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FDA reopens review of Moderna’s mRNA flu shot ahead of fall rollout

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Source: CNBC
FDA reopens review of Moderna’s mRNA flu shot ahead of fall rollout
Photo: CNBC
TL;DR

The FDA has agreed to review Moderna’s experimental mRNA flu vaccine after previously declining to file, with a decision due by August 5; Moderna seeks full approval for adults 50–64 and accelerated approval for 65+, contingent on a post‑marketing study, amid broader regulatory shifts and debate over vaccine oversight.

Topics:businesshealth#fda#flu-vaccine#health#moderna#mrna#regulatory-approval
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  1. FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal  CNBC
  2. FDA reverses course and will review Moderna’s mRNA-based flu shot  The Washington Post
  3. FDA reverses course and will review Moderna’s mRNA-based flu vaccine  The Guardian
  4. U.S. rejection of new mRNA flu vaccine 'sends chills,' epidemiologist says  PBS
  5. The FDA’s Moderna pirouette is one more sign of chaos at the agency  statnews.com

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