As FDA Delays Novavax' COVID Vaccine Approval, Patients Fight Back
- Novavax's protein-based COVID-19 vaccine, authorized under emergency use since 2022, awaited full FDA approval expected by April 1, 2025 in the U.S.
- The FDA delayed approval after requesting more clinical data and a post-approval trial, coinciding with leadership changes and reported clashes over vaccine safety.
- Novavax is actively collaborating with the FDA to address their requests, with the goal of obtaining full approval promptly so the vaccine remains accessible after the COVID emergency ends.
- The FDA’s full approval would let Novavax’s vaccine stay on the market permanently, unlike emergency use-only vaccines, and the announcement raised Novavax's stock by over 21%.
- The delay occurred amid concerns about possible influence from Health Secretary and vaccine skeptic Robert F. Kennedy Jr., who clashed with FDA officials before resignations.
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148 Articles
FDA Scrutiny of Novavax COVID Shot Sparks Uncertainty About Other Vaccines
(MedPage Today) -- The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine -- the nation's only traditional protein-based option for the coronavirus -- is sowing uncertainty about updates to other vaccines...
Trump’s FDA wants a new trial for Novavax’s COVID-19 shot, sparking uncertainty about updates to other vaccines
The Trump administration's effort to impose new requirements on Novavax's COVID-19 vaccine — the nation's only traditional protein-based option for the coronavirus — is sowing uncertainty about updates to other vaccines, too. Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded and that it believed its s…
New vaccine project launches
(CNN, KYMA/KECY) - A group of public health experts is organizing a response to concerns about U.S. vaccine misinformation and access. This initiative is called the Vaccine Integrity Project. It will be funded by a foundation backed by Walmart heiress Christine Walton. The Vaccine Integrity Project will consider what's needed in order to safeguard vaccine policies and use all across the U.S. This comes amid concerns that the nation's health and …
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