FDA Panel Votes to Waive Clinical Trials for New COVID Boosters

Megan Redshaw

The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster.

It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.

If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.

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