US FDA Advisory Committee votes to support effectiveness and safety of GSK’s respiratory syncytial virus older adult vaccine candidate

Phil Dormitzer, Global Head of Vaccines R&D, GSK said: “Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems. Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications. We’re delighted that the Advisory Committee recognised the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine.”

The Committee based its vote on the robust data package supporting the vaccine candidate. This includes results from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, recently published in the New England Journal of Medicine. In addition, GSK presented positive data on concomitant administration with seasonal quadrivalent influenza vaccination previously shared at IDWeek 2022.

The role of the VRBPAC is to provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. In November 2022, the FDA accepted the Biologics License Application (BLA) for GSK’s RSV older adult vaccine candidate under Priority Review and assigned a Prescription Drug User Fee Act action date of 3 May 2023.

GSK’s RSV older adult vaccine candidate is also under regulatory review by the European Medicines Agency, Japan’s Ministry of Health, Labour and Welfare, and several other regulators, with decisions expected in 2023. Additional regulatory submissions are anticipated to continue throughout this year.