Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO® for RSV in Older Adults
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 iN Older adults Immunized against RSV disease).
- 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 iN Older 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.
- 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.