{"id":29672,"date":"2026-08-06T09:36:22","date_gmt":"2026-08-06T04:36:22","guid":{"rendered":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/?p=29672"},"modified":"2026-08-06T09:36:22","modified_gmt":"2026-08-06T04:36:22","slug":"fda-approves-1st-mrna-flu-shot-from-moderna","status":"publish","type":"post","link":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/?p=29672","title":{"rendered":"FDA approves 1st mRNA flu shot, from Moderna"},"content":{"rendered":"<p><script>\r\n  atOptions = {\r\n    'key' : '644b717812d811d6a1c1fc5b6ccd6fa6',\r\n    'format' : 'iframe',\r\n    'height' : 90,\r\n    'width' : 728,\r\n    'params' : {}\r\n  };\r\n<\/script>\r\n<script src=\"https:\/\/www.highperformanceformat.com\/644b717812d811d6a1c1fc5b6ccd6fa6\/invoke.js\"><\/script>\r\n<br \/>\n<br \/><img decoding=\"async\" src=\"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_fit_1500w\/rockcms\/2026-08\/260803-moderna-vaccine-vl-401p-d33cb9.jpg\" \/><\/p>\n<div>\n<p id=\"anchor-60ac89\" class=\"body-graf\">The Food and Drug Administration on Wednesday approved the U.S.\u2019 first flu shot that uses mRNA technology: mFlusiva, from drugmaker Moderna.<\/p>\n<p id=\"anchor-2670c1\" class=\"body-graf\">The FDA granted approval for two age groups, adults 50 to 65 and adults 65 and up, on the condition that Moderna run an additional clinical trial in the older group, the company said in a release. In a late-stage trial, mFlusiva was found to be about 27% more effective than a standard flu shot. <\/p>\n<p id=\"anchor-ce1d67\" class=\"body-graf\">Many scientists and public health experts have touted the idea of an mRNA-based flu vaccine, which uses the same messenger RNA platform as the Covid vaccines from Moderna and Pfizer. That\u2019s because mRNA vaccines can be manufactured much faster than traditional vaccines, allowing scientists to better match circulating influenza strains.<\/p>\n<p id=\"anchor-827d04\" class=\"body-graf\">Moderna said it takes two to three months from picking the strain to rolling out its flu shot, compared with about six months for traditional flu shots.<\/p>\n<p id=\"anchor-873e55\" class=\"body-graf\">\u201cIf you\u2019re choosing the strain half a year before, how good can we be at sharpshooting?\u201d said<strong> <\/strong>Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children\u2019s Hospital. <\/p>\n<p id=\"anchor-b87e65\" class=\"body-graf\">The flu puts hundreds of thousands of people in the hospital every year, according to <a href=\"https:\/\/www.idsociety.org\/ID-topics\/infectious-disease\/influenza\/\" target=\"_blank\">the Infectious Diseases Society of America<\/a>, and there can be tens of thousands of deaths. Young children and older adults are more likely to get very sick from the flu.    <\/p>\n<p id=\"anchor-bbd2a7\" class=\"body-graf\">The traditional flu shot ranges in effectiveness from 22% to 56%, <a href=\"https:\/\/www.mayoclinic.org\/diseases-conditions\/flu\/in-depth\/flu-shots\/art-20048000\" target=\"_blank\">according to the Mayo Clinic<\/a>. \u201cWe wish it were higher, quite frankly,\u201d Levy said. <\/p>\n<p id=\"anchor-2f3cba\" class=\"body-graf\">Even though mFlusiva outperformed the traditional flu shot in a late-stage clinical trial, its approval was not a sure thing. <\/p>\n<p id=\"anchor-78ee9d\" class=\"body-graf\">Health and Human Services Secretary Robert F. Kennedy Jr. \u2014 an anti-vaccine activist \u2014 has repeatedly criticized mRNA technology, calling the Covid vaccines \u201cthe deadliest vaccine ever made.\u201d Last year, HHS under Kennedy canceled nearly $500 million in funding for mRNA vaccine research.<\/p>\n<p id=\"anchor-430d81\" class=\"body-graf\">The <a href=\"https:\/\/www.nbcnews.com\/health\/health-news\/fda-declines-review-modernas-mrna-flu-shot-rcna258436\" target=\"_blank\">FDA initially refused<\/a> this year to review Moderna\u2019s application <a href=\"https:\/\/www.nbcnews.com\/health\/health-news\/fda-reverses-course-will-review-modernas-mrna-flu-vaccine-rcna259531\" target=\"_blank\">before it reversed course a week later<\/a>. Agency officials said they wanted more data because Moderna had compared its vaccine with a standard flu shot in adults 65 and older, even though the Centers for Disease Control and Prevention recommends a high-dose flu vaccine for that age group. Moderna has said the FDA previously signed off on the trial design.<\/p>\n<p id=\"anchor-36ec2d\" class=\"body-graf\">In June, the FDA\u2019s independent vaccine advisory committee <a href=\"https:\/\/www.nbcnews.com\/health\/health-news\/fda-panel-recommends-modernas-mrna-flu-shot-older-adults-rcna350699\" target=\"_blank\">unanimously recommended approving<\/a> the vaccine.<\/p>\n<p id=\"anchor-2d11d9\" class=\"body-graf\">That decision was based on <a href=\"https:\/\/www.nbcnews.com\/health\/health-news\/moderna-mrna-flu-vaccine-better-trial-fda-rcna343857\" target=\"_blank\">a late-stage clinical trial<\/a> of more than 40,000 older adults across 11 countries, including the U.S. Rates of side effects \u2014 such as injection-site pain, fatigue and headaches \u2014 were more common in the mFlusiva group but still mild to moderate. <\/p>\n<p id=\"anchor-2ba99f\" class=\"body-graf\">A combination flu and Covid vaccine from Moderna, which also uses mRNA, was approved by the European Union in April. Moderna withdrew its application for U.S. approval for that shot last year <a href=\"https:\/\/www.nbcnews.com\/health\/health-news\/modernas-combo-covid-flu-mrna-shot-outperforms-current-vaccines-large-rcna205242\" target=\"_blank\">despite positive late-stage trial results<\/a>.<\/p>\n<p id=\"anchor-4d1e1d\" class=\"body-graf\">Moderna said mFlusiva will be available for this fall\u2019s flu season. <\/p>\n<p id=\"anchor-49481d\" class=\"body-graf\">Vaccines, however, are typically formally recommended by the CDC\u2019s vaccine advisory committee \u2014 called the Advisory Committee on Immunization Practices (ACIP) \u2014 before they are used. But a federal judge has blocked the committee from convening. <\/p>\n<p id=\"anchor-9e447f\" class=\"body-graf\">Levy said mFlusiva could still be legally prescribed in the U.S. without ACIP\u2019s sign-off.<\/p>\n<p id=\"anchor-b23a24\" class=\"body-graf\">However, he said, patients most likely would not be able to get insurance coverage, as private insurers generally cover only ACIP-recommended shots, and the public distribution of the vaccine would be severely limited with no official federal guidance on whom the shots should go to. Federal programs, such as Vaccines for Children and Medicaid, also rely on ACIP\u2019s guidance. <\/p>\n<p id=\"anchor-14af83\" class=\"endmark body-graf\">\u201cThat is a serious concern,\u201d he said.<\/p>\n<\/div>\n<script async=\"async\" data-cfasync=\"false\" src=\"https:\/\/pl30214220.effectivecpmnetwork.com\/9ab3d4df8a7e1a6171e16ddbf732cc19\/invoke.js\"><\/script>\r\n<div id=\"container-9ab3d4df8a7e1a6171e16ddbf732cc19\"><\/div>\r\n\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration on Wednesday approved the U.S.\u2019 first flu shot that uses mRNA technology: mFlusiva, from drugmaker Moderna. The FDA granted approval for two age groups, adults 50 to 65 and adults 65 and up, on the condition that Moderna run an additional clinical trial in the older group, the company said&#8230;<\/p>\n","protected":false},"author":1,"featured_media":29673,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_nbcnews-fp-1200-630,f_auto,q_auto:best\/rockcms\/2026-08\/260803-moderna-vaccine-vl-401p-d33cb9.jpg","fifu_image_alt":"","footnotes":""},"categories":[4],"tags":[],"class_list":["post-29672","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-hub"],"brizy_media":[],"_links":{"self":[{"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/posts\/29672","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=29672"}],"version-history":[{"count":0,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/posts\/29672\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=\/wp\/v2\/media\/29673"}],"wp:attachment":[{"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=29672"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=29672"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/usnews-14267fa.ingress-comporellon.ewp.live\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=29672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}