Pfizer Touts Positive Data From Global Maternal Immunization Trial For Its Bivalent RSV Vaccine Candidate

Pfizer Inc PFE announced topline data from the Phase 3 MATISSE trial investigating its bivalent RSV prefusion vaccine candidate administered to pregnant participants to help protect their infants from RSV disease after birth.
The study enrolled approximately 7,400 pregnant individuals.
If approved, Pfizer's RSV vaccine candidate could be the first maternal vaccine to help prevent RSV illness in young infants.
The pre-planned interim efficacy analysis conducted by an external and independent Data Monitoring Committee (DMC) met the success criterion for one of two primary endpoints.
Vaccine efficacy of 81.8% was observed against severe medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life, with high efficacy of 69.4% demonstrated through the first six months of life.
Although the statistical success criterion was not met for the second primary endpoint, clinically meaningful efficacy was observed for MA-LRTI of 57.1% in infants from birth through the first 90 days of life.
Efficacy for MA-LRTI of 51.3% was observed over the six-month follow-up period.
At the recommendation of the DMC and in consultation with the FDA, Pfizer has stopped enrollment in the study.
Pfizer plans to submit a Biologics License Application (BLA) to the FDA by the end of 2022 for the vaccine candidate, followed by other regulatory authorities in the coming months.
In August, Pfizer reported positive data from bivalent RSV prefusion F vaccine candidate in adults 60 years or older.
Price Action: PFE shares are up 2.53% at $47.73 on the last check Tuesday.

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