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# FDA Misses Novavax Covid Vaccine Review Action
- URL: https://www.fdaweb.com/fda-misses-novavax-covid-vaccine-review-action/
- Published: 2025-04-02T12:00:00.000Z
- Updated: 2026-09-14T14:56:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158943

Novavax says FDA has missed its 4/1 user fee review action target date on a BLA seeking full approval for its current Covid-19 vaccine, which is currently marketed under an emergency use authorization (EUA). “As of Tuesday, 4/1, we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval,” the company said in a statement. “As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.”

The submission included robust Phase 3 clinical trial data that showed the vaccine is safe and effective for preventing Covid-19, Novavax says. The traditional vaccine is intended to be an alternative to mRNA Covid-19 vaccines, which have already been converted from an EUA to full approval, it adds.

Senior FDA officials reportedly said the agency needed more data and the submission was unlikely to be approved soon, according to the *Wall Street Journal*. However, an HHS offficial told ***FDA Webview*** that a decision has not been made yet.

The delay in completing the review action is likely due to the upheaval at the agency over staff cuts, particularly with senior CBER officials who would need to sign off on approving the submission. On 3/28, CDER 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/)). 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.