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 PerformanceYear to date, shares of GSK have gained 13% against the industry’s 1% decline.Image Source: Zacks Investment ResearchGSK’s RSV Vaccine Sales Under PressureArexvy 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 VaccinesDespite 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.GSK PLC Sponsored ADR Price  GSK PLC Sponsored ADR price | GSK PLC Sponsored ADR QuoteGSK’s Zacks RankGSK currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the favorite stock to gain +100% or more in the months ahead. They includeStock #1: A Disruptive Force with Notable Growth and ResilienceStock #2: Bullish Signs Signaling to Buy the DipStock #3: One of the Most Compelling Investments in the MarketStock #4: Leader In a Red-Hot Industry Poised for GrowthStock #5: Modern Omni-Channel Platform Coiled to SpringMost of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. While not all picks can be winners, previous recommendations have soared +171%, +209% and +232%.Download Atomic Opportunity: Nuclear Energy's Comeback free today.Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks