Pfizer wins FDA AdCom backing for maternal RSV vaccine

• An independent panel of experts at the FDA voted on Thursday to recommend the approval of Abrysvo, the maternal vaccine candidate developed by Pfizer (NYSE:PFE), to prevent respiratory disorders linked to respiratory syncytial virus (RSV) in infants.
• In February, the FDA gave priority review for the company's Biologics License Application for the candidate, also known as PF-06928316 or RSVpreF, granting August 2023 as the regulatory action date.
• The investigational shot is designed for administration in pregnant women to prevent lower respiratory tract illness (LRTD) caused by RSV in children up to six months of age.
• Regarding whether the safety and efficacy data submitted by Pfizer (PFE) in the BLA can support the approval, the FDA's vaccine experts voted 10 - 4 and 14 - 0, respectively.
• In finalizing its decisions on marketing applications, the FDA typically follows the views of its advisory committees though the agency is not required to do so.
• Pfizer's (PFE) RSV vaccine candidate for older adults is also under FDA review, with a decision expected in May.

More about RSV vaccine race

• Pfizer eyes $10B-plus market for RSV vaccines with two-prong approach
• Johnson & Johnson drops RSV vaccine program
• GSK wins FDA AdCom backing for RSV vaccine
• Pfizer's Vaccine-Plus-Treatment Strategy For RSV