Novavax’s COVID-19 jab looks to be on track for approval

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Novavax’s COVID-19 Vaccine Nears Full FDA Approval Decision

Novavax has completed its Biologics License Application (BLA) for its COVID-19 vaccine with the U.S. Food and Drug Administration (FDA) and was expecting a decision by April 1, 20252 5.
As of mid-April 2025, Novavax has not yet received an official response from the FDA regarding full approval of its COVID-19 vaccine2 3 5.
Novavax’s vaccine had previously received emergency use authorization in the U.S. in 2022, but is now seeking standard approval, similar to that already granted for Pfizer and Moderna’s COVID-19 vaccines5.
The FDA review deadline for Novavax’s vaccine passed without a decision, partly due to organizational changes at the agency, including the resignation of a leading vaccine authority5.
Novavax has addressed all of the FDA’s information requests and maintains that its application is “ready for approval,” based on robust Phase 3 clinical trial data showing that its protein-based vaccine is safe and effective at preventing COVID-191 2 5.
The company positions its vaccine as an important alternative to mRNA vaccines currently authorized in the U.S.1 5.
The most recent available formula of Novavax's COVID-19 vaccine is no longer authorized for use in the United States as of late 2024, pending this full approval process4.