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Lecture 12 A - Vaccine Safety

Lecture 12 A - Vaccine Safety - VACCINE SAFETY Edwin Oaks...

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EVO VACCINE SAFETY Edwin Oaks, Ph.D. George Mason University Fall 2008
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EVO Vaccine Safety Risk vs Benefit Immunization has provided tremendous benefit in reducing morbidity and mortality of infectious diseases Widespread use of vaccines Improved control of many diseases Diphtheria Pertussis Measles Eradication of smallpox and near eradication of polio These advances are not free of risk . Vaccines can be associated with adverse events Transient to rare but serious & irreversible events
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EVO Vaccine Safety Because vaccines have an associated risk and because vaccines are most often given to healthy people - it is absolutely essential that vaccines are held to the highest standard of safety. Require rigorous scientific assessments To assure safety Pre and post licensure To assure benefit Today as many infectious diseases are under control and virtually eliminated it is even more important to provide vaccines that will be acceptable to the public (high benefit and very low risk).
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Evaluation of vaccines for causal association with adverse events Causal association can be identified by Isolation of live vaccine agent in affected tissue Only in vaccinees & not in controls No evidence of contamination No other explanation for illness If all of above is true - strong evidence for causal association Pre-licensure studies Controlled trials comparing individuals receiving vaccine to those receiving a placebo or a control vaccine » Best way to establish causal relationship between vaccines and adverse events » Good for identifying common adverse events that occur within a short time after vaccination » Will not identify delayed onset adverse events » Will not identify rare adverse events sample size is usually too small
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EVO Evaluation of vaccines for causal association with adverse events After licensure epidemiological studies Involves healthcare providers Observe and report adverse events Manufacturers Regulatory authorities In U.S. adverse events are are submitted to Vaccine Adverse Events Reporting System (VAERS) Maintained jointly by CDC and FDA Monitors reports of adverse events that might signal the need for further study
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EVO
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