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FDA Expands Moderna RSV Vaccine to Adults 18–59 at Risk

CDC endorsement is required before the shots reach this group following contested advisory panel appointments

Overview

  • mRESVIA marks the first non-COVID-19 mRNA vaccine authorized in the United States and was initially approved for adults 60 and older.
  • FDA’s June expansion covers at-risk adults aged 18 to 59 based on a late-stage trial showing strong immune responses and a favorable safety profile.
  • The CDC currently recommends the vaccine for adults 75 and older and at-risk adults aged 60 to 74, with a panel recommendation for at-risk 50 to 59-year-olds awaiting CDC sign-off.
  • Health Secretary Robert F. Kennedy Jr. fired all 17 ACIP members and appointed eight new advisers, some publicly opposing mRNA vaccines.
  • Moderna shares fell 2.5 percent on investor worries that the revamped advisory panel could delay wider vaccine endorsements.