{"id":21909,"date":"2025-04-29T23:44:00","date_gmt":"2025-04-29T23:44:00","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/fda-chief-says-theyre-looking-at-whether-to-approve-covid-shots-for-next-winter\/"},"modified":"2025-04-29T23:44:00","modified_gmt":"2025-04-29T23:44:00","slug":"fda-chief-says-theyre-looking-at-whether-to-approve-covid-shots-for-next-winter","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/fda-chief-says-theyre-looking-at-whether-to-approve-covid-shots-for-next-winter\/","title":{"rendered":"FDA chief says they&#8217;re looking at whether to approve COVID shots for next winter"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div id=\"\">\n<p>The head of the <a href=\"https:\/\/www.cbsnews.com\/tag\/food-and-drug-administration\/\" target=\"_blank\" rel=\"nofollow\" data-invalid-url-rewritten-http=\"\">Food and Drug Administration<\/a> said Tuesday that the agency is now looking at whether it will still approve <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/feature\/coronavirus\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">COVID-19<\/a><\/span> vaccines for next winter, citing a lack of data on booster shots.<\/p>\n<p>&#8220;We&#8217;re taking a look. I can&#8217;t comment on any particular application. As you know, we have a bunch of applications for those booster shots,&#8221; <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/fda-to-reverse-some-layoffs-food-drug-safety\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">FDA<\/a><\/span> Commissioner Dr. Marty Makary told CBS News chief Washington correspondent Major Garrett.<\/p>\n<p>Makary said many health care workers did not get the last round of COVID-19 vaccine booster shots, calling it &#8220;a bit of a public trust problem.&#8221;<\/p>\n<p>&#8220;I think there&#8217;s a void of data. And I think rather than allow that void to be filled with opinions, I&#8217;d like to see some good data,&#8221; Makary said.<\/p>\n<p>His answer marks a change from during the Biden administration, when FDA officials backed plans to routinely update the COVID-19 vaccines each year.<\/p>\n<p>Last year, the FDA issued guidance on what strain should be targeted by the shots for the following winter. Updates to Moderna and Pfizer&#8217;s COVID shots for the new strain <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/covid-vaccine-fall-2024-fda\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">were approved<\/a><\/span> in August.<\/p>\n<p>The <a href=\"https:\/\/www.cbsnews.com\/tag\/centers-for-disease-control-and-prevention\/\" rel=\"nofollow\" data-invalid-url-rewritten-http=\"\">Centers for Disease Control and Prevention<\/a> is also now weighing whether to <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/cdc-covid-vaccine-recommendations-advisers\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">significantly narrow<\/a><\/span> its recommendations for COVID-19 vaccines.<\/p>\n<p>Makary&#8217;s remarks echo his justification for delaying Novavax&#8217;s COVID-19 vaccine, which was expected to get full approval on April 1. Novavax <a href=\"https:\/\/ir.novavax.com\/press-releases\/Latest-update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine-1\" target=\"_blank\" rel=\"nofollow noopener\">said Monday<\/a> that the FDA had asked the company to commit to another clinical trial of the shot.<\/p>\n<p>&#8220;Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can&#8217;t give an honest evidence-based answer to that question,&#8221; Makary told the <a href=\"https:\/\/insidemedicine.substack.com\/p\/exclusive-in-conversation-with-fda\" target=\"_blank\" rel=\"nofollow noopener\">newsletter<\/a> &#8220;Inside Medicine&#8221; this week.<\/p>\n<p>Multiple companies are now also being asked &#8220;to do clinical studies, a basic clinical study, so we can educate the population and have information to work with,&#8221; Makary told CBS News.<\/p>\n<p>&#8220;It&#8217;s my general feeling, not with this particular product, which I can&#8217;t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them,&#8221; he said.\u00a0<\/p>\n<p>He also praised his special assistant, Dr. Tracy Beth H\u00f8eg, when asked what role she played in the agency&#8217;s evaluation of Novavax&#8217;s application.\u00a0<\/p>\n<p>&#8220;Dr. H\u00f8eg is an amazing M.D.-Ph.D. who has joined my staff as a special assistant to the commissioner. And she is involved in reviewing data sets at the agency. And I&#8217;m really excited to have her in the process,&#8221; Makary said.<\/p>\n<p>Trade industry publication The Pink Sheet <a href=\"https:\/\/insights.citeline.com\/pink-sheet\/agency-leadership\/us-fda\/highly-problematic-acting-fda-commissioner-paused-planned-ok-of-novavax-shot-GUT6LR4X6ZALRMMZAEXYZHY36Y\/\" target=\"_blank\" rel=\"nofollow noopener\">previously reported<\/a> that H\u00f8eg had been asked to step in on Novavax&#8217;s application. H\u00f8eg was also added to the CDC&#8217;s Advisory Committee on Immunizations, in <a href=\"https:\/\/www.cdc.gov\/acip\/membership\/index.html#accordion-panel-u8VYfF7hsP:~:text=Voting%20members-,Ex%20officio%20members,-Liaison%20representatives\" target=\"_blank\" rel=\"nofollow noopener\">a slot<\/a> previously filled by a career vaccines official from the FDA.<\/p>\n<p>Former FDA officials have criticized the agency&#8217;s new political leadership for their intervention in vaccine approvals, a process which is usually entrusted to career scientific officials.<\/p>\n<p>In a <a href=\"https:\/\/www.biocentury.com\/article\/655761\/safeguarding-sound-decision-making-at-fda\" target=\"_blank\" rel=\"nofollow noopener\">commentary<\/a>\u00a0published this week, former officials Phil Krause and Luciana Borio called on the FDA to &#8220;stick to its normal processes.&#8221;<\/p>\n<p>&#8220;Shifting standards and late-stage demands for new data \u2014 based on faulty scientific assumptions \u2014 erode trust, delay access to important tools, and discourage developers from advancing vaccine innovation,&#8221; they wrote.<\/p>\n<p>    <!-- data-recirc-source=\"chartbeat\" --><\/p>\n<aside class=\"component list recirculation component--type-recirculation component--type-recirculation-collection\">\n<div class=\"component__heading-wrapper\">\n<h3 class=\"component__title\">Coronavirus Pandemic<\/h3>\n<p>                      <a href=\"https:\/\/www.cbsnews.com\/feature\/coronavirus\/?intcid=CNI-00-10aaa3a\" class=\"component__view-more component__view-more--lg\" data-invalid-url-rewritten-http=\"\"><br \/>\n              More<br \/>\n              <svg viewbox=\"0 0 32 32\" class=\"icon__caret-right\" aria-hidden=\"true\">\n                <use xlink:href=\"#icon-caret-down\"\/>\n              <\/svg><br \/>\n            <\/a>\n                  <\/div>\n<p>                  <a href=\"https:\/\/www.cbsnews.com\/feature\/coronavirus\/?intcid=CNI-00-10aaa3a\" class=\"component__view-more component__view-more--sm\" data-invalid-url-rewritten-http=\"\"><br \/>\n            More<br \/>\n            <svg viewbox=\"0 0 32 32\" class=\"icon__caret-right\" aria-hidden=\"true\">\n              <use xlink:href=\"#icon-caret-down\"\/>\n            <\/svg><br \/>\n          <\/a><br \/>\n                    <\/aside>\n<p>    <!-- tags --><\/p>\n<div class=\"content-author\">\n      <a href=\"https:\/\/www.cbsnews.com\/team\/alexander-tin\/\" class=\"content-author__name\" data-invalid-url-rewritten-http=\"\">Alexander  Tin<\/a><\/p>\n<div class=\"content-author__bio\">\n<div class=\"content-author__full-information\">\n<p class=\"content-author__text\">Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.<\/p>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.cbsnews.com\/news\/fda-covid-booster-shots-marty-makary\/\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will<\/p>\n","protected":false},"author":1,"featured_media":21910,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[691,2454,1466,232],"class_list":["post-21909","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-2","tag-covid-19","tag-covid-19-vaccine","tag-fda","tag-food-and-drug-administration"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA chief says they&#039;re looking at whether to approve COVID shots for next winter - World News<\/title>\n<meta name=\"description\" content=\"FDA Commissioner Dr. Marty Makary said there is a &amp;quot;void of data&amp;quot; on the COVID booster shots.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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