June 17, 2025 – The FDA has expanded the use of Moderna's respiratory syncytial virus (RSV) shot to all adults, with some limits on who can get it.
First approved in 2024 for people 60 or older, the mRESVIA vaccine protects against lower respiratory infections caused by RSV. This vaccine is now approved for adults ages 18 to 59 who have a higher risk of getting a serious RSV illness.
RSV is a common virus that spreads easily in colder months through coughs, sneezes, or contact with contaminated surfaces. While it usually causes mild cold-like symptoms, it can be serious for babies and older adults. Vaccines and other preventive treatments offer the best protection against RSV.
Moderna said the approval was supported by a study showing the vaccine is safe and works well for younger adults (ages 18 to 59) with medical conditions. Their immune response was just as strong as in older adults (60+), who had been studied earlier. All younger adults produced similar levels of protective antibodies against the two main types of RSV (RSV-A and RSV-B), showing the vaccine works well across at-risk adults of different ages.
mRESVIA is an RNA vaccine that trains the body to make a harmless version of a protein used by the respiratory syncytial virus to enter human cells. This helps the immune system recognize the virus and build antibodies to protect against future infections. The vaccine does not contain RSV, so it cannot cause RSV illness.
In clinical trials, the shot was generally well-tolerated. The most common side effects were mild and included pain where the needle went in, tiredness, headaches, muscle aches, joint pain, chills, nausea or vomiting, fever, and hives.
Moderna plans to make mRESVIA available in the U.S. for the 2025-2026 respiratory virus season for high-risk adults ages 18 to 59 and all adults age 60 or older.
Patients should tell their health care provider about any medical conditions they may have before getting the vaccine. This includes allergies, any serious reactions to vaccines in the past, current fever, any bleeding disorder or use of blood thinners, and a weakened immune system or use of medications that affect it. Patients should also say if they've already received another RSV vaccine or if they've ever fainted after getting a shot. There is a very small chance that mRESVIA can cause a severe allergic reaction, so patients may be asked to stay a while for observation after the shot.
