US biopharmaceutical company Pfizer Inc (NYSE:PFE) said on Tuesday that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate PF-06928316 or RSVpreF.

This application concerns the use of RSVpreF 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 immunisation of pregnant individuals.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

Additionally, the European Medicines Agency (EMA) is conducting an accelerated assessment of Pfizer's RSV vaccine candidate for both older adults and maternal immunisation to help protect infants. A decision is expected in the second half of 2023.

Pfizer's maternal immunisation regulatory submission is supported by positive top-line results from a Phase 3 clinical trial evaluating the efficacy, safety and immunogenicity of RSVpreF against MA-LRTI and severe MA-LRTI in infants born to healthy women vaccinated during pregnancy.