FDA Delays Final Approval of Novavax COVID Vaccine

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Medically reviewed by Drugs.com.

By I. Edwards HealthDay Reporter

FRIDAY, April 4, 2025 -- The U.S. Food and Drug Administration (FDA) has delayed the full approval of Novavax’s COVID-19 vaccine.

The decision had been expected by April 1, but the agency now says it needs more information before moving forward.

The Novavax shot is already available under emergency use. But full FDA approval would allow the vaccine to be used more widely and could offer more reassurance to people looking for options besides the existing mRNA vaccines, CNN reported.

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, according to KFF Health News, are also pressing regulators to revoke federal approval for mRNA-based COVID shots, which President Donald Trump has touted as a key first- term achievement.

Novavax uses protein-based technology, a more traditional method than the mRNA vaccines from Pfizer and Moderna.

“As of Tuesday, April 1, we had responded to all of the FDA’s information requests and we believe that our [Biologics License Application] is ready for approval,” Novavax said in a statement, adding that its 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.,” Novavax added.

The delay comes as the FDA is undergoing leadership changes. Dr. Scott Steele was recently named acting director of the FDA’s vaccine division after Dr. Peter Marks stepped down last month.

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has long opposed vaccines, has made false claims about the COVID shots and recently shared misleading information about the measles vaccine -- which came amid a deadly measles outbreak.

An HHS spokesman told CNN, “the FDA’s independent review process for the Novavax vaccine, like all vaccines is based solely on ensuring safety and efficacy, not political considerations. Any delays are a result of scientific review.”

The FDA’s press office was also placed on administrative leave this week as part of a government downsizing effort.

Sources

  • CNN, April 2, 2025
  • KFF Health News, March 10, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-04-05 00:00

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