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US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
- On June 12, 2025, the FDA expanded approval of Moderna's RSV vaccine mRESVIA to include adults aged 18 to 59 at increased risk in the United States.
- This expansion follows earlier FDA approval in 2024 for adults 60 and older and an April CDC advisory panel recommendation for at-risk adults aged 50 to 59, though the CDC director has not yet endorsed it.
- MRESVIA protects against serious RSV infections affecting the lungs and airways, demonstrating an effectiveness between 79 and 83.7 percent in late-stage clinical trials, with more than one-third of adults aged 18 to 59 having health conditions that raise their risk of severe RSV illness.
- Moderna CEO Stéphane Bancel highlighted that RSV represents a significant threat to adults with specific chronic illnesses, and he described the vaccine’s authorization as a key advancement in protecting more people from severe RSV disease. The vaccine is anticipated to be available for the 2025-2026 respiratory season.
- Despite FDA approval, the CDC's vaccine panel was recently fired and replaced by appointees of Health Secretary Kennedy, leaving official recommendations and insurance coverage for the new age group uncertain.
28 Articles
28 Articles
NWAHOMEPAGE
FDA approves expanded use of Moderna's RSV shot, but uncertainty remains
(The Hill) -- The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include individuals 18-59 years of age who are at increased risk for severe illness from respiratory syncytial virus, the company said. The vaccine was previously only licensed for adults aged 60 years and older. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important s…
FDA approves expanded use of Moderna’s RSV shot, but uncertainty remains
The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to 59 years old who are at increased risk for severe illness from respiratory syncytial virus, the company said. The vaccine was previously only licensed for adults 60 years and older. “RSV poses a serious health…
MyCentralOregon.com
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
Plexi Images/GHI/UCG/Universal Images Group via Getty Images (NEW YORK) — The U.S. Food and Drug Administration expanded its approval of Moderna’s respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease. Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older. Approval for mRESVIA came after Moderna conducted a late-stage clinical trial …
FDA Approves Moderna’s RSV Vaccine for Some Younger Adults, Company Says
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…
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