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February 11, 2026<\/p>\n
2 min read<\/p>\n
Add Us On Google<\/span>Add SciAm<\/span><\/span><\/p>\n FDA won\u2019t consider a new mRNA vaccine for flu despite the technology\u2019s life-saving promise<\/p>\n The U.S.\u2019s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots<\/p>\n By Jackie Flynn Mogensen edited by Claire Cameron<\/span><\/p>\n An assistant conducts cancer vaccine research in the lab at the Moderna headquarters in Cambridge, Mass.<\/p>\n The U.S. Food and Drug Administration is refusing to consider a new mRNA flu vaccine made by Moderna, the company revealed in a statement on Tuesday.<\/p>\n The vaccine uses mRNA to inoculate the recipient\u2014the 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\u2019 case, the mRNA carries the instructions the body\u2019s cells need to make a protein that can trigger an immune response to the targeted virus.<\/p>\n The FDA\u2019s decision didn\u2019t identify safety or efficacy concerns, according to Moderna. It was based on complaints about the studies Moderna conducted to assess the vaccine, the company said, citing a letter signed by Center for Biologics Evaluation and Research (CBER) director Vinay Prasad.<\/p>\n If you’re enjoying this article, consider supporting our award-winning journalism by subscribing. By purchasing a subscription you are helping to ensure the future of impactful stories about the discoveries and ideas shaping our world today.<\/p>\n \u201cThis was a clinical trial performed with the FDA\u2019s blessing,\u201d says Angie Rasmussen, a virologist at the University of Saskatchewan. \u201cThe top U.S. vaccine regulator should make decisions based on a thoughtful, systematic, transparent review of the evidence that relies on diverse expertise. Based on Prasad\u2019s refusal-to-file letter, this was not informed by any type of advisory or review process other than Prasad deciding it was insufficiently controlled.\u201d<\/p>\n On a press call Wednesday, Department of Health and Human Services spokesperson Andrew Nixon said that the FDA rejected Moderna\u2019s application \u201cbecause the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy. Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists.\u201d<\/p>\n The FDA\u2019s decision comes amid a broader campaign, spearheaded by HHS secretary Robert F. Kennedy, Jr., to remake America\u2019s vaccine schedule. Kennedy, a long-time vaccine skeptic, has repeatedly criticized mRNA technology.<\/p>\n This year\u2019s flu season has been remarkable in its severity, driven in large part by the arrival of flu variant subclade K. So far, influenza has sickened at least 22 million people in the U.S. and killed 12,000. Rasmussen notes that mRNA vaccine technology is extremely flexible and adaptable, and shots could be quickly formulated using it to help fight new virus variants like subclade K.<\/p>\n \u201cIf we had recognized that [subclade K] was going to be driving things, and we were using mRNA vaccines instead of conventional flu vaccine technology platforms, we would potentially be able to make an updated flu shot in time for flu season,\u201d Rasmussen says.<\/p>\n This is a breaking news story and may be updated.<\/p>\n Additional reporting by Lauren J. Young.<\/p>\n If you enjoyed this article, I\u2019d like to ask for your support. Scientific American<\/span> has served as an advocate for science and industry for 180 years, and right now may be the most critical moment in that two-century history.<\/p>\n I\u2019ve been a Scientific American<\/span> subscriber since I was 12 years old, and it helped shape the way I look at the world. SciAm <\/span>always educates and delights me, and inspires a sense of awe for our vast, beautiful universe. I hope it does that for you, too.<\/p>\n If you subscribe to Scientific American<\/span>, you help ensure that our coverage is centered on meaningful research and discovery; that we have the resources to report on the decisions that threaten labs across the U.S.; and that we support both budding and working scientists at a time when the value of science itself too often goes unrecognized.<\/p>\n In return, you get essential news, captivating podcasts, brilliant infographics, can’t-miss newsletters, must-watch videos, challenging games, and the science world’s best writing and reporting. You can even gift someone a subscription.<\/p>\n There has never been a more important time for us to stand up and show why science matters. I hope you\u2019ll support us in that mission.<\/p>\n","protected":false},"excerpt":{"rendered":" February 11, 2026 2 min read Add Us On GoogleAdd SciAm FDA won\u2019t consider a new mRNA vaccine for flu despite the technology\u2019s life-saving promise The U.S.\u2019s drug safety agency declined to review a next-gen flu vaccine that uses the same tech as the coronavirus shots By Jackie Flynn Mogensen edited by Claire Cameron An<\/p>\n","protected":false},"author":1,"featured_media":44310,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[249,4255,7988,3786,8847,23027,2133,3982],"class_list":{"0":"post-44309","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-science","8":"tag-fda","9":"tag-flu","10":"tag-lifesaving","11":"tag-mrna","12":"tag-promise","13":"tag-technologys","14":"tag-vaccine","15":"tag-wont"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/44309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=44309"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/44309\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/44310"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=44309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=44309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=44309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}On supporting science journalism<\/h2>\n
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