FDA Panel Debates COVID Vaccine Recipe
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Novavax's full FDA approval for NUVAXOVID is a transformative milestone, unlocking a $175M Sanofi payment and validating their protein-based vaccine technology. The approval positions Novavax as the only non-mRNA COVID-19 vaccine with full FDA approval, offering a differentiated alternative amid growing mRNA fatigue.
The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.
Novavax shares jumped more than 15% on Monday after the company secured a long-awaited U.S. regulatory approval for its COVID-19 vaccine, albeit with new conditions, which helped allay some investor concerns over the future of the shot.
WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.