United States: Novavax (NVAX.O) faces an uncertain future since the U.S. Food and Drug Administration (FDA) has not confirmed any decision regarding full approval of its COVID-19 vaccine. The company expected an official response before April 1 with no official reply received so far, as reported by Reuters.
Leadership Changes at FDA Add to Delays
The FDA is facing delays in their decision process as Peter Marks the top vaccine scientist plans to quit on April 5. According to recent reports Marks led the vaccine development effort until his forced departure during the time of former President Donald Trump’s administration. Industry leaders express worry about upcoming regulatory choices being affected by Peter Marks’ resignation.
Pharmaceutical stocks registered a fall soon after Marks announced his departure while experts projected that companies may encounter new regulatory barriers when pushing for approvals.
#GlobalNews | FDA misses full approval deadline for Novavax Covid vaccine (Agencies)#FDA #Novavax pic.twitter.com/r1lwhfed0K
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FDA Requests More Data from Novavax
According to The Wall Street Journal, FDA officials have requested further data from Novavax and have indicated that approval is not imminent. Despite this, Novavax asserts that it has met all necessary requirements and has responded to all FDA inquiries since April 1, as reported by Reuters.
The FDA and the Department of Health and Human Services have not provided comments on the delay.
Novavax Struggles to Gain U.S. Market Share
Novavax presents an established protein-based vaccine approach instead of using the standard Pfizer-BioNTech and Moderna mRNA vaccine technologies. Emergency use authorization in 2022 did not result in widespread acceptance of this vaccine within the American market.