New COVID-19 Boosters To Be Authorized Without Human Trials Completed
New variant-specific COVID-19 vaccine booster doses are set to be authorized by the Food and Drug Administration (FDA) before human testing is complete.
FDA Commissioner Robert Califf tweeted last week that the agency will not hold a meeting of its expert vaccine advisers to discuss the new boosters and that it will rely on existing clinical trial data and real-world results in its determination about Emergency Use Authorizations (EUAs) for Omicron-targeting booster shots. The Centers for Disease Control and Prevention (CDC) based its fall booster rollout plan on the assumption that the new vaccines would receive EUAs by Sept. 1. . .
FDA will not hold a VRBPAC meeting about these submissions, as the agency feels confident in the extensive discussion that was held in June. VRBPAC voted overwhelmingly to include an omicron component in COVID-19 boosters. FDA has no new questions that warrant committee input.
— Dr. Robert M. Califf (@DrCaliff_FDA) August 25, 2022
The typical process for granting an EUA to a new vaccine involves a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA’s group of outside experts that examines research and evidence pertaining to the vaccine’s safety and efficacy. The panel votes on whether to grant the EUA, and under what circumstances to grant it, and passes that recommendation onto the FDA commissioner for a final ruling. (Read more from “New COVID-19 Boosters to Be Authorized Without Human Trials Completed” HERE)
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