FDA follows EMA in accepting Pfizer's RSV vaccine filing

22 February 2023

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for Pfizer’s (NYSE: PFE) respiratory syncytial virus (RSV) vaccine candidate.

Known as PF-06928316 or RSVpreF, the vaccine has been developed for the prevention of medically attended lower respiratory tract illness (MA-LRTI) and severe MA-LRTI caused by RSV in infants from birth up to six months of age, by active immunization of pregnant individuals.

"If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease"

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