October 27, 2020

FDA drafting protocols to track COVID-19 vaccine safety

By: Judy Mathias

Editor's Note

The Food and Drug Administration’s (FDA’s) Office of Biostatistics and Epidemiology is currently developing master protocols to be used in monitoring the safety and effectiveness of a COVID-19 vaccine once it is authorized or approved, in addition to postmarket surveillance requirements, the October 22 Regulatory Focus reports.

The FDA will draw on big data resources and the Centers for Disease Control and Prevention to follow the vaccines’ track records.

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The protocols will be posted for public comment.


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