Thursday, Pfizer Inc PFE 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 trial RENOIR.
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%.
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Vaccine efficacy following season one was 88.9%, demonstrating durable efficacy after two seasons.
Consistent vaccine efficacy was demonstrated for 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% after season one to 55.7% 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%.
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.
In August last year, the FDA approved Abrysvo to prevent infection in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.
In fiscal year 2023, Abrysvo generated sales of $890 million.
Price Action: PFE shares are down 1.07% at $26.76 on the last check Thursday.
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