NEW YORK - Pfizer Inc. (NYSE: NYSE:PFE) reported that its respiratory syncytial virus (RSV) vaccine, ABRYSVO®, maintained high efficacy in adults aged 60 and over through a second RSV season. According to the company's ongoing Phase 3 RENOIR trial, the vaccine showed 77.8% efficacy against RSV-associated lower respiratory tract disease with three or more symptoms.
The data, derived from disease surveillance in the Northern and Southern Hemispheres, indicated that the vaccine's protection was consistent for both major RSV subgroups, A and B. After two seasons, ABRYSVO demonstrated an overall efficacy of 81.5% across both subtypes. The vaccine also continued to show efficacy against less severe cases of the disease, with a protection rate of 55.7% after the second season, slightly lower than the 65.1% observed after the first season.
No new adverse events were reported in the second season, and Pfizer plans to continue post-marketing studies to further understand ABRYSVO's safety profile. Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer at Pfizer, highlighted the importance of the vaccine's broad and durable protection against both types of RSV.
The U.S. Food and Drug Administration (FDA) approved ABRYSVO in May 2023 for the prevention of RSV in individuals 60 years of age or older. The vaccine received further approvals for maternal immunization to protect infants against RSV, with recommendations for administration during 32 through 36 weeks of gestation.
Pfizer has initiated additional clinical trials to evaluate the vaccine's efficacy in children at higher risk for RSV disease and adults with underlying medical conditions. The company intends to submit the recent findings to regulatory authorities and aims to publish the data in a peer-reviewed scientific journal.
RSV is a common and contagious virus that can cause serious respiratory illness, particularly in young infants, older adults, and individuals with chronic medical conditions. Each year in the United States, RSV is responsible for a significant number of hospitalizations and deaths among older adults.
The information presented in this article is based on a press release statement from Pfizer Inc.
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