The P-III (RENOIR) trial evaluates the efficacy, immunogenicity, and safety of a single dose of RSVpreF (120μg) vs PBO in a ratio (1:1) in ~37,000 adult patients aged ≥60yrs. with RSV
The results showed vaccine efficacy of 85.7% in patients with more severe disease 1EPs of LRTI-RSV defined by analysis of three or more RSV-associated symptoms & was found to be well tolerated with no safety concerns. The pre-planned, interim analysis of RSVpreF vaccine efficacy of 66.7% which evaluate protection against RSV-associated LRTI-RSV
The company plans to submit a BLA to the US FDA for RSVpreF & prepare to file for additional regulatory authorities in the coming months, based on the pre-planned, interim efficacy analysis
Ref: Businesswire | Image: Pfizer
