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# FDA Seeks Post-Marketing Commitment from Novavax
- URL: https://www.fdaweb.com/fda-seeks-post-marketing-commitment-from-novavax/
- Published: 2025-04-23T12:00:00.000Z
- Updated: 2026-09-14T15:10:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159047

Novavax says its Covid-19 vaccine BLA, which the company is seeking to transition from an emergency use authorization to full approval, is being held up while FDA seeks to conclude a post-marketing commitment from the company. The agency had initially set a user fee-related review action target of 4/1, but that was deferred when FDA principal deputy commissioner **Sara Brenner** asked for additional clinical data. At the time, Brenner was serving as acting commissioner while **Marty Makary**’s nomination was under consideration.

The delay was likely due to FDA staff cuts, particularly the loss of CBER officials who would need to sign off on approving the submission. On 3/28, CBER director **Peter Marks** resigned in protest over disagreements with HHS secretary **Robert F. Kennedy Jr.**’s vaccine skepticism ([see story](https://www.fdaweb.com/marks-firing-challenges-rfk-jr-s-fitness-for-office/)). Then Marks’ deputy **Julie Tierney** was laid off on 4/1, and CBER senior advisor for translational science [**Scott Steele**](https://www.fda.gov/about-fda/fda-organization/scott-steele?ref=fdaweb.com) has just been appointed acting CBER director.

Novavax says in 4/23 SEC filing that FDA recently sent an information request to clarify a post-marketing commitment (PMC) that will “generate additional clinical data.” The company says it looks “forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.” It expressed optimism in the regulatory filing, stating that it believes its application is approvable.

Novavax's vaccine is the only protein-based Covid-19 vaccine currently available in the U.S., offering an alternative to mRNA vaccines from Pfizer-BioNTech and Moderna. Full FDA approval would allow the vaccine to remain on the market indefinitely, beyond the duration of the public health emergency.

The BLA included robust Phase 3 clinical trial data that showed the vaccine is safe and effective for preventing Covid-19, Novavax says.