Vaccine Safety Elizabeth Tatum Draper RN Clinical Consultant North Carolina Immunization Branch July 2011

Vaccine Vaccine SafetySafety

Elizabeth Tatum Draper RNElizabeth Tatum Draper RNClinical ConsultantClinical Consultant

North Carolina Immunization BranchNorth Carolina Immunization Branch

July 2011 July 2011

2011 NC State Immunization Con2011 NC State Immunization Conferenceference

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Goals for todayGoals for today

Only one:Only one:Discuss vaccine safety; what that Discuss vaccine safety; what that means and how to incorporate this means and how to incorporate this

into discussions with parents/patientsinto discussions with parents/patients

OK—guess technically that is three….OK—guess technically that is three….


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What we What we won’twon’t do today do today Answer ALL of the questions that you Answer ALL of the questions that you

havehave

Solve the anti-vaccine movement issueSolve the anti-vaccine movement issue

Learn how to convince EVERY Learn how to convince EVERY patient/parent that vaccines are safe patient/parent that vaccines are safe in terms of risks vs. benefits in terms of risks vs. benefits


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"Safer Healthier Children." "Safer Healthier Children." An overview of how vaccines are produced and how they work.An overview of how vaccines are produced and how they work.

Produced by Centers for Disease Control and Prevention.Produced by Centers for Disease Control and Prevention.


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Why all the questions from Why all the questions from parents??parents??

Parents today haven’t had to experience most of the Parents today haven’t had to experience most of the diseases that used to be commonplace. That’s the diseases that used to be commonplace. That’s the success of immunizations. success of immunizations.

Many Americans today distrust “the government” only Many Americans today distrust “the government” only slightly less than they distrust “big corporations.” slightly less than they distrust “big corporations.”

People now see and hear many arguments People now see and hear many arguments questioning vaccines in the media and on the questioning vaccines in the media and on the Internet. Internet.


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But still………..why???But still………..why???

Take a moment to think about Take a moment to think about something that you were told as a child something that you were told as a child

or young adult that even though you or young adult that even though you now KNOW there is no “scientific” now KNOW there is no “scientific”

evidence to back this up that you still evidence to back this up that you still believe or follow ……….believe or follow ……….

We are scientific people why do we still We are scientific people why do we still do this ???do this ???


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What/Who we are up What/Who we are up against……against……

Dr. Andrew Wakefield –Dr. Andrew Wakefield –study now study now found to be a fraud, but damage already found to be a fraud, but damage already donedone

Moms Against MercuryMoms Against Mercury– their web site – their web site has “stepped out for a bit” has “stepped out for a bit”

Hollywood celebritiesHollywood celebrities touting anti- touting anti-vaccine informationvaccine information

Dr. Bob SearsDr. Bob Sears The Internet in generalThe Internet in general


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Answering the questionsAnswering the questions

Effective, empathetic communication is Effective, empathetic communication is critical in responding to parents who are critical in responding to parents who are considering not vaccinating their children. considering not vaccinating their children. Parents should be helped to feel comfortable Parents should be helped to feel comfortable voicing any concerns or questions they have voicing any concerns or questions they have about vaccination, and providers should be about vaccination, and providers should be prepared to listen and respond effectively.prepared to listen and respond effectively.

From CDC’s ―Providers Guide: Helping Parents Who Question VaccinesFrom CDC’s ―Providers Guide: Helping Parents Who Question Vaccines


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Don’t worry about every possible question

Be able to recommend good websites and handouts for patients/parents.

Be aware of major anti-vaccine groups and individuals and become familiar with their websites.

Be ready to answer the most common questions--many concerns haven’t changed in over 200 years!

It’s OK to say you will research the answer and get back with them.

It is worth your time-most people do still respect the opinion of their healthcare provider.


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But is the problem really related But is the problem really related to the vaccine ?to the vaccine ?

How does the parent know if the How does the parent know if the vaccine is what caused the problem vaccine is what caused the problem with their child. with their child.

Many times they won’t and when a Many times they won’t and when a child becomes sick, is injured, or dies child becomes sick, is injured, or dies parents are desperate to find a cause parents are desperate to find a cause or something to blame for the injury or something to blame for the injury but “A” does not always cause “B”but “A” does not always cause “B”


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So are vaccines safe ??So are vaccines safe ??To really answer the question depends To really answer the question depends

on how you define safe. If you define on how you define safe. If you define safe as completely free of any safe as completely free of any possible negative effects then the possible negative effects then the answer is no. answer is no.

The better question is, Do the benefits The better question is, Do the benefits of vaccines (avoiding infections) of vaccines (avoiding infections) outweigh their risks (side effects)? outweigh their risks (side effects)?


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So are vaccines safe ??So are vaccines safe ??This is not a yes/no question—a This is not a yes/no question—a

vaccine is safe if its benefits clearly vaccine is safe if its benefits clearly and definitely outweigh its risks. BUT and definitely outweigh its risks. BUT any medical product that has a any medical product that has a positive effect –whether it is a drug positive effect –whether it is a drug or a vaccine –can have a negative or a vaccine –can have a negative effect. effect.

So again no vaccine is absolutely safe. So again no vaccine is absolutely safe.


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So what are some of the common So what are some of the common questions??questions??

Who decides vaccines are safe and needed?Who decides vaccines are safe and needed?

What about after they are on the market?What about after they are on the market?

Do vaccines cause autism? Do vaccines cause autism?

What about thimerosal in vaccines?What about thimerosal in vaccines?

Is it okay for my baby to have so many shots at Is it okay for my baby to have so many shots at once?once?


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Who licenses, recommends and requires Who licenses, recommends and requires vaccines?vaccines?

Vaccines, like prescription drugs, are Vaccines, like prescription drugs, are only given to children after a long and only given to children after a long and careful review by a number of careful review by a number of different groups. These different different groups. These different groups either:groups either:

licenselicense recommend recommend or require vaccines or require vaccines


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LicensureLicensure Involves gaining approval from the Involves gaining approval from the

FDAFDA

This is the longest of the processesThis is the longest of the processes

Varicella vaccine took about 11 years Varicella vaccine took about 11 years to be licensed by the FDA.to be licensed by the FDA.

Monitoring does not stop with the Monitoring does not stop with the initial approvalinitial approval


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The RecommendationsThe Recommendations The Advisory Committee on The Advisory Committee on

Immunization Practices (ACIP) Immunization Practices (ACIP)

The Committee on Infectious The Committee on Infectious Diseases of the American Academy Diseases of the American Academy of Pediatrics (AAP)of Pediatrics (AAP)

the American Academy of Family the American Academy of Family Physicians (AAFP)Physicians (AAFP)


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The RequirementsThe Requirements Some of this deals with state funding Some of this deals with state funding

capacitycapacity

Looked at from a practical standpointLooked at from a practical standpoint

Even if a vaccine is not required it Even if a vaccine is not required it should be given if it has been should be given if it has been determined to be safe, effective and determined to be safe, effective and useful. useful.


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VAERS-VAERS-continued monitoringcontinued monitoring The Vaccine Adverse Event Reporting The Vaccine Adverse Event Reporting

System (VAERS) System (VAERS)

Doctors must report serious side effects Doctors must report serious side effects of vaccines to VAERSof vaccines to VAERS

Parents can also file a report with Parents can also file a report with VAERSVAERS


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VAERS-VAERS-continued monitoringcontinued monitoring Based on VAERS reports, vaccine safety Based on VAERS reports, vaccine safety

professionals continuously look for any professionals continuously look for any problem with a vaccine, study the problem with a vaccine, study the problem, and decide what to do. And if problem, and decide what to do. And if there is a problem, changes are made as there is a problem, changes are made as soon as possible.soon as possible.

For example,For example, If a vaccine is no longer safe, it is no longer If a vaccine is no longer safe, it is no longer

given. given. If there are new side effects, safety alerts are If there are new side effects, safety alerts are

sent out to your health care providerssent out to your health care providers


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Do vaccines cause autism?

Autism rates are the same in Autism rates are the same in vaccinated and vaccinated and unvaccinatedunvaccinated children children

No one knows yet what causes autismNo one knows yet what causes autism Twenty-three studies have tested Twenty-three studies have tested

hundreds of thousands of children and hundreds of thousands of children and found no link between autism and found no link between autism and vaccines.vaccines.


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What about thimerosal (or mercury) in vaccines?

Thimerosal was Thimerosal was removedremoved from all child from all child vaccines in 2001(except for some flu vaccines in 2001(except for some flu shots)shots)

Autism rates have continued to go upAutism rates have continued to go up

This is the This is the oppositeopposite effect of what would effect of what would be expected if thimerosal caused autismbe expected if thimerosal caused autism


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Is it ok for my baby to have so many shots at Is it ok for my baby to have so many shots at once?once?

Children are exposed to hundreds of viruses or Children are exposed to hundreds of viruses or bacteria (called antigens) everydaybacteria (called antigens) everyday

Getting vaccine is no extra burden---not even Getting vaccine is no extra burden---not even for babiesfor babies

Vaccines are a drop in the bucket compared to Vaccines are a drop in the bucket compared to what they face daily on the playground, what they face daily on the playground, outside, even in your home that is clean and outside, even in your home that is clean and safesafe


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Questions & Questions & DiscussionDiscussion


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ResourcesResources Vaccines and Your Child: Separating Fact from

Fiction by Paul Offit, M.D. & Charlotte A. Moser

Immunize NC www.immunize.nc.gov (new web address)

Immunization Action Coalition www.immunize.org

American Academy of Pediatrics www.aap.org www.cispimmunize.org


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Resources continued Resources continued Food and Drug AdministrationFood and Drug Administration

www.fda.govwww.fda.gov

Centers for Disease Control and PreventionCenters for Disease Control and Prevention www.cdc.gov/vaccineswww.cdc.gov/vaccines

National Network for Immunization InformationNational Network for Immunization Information www.immunizationinfo.orgwww.immunizationinfo.org

http://www.fda.gov/

http://www.cdc.gov/vaccines

http://www.immunizationinfo.org/

Documents

Vaccine Safety Elizabeth Tatum Draper RN Clinical Consultant North Carolina Immunization Branch July 2011