1. VACCINE SAFETY: 101 Pandemic Influenza Vaccine Safety Conference Atlanta, Georgia August 21, 2008

2. VACCINE SAFETY:OVERVIEW IMPORTANCE OF VACCINE SAFETY IN A PANDEMIC CLINICIAN’S ROLE IN VACCINE SAFETY VACCINE SAFETY SURVEILLANCE RISK COMMUNICATION QUESTIONS & ANSWERS

3. Importance of Vaccine Safety Historical Perspective

4. ROLE OF THE CLINICIAN IN VACCINE SAFETY Proper storage and administration Identify contraindications Education Report and treat Reactions Refer as appropriate Follow up

5. VACCINE MANAGEMENT Storage and Handling Timing and Spacing Administration Issues  Equipment  Site of entry

6. SPECIAL POPULATIONS should talk with a Health Care Provider before getting Flu vaccine History of severe allergy to the vaccine or any vaccine component History of Guillain-Barre Syndrome People with moderate or severe illness Pan Flu outbreak will have different considerations

7. CDC VACCINE INFORMATION STATEMENTS Public Health law requires them to be provided to parent/ vaccinee who receive childhood vaccines at each visit Contains Vaccine Safety information  Known side effects  Contraindications  Reporting vaccine adverse events  Vaccine Injury Compensation www.cdc.gov/vaccines/pubs/vis/default.htm

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

9. VACCINE REACTIONS Local Reactions Systemic Reactions Allergic Reactions Emotional

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

11. 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)

12. VACCINE INJURY COMPENSATION PROGRAM 1-800-338-2382 WWW.HRSA.DHHS.GOV Covers childhood vaccines only No fault basis Vaccine Injury Table or  Proof vaccine caused problem  Proof vaccine aggravated existing health condition

13. 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

14. 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

15. 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

16. “Registry” of adverse events. Vaccine adverse event does not mean vaccine caused the event Unified national spontaneous reporting system/passive surveillance Jointly administered by CDC and FDA since 1990 Receives more than 20,000 reports per year 1-800-822-7967 www.vaers.hhs.gov

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

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

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

20. 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.

21. Develops globally accepted case definitions and guidelines for vaccine safety data Standardizes vaccine adverse event terms Used in surveillance and research Definitions include:  Persistent crying, fever, hypotonic-hyporesponsive episode, intussusception, injection site reactions, Seizure, Anaphylaxis, SIDs, and others Available free on the web http://www.brightoncollaboration.org

22. Vaccine Risk Communication

23. Hot Topic in Flu Vaccine Safety Mercury and Vaccines Thimerosal -mercury based preservative 2001 - Precautionary measure – thimerosal removed or reduced in US vaccines No evidence of harm More information: www.cdc.gov/odscienceiso/conce rns/thimerosal

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

25. Credibility Ladder High  Health Professionals (e.g., Nurses, Physicians)  Safety Professionals (e.g., Fire, Police)  University Scientists Medium  Environmental Professionals  Media  Activist Groups Low  Industry  Federal Government  Paid External Consultants

26. Adverse Event Communication Vincent, Covello. (2003) Respect the opinion of people who believe they have been harmed If the adverse event has no basis, give a complete and sympathetic explanation of why the immunization could not have caused such an effect. Acknowledge uncertainty if it exists Be open about an apparent apparent adverse event and discuss what measures could be taken to prevent or treat a similar event in the future. Report all suspected adverse events to the Vaccine Adverse Event Reporting System

27. Questions