Drug major Pfizer Inc. (PFE) announced Tuesday positive top-line data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus or RSV vaccine candidate, when administered to pregnant participants to help protect their infants from RSV disease after birth.v.
Pfizer said this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth.
At the recommendation of the DMC, and in consultation with the U.S. Food and Drug Administration, Pfizer has stopped enrollment in the study.
Based on these positive results Pfizer plans to submit a Biologics License Application or BLA to the FDA by the end of 2022 for the vaccine candidate followed by other regulatory authorities in the coming months.
The Phase 3 clinical trial (NCT04424316) MATISSE (MATernal Immunization Study for Safety and Efficacy) investigated its bivalent RSV prefusion vaccine candidate, RSVpreF or PF-06928316.
The company said the pre-planned, interim efficacy analysis conducted by an external and independent Data Monitoring Committee met the success criterion for one of two primary endpoints. The observed efficacy for severe medically attended lower respiratory tract illness was 81.8% through the first 90 days of life.
Substantial efficacy of 69.4% was demonstrated for infants over the six-month follow-up period.
For the second primary endpoint, the statistical success criterion was not met, but clinically meaningful efficacy was observed for MA-LRTI of 57.1% in infants from birth through the first 90 days of
Pre-planned safety reviews conducted at regular intervals throughout the duration of the study by the Committee also indicate the investigational vaccine is well-tolerated with no safety concerns for both the vaccinated individuals and their newborns.
Pfizer intends to submit these results for peer-review in a scientific journal.
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