FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV
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A panel of independent advisors to the Food and Drug Administration unanimously recommended Thursday that the antibody nirsevimab be approved for use to protect infants from respiratory syncytial virus , the leading cause of hospitalization among newborns. If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the U.S. that can protect all infants from RSV . The FDA, which is not obligated to follow the recommendation of its advisory panel, is expected to make a final decision on nirsevimab in the third quarter. Nirsevimab is a monoclonal antibody made by AstraZeneca . The medication would be marketed by Sanofi . The advisory panel voted 21-0 to recommend its approval. In a separate vote, the advisors also recommended nirsevimab's use in children up to 2 years old who remain vulnerable to the virus in their second RSV season. That vote was 19-2. RSV kills nearly 100 babies in the United States every year, according to sci...