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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

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FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., on Monday, May 18, 2020. Moderna shares slipped Tuesday, April 11, 2023, after the COVID-19 vaccine developer said its potential flu vaccine needs more study in a late-stage clinical trial. (AP Photo/Bill Sikes, File)
People pose with syringe with needle in front of displayed Moderna logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

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.