GSK shares positive data for AREXVY, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons - Seite 2

Revaccination
The trial also evaluated efficacy following an annual revaccination schedule as a confirmatory secondary endpoint. Cumulative efficacy over two seasons in participants who received a second dose of the vaccine was 67.1% (97.5% CI, 48.1-80.0, 30 of 12,469 vs 139 of 12,498), suggesting revaccination after 12 months does not appear to confer additional benefit for the overall population. The clinical development program will continue to evaluate longer term follow up and the optimal timing for potential revaccination.

Tony Wood, Chief Scientific Officer, GSK, said: “Our goal is to provide a high level of protection for older adults most at risk from RSV. These data show the efficacy of a single dose of our vaccine over two RSV seasons against RSV-LRTD, including in the populations most at risk due to age or underlying medical conditions. This reinforces our confidence in its potential to make a significant public health impact. We look forward to discussing these results with regulators and vaccine recommending bodies and to collecting more data from the ongoing clinical development program.”

Safety and reactogenicity data were consistent with initial observations from the phase III program. The vaccine was generally well tolerated. The most frequently observed adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.

GSK will present these data at the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on June 21, 2023. Data from two influenza co-administration trials (quadrivalent high dose and quadrivalent adjuvanted) will also be presented, adding to the seasonal quadrivalent influenza vaccination co-administration data in the current US product label. These data will be submitted to the US Food and Drug Administration (FDA) and other regulators for review.

About AReSVi-006
This is a randomized, placebo-controlled, observer-blind, multi-country phase III trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSV older adult vaccine over three years and following an annual revaccination schedule in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries. The trial’s primary endpoint was vaccine efficacy against RSV-LRTD after one RSV season. Initial results were published in the New England Journal of Medicine in February 2023.