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US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
- 6/12/2025
(Reuters) -The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease.
Moderna's RSV shot, mRESVIA, was the first non-COVID-19 messenger RNA-based (mRNA) vaccine to be approved in the United States. The shot, the company's second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older.
While the FDA approval is a necessary step, the U.S. Centers for Disease Control and Prevention still has to recommend the shots before they are available for the age group.
The CDC currently recommends the vaccine for adults aged 75 and older, as well as for adults aged 60 to 74 who are at increased risk of infection.
In April, the CDC's panel of outside experts recommended the use of approved RSV vaccines in at-risk adults aged 50 to 59.
Health Secretary Robert F. Kennedy Jr. on Wednesday named eight new members to serve on the key panel of vaccine advisers, known as the Advisory Committee on Immunization Practices, after previously firing all 17 of its members, saying it would "re-establish public confidence in vaccine science."
However, public health experts warn that this could undermine public confidence in available vaccines.
Some of the new appointees have openly expressed anti-vaccine views, including against the mRNA vaccine technology.
The panel, which provides guidance to the CDC on which groups of people would most benefit from an already-approved vaccine, is scheduled to meet later this month.
RSV typically causes cold-like symptoms, but is also a leading cause of pneumonia in toddlers and older adults. The CDC estimates 15,000–20,000 annual RSV-associated hospitalizations in the U.S. in adults aged 50 to 59.
The FDA's approval for mRESVIA was based on results from a late-stage trial where the shot helped initiate significant immune responses in adults aged 18 to 59 years with underlying health conditions.
The vaccine was well-tolerated with no safety concerns, the company said.
The FDA approved mRESVIA in adults aged 60 or older last year, but with a lower efficacy label indicating the shot was 79% effective at preventing at least two symptoms of RSV, such as cough and fever. Moderna had said the shot was shown to be 83.7% effective in a late-stage trial.
All currently approved shots against RSV, including Pfizer's Abrysvo and GSK's Arexvy, are for adults aged 60 years and above.
Arexvy and Abrysvo are also approved to prevent RSV-associated disease in at-risk adults aged 50 to 59 and 18 to 59, respectively.
(Reporting by Mariam Sunny, Sriparna Roy and Surbhi Misra in Bengaluru; Editing by Sriraj Kalluvila and Alan Barona)