FDA Panel Backs GSK's RSV Vaccine For Older Adults

(RTTNews) - The US Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of GSK plc's (GSK,GSK.L) respiratory syncytial virus or RSV vaccine for older adults.

GSK said Thursday that the Committee voted unanimously 12-0 on effectiveness and 10-2 on safety of GSK's respiratory syncytial virus older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

The role of the Committee 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 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.

On Tuesday, Pfizer said that the VRBPAC voted 7 to 4 on safety and 7 to 4 on effectiveness of the company's RSV bivalent vaccine candidate PF-06928316 or RSVpreF. The FDA decision is expected by the Prescription Drug User Fee Act goal date in May 2023.

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