GSK Advances Co-Administration of RSV and Shingles Vaccines with Positive Phase III Data

Positive Phase III Data:
GSK has announced positive topline data from a Phase III trial evaluating the co-administration of its RSV vaccine, Arexvy, and shingles vaccine, Shingrix, in adults 50 years and older.

Non-Inferior Immune Response:
The trial showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits.

Safety Profile:
Co-administration was well-tolerated, with acceptable reactogenicity and safety profiles. The most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.

Regulatory Submissions:
GSK plans to use these data to support regulatory submissions to the FDA and the European Medicines Agency, aiming to approve the co-administration of Arexvy and Shingrix.

Market Impact:
Approval could help GSK shore up sales for both vaccines, which have faced challenges. Arexvy, the first approved RSV vaccine, has seen narrowed guidelines from the CDC, while Shingrix sales have slowed due to a new Medicare rule.

Public Health Benefits:
The co-administration could reduce barriers to adult immunization by potentially decreasing the number of visits to healthcare offices and pharmacies, helping to combat RSV and shingles more effectively.