{"id":29233,"date":"2025-05-31T20:49:16","date_gmt":"2025-05-31T20:49:16","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/modernas-new-covid-19-vaccine-mnexspike-approved-by-fda-but-theres-a-limit-on-who-can-use-it\/"},"modified":"2025-05-31T20:49:16","modified_gmt":"2025-05-31T20:49:16","slug":"modernas-new-covid-19-vaccine-mnexspike-approved-by-fda-but-theres-a-limit-on-who-can-use-it","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/modernas-new-covid-19-vaccine-mnexspike-approved-by-fda-but-theres-a-limit-on-who-can-use-it\/","title":{"rendered":"Moderna&#8217;s new COVID-19 vaccine mNexspike approved by FDA, but there&#8217;s a limit on who can use it"},"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 U.S. approved a new <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/cdc-kids-covid-19-vaccine-recommendation\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">COVID-19 vaccine<\/a><\/span> made by Moderna late Friday but with limits on who can use it \u2014 not a replacement for the company&#8217;s existing shot, but a second option.<\/p>\n<p>The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It&#8217;s made in a way that allows for a lower dose &#8211; a fifth of the dose of its current COVID-19 vaccine, Spikevax &#8211; by refining its immune target.<\/p>\n<p>The approval &#8220;adds an important new tool to help protect people at high risk of severe disease from COVID-19,&#8221; Stephane Bancel, Moderna&#8217;s CEO, said in a statement Saturday.<\/p>\n<p>The <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/video\/why-the-fda-is-limiting-access-to-covid-19-vaccines\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">Food and Drug Administration<\/a><\/span> approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.<\/p>\n<p>That&#8217;s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.<\/p>\n<p>Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/rfk-jr-covid-vaccines-cdc-children-pregnant-women\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">Health Secretary Robert F. Kennedy Jr.<\/a><\/span> and other Trump officials.\u00a0<\/p>\n<p>Moderna&#8217;s existing vaccine doesn&#8217;t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.<\/p>\n<p>The FDA&#8217;s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna&#8217;s existing vaccine. It found the new vaccine was safe and was at least as effective &#8211; and more by some measures &#8211; than the original shot, the company said.<\/p>\n<p>The news came just days after the Trump administration <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/moderna-bird-flu-vaccine-research-funding-trump-administration-yanks\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">canceled funding for Moderna<\/a><\/span> to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.<\/p>\n<p>It also comes as the Centers for Disease Control and Prevention changes its recommendation to children for COVID-19 vaccine under Kennedy&#8217;s directive.<\/p>\n<p>The agency on Thursday <span class=\"link\"><a href=\"https:\/\/www.cbsnews.com\/news\/cdc-kids-covid-19-vaccine-recommendation\/\" target=\"_blank\" data-invalid-url-rewritten-http=\"\">dropped its recommendation<\/a><\/span> for all children to get the vaccinated but still broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children, in addition to most adults for now.<\/p>\n<p>Kennedy&#8217;s directive cited &#8220;a review of the recommendations&#8221; of the Food and Drug Administration and National Institutes of Health, saying that the risks of the COVID-19 vaccine for healthy children &#8220;do not outweigh the purported benefits of the vaccine.&#8221; The directive also cited &#8220;the lack of high-quality data demonstrating safety of the mRNA vaccines during pregnancy combined with the uncertainty of the benefits&#8221; for pregnant moms and their baby.<\/p>\n<p>&#8220;Truly the death of expertise. This would be like the secretary of transportation directing that all planes must fly 5,000 feet higher than current. It&#8217;s vibe-based decision making,&#8221; one federal health official said of the directive.<\/p>\n<p>    <!-- data-recirc-source=\"chartbeat\" --><\/p>\n<aside class=\"component list recirculation component--type-recirculation component--type-recirculation-collection\">\n<\/aside>\n<p>    <!-- tags --><\/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\/mnexspike-moderana-new-covid-vaccine\/\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it<\/p>\n","protected":false},"author":1,"featured_media":29234,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[691,2454,1466,7300],"class_list":["post-29233","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-2","tag-covid-19","tag-covid-19-vaccine","tag-fda","tag-moderna"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Moderna&#039;s new COVID-19 vaccine mNexspike approved by FDA, but there&#039;s a limit on who can use it - World News<\/title>\n<meta name=\"description\" content=\"The new COVID-19 vaccine from Moderna, mNexspike, is made in a way that allows for a lower dose.\" \/>\n<meta name=\"robots\" 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