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The Committee voted 14 to on effectiveness and 10 to 4 on safety. In December 2022, Pfizer announced that the FDA had granted priority review to a biologics license application for RSVpreF for review for the prevention of medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in Infants and Young Children. Burden of RSV in infants less than six months of age, with approximately 45,000 dying each year from complications associated with the infection, and the vast majority in developing countries.

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RSV vaccine candidate is currently the only company pursuing regulatory applications for an RSV investigational vaccine candidate. If approved, our RSV vaccine candidate would help protect infants through maternal immunization to help protect. RSV in Infants and Young Children.

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