{"id":169737,"date":"2026-02-19T10:24:11","date_gmt":"2026-02-19T10:24:11","guid":{"rendered":"https:\/\/www.europesays.com\/se\/169737\/"},"modified":"2026-02-19T10:24:11","modified_gmt":"2026-02-19T10:24:11","slug":"fda-andrar-sig-om-modernas-influensavaccin","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/se\/169737\/","title":{"rendered":"FDA \u00e4ndrar sig om Modernas influensavaccin"},"content":{"rendered":"<p>Den amerikanska l\u00e4kemedelsmyndigheten FDA g\u00f6r en kurs\u00e4ndring och kommer att granska ans\u00f6kan om godk\u00e4nnande av l\u00e4kemedelsbolaget Modernas influensavaccin. Det skriver Moderna i ett <a href=\"https:\/\/feeds.issuerdirect.com\/news-release.html?newsid=8923338804483797&amp;symbol=MRNA\" rel=\"nofollow noopener\" target=\"_blank\">pressmeddelande<\/a>.<\/p>\n<p><strong>Beskedet kommer en<\/strong> vecka efter FDA:s beslut att avvisa bolagets ursprungliga ans\u00f6kan, som<a href=\"https:\/\/www.lakemedelsvarlden.se\/fda-nobbar-moderna\/\" rel=\"nofollow noopener\" target=\"_blank\"> L\u00e4kemedelsv\u00e4rlden rapporterat om<\/a>.<\/p>\n<p>Detta har h\u00e4nt<\/p>\n<p>Moderna gjorde d\u00e5 det ovanliga draget att offentligg\u00f6ra inneh\u00e5llet i FDA:s brev om att neka granskning av mRNA-vaccinet. Moderna uppgav \u00e4ven att FDA tidigare hade godk\u00e4nt den studiedesign som man nu underk\u00e4nde.<\/p>\n<p><strong>FDA:s kommission\u00e4r Marty<\/strong> Makary f\u00f6rsvarade beslutet i TV. Ledande FDA-f\u00f6retr\u00e4dare h\u00f6ll ocks\u00e5 en presstr\u00e4ff d\u00e4r de sade att bolaget utsatte patienter f\u00f6r risk genom att inte ge en h\u00f6gre dos till \u00e4ldre deltagare i kontrollgruppen i studien.<\/p>\n<p>I tisdags tr\u00e4ffades Moderna och FDA f\u00f6r att diskutera situationen. D\u00e4refter kom beskedet att bolaget reviderar sin ans\u00f6kan och att FDA accepterat att granska den. Revideringen inneb\u00e4r att Moderna ans\u00f6ker om fullt godk\u00e4nnande f\u00f6r personer i \u00e5ldrarna 50 till 64 \u00e5r samt ett s\u00e5 kallat p\u00e5skyndat godk\u00e4nnande f\u00f6r personer som \u00e4r 65 \u00e5r och \u00e4ldre.<\/p>\n<p><strong>Ett s\u00e5dant p\u00e5skyndat<\/strong> godk\u00e4nnande kr\u00e4ver en bekr\u00e4ftande studie efter marknadsintroduktion f\u00f6r att kunna omvandlas till ett ordinarie godk\u00e4nnande.<\/p>\n<p>Modernas influensavaccin f\u00f6rst i sitt slag<\/p>\n<p>FDA v\u00e4ntas fatta beslut om Modernas influensavaccin senast 5 augusti i \u00e5r. Om detta g\u00e5r i l\u00e5s och vaccinet blir godk\u00e4nt kommer det f\u00f6rsta mRNA-vaccinet mot s\u00e4songsinfluensa att kunna bli tillg\u00e4ngligt i USA inf\u00f6r influensas\u00e4songen 2026\/2027.<\/p>\n<p><strong>Nyhetsbyr\u00e5n <a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-initiate-review-modernas-influenza-vaccine-2026-02-18\/\" rel=\"nofollow noopener\" target=\"_blank\">Reuters skriver<\/a><\/strong> att turerna kring det mRNA-baserade vaccinet \u00e4r ett tecken p\u00e5 den turbulens som f\u00f6r n\u00e4rvarande r\u00e5der inom FDA, d\u00e4r flera h\u00f6gt uppsatta tj\u00e4nstem\u00e4n har l\u00e4mnat sina poster under h\u00e4lsominister Robert F. Kennedy Jr.<\/p>\n","protected":false},"excerpt":{"rendered":"Den amerikanska l\u00e4kemedelsmyndigheten FDA g\u00f6r en kurs\u00e4ndring och kommer att granska ans\u00f6kan om godk\u00e4nnande av l\u00e4kemedelsbolaget Modernas influensavaccin.&hellip;\n","protected":false},"author":2,"featured_media":169738,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[65],"tags":[72,70,71,2101,15205,34,31,33,32,30],"class_list":["post-169737","post","type-post","status-publish","format-standard","has-post-thumbnail","category-ekonomi","tag-business","tag-economy","tag-ekonomi","tag-fda","tag-moderna","tag-se","tag-svenska","tag-sverige","tag-sweden","tag-swedish"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@se\/116096812047898528","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts\/169737","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/comments?post=169737"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/posts\/169737\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/media\/169738"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/media?parent=169737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/categories?post=169737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/se\/wp-json\/wp\/v2\/tags?post=169737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}