1. Immunization Safety Office Nuts and Bolts a Basic Course VACCINE SAFETY: 101 42 nd National Immunization Conference Atlanta, Georgia March 17, 2008

2. OBJECTIVES Discuss 2 functions of government agencies to assure vaccine safety Identify 2 vaccine safety responsibilities of the clinician Discuss how vaccines are monitored for safety after they are licensed List 2 vaccine safety resources

3. Historical Perspective

4. The Bigger Picture Immunization Safety Office Centers for Disease Control and Prevention (CDC) Health Resources and Services Administration (HRSA) Food and Drug Administration (FDA) National Institutes of Health (NIH) Department of Health and Human Services (DHHS) National Vaccine Program Office (NVPO)

5. PRE-LICENSURE TESTING Laboratory tests and computer models Animal tests - Test immune response. Assure no major side effects Human clinical trials –Phase I gross toxicity –Phase II use/dose –Phase III efficacy

6. Every Lot Of Vaccine is Tested and Sampled After approval, samples of each lot of a vaccine must be submitted to the FDA before it can be released for use. Tested for safety, potency, and purity

7. POST-LICENSURE MONITORING Vaccine Adverse Events Reporting System (VAERS) Vaccine Safety Datalink (VSD) Project Clinical Immunization Safety Assessment (CISA) Centers Institute of Medicine (IOM) Vaccine Safety Reviews

8. 1-800-822-7967 www.vaers.hhs.gov Unified national spontaneous reporting system/passive surveillance Jointly administered by CDC and FDA since 1990 Receives ~20,000 reports per year “Registry” of adverse events

9. TYPES OF ADVERSE EVENTS REPORTED TO VAERS  Vaccine reaction or side effect  Vaccine potentiated  Programmatic or human error  Coincidental

10. VAERS REPORTS EVENT SEVERITY 11/90-12/01*

11. CASE FOLLOW UP Letter to Reporters Serious cases –Medical records Deaths –Autopsy reports Not recovered –60 day follow up –1 year follow up

12. VAERS STRENGTHS National scope Detects very rare events Timely reporting Generates signals Low cost

13. VAERS WEAKNESSES Complexity Coincidental events Statistical limitations Can not determine vaccine causality by case Additional studies required to confirm signals

14. Establishing Causal Link: Adverse Event & Vaccine ab cd Yes No Yes No Vaccination Illness or Syndrome VAERS = biased cell “a”

15. Vaccine Adverse Event does not mean the vaccine CAUSED the event

16. Vaccine Safety Datalink Population under “active surveillance” – 8 Medical Care Organizations (MCOs) –~2.5% of the US population Large-linked databases –Exposure (vaccination) –Outcome (ER, OPD, hosp, lab) –Covariates (birth, death certificates) Scientifically rigorous hypothesis testing

17. VSD SELECTED FINDINGS Rotateq vaccination is not associated with an increased risk for intussuception No increased risk of Grave’s disease or Hashimoto’s Thyroiditis following receipt of Hepatitis B vaccine No increased risk of serious, significant medically attended events following Trivalent Influenza Vaccine Among children 6-23 months Measles-Mumps-Rubella vaccine that is given in the 2 nd year of life is associated with increased risk of immune thrombocytopenia purpura

18. CLINICAL IMMUNIZATION SAFETY ASSESSMENT (CISA) CENTERS Designed to conduct clinical research of adverse events following immunization (AEFI) Activities –study the pathophysiology of AEFIs, –identify risk factors (including genetic host risk factors) associated with developing an AEFI –develop evidence-based guidance to assist clinicians in their decision making when assessing and managing AEFIs.

19. Brighton Collaboration http://www.brightoncollaboration.org/ Develops globally accepted case definitions and guidelines for vaccine safety data comparability of vaccine adverse events. 22 definitions includes: –Persistent crying –fever –hypotonic-hyporesponsive episode, – intussusception, – injection site reactions –Seizure –Anaphylaxis –SIDs for use in surveillance and research which can be downloaded freely at their website

20. ROLE OF THE CLINICIAN IN VACCINE SAFETY

21. VACCINE MANAGEMENT Storage and Handling Timing and Spacing Administration Issues –Equipment –Injection site recommendations

22. CDC VACCINE INFORMATION STATEMENTS Public Health law requires them to be provided to parents at each visit Contains Vaccine Safety information –VAERS –Vaccine Injury Compensation Referral information www.cdc.gov/vaccines/pubs/vis /default.htm

23. SPECIAL POPULATIONS People with moderate or severe illness History of serious vaccine reaction Pregnant women Recent Blood Product Recipients

24. WHEN IS IT SAFE TO IMMUNIZE? Mild illness Disease exposure Antibiotic therapy Breast Feeding Premature birth Most allergies Family history of vaccine reaction

25. VACCINE REACTIONS Local Reactions Systemic Reactions Allergic Reactions Emotional

26. VACCINE REACTIONS What You Can Do React to needs –Physical –Emotional Refer –Specialists –Information Reassure Report Follow up

27. Hot Topics in Vaccine Safety

28. Mercury And Vaccines Thimerosal -mercury based preservative 2001 - Precautionary measure – thimerosal removed or reduced in US vaccines for children No evidence of harm More information: www.cdc.gov/odscienceis o/concerns/thimerosal

29. AUTISM AND VACCINES Theory: vaccines cause autism Scientific evidence does not support a casual link Evidence reviewed by CDC; Institute of Medicine; American Academy of Pediatrics

30. Can vaccines overload the immune system ? Giving multiple vaccines at the same time is safe People are exposed daily to hundreds of antigens Multiple vaccines work with the immune system to boost it Advantages of Simultaneous vaccination: –Protects against several diseases –Ensures children are less likely to fall behind schedule Combo vaccines, reduce discomfort and costs

31. Intussusception & RotaTeq® Vaccine The number of reported cases of intussusception after RotaTeq is not greater than what we would expect to see in unvaccinated children by chance alone. CDC and FDA encourage healthcare providers to report intussusception and other serious cases to the Vaccine Adverse Event Reporting System

32. HRSA’s Vaccine Injury Compensation Program CDC does not have a role in the National Vaccine Injury Compensation Program (VICP). Neither CDC nor any other government agency has found any evidence to support the claim that vaccines cause autism. No court has conceded that there is a link between vaccines and autism. Government is prohibited from discussing any active VICP

33. Vaccine Risk Communication

34. Goals of Risk Communication Inform/Educate Build or Regain Trust Achieve Agreement/ Consensus

35. Why Communicate About Vaccine Risks and Benefits? Legal requirement People want to know Guidance is needed

37. Vaccine Adverse Events Reporting System (VAERS) www.cdc.gov/vaccinesafety

38. Questions