FDA nod for Moderna’s RSV Vaccine, mRESVIA for younger adults

13 June 2025

US mRNA specialist Moderna (Nasdaq: MRNA) 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.

This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.

"RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," said Stéphane Bancel, chief executive Officer of Moderna, adding: "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV."

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