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CBER BEST Initiative Seminar Series – Vaccine Safety Surveillance Systems for Routine and Pandemic Immunization Programs
Vaccine Safety Surveillance Systems for Routine and Pandemic Immunization Programs

Description: Post-authorization safety surveillance is critically important to fully define the safety profile of vaccines, including uncommon adverse reactions and those that have delay in onset or among subpopulation that cannot be adequately studied through clinical trials. Safety surveillance is particularly important for mass vaccination programs where large numbers of people will be quickly vaccinated and coincidental adverse events following immunization can derail the vaccine program. Rigorous, rapid and credible safety surveillance and risk assessment are essential. Healthcare databases can enhance both rigor and speed of evaluations. However, well validated methods are essential, size of populations under surveillance greatly impacts speed, and often chart review using standardized case definitions are necessary. Credibility of risk assessment can be enhanced through careful planning, separation of risk assessment from risk management, and transparency. 2009-10 H1N1 vaccine safety monitoring provides a model for safety monitoring during use of pandemic vaccines.

Presented by: Dr. Daniel Salmon, Johns Hopkins Bloomberg School of Public Health

Mar 24, 2021 11:00 AM in Eastern Time (US and Canada)

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