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Vaccine Safety

Vaccine Safety. Epidemiology and Prevention of Vaccine-Preventable Diseases National Immunization Program Centers for Disease Control and Prevention. Revised January 2006. Importance of Vaccine Safety. Decreases in disease risks and increased attention on vaccine risks

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Vaccine Safety

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  1. Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable Diseases National Immunization Program Centers for Disease Control and Prevention Revised January 2006

  2. Importance of Vaccine Safety • Decreases in disease risks and increased attention on vaccine risks • Public confidence in vaccine safety is critical • higher standard of safety is expected of vaccines • vaccinees generally healthy (vs. ill for drugs) • lower risk tolerance = need to search for rare reactions • vaccination universally recommended and mandated

  3. Disease Pre-vaccine Era* 2000 % change Diphtheria 31,054 1 -99 Measles 390,852 86 -99 Mumps 21,342 338 -99 Pertussis 117,998 7,867 -93 Polio (wild) 4,953 0 -100 Rubella 9,941 176 -98 Cong. Rubella Synd. 19,177 9 -99 Tetanus 1,314 35 -97 Invasive Hib Disease** 24,856 112 -99 Total 566,706 8,624 -98 Vaccine Adverse Events 0 13,497 ^ +++ Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases andVaccine Adverse Events, United States * Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the prevaccine era ^ Adverse events after vaccines against diseases shown on Table = 5,296 ** Invasive type b and unknown serotype

  4. Importance of Vaccine Safety • Ongoing safety monitoring needed for the development of sound policies and recommendations

  5. Prelicensure Vaccine Safety Studies • Laboratory • Animals • Humans

  6. Prelicensure Human Studies • Phases I, II, III trials • Common reactions are identified • Vaccines are tested in thousands of persons before being licensed and allowed on the market

  7. Postlicensure Surveillance • Identify rare reactions • Monitor increases in known reactions • Identify risk factors for reactions • Identify vaccine lots with unusual rates or types of events • Identify signals

  8. Postlicensure Vaccine Safety Activities • Phase IV Trials • ~10,000 participants • better but still limited • Large-Linked Databases • Clinical Immunization Safety Assessment Network

  9. Vaccine Adverse Event Reporting System (VAERS) • National reporting system • Jointly administered by CDC and FDA • Passive (depends on healthcare providers and others to report) • Receives ~15,000 reports per year

  10. Vaccine Adverse Event Reporting System (VAERS) • Detects • new or rare events • increases in rates of known side effects • patient risk factors • Additional studies required to confirm VAERS signals • Not all reports of adverse events are causally related to vaccine

  11. Adverse Event Classification • Vaccine-induced • Vaccine-potentiated • Programmatic error • Coincidental

  12. Vaccine Safety Datalink (VSD) • Large-linked database • Links vaccination and health records • “Active surveillance” • 8 HMOs • ~2% of the U.S. population • Powerful tool for monitoring vaccine safety

  13. Clinical Immunization Safety Assessment (CISA) Network • Improve understanding of vaccine safety issues at individual level • Evaluate persons who experience adverse health events • Gain better understanding of events • Develop protocols for healthcare providers

  14. Vaccine Injury Compensation Program (VICP) • Established by National Childhood Vaccine Injury Act (1986) • “No fault” program • Covers all routinely recommended childhood vaccines • Vaccine Injury Table

  15. The Provider’s Role • Immunization providers can help to ensure the safety and efficacy of vaccines through proper: • vaccine storage and administration • timing and spacing of vaccine doses • observation of contraindications and precautions

  16. The Provider’s Role • Immunization providers can help to ensure the safety and efficacy of vaccines through proper: • management of vaccine side effects • reporting of suspected side effects to VAERS • vaccine benefit and risk communication

  17. Contraindication A condition in a recipient that increases the chance of a serious adverse reaction

  18. Precaution A condition in a recipient that might • Increase the chance or severity of an adverse reaction, or • Compromise the ability of the vaccine to produce immunity

  19. Invalid Contraindications to Vaccination • Minor illness • Mild/moderate local reaction or fever following a prior dose • Antimicrobial therapy • Disease exposure or convalescence • Pregnancy or immunosuppression in the household • Premature birth • Breastfeeding • Allergies to products not in vaccine • Family history (unrelated to immunosuppression)

  20. Benefit and Risk Communication • Opportunities for questions should be provided before each vaccination • Vaccine Information Statements (VISs) • must be provided before each dose of vaccine • public and private providers • available in multiple languages

  21. National Immunization ProgramContact Information • Telephone 800.CDC.INFO • Email nipinfo@cdc.gov • Website www.cdc.gov/nip

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