RSV Vaccine Eligibility Expands
Trial data show noninferior immune response in high-risk adults aged 18 to 49 years.
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By
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Kathryn Wighton
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March 13, 2026
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The FDA has expanded the RSV vaccine Arexvy's approval to include adults aged 18 to 49 at increased risk for severe disease.
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Previously, Arexvy was approved for adults aged 60 and older and those aged 50 to 59 with increased risk.
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An estimated 21 million adults under 50 in the US have risk factors for severe RSV infection.
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A phase 3b trial showed noninferior immune response and consistent safety profile for the vaccine in the younger high-risk group.
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Common adverse events after vaccination included injection site pain, fatigue, and headache, generally mild to moderate.