Shots:
The P-III (MATISSE) trial evaluated the efficacy, safety, and immunogenicity of RSVpreF (120µg) vs PBO in a ratio (1:1) in 7400 patients aged ≤49yrs. with RSV
The results showed the vaccine efficacy of 81.8% & 57.1 against sev. MA-LRTI & MA-LRTI due to RSV in infants from birth through the first 90 days of life with 69.4% & 51.3% high efficacy over 6mos. follow-up period. The vaccine was well-tolerated with no safety concerns for vaccinated individuals and newborns
The results met one of the study protocol’s pre-specified regulatory success criteria. The company is expected to submit a BLA to the US FDA at the end of 2022, followed by other regulatory authorities in the coming months
Ref: Businesswire | Image: Pfizer
