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What You Should Know About Vaccine Safety

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. Objectives.

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What You Should Know About Vaccine Safety

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  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

  2. 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

  3. Historical Perspective

  4. Department of Healthand Human Services (DHHS) National Vaccine Program Office (NVPO) National Institutes of Health (NIH) Centers for DiseaseControl and Prevention (CDC) Health Resources and Services Administration (HRSA) Food and Drug Administration (FDA) NCIRD ISO Federal Agencies

  5. Centers for Disease Control and Prevention CDC and Vaccine Safety Advisory Committee on Immunization Practice Coordinating Center for Infectious Diseases (CCID) 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

  6. Vaccine Injury Compensation ProgramHealth 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 • 1-800-338-2382www.HRSA.DHHS.GOV

  7. 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

  8. Post-Licensure Vaccine SafetyUS 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

  9. Post-Licensure Vaccine SafetyAdvisory 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

  10. Key ACIP Decisions on Vaccine Safety 11

  11. 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

  12. ISO Surveillance 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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/mmwrhtml/rr5515a1.htm • Immunization Action Coalition Screening questionnaires • http://www.immunize.org/catg.d/p4060.pdf • http://www.immunize.org/catg.d/p4065.pdf

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

  21. 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

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

  23. CommunicateVaccine 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

  24. Vaccine Reactions • Local Reactions • Systemic Reactions • Allergic Reactions • Emotional

  25. 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

  26. 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

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

  28. 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

  29. 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.

  30. 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

  31. 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

  32. 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

  33. Questions Thank you!

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