- 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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