WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has missed its April 1 deadline to decide on the full approval of Novavax’s COVID-19 vaccine, NVX-CoV2373. This delay follows significant leadership changes within the agency and requests for additional data, leaving Novavax’s application in limbo.
Novavax, a biotechnology company based in Gaithersburg, Maryland, had submitted a Biologics License Application (BLA) supported by Phase 3 clinical trial data demonstrating the vaccine’s safety and efficacy. The company asserts that it has responded to all of the FDA’s information requests and believes its application is ready for approval. As of today, however, Novavax has not received an official decision from the FDA.
The delay coincides with the recent departure of Dr. Peter Marks, the FDA’s top vaccine scientist, whose resignation is effective April 5. Dr. Marks played a pivotal role in the rapid development and approval of COVID-19 vaccines during President Donald Trump’s first term. His exit has raised concerns about potential impacts on ongoing and future vaccine approvals.
Dr. Sara Brenner, the FDA’s Principal Deputy Commissioner, has intervened in the review process by requesting additional data on Novavax’s vaccine. This move is considered highly unusual, as it deviates from the agency’s standard practice of insulating scientific assessments from political influence. Typically, political appointees at the FDA adhere to the recommendations of career scientists responsible for evaluating drug and vaccine applications.
The FDA’s request for more data suggests that full approval of Novavax’s vaccine is unlikely in the immediate future.This development poses challenges for Novavax, which had anticipated leveraging full approval to expand its market presence and solidify partnerships. Notably, a $175 million deal with Sanofi, set to commence in the 2025-2026 virus season, is contingent upon the FDA granting full licensure.
Novavax’s vaccine employs a traditional protein-based approach, differing from the mRNA technology used by Pfizer-BioNTech and Moderna. While it has been available under Emergency Use Authorization (EUA) since July 2022, full approval would facilitate broader distribution and potentially increase public confidence in the vaccine.
The delay has also impacted Novavax’s financial standing. The company’s stock experienced volatility following reports of the FDA’s postponed decision, reflecting investor concerns about the vaccine’s commercial prospects.