1. What You Should Know About Vaccine Safety National Immunization Conference April 1, 2009 Beth Hibbs, RN, MPH Tanya Johnson, MPH Nancy Levine, RN, PhD Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention

3. Objectives Discuss roles of federal agencies in pre- and post-licensure vaccine safety Describe CDC’s role in vaccine safety Outline the clinician’s role in vaccine safety Present selected vaccine safety concerns

4. Historical Perspective

5. Federal Agencies NCIRD ISO 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)

6. CDC and Vaccine Safety Coordinating Center for Infectious Diseases (CCID) Centers for Disease Control and Prevention Advisory Committee on Immunization Practice National Center for Immunization and Respiratory Diseases National Center for Preparedness, Detection, and Control of Infectious Diseases Division of Healthcare Quality Promotion Immunization Safety Office

7. Vaccine Injury Compensation Program Health Resources and Services Administration (HRSA) Created in 1988, located in HRSA Funded by excise tax on manufacturers Covers childhood vaccines only No fault alternative for resolving vaccine injury claims Involves 3 federal agencies: –Department of Health and Human Services –Department of Justice –US Court of Federal Claims 1-800-338-2382 www.HRSA.DHHS.GOV

8. Pre-Licensure Testing Animal tests - Test immune response. Assure no major side effects. Human clinical trials –Phase I gross toxicity –Phase II safety effectiveness –Phase III safety and effectiveness Manufacturer applies for two licenses FDA advisory committee reviews clinical data and makes recommendation

9. Post-Licensure Vaccine Safety US Food and Drug Administration (FDA) After approval, samples of each lot of a vaccine must be submitted to the FDA before it can be released for use. Tested for bacterial and fungal sterility, general safety, potency, and purity

10. Post-Licensure Vaccine Safety Advisory Committee on Immunization Practices (ACIP) Advises HHS Secretary and CDC Director about reducing incidence of vaccine-preventable diseases and increasing vaccine safety Advises on the safety and efficacy of vaccines in the civilian population and makes written recommendations on: –US-licensed vaccines –Other agents related to controlling vaccine- preventable diseases such as immune globulin preparations, antimicrobial therapy and chemoprophylaxis

11. 11 YearACIP Recommendation for United States 1997Use 5-dose of diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) schedule, instead of whole cell pertussis vaccine (DTP) 1997Use Inactivated Poliovirus Vaccine (IPV) for first 2 doses of polio vaccination, instead of oral poliovirus vaccine (OPV) 1999Use IPV for all 4 doses instead of OPV 1999Withdraw recommendation for rotavirus vaccine (Rotashield ® ) use 2008Remove preference for administering combination measles, mumps, rubella and varicella (MMRV) vaccine over separate injections MMR and varicella vaccines Key ACIP Decisions on Vaccine Safety

12. ISO ’ s Role in Post-licensure Vaccine Safety Surveillance  Monitors the safety of all vaccines licensed for use in the United States Research  Investigates adverse events and identifies risk factors for adverse events Cross-cutting Activities  Develops standardized terminology, new research techniques and guidelines for enhancing clinical practice in vaccine safety Communication  Communicates with partners and the public about adverse events associated with immunization

13. Step One: detecting a potential vaccine safety problem Vaccine Adverse Event Reporting System (VAERS) – National passive surveillance system – Co-administered by CDC and FDA – Receives ~30,000 reports per year – Creates database of adverse events Clinical review of VAERS reports – CDC and FDA staff – Clinical Immunization Safety Assessment (CISA) Network Conducting near real-time surveillance for specified adverse events – Vaccine Safety Datalink (VSD) Project ISO Surveillance

14. VAERS Limitations Reporting biases Statistical limitations Additional studies required to confirm signals Can not determine vaccine causality: An adverse event following immunization does not mean the vaccine caused the event

15. ISO Research and Investigation Step Two: testing hypotheses through research Vaccine Safety Datalink (VSD) Project – Collaboration with eight managed care organizations – Large linked databases on ~3% of US population – Provides information on health outcomes and vaccine histories CISA – Network of six academic centers – Conducts individual-level clinical studies – Identifies risk factors associated with developing AEFI Vaccine Analytic Unit (VAU) – CDC-DoD-FDA collaboration initiated to address safety of anthrax vaccination program – Military database on ~7 million people – Great potential to contribute to understanding of safety of other vaccines

16. ISO Cross-cutting Activities Step Three: standardizing terminology, creating new research techniques and enhancing clinical practice in vaccine safety Creating a common “language” – Brighton Collaboration –International scope – 1800 participants in 94 countries –Standardizes case definitions and guidelines for AEFI –Enhances ability to compare pre and post-licensure studies Developing newer, faster research methods –VSD: Rapid Cycle Analysis Helping clinicians assess and manage AEFI –CISA: Algorithm for health care providers to use in managing individuals with immediate hypersensitivity reactions following vaccination

17. ISO Communication, Collaboration and Education Step Four: translating vaccine safety surveillance and research for partners, providers and the public Journal articles Web site Educational materials: VAERS brochure Presentations at national conferences Media briefings Conference calls Technical assistance

18. Role of the Clinician in Vaccine Safety Assure proper vaccine storage and handling Screen for contraindications/ precautions Communicate vaccine risks/benefits Proper administration Manage possible vaccine reactions Document and report vaccine adverse events

19. Storage and Handling of Vaccines Proper condition on arrival Storage (refrigerate, freeze, light-protected) Shelf life (18m - 3yrs) Reconstitution (shaking, dilution) Shelf life after reconstitution (8 hrs - until outdated) Rotate stock so shortest dated material is used first Pre-filling syringes-not recommended

20. Screen for Contraindications/ Precautions Contraindications –conditions that increase the risk of serious adverse events Precautions –majority are temporary –vaccine can be given later Package inserts for each vaccine CDC General Recommendations on Immunization –http://www.cdc.gov/mmwr/preview/mmwrht ml/rr5515a1.htm Immunization Action Coalition Screening questionnaires –http://www.immunize.org/catg.d/p4060.pdf –http://www.immunize.org/catg.d/p4065.pdf

21. SPECIAL POPULATIONS History of severe allergic reaction People with moderate or severe illness Pregnant women Recent blood product recipients

22. When is it safe to immunize? Mild illness Disease exposure Antibiotic therapy Otis media Diarrhea Breast feeding Premature birth Most allergies Family history of vaccine reaction

23. Vaccine Administration Wash hands, gloves not required Equipment: needle length and gauge 5 rights: administer the correct –patient –vaccine –dose –route –time

24. Communicate 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/de fault.htm

25. Vaccine Reactions Local Reactions Systemic Reactions Allergic Reactions Emotional

26. Vaccine Reactions: What You Can Do React to needs –Physical Immediate e.g. Anaphalaxsis, Syncope Delayed – e.g. fever, injection site reactions, other rare events –Emotional Refer as needed –Specialists –Information Reassure Report Follow up

27. Reporting Adverse Events to VAERS 3 ways to report Online: Secure website https://secure.vaers.org/VaersDataEntryintro.htm Fax: 877-721-0366 Mail: VAERS, P.O. Box 1100, Rockville, MD, 20849 Download form at www.vaers.hhs.gov/pdf/vaers_form.pdf

28. Vaccine Safety: Current Issues Concerns about Autism Safety of human papillomavirus (HPV) vaccine Vaccine Ingredients Vaccine Scheduling Simultaneous Vaccination Combination Vaccines Trust

29. Concerns about Autism Scientific evidence does not support a casual link between vaccines and autism Omnibus Autism Proceedings Concerns among parents and the public persist www.cdc.gov/autism

30. HPV Vaccine Safety Human papillomavirus (HPV) vaccine protects against the types of HPV that most commonly cause cervical cancer and genital warts, and is recommended for adolescent girls and young women Media attention on the safety of the HPV vaccine has focused on the adverse events reported following vaccination – 94% of reports non-serious Fainting, pain at the injection site, headache, nausea, fever – 6% of reports serious Guillain-Barré Syndrome (GBS), blood clots, death All serious reports have been carefully analyzed. Experts have not found a common medical pattern to the reports of serious adverse events reported for the HPV vaccine that would suggest that they were caused by the vaccine.

31. Concerns about Ingredients in Vaccines Thimerosal – a mercury based preservative to prevent contamination Aluminum – used to enhance the immune system response Formaldehyde – used to inactivate bacteria and viruses

32. Vaccine Schedule & Combination Vaccines Concerns have been raised about: – The increasing number of recommended vaccines – Simultaneous vaccination Protects against several diseases in one visit Ensures children are less likely to fall behind schedule No evidence that giving multiple vaccines at the same time is harmful – Combination vaccines Reduce discomfort and costs

33. HHS Vaccine Safety Resources 800-CDC-INFO (232-4636) CDCinfo@cdc.gov CDC Immunization Safety Office (ISO) www.cdc.gov/vaccinesafety Report Vaccine Adverse Events (VAERS) 800-822-7967 http://vaers.hhs.gov Vaccine Injury Compensation Program (VICP) 800-338-2382 www.hrsa.gov/vaccinecompensation/ US Food and Drug Administration (FDA) www.fda.gov/cber

34. Questions Thank you!