1 abcs safety

8/14/2019 1 ABCs Safety

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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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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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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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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

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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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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

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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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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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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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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 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

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