{"id":99395,"date":"2026-02-13T05:23:56","date_gmt":"2026-02-13T04:23:56","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=99395"},"modified":"2026-02-13T05:23:56","modified_gmt":"2026-02-13T04:23:56","slug":"fda-zastavuje-modernu-trumpova-zdravotni-politika-otrasa-prumyslem-mrna","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/02\/13\/fda-zastavuje-modernu-trumpova-zdravotni-politika-otrasa-prumyslem-mrna\/","title":{"rendered":"FDA zastavuje Modernu: Trumpova zdravotn\u00ed politika ot\u0159\u00e1s\u00e1 pr\u016fmyslem mRNA"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p><strong><span dir=\"auto\">V americk\u00e9 zdravotn\u00ed politice nyn\u00ed p\u0159evl\u00e1daj\u00ed nov\u00e1 paradigmata. Spole\u010dnost Moderna nedok\u00e1zala prosadit svou experiment\u00e1ln\u00ed mRNA vakc\u00ednu proti ch\u0159ipce prost\u0159ednictv\u00edm FDA, jak se o\u010dek\u00e1valo. D\u00edky Trumpovi a Kennedymu jsou tyto dny pry\u010d.<\/span><\/strong><\/p>\n<p><span dir=\"auto\">Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA)\u00a0<\/span><a href=\"https:\/\/archive.is\/0Gt0s\"><span dir=\"auto\">odm\u00edt\u00e1<\/span><\/a><span dir=\"auto\"> i jen p\u0159ezkoumat \u017e\u00e1dost spole\u010dnosti Moderna o experiment\u00e1ln\u00ed mRNA vakc\u00ednu proti ch\u0159ipce. \u017d\u00e1dn\u00e9 \u017e\u00e1dosti o dal\u0161\u00ed informace, \u017e\u00e1dn\u00fd zdlouhav\u00fd proces p\u0159ezkumu, \u017e\u00e1dn\u00e9 form\u00e1ln\u00ed ozn\u00e1men\u00ed o zam\u00edtnut\u00ed po m\u011bs\u00edc\u00edch hodnocen\u00ed, ale jasn\u00e9 \u201eOdm\u00edtnut\u00ed p\u0159ezkumu\u201c. M\u00edsto politick\u00e9 podpory, jako tomu bylo b\u011bhem pandemie COVID-19, nyn\u00ed Moderna \u010del\u00ed siln\u00fdm nep\u0159\u00edzniv\u00fdm okolnostem.<\/span><\/p>\n<figure class=\"wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter\">\n<div class=\"wp-block-embed__wrapper\">\n<div class=\"twitter-tweet twitter-tweet-rendered\"><iframe id=\"twitter-widget-0\" class=\"\" title=\"X P\u0159\u00edsp\u011bvek\" src=\"https:\/\/platform.twitter.com\/embed\/Tweet.html?dnt=true&amp;embedId=twitter-widget-0&amp;features=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%3D%3D&amp;frame=false&amp;hideCard=false&amp;hideThread=false&amp;id=2021584436643409984&amp;lang=cs&amp;origin=https%3A%2F%2Freport24.news%2Ffda-stoppt-moderna-trumps-gesundheitskurs-bringt-mrna-industrie-ins-wanken%2F&amp;sessionId=fdcc1780442acfe86e57c75c6998a29ea36e8f37&amp;theme=light&amp;widgetsVersion=2615f7e52b7e0%3A1702314776716&amp;width=550px\" frameborder=\"0\" scrolling=\"no\" allowfullscreen=\"allowfullscreen\" data-tweet-id=\"2021584436643409984\" data-mce-fragment=\"1\"><\/iframe><\/div>\n<\/div>\n<\/figure>\n<p><span dir=\"auto\">Dopis podepsal Vinayak Prasad, vedouc\u00ed Centra pro biologick\u00e9 l\u00e1tky \u00da\u0159adu pro kontrolu potravin a l\u00e9\u010div (FDA). Jeho zd\u016fvodn\u011bn\u00ed:\u00a0<\/span><strong><span dir=\"auto\">Design studie mRNA-1010 nespl\u0148uje po\u017eadavky na \u201e\u0159\u00e1dnou a dob\u0159e kontrolovanou\u201c klinickou studii.<\/span><\/strong><span dir=\"auto\">\u00a0Jin\u00fdmi slovy: Data jsou nedostate\u010dn\u00e1 k tomu, aby se dala v\u00e1\u017en\u011b diskutovat o \u00fa\u010dinnosti a p\u0159\u00ednosu.<\/span><\/p>\n<p><span dir=\"auto\">Spole\u010dnost Moderna reagovala s p\u0159edv\u00eddateln\u00fdm pobou\u0159en\u00edm. Gener\u00e1ln\u00ed \u0159editel St\u00e9phane Bancel pouk\u00e1zal na to, \u017ee jako srovn\u00e1n\u00ed pou\u017eili vakc\u00ednu ji\u017e schv\u00e1lenou FDA a \u017ee design studie byl s agenturou p\u0159edem koordinov\u00e1n. Tentokr\u00e1t se v\u0161ak d\u0159\u00edve standardn\u00ed schvalovac\u00ed proces ji\u017e neuplat\u0148uje. Cel\u00e1 \u017e\u00e1dost jednodu\u0161e selhala kv\u016fli metodologick\u00e9 chyb\u011b, kter\u00e1 byla v minulosti pohodln\u011b ignorov\u00e1na.<\/span><\/p>\n<figure class=\"wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter\">\n<div class=\"wp-block-embed__wrapper\">\n<div class=\"twitter-tweet twitter-tweet-rendered\"><iframe id=\"twitter-widget-1\" class=\"\" title=\"X P\u0159\u00edsp\u011bvek\" src=\"https:\/\/platform.twitter.com\/embed\/Tweet.html?dnt=true&amp;embedId=twitter-widget-1&amp;features=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%3D%3D&amp;frame=false&amp;hideCard=false&amp;hideThread=false&amp;id=2021550281503174992&amp;lang=cs&amp;origin=https%3A%2F%2Freport24.news%2Ffda-stoppt-moderna-trumps-gesundheitskurs-bringt-mrna-industrie-ins-wanken%2F&amp;sessionId=fdcc1780442acfe86e57c75c6998a29ea36e8f37&amp;theme=light&amp;widgetsVersion=2615f7e52b7e0%3A1702314776716&amp;width=550px\" frameborder=\"0\" scrolling=\"no\" allowfullscreen=\"allowfullscreen\" data-tweet-id=\"2021550281503174992\" data-mce-fragment=\"1\"><\/iframe><\/div>\n<\/div>\n<\/figure>\n<p><span dir=\"auto\">Skute\u010dnost, \u017ee Moderna byla sou\u010dasn\u011b schv\u00e1lena k testov\u00e1n\u00ed v EU, Kanad\u011b a Austr\u00e1lii, o to jasn\u011bji podtrhuje p\u0159\u00edstup USA. Zat\u00edmco ostatn\u00ed z\u00e1padn\u00ed regula\u010dn\u00ed org\u00e1ny zjevn\u011b z\u016fst\u00e1vaj\u00ed ochotny schvalovat produkty mRNA na z\u00e1klad\u011b pom\u011brn\u011b omezen\u00fdch dat, za Trumpa a Kennedyho se nyn\u00ed pozornost soust\u0159ed\u00ed na robustn\u00ed v\u00fdsledky studi\u00ed jako z\u00e1klad pro takov\u00e1 regula\u010dn\u00ed rozhodnut\u00ed.<\/span><\/p>\n<p><span dir=\"auto\">Pro farmaceutick\u00e9 firmy je to varovn\u00fd sign\u00e1l. \u00c9ra, v n\u00ed\u017e mohly politick\u00e9 narativy nahradit v\u011bdeck\u00e9 standardy, se zjevn\u011b ch\u00fdl\u00ed ke konci. Trumpova reforma americk\u00e9ho syst\u00e9mu zdravotn\u00ed p\u00e9\u010de \u2013 od p\u0159ehodnocen\u00ed stravovac\u00edch doporu\u010den\u00ed a zefektivn\u011bn\u00ed o\u010dkovac\u00edho kalend\u00e1\u0159e a\u017e po otev\u0159enou debatu o vedlej\u0161\u00edch \u00fa\u010dinc\u00edch \u2013 m\u00e1 sv\u00e9 v\u00fdsledky. Proto\u017ee nyn\u00ed maj\u00ed p\u0159ednost z\u00e1jmy obyvatelstva, nikoli z\u00e1jmy farmaceutick\u00e9ho pr\u016fmyslu.<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-1185\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2021\/04\/kuryr-podpis.png\" alt=\"\" width=\"84\" height=\"24\" \/><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>V americk\u00e9 zdravotn\u00ed politice nyn\u00ed p\u0159evl\u00e1daj\u00ed nov\u00e1 paradigmata. Spole\u010dnost Moderna nedok\u00e1zala prosadit svou experiment\u00e1ln\u00ed mRNA&#8230;<\/p>\n","protected":false},"author":2,"featured_media":99396,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[10581,573,694,37],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/99395"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=99395"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/99395\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/99396"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=99395"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=99395"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=99395"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}