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Federal regulators approved Moderna’s vaccine against Respiratory Syncytial Virus (RSV) for some adults as young as 18, the company said on June 12.
The Food and Drug Administration (FDA) expanded approval of the shot to people aged 18 to 59 who face an increased risk from RSV, a virus that typically causes cold-like symptoms, Moderna said in a statement.
The FDA, which in 2024 approved the vaccine for adults aged 60 and up, did not respond to a request for comment.
“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,” Stéphane Bancel, Moderna’s CEO, said in a statement.
The expanded approval was based on a phase 3 clinical study that determined the vaccine triggered non-inferior immune responses in adults aged 18 to 59 with at least one underlying condition that places them at increased risk of RSV, when compared to the immune system activation recorded in adults 60 and older.
No recent updates have been posted for the vaccine, known as mRESVIA, on the FDA’s website.
Two other RSV vaccines are approved for older adults, one from Pfizer and one from GlaxoSmithKline.
Moderna said that it plans to have the vaccine ready in time for the upcoming virus season, which spans the fall and winter.
The FDA approves vaccines, while the Centers for Disease Control and Prevention decides which populations can access the shots.
Experts on the Advisory Committee on Immunization Practices, which provides advice concerning immunizations, in April unanimously recommended that the CDC allow people aged 50 to 59 with at least one risk factor to receive RSV vaccines.
Health Secretary Robert F. Kennedy Jr. recently dismissed all members of the advisory panel. He named eight replacements on Wednesday.
The committee has a three-day meeting scheduled to start on June 25. According to a meeting notice, the agenda will include discussions on RSV vaccines for adults, pregnant women, and children. Recommendation votes are expected to take place for RSV vaccines for those populations.
RSV infects the nose, throat, and lungs, typically leading to common symptoms such as a runny nose and coughing, according to the CDC. Most infections resolve on their own.
The virus can cause severe symptoms, mostly in infants and older adults, the public health agency says. It currently recommends RSV vaccination for adults aged at least 60 and pregnant women. If a woman does not receive an RSV vaccine prior to giving birth, the CDC recommends an RSV antibody for the baby.
The FDA, earlier in June, approved Merck’s RSV drug for infants. The agency first approved an RSV drug for infants, from Sanofi and AstraZeneca, in 2023.
Zachary Stieber
Senior Reporter
Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. Contact Zachary at [email protected]
