"Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults."
"The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said Wednesday.
Last week, Vinay Prasad, the agency’s top vaccine regulator, declined to review the vaccine, a rare move that shocked the company and that public health experts saw as the latest example of the Trump administration’s hostility toward immunization. Federal health officials argued that Moderna lacked an “adequate and well-controlled” study and should have used a high dose flu shot for adults 65 and older in a large clinical trial.
The company met with the FDA and proposed seeking full approval for the vaccine for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a requirement to further study the vaccine in older adults, according to Moderna."
Rachel Roubein reports for the Washington Post February 18, 2026.
