Moderna Wins Expanded FDA Approval for RSV Vaccine in At-Risk Younger Adults

The U.S. FDA has expanded approval of Moderna's RSV vaccine, mRESVIA (mRNA-1345), allowing its use in adults aged 18–59 who are at increased risk for RSV disease due to underlying conditions such as cardiovascular, respiratory, and endocrine disorders134.

Previously, mRESVIA was only approved for adults aged 60 and older; this new approval extends the indication to a broader group of adults ahead of the 2025–2026 respiratory virus season13.

More than one-third of adults between 18 and 59 have at least one condition that puts them at increased risk of severe RSV, with disease burden and hospitalization rates in this group being comparable to, or even exceeding, those in older adults13.

The expanded indication is based on Phase III trial data showing that the immune response in this younger at-risk population was comparable to that seen in older adults2.

While the FDA has approved the expanded use, the CDC determines recommendations regarding who should receive the vaccine; currently, CDC recommendations for RSV vaccination remain limited to older and highest-risk populations1.

Sources:

1. https://abcnews.go.com/Health/fda-expands-approval-modernas-rsv-vaccine-adults-age/story?id=122815441

2. https://www.pharmaceutical-technology.com/news/modernas-mrna-rsv-vaccine-wins-expanded-fda-approval-for-younger-adults/

3. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-RSV-Vaccine-mRESVIA-in-Adults-Aged-1859-at-Increased-Risk-for-RSV-Disease/default.aspx

4. https://www.patientcareonline.com/view/fda-expands-label-for-moderna-s-mrna-rsv-vaccine-to-include-at-risk-adults-aged-18-to-59-years