GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the EMA for the prevention of RSV disease in adults aged 50-59 at increased risk

GSK

29 January 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile in this population.

GSK today announced that the EMA has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.

Read GSK press release

Michael Wonder

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Michael Wonder

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Europe , Vaccine , Dossier