The U.S. FDA has accepted Pfizer's BLA for its respiratory syncytial virus (RSV) maternal vaccine candidate, putting Pfizer on track for a landmark approval.
Pfizer's candidate, PF-06928316 or RSVpreF, was submitted 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.
The maternal immunization regulatory submission is supported by the positive top-line results from MATISSE, 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. Pfizer announced positive top-line data from the trial back in Nov.
The FDA has accepted the BLA for priority review, teeing up Pfizer for approval of the first vaccine for administration to pregnant individuals to help protect against the complications of RSV disease in infants from birth through six months. The agency has set a PDUFA action date of August 2023, putting Pfizer in the lead amid an ongoing RSV race.
Last Feb., GSK halted enrollment in trials for its maternal vaccine candidate, following safety concerns — and has yet to resume. AstraZeneca and Sanofi are collaborating on a single-dose preventative option for the broad infant population, called nirsevimab. The FDA accepted their BLA last month, granting a PDUFA date in the third quarter of 2023.
