Pharmaceutical companies AstraZeneca and Sanofi have received unanimous approval from the FDA's Antimicrobial Drugs Advisory Committee for their respiratory syncytial virus (RSV) antibody, nirsevimab, to be used in pediatric settings. The committee voted 21-0 in favor of approving the immunizing antibody for use in infants during their first RSV season, while also recommending its approval for high-risk children up to two years old who remain vulnerable to severe RSV through their second season. If approved by the FDA later this year, nirsevimab would become the first immunization option specifically designed to protect all infants through their first RSV season. Pfizer is also developing an investigational vaccine that won backing last month.
Keywords: AstraZeneca, Sanofi, FDA, pediatric settings, respiratory syncytial virus (RSV) antibody
AstraZeneca and Sanofi have been granted approval by the US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee for nirsevimab as a preventative treatment against respiratory syncytial virus (RSV). The drug is intended for use in paediatric settings with a focus on infants during their first RSV season. The advisory committee voted 21-0 in favour of approving the drug for