Novavax COVID vaccine strikes nearer to full FDA approval

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by I. Edwards

Novavax COVID vaccine moves closer to full FDA approval

Novavax’s COVID-19 vaccine may quickly obtain full approval from the U.S. Meals and Drug Administration (FDA), the corporate mentioned Wednesday.

The replace despatched Novavax’s top off greater than 21% in early buying and selling. It additionally helped ease fears that the choice had been delayed by the Trump Administration, The Related Press reported.

Novavax makes the one protein-based COVID-19 vaccine that is nonetheless out there in america. Proper now, it’s only authorised beneath emergency use. That is completely different from the mRNA vaccines from Pfizer and Moderna, which have full FDA approval for sure age teams.

In a brand new assertion, Novavax mentioned the FDA has requested the corporate to gather extra medical information from individuals who obtain its shot.

The corporate added that it’s “partaking with the FDA expeditiously” in hopes to get full approval “as quickly as potential.”

Below emergency use, vaccines will be eliminated even after a well being emergency is taken into account to be over. Full approval from the FDA means a product can keep in the marketplace even after a well being emergency ends. (The World Well being Group declared an finish to the COVID emergency in Might 2023.)

The vaccine was on monitor for FDA approval by April 1. However appearing FDA Commissioner Dr. Sara Brenner instructed the company to pause the choice, AP mentioned.

This sparked considerations that U.S. Well being Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, could have influenced the delay. FDA vaccine chief Dr. Peter Marks stepped down final month after clashing with Kennedy over vaccine security.

The COVID vaccines used within the U.S. prepare the physique to acknowledge the tell-tale spike protein on the SARS-CoV2 virus.

In contrast to the Pfizer and Moderna vaccines, which depend on a genetic code to set off an immune response, Novavax’s vaccine combines lab-grown copies of the spike protein with an agent that helps increase the immune system.

Annually, vaccine makers replace their COVID-19 photographs to higher goal new variants, very like how flu photographs are modified yearly.

Quotation:
Novavax COVID vaccine strikes nearer to full FDA approval (2025, April 25)
retrieved 26 April 2025
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