An Approvable Protein-Based COVID-19 Vaccine

Novavax Inc. recently stated that it believes its Biologics License Application for its protein-based COVID-19 vaccine is approvable, based on conversations with the U.S. Food and Drug Administration (FDA) from April 1, 2025, to April 24, 2025.

In its press release on April 23, 2025, Novavax announced that the FDA had issued a formal request, asking the company to provide a postmarketing commitment to generate “additional clinical data” for the COVID-19 vaccine.

'We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible,' concluded Novavax.

The World Health Organization granted the Novavax COVID-19 vaccine (Nuvaxovid™) Emergency Use Listing on December 17, 2021, and it remains available today in numerous countries.