Pfizer Announces Positive Efficacy Data for ABRYSVO® in Older Adults for Full Season Two
Pfizer Inc. (NYSE: PFE) today announced top-line ABRYSVO® vaccine efficacy and safety data for respiratory syncytial virus (RSV) in adults 60 years of age and older following a second season in the Northern and Southern Hemispheres from the ongoing pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease). Vaccine efficacy against RSV-associated lower respiratory tract disease (LRTD), defined by three or more symptoms, after disease surveillance in season two was 77.8% (95.0% CI: 51.4, 91.1); vaccine efficacy following season one was 88.9% (95.0% CI: 53.6%, 98.7%)1, which demonstrates durable efficacy after two seasons.
Consistent vaccine efficacy was demonstrated for both RSV A and RSV B after season two with vaccine efficacy against each subtype of ≥80% for LRTD with three or more symptoms. Vaccine efficacy was also sustained against less severe LRTD, defined by two or more symptoms, from 65.1% (95.0%% CI: 35.9%, 82.0%)1 after season one to 55.7% (95.0% CI: 34.7%, 70.4%) after the end of season two. Vaccine efficacy against RSV-associated LRTD, defined by three or more symptoms, across both seasons after approximately 16.4 months of disease surveillance was 81.5% (95.0% CI: 63.3, 91.6).
No new adverse events were reported through the second RSV season beyond what was reported by subjects in the clinical trial during the first season. Pfizer is conducting post-marketing studies and surveillance programs to inform the safety profile of ABRYSVO.
“We are encouraged by the level of protection that we observed after two full RSV seasons for ABRYSVO,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “This new data indicate that broad and durable protection against both types of RSV that cause disease, RSV A and RSV B, is the potential benefit to having a bivalent vaccine.”
Pfizer intends to submit these data to regulatory authorities and vaccine technical committees. The company also intends to publish these findings in a peer-reviewed scientific journal and share them at an upcoming scientific congress.