FDA Approves GSK’s Arexvy, the First RSV Vaccine for Adults Over 60

May 9, 2023

On May 3, 2023, the FDA issued approval for GlaxoSmithKline’s (GSK) Arexvy RSV vaccine for adults 60 and older. RSV is a respiratory virus that hospitalizes around 177,000 adults over 65 each year, with 14,000 resulting in death. Arexvy is an adjuvanted recombinant glycoprotein antigen and the first RSV vaccine to be approved in adults. Clinical trials have shown efficacy above 82% in older adults and over 94% in those with relevant medical conditions. The Westside Center for Clinical Research, an ENCORE Research Group clinical site, has been participating in the Phase III study to show efficacy and safety of Arexvy against placebo treatment. GSK aims to make the vaccine available for adults over 60 before the end of 2023.



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