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FDA advisers vote in favor of AstraZeneca, Sanofi antibody for infant RSV protection

6/8/23 4:24 PM ET (MarketWatch)Print

Advisers to the U.S. Food and Drug Administration voted unanimously Thursday to recommend a monoclonal antibody developed by Sanofi (SAN.FR) and AstraZeneca (AZN.LN) to protect infants from respiratory syncytial virus. RSV is a common respiratory virus that can cause severe illness in infants and older adults. In a separate vote, 19 of 21 members voted to recommend the monoclonal antibody, nirsevimab, for prevention of RSV lower respiratory disease in children up to two years of age who remain vulnerable to severe RSV. FDA advisory-committee votes are not binding, but the agency often follows committee recommendations. Shares of Sanofi and AstraZeneca were both up 1.3% on Thursday.

-Eleanor Laise

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