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

2. 2011 NC State Immunization Conference2 Goals for today Only one: Discuss vaccine safety; what that means and how to incorporate this into discussions with parents/patients OK—guess technically that is three….

3. 2011 NC State Immunization Conference3 What we won’t do today Answer ALL of the questions that you have Answer ALL of the questions that you have Solve the anti-vaccine movement issue Solve the anti-vaccine movement issue Learn how to convince EVERY patient/parent that vaccines are safe in terms of risks vs. benefits Learn how to convince EVERY patient/parent that vaccines are safe in terms of risks vs. benefits

4. 2011 NC State Immunization Conference4 "Safer Healthier Children." An overview of how vaccines are produced and how they work. Produced by Centers for Disease Control and Prevention.

5. 2011 NC State Immunization Conference5

6. 6 Why all the questions from parents?? Parents today haven’t had to experience most of the diseases that used to be commonplace. That’s the success of immunizations. Parents today haven’t had to experience most of the diseases that used to be commonplace. That’s the success of immunizations. Many Americans today distrust “the government” only slightly less than they distrust “big corporations.” Many Americans today distrust “the government” only slightly less than they distrust “big corporations.” People now see and hear many arguments questioning vaccines in the media and on the Internet. People now see and hear many arguments questioning vaccines in the media and on the Internet.

7. 2011 NC State Immunization Conference7 But still………..why??? Take a moment to think about something that you were told as a child or young adult that even though you now KNOW there is no “scientific” evidence to back this up that you still believe or follow ………. We are scientific people why do we still do this ???

8. 2011 NC State Immunization Conference8 What/Who we are up against…… Dr. Andrew Wakefield – study now found to be a fraud, but damage already done Dr. Andrew Wakefield – study now found to be a fraud, but damage already done Moms Against Mercury – their web site has “stepped out for a bit” Moms Against Mercury – their web site has “stepped out for a bit” Hollywood celebrities touting anti-vaccine information Hollywood celebrities touting anti-vaccine information Dr. Bob Sears Dr. Bob Sears The Internet in general The Internet in general

9. 2011 NC State Immunization Conference9 Answering the questions Effective, empathetic communication is critical in responding to parents who are considering not vaccinating their children. Parents should be helped to feel comfortable voicing any concerns or questions they have about vaccination, and providers should be prepared to listen and respond effectively. Effective, empathetic communication is critical in responding to parents who are considering not vaccinating their children. Parents should be helped to feel comfortable voicing any concerns or questions they have about vaccination, and providers should be prepared to listen and respond effectively. From CDC’s ―Providers Guide: Helping Parents Who Question Vaccines

10. 2011 NC State Immunization Conference10 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.

11. 2011 NC State Immunization Conference11 But is the problem really related to the vaccine ? How does the parent know if the vaccine is what caused the problem with their child. Many times they won’t and when a child becomes sick, is injured, or dies parents are desperate to find a cause or something to blame for the injury but “A” does not always cause “B”

12. 2011 NC State Immunization Conference12 So are vaccines safe ?? To really answer the question depends on how you define safe. If you define safe as completely free of any possible negative effects then the answer is no. The better question is, Do the benefits of vaccines (avoiding infections) outweigh their risks (side effects)?

13. 2011 NC State Immunization Conference13 So are vaccines safe ?? This is not a yes/no question—a vaccine is safe if its benefits clearly and definitely outweigh its risks. BUT any medical product that has a positive effect – whether it is a drug or a vaccine –can have a negative effect. So again no vaccine is absolutely safe.

14. 2011 NC State Immunization Conference14 So what are some of the common 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 once? Is it okay for my baby to have so many shots at once?

15. 2011 NC State Immunization Conference15 Who licenses, recommends and requires vaccines? Vaccines, like prescription drugs, are only given to children after a long and careful review by a number of different groups. These different groups either: license license recommend recommend or require vaccines or require vaccines

16. 2011 NC State Immunization Conference16 Licensure Involves gaining approval from the FDA Involves gaining approval from the FDA This is the longest of the processes This is the longest of the processes Varicella vaccine took about 11 years to be licensed by the FDA. Varicella vaccine took about 11 years to be licensed by the FDA. Monitoring does not stop with the initial approval Monitoring does not stop with the initial approval

17. 2011 NC State Immunization Conference17 The Recommendations The Recommendations The Advisory Committee on Immunization Practices (ACIP) The Advisory Committee on Immunization Practices (ACIP) The Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) The Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) the American Academy of Family Physicians (AAFP) the American Academy of Family Physicians (AAFP)

18. 2011 NC State Immunization Conference18 The Requirements Some of this deals with state funding capacity Some of this deals with state funding capacity Looked at from a practical standpoint Looked at from a practical standpoint Even if a vaccine is not required it should be given if it has been determined to be safe, effective and useful. Even if a vaccine is not required it should be given if it has been determined to be safe, effective and useful.

19. 2011 NC State Immunization Conference19 VAERS- continued monitoring The Vaccine Adverse Event Reporting System (VAERS) The Vaccine Adverse Event Reporting System (VAERS) Doctors must report serious side effects of vaccines to VAERS Doctors must report serious side effects of vaccines to VAERS Parents can also file a report with VAERS Parents can also file a report with VAERS

20. 2011 NC State Immunization Conference20 VAERS- continued monitoring Based on VAERS reports, vaccine safety professionals continuously look for any problem with a vaccine, study the problem, and decide what to do. And if there is a problem, changes are made as soon as possible. Based on VAERS reports, vaccine safety professionals continuously look for any problem with a vaccine, study the problem, and decide what to do. And if there is a problem, changes are made as soon as possible. For example, If a vaccine is no longer safe, it is no longer given. If a vaccine is no longer safe, it is no longer given. If there are new side effects, safety alerts are sent out to your health care providers If there are new side effects, safety alerts are sent out to your health care providers

21. 2011 NC State Immunization Conference21 Do vaccines cause autism? Autism rates are the same in vaccinated and unvaccinated children Autism rates are the same in vaccinated and unvaccinated children No one knows yet what causes autism No one knows yet what causes autism Twenty-three studies have tested hundreds of thousands of children and found no link between autism and vaccines. Twenty-three studies have tested hundreds of thousands of children and found no link between autism and vaccines.

22. 2011 NC State Immunization Conference22 What about thimerosal (or mercury) in vaccines? Thimerosal was removed from all child vaccines in 2001(except for some flu shots) Thimerosal was removed from all child vaccines in 2001(except for some flu shots) Autism rates have continued to go up Autism rates have continued to go up This is the opposite effect of what would be expected if thimerosal caused autism This is the opposite effect of what would be expected if thimerosal caused autism

23. 2011 NC State Immunization Conference23 Is it ok for my baby to have so many shots at once? Children are exposed to hundreds of viruses or bacteria (called antigens) everyday Children are exposed to hundreds of viruses or bacteria (called antigens) everyday Getting vaccine is no extra burden---not even for babies Getting vaccine is no extra burden---not even for babies Vaccines are a drop in the bucket compared to what they face daily on the playground, outside, even in your home that is clean and safe Vaccines are a drop in the bucket compared to what they face daily on the playground, outside, even in your home that is clean and safe

24. 2011 NC State Immunization Conference24 Questions & Discussion

25. 2011 NC State Immunization Conference25 Resources 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) www.immunize.nc.gov Immunization Action Coalition www.immunize.org American Academy of Pediatrics www.aap.org www.cispimmunize.org

26. 2011 NC State Immunization Conference26 Resources continued Food and Drug Administration Food and Drug Administration www.fda.gov www.fda.gov www.fda.gov Centers for Disease Control and Prevention Centers for Disease Control and Prevention www.cdc.gov/vaccines www.cdc.gov/vaccines www.cdc.gov/vaccines National Network for Immunization Information National Network for Immunization Information www.immunizationinfo.org www.immunizationinfo.org www.immunizationinfo.org