GSK's RSV shot gains expanded US approval amid scrutiny

GSK's Arexvy received expanded FDA approval to cover all high-risk adults, increasing the eligible U.S. population by about 21 million; a U.S. vaccine advisory panel is scheduled to consider recommendations for this age group next week.

GSK's RSV vaccine Arexvy received expanded approval in the United States to include all high-risk adults. It had previously been authorized for people 60 and older and for adults 50 to 59 with at least one health condition that raises risk. The expansion increases the pool of eligible U.S. adults by around 21 million. The decision comes as federal vaccine reviews face increased scrutiny and after recent leadership changes in the FDA's vaccine division. Key details: - Arexvy's expanded approval covers all high-risk adults in the U.S. - The vaccine was already approved for adults 60+ and for 50–59 year-olds with at-risk conditions. - The expansion adds about 21 million eligible adults, as reported in the article. - The shot includes an immune-boosting adjuvant supplied by Agenus Inc. - The article mentions this puts Arexvy on par with a rival vaccine from Pfizer. - The U.S. panel of vaccine advisers will consider Arexvy for this age group and is meeting next week; decisions on repeat RSV immunizations remain undetermined at this time. Summary: The expanded approval broadens eligibility for GSK's Arexvy and aligns the vaccine's coverage with a competing product. The immediate next step is review by the U.S. vaccine advisory panel, and the committee's recommendations and any guidance on repeat immunizations are undetermined at this time.