Novavax COVID Vaccine Moves Closer to Full FDA Approval

FRIDAY, April 25, 2025 (HealthDay News) — Novavax’s COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday.

The update sent Novavax’s stock up more than 21% in early trading. It also helped ease fears that the decision had been delayed by the Trump Administration, The Associated Press reported.

Novavax makes the only protein-based COVID-19 vaccine that's still available in the United States. Right now, it is only approved under emergency use. That’s different from the mRNA vaccines from Pfizer and Moderna, which have full FDA approval for certain age groups.

In a new statement, Novavax said the FDA has asked the company to collect more clinical data from people who receive its shot.

The company added that it is “engaging with the FDA expeditiously” in hopes to get full approval “as soon as possible.”

Under emergency use, vaccines can be removed even after a health emergency is considered to be over. Full approval from the FDA means a product can stay on the market even after a health emergency ends. (The World Health Organization declared an end to the COVID emergency in May 2023.)

The vaccine was on track for FDA approval by April 1. But acting FDA Commissioner Dr. Sara Brenner told the agency to pause the decision, AP said.

This sparked concerns that U.S. Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, may have influenced the delay. FDA vaccine chief Dr. Peter Marks stepped down last month after clashing with Kennedy over vaccine safety.

The COVID vaccines used in the U.S. train the body to recognize the tell-tale spike protein on the SARS-CoV2 virus. 

Unlike the Pfizer and Moderna vaccines, which rely on a genetic code to trigger an immune response, Novavax's vaccine combines lab-grown copies of the spike protein with an agent that helps boost the immune system. 

Each year, vaccine makers update their COVID-19 shots to better target new variants, much like how flu shots are changed yearly.

More information

Learn more about Novavax on its website.

SOURCE: The Associated Press, April 23, 2025