
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VACCINE SAFETY
Immunization
Creating Vaccines: Safety And Effectiveness GoHand In Hand.
It takes a long time to develop a single vaccineusually 10 years or more.
Why? Because vaccines must be provensafe and effective before ever reachingthe public.
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VACCINE SAFETY
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Vaccines Start With Research
In the laboratory, scientists look for cluesabout how a bacterium or virus causes adisease, because making a vaccine startswith finding the cause.
Every human being has a genetic code
the thing that makes us uniqueand so doviruses and bacteria.
When scientists learn the code for adisease, they can identify the points wherea vaccine could make antibodies to fight off
viruses or bacteria.
Computer models and lab tests helppredict how the vaccine will affect thehuman immune system.
ResearchAnd More Research.
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After Research, Testing Starts(But Not On People).
Once a prototype vaccine is created, the firststudies are conducted in animals (these arecalled pre-clinical studies).
Animals are used because their immune
systems are similar to those of humans. Testson animals help predict the effect on people.
These tests help to make sure a vaccine hasno major side effects. If it does, its time tostart over!
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Four Phases Of Clinical Trials On People:Phase I Involves Animal Testing.
By now, years may have passed sincescientists first started research. But the workis just beginning.
Ip
has
e In Phase I, anywhere from 20 to 100 volunteersreceive the vaccine.
The first phase is limited to just a few people,
because scientists are triple-checking for safety,looking for serious side effects.
A vaccine thats been proven safe on animalsgoes through four phases of trials on people.
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VACCINE SAFETY
Immunization
Phase II Trials Are LongAnd Complicated.
Hundreds of volunteers take part in Phase II trials.
These trials might take a few months, or they mightlast for years.
Safety, safety, safetythats still being studied
in Phase II.
Phase II tests also explore how the human immunesystem responds to the vaccine.
IIp
has
e
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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 isgiven. General bodily reactions, such as fever ormuscle 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 comparereactions in an immunized person with reactions in someone whoisnt immunized with the vaccine under study.
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VACCINE SAFETY
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Now Its On To Phase III,(And Thats The Longest One Of All).
Phase III trials may last several years. A fewhundred to tens of thousands volunteers may beinvolved.
Some volunteers receive another already-licensedvaccine instead of the vaccine under study.
IIIp
has
e That way, researchers can compare one vaccine toanother for adverse effectsanything from a sore armto a serious reaction.
If everything about the proposed vaccine checks outfor safety and effectiveness in Phase III, themanufacturer applies for a license from the Food andDrug Administration (FDA).
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VACCINE SAFETY
Immunization
One License Wont DoThere Have To Be Two.
A biologic license is the license the FDA
gives for the vaccine itself and for themanufacturing plant where the vaccine ismade.
During the application phase, the FDA
reviews everything: clinical trial results,product labeling, the manufacturing plantitself, and the manufacturing protocols.
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VACCINE SAFETY
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Phase IV Tracks Vaccines After Licensing.
A license can be recommended or refused. This decision is madeafter an FDA team of specialists (microbiologists, chemists,biostatisticians, and medical officers) assess the safety data from thevaccine trials.
If a license is issued,
post-licensure monitoringtakes place.
Monitoring is the continual trackingof tens of thousands of peoplewho have been immunized
with the vaccine under study.
Post-licensure monitoringgives valuable informationabout the vaccines long-termsafety and effectiveness.
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VACCINE SAFETY
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Every Lot Of Vaccine is Testedand Sampled.
After a vaccine is approved and inproduction, samples of each lot (separatemanufacturing run) of a vaccine must besubmitted to the FDA before it can bereleased for use.
Each lot must be tested for safety, potency,and purity to assure uniformity in every doseof vaccine given.
Why test each lot? Because vaccines arevery sensitive. Changes in temperature
during the manufacturing process, forexample, can make them lose strength.
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VACCINE SAFETY
Immunization
Vaccine Safety Datalink (VSD)
In 1990, the CDC started its Vaccine SafetyDatalink projectVSD for short.
Eight large health maintenance organizations(HMOs) joined with the CDC to help keep an eyeon vaccine safety.
Since its beginning in 1990, VSD has collectedsafety statistics on more than 7 million people whohave received vaccines. These statistics are apowerful tool for assuring safety.
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Vaccine Adverse Event Reporting System (VAERS)
Sometimes, rare side effects and delayed
reactions dont 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 ReportingSystem (VAERS) in 1990.
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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
Vaccine Adverse Event Reporting System (VAERS)
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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 adverseevents for parents, patients, and
healthcare providers.
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Clinical Immunization Safety Assessment Centers(CISA)
Prior to the CISA network there were nocoordinated 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 ReportingSystem (VAERS).
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Vaccine Additives
Tiny amounts of three types of substancesmay be added to vaccines.
Stabilizers
Preservatives
Adjuvants
Preservatives keep bacteria or fungus fromgrowing, which could otherwise give vaccinerecipients serious infections.
Stabilizers help the vaccine keep its correctchemical composition even if conditions(such as temperature) change dramatically.
Adjuvants boost the vaccines ability toprovide an immune response.
All additives are within the safety marginsestablished by federal agencies.
Some additives can cause redness andsoreness on the skin where the vaccinationhas been given.
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All Additives Are Disclosed,And You Should Talk About Them.
Every vaccine comes with a packageinsert listing every ingredient, includingevery additive.
The insert lists every known adversereaction ever reported, no matter
how minor.
If you wonder just whats 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 orconcerns, talk with your doctor.
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Key Facts
As weve seen, vaccines are createdslowly and carefully. Research, labtests, and tests on human volunteerstake years for each vaccine.
At every step, safety and effectiveness
are checked, double-checked andtriple-checked.
Even after a vaccine is licensed, theFDA and the CDC keep gatheringinformation on adverse events and
overall vaccine safety.
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Additional Resources
Centers for Disease Control and Prevention website:www.cdc.gov. Click Vaccines & Immunizations, then click NIP HomePage in the right column or go directly to www.cdc.gov/nip
National Immunization Hotline: 1-800-232-2522
Parents Guide to Childhood Immunization: Publication availableonline 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 orlook under public health in the blue pages of your local phone book
For information on childrens health insurance: www.insurekidsnow.gov
Additional ABCs of Childhood Vaccines slide shows cover the followingtopics: Risks of Not Vaccinating; How Vaccines Work; Natural Immunity;Primary Vaccinations
Immunization