Source: Washington Post
“The Food and Drug Administration has declined to review Moderna’s application for the first mRNA-based flu vaccine, a decision that shocked the company and that comes as the agency plans to tighten federal vaccine approvals. The nation’s top vaccine regulator, Vinay Prasad, told Moderna that it lacked an ‘adequate and well-controlled’ study, the company said in a news release Tuesday. In a large clinical trial, the vaccine was compared with Fluarix, an approved standard-dose flu vaccine. Prasad’s letter did not detail concerns with the safety or efficacy of the vaccine, which Moderna was aiming to target for adults ages 50 and older. Moderna President Stephen Hoge said that the company had previously engaged with the FDA on the trial design and that the agency earlier indicated it would be acceptable.” (02/10/26)