FDA & Government News

RSV Vaccine Eligibility Expands

Trial data show noninferior immune response in high-risk adults aged 18 to 49 years.

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The FDA has expanded the approval for the RSV vaccine Arexvy, now including adults aged 18 to 49 years at increased risk for lower respiratory tract disease caused by respiratory syncytial virus (RSV). The vaccine was previously approved for older adults. An estimated 21 million adults under 50 have risk factors for severe RSV, leading to thousands of hospitalizations annually. The expansion was supported by a phase 3b trial showing a noninferior immune response in the younger group. Most adverse events reported were mild and transient.

Original Source(s)

RSV Vaccine Eligibility Expands

  • by Kathryn Wighton

  • March 13, 2026

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