FDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger Adults

GSK plc GSK announced that the FDA has accepted its regulatory filing seeking to expand the use of its RSV vaccine, Arexvy, in adults under 50 who are at a higher risk of the disease. A final decision is expected in the first half of 2026.

Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59. If approved for the younger population, the GSK vaccine would become the third FDA-approved RSV vaccine in this age group, joining Pfizer’s PFE Abrysvo and Moderna’s MRNA mResvia.

The filing is supported by data from a late-stage study, which showed that Arexvy’s safety and reactogenicity profile was consistent with those seen in previously conducted studies on the vaccine.

A similar regulatory filing was accepted by the EMA last month, with approval also expected early next year.

GSK Stock’s Performance

Year to date, shares of GSK have gained 13% against the industry’s 1% decline.

GSK’s RSV Vaccine Sales Under Pressure

Arexvy has been one of GSK’s top-selling products since its initial approval in 2023. However, the vaccine’s sales were significantly impacted last year, declining 51% year over year to £590 million (around $755 million) in full-year 2024. This drop was largely due to narrower vaccination recommendations issued by the U.S. Advisory Committee on Immunization Practices (“ACIP”).

In June 2024, the ACIP recommended Arexvy for adults aged 75 and older. However, for those aged 60-74, the guidance limited vaccination to individuals at increased risk of severe RSV disease — a decision that reduced the eligible population and weighed on demand.

Meanwhile, GSK’s competitive position has weakened. Although Arexvy was the first RSV vaccine approved in the United States, both Pfizer and Moderna have since gained regulatory approval for broader adult use, covering high-risk individuals aged 18–74, in addition to the 75 and older age group. Pfizer’s Abrysvo also holds a unique position as the only RSV vaccine approved for use in infants via maternal immunization during pregnancy.

Competitive Landscape for RSV Vaccines

Despite the setbacks, the outlook for the upcoming RSV season appears more favorable. Recently, the CDC updated its guidelines to recommend vaccination for high-risk adults aged 50-59, a group for which Arexvy is already approved.

While Pfizer and Moderna hold FDA approvals for high-risk adults under 50, the absence of CDC guidance for this group puts all three vaccine-makers — GSK, Pfizer and Moderna — on relatively equal footing. With regulatory decisions pending and public health policy on RSV vaccines still evolving, the next wave of updates could play a pivotal role in determining which vaccine-maker secures an early advantage in the under-50 segment.

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GSK’s Zacks Rank

GSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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