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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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ramaonhealthcare.com broke the news in on Wednesday, April 23, 2025.
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