The Food and Drug Administration has refused to review Moderna’s application for an mRNA flu vaccine, the company revealed Tuesday.
While the move came as a surprise to the high-profile vaccine maker, it is just the latest hostility toward vaccines—and mRNA vaccines in particular—from an agency overseen by the fervent anti-vaccine activist Robert F. Kennedy Jr. In his first year in office, Kennedy has already dramatically slashed childhood vaccine recommendations and canceled $500 million in research funding for mRNA vaccines against potential pandemic threats.
In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA-1010. Specifically, the FDA’s rejection was over the comparator vaccine Moderna used.
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