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[ad_1] 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...

[ad_1] A doctor is injecting a vaccine to a baby boy Karl Tapales | Moment | Getty Images Sanofi expects its infant RSV shot to roll out in the U.S. before respiratory virus season this fall, a company spokesperson said Friday. The Food and Drug Administration on Monday approved Beyfortus , a monoclonal antibody that is administered as a single dose to infants before or during their first respiratory syncytial virus season. related investing news The Sanofi spokesperson said the company does not expect any challenges with manufacturing or capacity to meet demand this RSV season. The French drugmaker jointly developed Beyfortus with AstraZeneca , which is based in England. A panel of independent advisors to the Centers for Disease Control and Prevention will meet on Aug. 3 to make recommendations about how the shot should be administered. Sanofi is working with the panel to place Beyfortus on the U.S. childhood immunization schedule, the company spokesperson said. The Affordable...

[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images The Food and Drug Administration on Monday approved AstraZeneca and Sanofi 's shot that protects infants and toddlers against respiratory syncytial virus , which is the leading cause of hospitalization among babies in the U.S. Nirsevimab is the first shot approved by the FDA to protect all infants against RSV regardless of whether they are healthy or have a medical condition. related investing news The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of RSV season this fall. The Centers for Disease Control and Prevention's panel of independent experts will meet in August to make recommendations on how the shot should be administered by doctors. Another shot called palivizumab is already on the market, but it is given mainly to infants who are preterm or who have lung and congenital heart conditions that put them at high risk of severe disease. Nirs...