(News Bulletin 247) – The FDA Advisory Committee unanimously recommends nirsevimab as the first immunizing agent against RSV infections for all infants.
The Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) ruled unanimously, by a vote of 21 to 0, that the benefit/risk ratio of nirsevimab from Sanofi and AstraZeneca was favorable for the prevention of lower respiratory tract infections due to respiratory syncytial virus (RSV) in neonates and infants born during the RSV circulation season or entering their first exposure season to this virus.
The Committee also came out in favour, by 19 votes to 2, on the benefit/risk ratio of nirsevimab in children up to 24 months of age who remain at risk of severe RSV infection during of their second season of exposure to the virus.
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi said: ‘Most infants hospitalized with RSV infection are born full term and healthy, so interventions designed specifically to protect all infants have all the chances of having maximum impact. The positive vote from the FDA advisory committee is encouraging. He is motivated by compelling data from our clinical development program, which illustrates the potential of nirsevimab and its ability to alleviate the annual burden of RSV. ‘
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