07:31 AM EDT, 07/29/2024 (MT Newswires) -- GSK (GSK) said Monday the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanding the approval of its respiratory syncytial virus or RSV vaccine to include a new patient group.

The company's RSV vaccine is approved in Europe for the prevention of lower respiratory tract disease caused by RSV in patients 60 years old and above, and the recommended expansion will include adults aged 50 to 59 years old, the company said.

GSK said the regulator's positive opinion was based on the results of a phase 3 trial that evaluated the vaccine's immune response and safety in patients aged 50 to 59 years old. The company said the European Commission's final decision on the expansion is expected by September.

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