FDA Votes in Favor of Benefit-Risk Profile for Moderna's Flu Vaccine
By Kelly Cloonan
A Food and Drug Administration advisory committee voted that the benefits of a seasonal flu vaccine from Moderna outweigh its risks, part of the agency's review of a potential new treatment.
Moderna said Thursday the FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously that the benefits of the vaccine, mRNA-1010, exceed the risks for the prevention of flu in adults 50 through 64 years old, and in adults 65 years of age and older.
The FDA plans to consider the committee's recommendations as part of its ongoing review of Moderna's biologics license application for mRNA-1010, the company said. Advisory committee recommendations are non-binding, and the FDA is responsible for making final approval.
The treatment has been accepted for regulatory review in the U.S., European Union, Canada and Australia.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
June 18, 2026 16:30 ET (20:30 GMT)
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