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December 12, 2025<\/p>\n
3 min read<\/p>\n
Add Us On Google<\/span>Add SciAm<\/span><\/span><\/p>\n Health Experts Slam Possible FDA \u2018Black Box\u2019 Warning for COVID Vaccines<\/p>\n The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say may cause unfounded concerns over safety<\/p>\n By Lauren J. Young edited by Claire Cameron<\/span><\/p>\n PATRICK T. FALLON\/AFP via Getty Images<\/p>\n The U.S. Food and Drug Administration is reportedly weighing whether it will place a \u201cblack box\u201d warning label on COVID vaccines, according to CNN, despite research and real-world data demonstrating their safety.<\/p>\n Black box warnings are the FDA\u2019s highest health warning for drugs and medical devices. Adding them to COVID vaccines \u201cwould be an unprecedented action by the FDA and would likely result in significant reduction in use of the product,\u201d says physician Robert Hopkins, medical director of the National Foundation for Infectious Diseases.<\/p>\n It\u2019s unclear whether the warning, if applied, would be put on some or all the available COVID vaccines produced by Pfizer, Moderna and Novavax or if it would affect specific groups, such as pregnant people or children.<\/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 The report comes a week after a leaked memo, allegedly written by the FDA\u2019s chief medical and scientific officer Vinay Prasad, detailed plans to change COVID vaccine approvals and linked the deaths of 10 children to the vaccines, without evidence.<\/p>\n In response to Scientific American, Department of Health and Human Services spokesperson Andrew Nixon dismissed the claims as \u201cpure speculation\u201d and said that \u201cthe FDA takes very seriously any death that is attributed to a regulated medical product.\u201d<\/p>\n Black box warnings, also called boxed warnings, are designed to inform people of major health risks associated with a drug, treatment or other medical intervention, including a vaccine, and generally indicate a risk of serious injury or life-threatening harm. Opioid painkillers carry such a warning, for example. The FDA has the power to add these labels, update them or remove them at any point as data becomes available to the agency.<\/p>\n More than 400 medications approved for use in the U.S. have a black box warning label. Vaccines with black box warnings \u201care exceedingly rare,\u201d says Peter Chin-Hong, an infectious disease physician and a professor of medicine at the University of California, San Francisco, because vaccines undergo rigorous trials and safety and efficacy assessments before the FDA authorizes them for use.<\/p>\n And while some vaccines, such as the live ACAM2000 vaccine for smallpox and mpox, carry health risk warnings, these examples are \u201ccertainly nothing [as] big\u201d as the FDA\u2019s potential decision to put a black box warning on COVID vaccines, says Katelyn Jetelina, an epidemiologist and founder of the newsletter Your Local Epidemiologist.<\/p>\n \u201cThe science is clear: the benefits continue to outweigh the risks by a wide margin,\u201d Jetelina says. \u201cIf FDA disagrees, transparency about their data and reasoning is essential. Closed-door analyses won\u2019t cut it. Americans deserves better.\u201d<\/p>\n The COVID vaccines have been safely administered to billions of people worldwide and have been shown to have prevented millions of deaths from the virus that causes the disease. Initial and ongoing safety monitoring continues to show the benefits of these vaccines outweigh the risk for most populations, Hopkins says.<\/p>\n He and other experts have expressed concern that a severe safety warning may ultimately impede access to the vaccines. A black box label may cause clinicians to be more cautious in recommending the shots to groups who are at high risk of severe COVID, such as children and pregnant people, Chin-Hong says.<\/p>\n If the black box label is added, \u201cvaccine hesitancy will increase in the groups who need it the most,\u201d he says. \u201cBut most of all, a continued erosion of trust in the proven power of vaccines in general will lead to more illness and deaths\u2014and more suffering in Americans.\u201d<\/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":" December 12, 2025 3 min read Add Us On GoogleAdd SciAm Health Experts Slam Possible FDA \u2018Black Box\u2019 Warning for COVID Vaccines The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say may cause unfounded concerns over safety By Lauren J. Young edited by Claire<\/p>\n","protected":false},"author":1,"featured_media":37119,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[706,1922,5333,320,249,37,5133,78,312],"class_list":{"0":"post-37118","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-science","8":"tag-black","9":"tag-box","10":"tag-covid","11":"tag-experts","12":"tag-fda","13":"tag-health","14":"tag-slam","15":"tag-vaccines","16":"tag-warning"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/37118","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=37118"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/37118\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/37119"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=37118"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=37118"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=37118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}On supporting science journalism<\/h2>\n
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