FDA AdCom votes for approval of Pfizer's RSV vaccine in older adult

1 March 2023

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) yesterday voted that available data is adequate to support the safety and effectiveness of the respiratory syncytial virus (RSV) bivalent vaccine candidate PF-06928316 or RSVpreF, from US pharma giant Pfizer (NYSE: PFE).

The Committee voted 7 to 4 on safety and 7 to 4 – both with one abstainer - on effectiveness. The vaccine candidate is currently under FDA review for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults 60 years of age and older.

Concerns over adverse events

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