FDA Signals Review for Moderna's Next-Gen Flu Vaccine
TL;DR Summary
The FDA has reversed its earlier stance and agreed to review Moderna’s updated mRNA flu vaccine, with plans for full approval in adults 50–64 and accelerated approval for those 65 and older, plus a post-marketing study in older adults. A decision is expected by August 5, and Moderna shares rose on the news.
- FDA reverses course, will review Moderna's mRNA flu vaccine NBC News
- F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine The New York Times
- FDA reverses course and will review Moderna’s mRNA-based flu shot The Washington Post
- U.S. rejection of new mRNA flu vaccine 'sends chills,' epidemiologist says PBS
- FDA reverses course, will review Moderna flu shot after controversial refusal The Boston Globe
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