The vaccine uses mRNA to inoculate the recipientthe same technology used in the Moderna and Pfizer coronavirus vaccines. The way these vaccines work is by delivering a copy of messenger RNA, which acts like a blueprint for cells to make proteins. In the vaccines' case, the mRNA carries the instructions the body's cells need to make a protein that can trigger an immune response to the targeted virus.
The news is the latest sign of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation's top health official. Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today.
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.
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The avian influenza vaccine candidate mRNA-1018 showed promising interim results, yet the U.S. government has canceled the contract that would fund its late-stage trials.