The U.S. Food and Drug Administration (FDA) has approved expanding the use of Moderna’s respiratory syncytial virus (RSV) vaccine, mRESVIA, to include adults aged 18 to 59 who are at increased risk for the disease. This vaccine, the first non-COVID-19 mRNA vaccine approved in the U.S., was already authorized for adults aged 60 and older.
The Centers for Disease Control and Prevention (CDC) still needs to recommend the vaccine for this younger age group before it becomes widely available. Currently, the CDC advises vaccination for adults 75 and older, and those 60 to 74 at higher risk.
RSV can cause cold-like symptoms and is a leading cause of pneumonia in young children and older adults. Each year, RSV leads to an estimated 15,000 to 20,000 hospitalizations among adults aged 50 to 59 in the U.S.
The FDA’s approval is based on a late-stage trial showing strong immune responses and good safety in adults 18 to 59 with underlying health conditions. Moderna reported that the vaccine was well tolerated with no safety concerns.
Other RSV vaccines, including Pfizer’s Abrysvo and GSK’s Arexvy, are approved for adults 60 and older, with some authorized for at-risk adults aged 18 to 59 as well. The CDC’s vaccine advisory panel will meet soon to discuss recommendations for these age groups.
Public health experts note the importance of maintaining confidence in vaccines as new members join the CDC advisory committee, some of whom have expressed skepticism about mRNA technology.
This expanded approval marks an important step toward protecting more adults from RSV-related illness.