Pfizer’s announcement of positive trial results for its RSV vaccine, Abrysvo, in high-risk adults under 60 led to a 3% increase in its stock, while Moderna’s rose by 8%. Abrysvo showed promise in preventing RSV-related lower respiratory tract disease in younger adults with chronic conditions. Pfizer plans to seek regulatory approval for this expanded age group, marking a significant step forward in RSV prevention.
Pfizer announces positive top-line results from Phase 3 study of ABRYSVO® in adults aged 18 to 59 at increased risk for RSV disease.
The trial, MONeT, evaluated a single dose of ABRYSVO versus placebo in adults at risk of severe RSV-associated lower respiratory tract disease (LRTD).
Adults with underlying chronic conditions like asthma, diabetes, and COPD are at increased risk.
The study achieved co-primary immunogenicity endpoints and primary safety endpoint.
Participants demonstrated non-inferior RSV subgroup neutralizing responses compared to older adults.
A four-fold increase in serum neutralizing titers for RSV-A and RSV-B was observed post-vaccination.
ABRYSVO was well-tolerated with consistent safety findings.
Pfizer met diversity recruitment goals for the study.
Pfizer intends to seek approval for ABRYSVO in adults 18 to 59 years of age.
The company plans to submit data to regulatory agencies for expansion of the age group indication and publish findings in a peer-reviewed journal.
