FDA Tightens Vaccine Guidelines, Affects Moderna's Development Timeline

Tuesday, Dec 2, 2025 11:18 am ET1min read
MRNA--

Moderna's stock fell 6% after the FDA announced stricter vaccine approval requirements, potentially delaying the development of its pipeline products, including flu and combined flu/COVID vaccines. The agency cited reports of pediatric deaths linked to COVID-19 vaccines and plans to require additional safety testing. The move also weighed on Novartis' stock, which fell over 3%.

FDA Tightens Vaccine Guidelines, Affects Moderna's Development Timeline

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