FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine (UPDATED)

Editor’s Note: The story has been updated with comments from Novavax

In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to Novavax Inc.'s NVAX COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in individuals aged 12 and older.

Novavax's vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on June 27, 2024.

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According to a media report on Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax's shot.

In an emailed statement to Benzinga, Novavax said, “Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (FDA)'s Prescription Drug User Fee Act date for our Biologics License Application (BLA) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our BLA is ready for approval.

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. Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.”

Earlier this week, Peter Marks resigned from his role at the FDA's Center for Biologics Evaluation and Research.

Marks was a top regulator at the FDA and played a key role in pushing quick approvals of vaccines during the COVID-19 pandemic.

The Wall Street Journal writes that the agency is now delaying the decision and has reportedly asked for more data and that the application isn't likely to be approved soon, according to sources.

The FDA set an April 1 deadline for a decision.

Novavax reported fourth-quarter 2024 sales of $88.31 million, compared to $291 million a year, beating the consensus of $84.35 million. The decrease was due to lower product sales under APA agreements.

The COVID-19 vaccine maker reported an earning loss of 51 cents per share, down from $1.44 a year ago, in line with the Wall Street Estimate.

The news comes after vaccine stocks came under pressure last week following reports that the Trump administration plans to end financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. The Trump administration reportedly plans to cut billions in global health initiatives.

Price Action: NVAX stock is up 1.25% at $6.09 at the last check on Wednesday.

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