FDA advisory committee gives thumbs up to effectiveness and safety of GSK’s RSV older adult vaccine candidate

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  • Committee votes unanimously that the data support the effectiveness of the vaccine, and 10-2 that the data support the safety of the vaccine.
  • FDA decision on U.S. approval expected by May 3, 2023, with the potential for the vaccine to be the first approved for older adults.
  • Evidence reviewed by the committee was supported by pivotal data recently published in the New England Journal of Medicine.

GSK plc announced that the U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. The committee voted unanimously 12-0 on effectiveness and 10-2 on safety.Philip DormitzerPhilip Dormitzer

“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 health care systems," said Philip Dormitzer, global head of vaccines R&D for GSK. "Thousands of older adults in the U.S. are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complicationsWe’re delighted that the advisory committee recognized 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. GSK also 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 for GSK’s RSV older adult vaccine candidate under priority review and assigned a Prescription Drug User Fee Act action date of May 3, 2023.

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

GSK’s RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. Across multiple trials, the vaccine candidate was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia and headache. These were typically mild to moderate and transient. The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.


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