"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."
"Moderna said the FDA reviewed and accepted its trial design on at least two occasions (in April 2024 and again in August 2025) before it applied for approval of mRNA-1010. It also noted that Fluarix has been used as a comparator vaccine in previous flu vaccine trials, which tested vaccines that went on to earn approval."
FDA refused to review Moderna's application for the mRNA flu vaccine mRNA-1010, citing the Phase 3 trial comparator choice. An agency overseen by Robert F. Kennedy Jr. has shown opposition to vaccines, including cutting childhood vaccine recommendations and canceling $500 million in mRNA pandemic research funding. Moderna reported being blindsided by the refusal and said the FDA previously reviewed and accepted the trial design in April 2024 and August 2025. The Phase 3 trial enrolled nearly 41,000 participants, cost hundreds of millions of dollars, compared mRNA-1010 to licensed standard-dose influenza vaccines including GlaxoSmithKline's Fluarix, and found mRNA-1010 superior to the comparators.
Read at Ars Technica
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