{"id":12857881,"date":"2026-02-11T19:07:11","date_gmt":"2026-02-12T00:07:11","guid":{"rendered":"https:\/\/www.philstockworld.com\/?p=12857881"},"modified":"2026-02-11T20:14:14","modified_gmt":"2026-02-12T01:14:14","slug":"the-fda-refuses-to-review-modernas-flu-vaccine","status":"publish","type":"post","link":"https:\/\/www.philstockworld.com\/2026\/02\/11\/the-fda-refuses-to-review-modernas-flu-vaccine\/","title":{"rendered":"The FDA Refuses To Review Moderna\u2019s Flu Vaccine"},"content":{"rendered":"<div class=\"h9nLs headline-embed\">\n<div class=\"cxkrv\">\n<div class=\"HQYQR\">\n<div class=\"FBQIu fROHd\">\n<p class=\"speakable-headline color-base aY5Zr\"><em>We don&#8217;t have a real FDA anymore. \ud83d\ude25\u00a0<\/em><\/p>\n<h2><a href=\"https:\/\/www.forbes.com\/sites\/innovationrx\/2026\/02\/11\/the-fda-refuses-to-review-modernas-flu-vaccine\/?utm_source=flipboard&amp;utm_content=user%2Fforbes\" target=\"_blank\" rel=\"noopener\">The FDA Refuses To Review Moderna\u2019s Flu Vaccine<\/a><\/h2>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"cO11L OtGY6\">\n<div class=\"AhtZ3\">\n<div class=\"ZgVJj\">\n<div class=\"vDF8R\">\n<div class=\"_9GOxm yF_7D\" data-testid=\"truncation-inner\">\n<div class=\"Na3NTglQ _51GWpoAk CF_dd\">\n<p class=\"ujvJmzbB LfmqX\">By <a class=\"_4tin10wS _9xFYp YbfXuVMn\" title=\"https:\/\/www.forbes.com\/sites\/amyfeldman\/\" href=\"https:\/\/www.forbes.com\/sites\/amyfeldman\/\" target=\"_self\" aria-label=\"Amy Feldman\">Amy Feldman <\/a><span style=\"font-family: Verdana, BlinkMacSystemFont, -apple-system, 'Segoe UI', Roboto, Oxygen, Ubuntu, Cantarell, 'Open Sans', 'Helvetica Neue', sans-serif;\">and <\/span><a class=\"_4tin10wS _9xFYp YbfXuVMn\" style=\"font-family: Verdana, BlinkMacSystemFont, -apple-system, 'Segoe UI', Roboto, Oxygen, Ubuntu, Cantarell, 'Open Sans', 'Helvetica Neue', sans-serif;\" title=\"https:\/\/www.forbes.com\/sites\/alexknapp\/\" href=\"https:\/\/www.forbes.com\/sites\/alexknapp\/\" target=\"_self\" aria-label=\"Alex Knapp\">Alex Knapp, Forbes<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"p5_3X fs-premium\">\n<div class=\"fs-article fs-premium fs-responsive-text current-article font-body color-body bg-base font-accent article-subtype__masthead\">\n<div class=\"b6Cr_ article-body-container\">\n<div class=\"fs-article fs-premium fs-responsive-text current-article font-body color-body bg-base font-accent article-subtype__masthead article-body premium-container\">\n<p><strong><abbr class=\"drop-cap color-accent font-accent\">T<\/abbr>he FDA refused to review<\/strong>\u00a0Moderna\u2019s application for its seasonal flu vaccine,\u00a0<a class=\"color-link\" title=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=7346090610333866&amp;symbol=MRNA\" href=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=7346090610333866&amp;symbol=MRNA\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" data-ga-track=\"ExternalLink:https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=7346090610333866&amp;symbol=MRNA\" aria-label=\"the company\">the company<\/a>\u00a0said on Tuesday. The decision was a surprise and raises questions about the Trump Administration\u2019s vaccine policies. Moderna released the\u00a0<a class=\"color-link\" title=\"https:\/\/static.modernatx.com\/pm\/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867\/38ab7558-636c-40d1-b49a-c8f51a7afa1a\/38ab7558-636c-40d1-b49a-c8f51a7afa1a_viewable_rendition__v.pdf\" href=\"https:\/\/static.modernatx.com\/pm\/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867\/38ab7558-636c-40d1-b49a-c8f51a7afa1a\/38ab7558-636c-40d1-b49a-c8f51a7afa1a_viewable_rendition__v.pdf\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" data-ga-track=\"ExternalLink:https:\/\/static.modernatx.com\/pm\/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867\/38ab7558-636c-40d1-b49a-c8f51a7afa1a\/38ab7558-636c-40d1-b49a-c8f51a7afa1a_viewable_rendition__v.pdf\" aria-label=\"Refusal-to-File letter\">Refusal-to-File letter<\/a>\u00a0it received from Vinay Prasad, who heads Center for Biologics Evaluation and Research (CBER).<\/p>\n<p>On its face, the dispute is what controls Moderna should have used in testing its new shot\u2019s efficacy. Prasad claimed in the letter that Moderna\u2019s application lacked data from an \u201cadequate and well-controlled\u201d study. The company called that \u201cinconsistent\u201d with previous guidance it had received from the agency, and said that it had requested an urgent meeting with CBER. Prasad\u00a0<a class=\"color-link\" title=\"https:\/\/www.statnews.com\/2026\/02\/11\/moderna-flu-vaccine-application-rejected-by-prasad-overruling-fda-staff\/\" href=\"https:\/\/www.statnews.com\/2026\/02\/11\/moderna-flu-vaccine-application-rejected-by-prasad-overruling-fda-staff\/\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" data-ga-track=\"ExternalLink:https:\/\/www.statnews.com\/2026\/02\/11\/moderna-flu-vaccine-application-rejected-by-prasad-overruling-fda-staff\/\" aria-label=\"reportedly overruled\">reportedly overruled<\/a>\u00a0his own staff in making the determination.<\/p>\n<p>Moderna\u2019s seasonal flu vaccine delivers messenger RNA to the body that encodes for proteins that can be found on the surface of different flu strains. This teaches the cells of the body to produce those proteins\u2013which are not harmful in and of themselves\u2013in order to train the body\u2019s immune system to detect and fight flu viruses. In clinical trials, Moderna\u2019s shot\u2013which was expected to be the first mRNA flu vaccine to reach market\u2013was shown to be about\u00a0<a class=\"color-link\" title=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=4899326521164266&amp;symbol=MRNA\" href=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=4899326521164266&amp;symbol=MRNA\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" data-ga-track=\"ExternalLink:https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=4899326521164266&amp;symbol=MRNA\" aria-label=\"27% more effective\">27% more effective<\/a>\u00a0than a seasonal flu vaccine from GSK, and\u00a0<a class=\"color-link\" title=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0264410X25001446\" href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0264410X25001446\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" data-ga-track=\"ExternalLink:https:\/\/www.sciencedirect.com\/science\/article\/pii\/S0264410X25001446\" aria-label=\"showed no safety concerns\">showed no safety concerns<\/a>.<\/p>\n<p><a href=\"https:\/\/www.forbes.com\/sites\/innovationrx\/2026\/02\/11\/the-fda-refuses-to-review-modernas-flu-vaccine\/?utm_source=flipboard&amp;utm_content=user%2Fforbes\" target=\"_blank\" rel=\"noopener\">More here &gt;<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>We don&#8217;t have a real FDA anymore. \ud83d\ude25\u00a0 The FDA Refuses To Review Moderna\u2019s Flu Vaccine By Amy Feldman and Alex Knapp, Forbes The FDA refused to review\u00a0Moderna\u2019s application for its seasonal flu vaccine,\u00a0the company\u00a0said on Tuesday. The decision was a surprise and raises questions about the Trump Administration\u2019s vaccine policies. Moderna released the\u00a0Refusal-to-File letter\u00a0it [&hellip;]<\/p>\n","protected":false},"author":183,"featured_media":12444902,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[25541,26293,26294,26922,21,1,12,25391,26281],"tags":[26297,26296,1335,371,858],"class_list":{"0":"post-12857881","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-biotech","8":"category-covid","9":"category-health","10":"category-market-news","11":"category-available","12":"category-uncategorized","13":"category-phils-favorites","14":"category-members-corner","15":"category-sciences","16":"tag-biotech","17":"tag-covid","18":"tag-health","19":"tag-politics","20":"tag-science"},"_links":{"self":[{"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/posts\/12857881","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/users\/183"}],"replies":[{"embeddable":true,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/comments?post=12857881"}],"version-history":[{"count":2,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/posts\/12857881\/revisions"}],"predecessor-version":[{"id":12857883,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/posts\/12857881\/revisions\/12857883"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/media\/12444902"}],"wp:attachment":[{"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/media?parent=12857881"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/categories?post=12857881"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.philstockworld.com\/wp-json\/wp\/v2\/tags?post=12857881"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}