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FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval

 
• By Brenda Sandburg

Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.

RSV vaccine
Advisory committee votes in support of GSK's RSV vaccine for older adults but wants US FDA to delay approval • Source: Shutterstock

US FDA advisory committee members agreed that GlaxoSmithKline Biologicals SA’s respiratory syncytial virus (RSV) vaccine is safety and effective for older adults, but there also seemed to be consensus that the agency should wait to approve the vaccine until there is further data from the company’s ongoing pivotal Phase III trial.

At its 1 March meeting, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 10-2 that the available data are adequate to support the safety of GSK’s adjuvanted vaccine Arexvy (RSVPreF3+ASO1E) when administered to individuals 60 years of age and older for the prevention of lower respiratory tract

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