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  • Moderna Receives U. S. FDA Approval for RSV Vaccine, mRESVIA, in Adults . . .
    Expanded indication builds on existing U S FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA ACCESS Newswire June 12, 2025 Moderna, Inc (NASDAQ:MRNA) today announced that the U S Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD
  • FDA expands approval of Modernas RSV vaccine to some adults under age . . .
    The U S Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease
  • FDA expands approval for Modernas RSV vaccine - The Hill
    The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include individuals 18-59 years of age who are at increased risk for severe illness
  • Moderna’s mRNA RSV vaccine wins expanded FDA approval for younger . . .
    The expanded approval now includes individuals aged 18 to 59 who are at risk of RSV This approval was supported by results from Moderna’s Phase III study (NCT06067230), which demonstrated the vaccine’s immune response worked just as well in this age group compared to the existing approved age group of 60 years and older
  • FDA approves Moderna RSV vaccine use for people aged 18 to 59 - STAT
    The Food and Drug Administration expanded the approval of Moderna’s RSV vaccine on Thursday, extending the license to include adults aged 18 to 59 who are at high risk of severe illness if they
  • Moderna wins FDA OK to widen use of RSV vaccine
    The FDA cleared Moderna's RSV shot for use in certain adults between the ages of 18 and 59 on June 12, 2025 The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a company that’s been negatively impacted by the recent leadership changes atop U S public health agencies
  • FDA nod for Moderna’s RSV Vaccine, mRESVIA for younger adults
    US mRNA specialist Moderna today announced that the US Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), the company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease
  • FDA Approves Moderna’s RSV Vaccine for Younger Adults
    US regulators approved Moderna Inc ’s vaccine to prevent a common respiratory illness for more adults, a potential easing of the Trump administration’s opposition to mRNA technology
  • US FDA approves expanded use of Moderna’s RSV vaccine for at-risk . . .
    The FDA approved mRESVIA in adults aged 60 or older in 2024, but with a lower efficacy label indicating the shot was 79 per cent effective at preventing at least two symptoms of RSV, such as cough
  • FDA Expands Label for Modernas mRNA RSV Vaccine to Include At-Risk . . .
    Moderna’s Phase 3 study (NCT06067230) supported the approval, demonstrating that immune responses in at-risk adults under 60 met prespecified non-inferiority criteria when compared to those seen in older adults in a prior pivotal trial 2 Specifically, neutralizing antibody responses to both RSV-A and RSV-B were consistent across the subgroups aged 18 to 49 and 50 to 59 years, indicating





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