Key Takeaways
Novavax is working closely with federal drug regulators to get full approval for its COVID shot
The vaccine is the only protein-based COVID shot still in use in the U.S.
This approval would allow the vaccine to stay on the market long-term
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 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 told the agency to pause the decision, AP said.
This sparked concerns that U.S. Health Secretary , a longtime vaccine skeptic, may have influenced the delay. FDA vaccine chief 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
What This Means For You
Novavax’s vaccine may soon be fully approved and more widely available.