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FDA Approves First RSV Vaccine

May 10, 2023


FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and older, according to an agency press release.

FDA based its approval on analysis of data from an ongoing, randomized, placebo-controlled clinical study in individuals aged 60 and older. The study, which had 12,500 participants receive the vaccine and 12,500 receive placebo, showed that the vaccine reduced the risk of developing RSV-associated LRTD by 82.6% and severe RSV-associated LRTD by 94.1%.

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