{"id":113161,"date":"2026-08-14T00:31:11","date_gmt":"2026-08-13T22:31:11","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=113161"},"modified":"2026-08-13T16:09:55","modified_gmt":"2026-08-13T14:09:55","slug":"nova-analyza-vyvolava-vazne-otazky-ohledne-schvaleni-mrna-vakciny-proti-chripce-od-spolecnosti-moderna","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/08\/14\/nova-analyza-vyvolava-vazne-otazky-ohledne-schvaleni-mrna-vakciny-proti-chripce-od-spolecnosti-moderna\/","title":{"rendered":"Nov\u00e1 anal\u00fdza vyvol\u00e1v\u00e1 v\u00e1\u017en\u00e9 ot\u00e1zky ohledn\u011b schv\u00e1len\u00ed mRNA vakc\u00edny proti ch\u0159ipce od spole\u010dnosti Moderna"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<div class=\"elementor-element elementor-element-1fb4c2c elementor-widget elementor-widget-theme-post-content\" data-id=\"1fb4c2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-content.default\">\n<div class=\"elementor-widget-container\">\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky, kter\u00e9 se objevily ve schvalovac\u00ed studii nov\u00e9 mRNA vakc\u00edny proti ch\u0159ipce od spole\u010dnosti Moderna, byly statisticky zm\u00edrn\u011bny v posouzen\u00ed p\u0159\u00ednos\u016f a rizik ze strany FDA kombinac\u00ed v\u00edce studi\u00ed, uv\u00e1d\u00ed investigativn\u00ed novin\u00e1\u0159ka Maryanne Demasi. Demasi k tomuto z\u00e1v\u011bru dosp\u011bla po anal\u00fdze dokument\u016f z\u00a0<\/span><a href=\"https:\/\/blog.maryannedemasi.com\/p\/fdas-botched-review-of-modernas-flu\" target=\"_blank\" rel=\"noreferrer noopener\" data-type=\"link\" data-id=\"https:\/\/blog.maryannedemasi.com\/p\/fdas-botched-review-of-modernas-flu\"><span dir=\"auto\">klinick\u00fdch<\/span><\/a><span dir=\"auto\">\u00a0studi\u00ed a z\u00e1znam\u016f FDA. Jej\u00ed zji\u0161t\u011bn\u00ed vyvol\u00e1vaj\u00ed z\u00e1sadn\u00ed ot\u00e1zky ohledn\u011b posouzen\u00ed bezpe\u010dnostn\u00edho profilu vakc\u00edny.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">O \u010dem m\u00e9dia neinformovala<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Pot\u00e9, co FDA schv\u00e1lila vakc\u00ednu, mainstreamov\u00e1 m\u00e9dia informovala t\u00e9m\u011b\u0159 v\u00fdhradn\u011b o jej\u00ed \u00fa\u010dinnosti. Vakc\u00edna byla \u00fadajn\u011b o 26,6 procenta \u00fa\u010dinn\u011bj\u0161\u00ed ne\u017e konven\u010dn\u00ed vakc\u00edna proti ch\u0159ipce \u2013 \u010d\u00edslo, kter\u00e9 zn\u00ed impozantn\u011b, ale v absolutn\u00edch \u010d\u00edslech odpov\u00edd\u00e1 sn\u00ed\u017een\u00ed rizika pouze o 0,8 procenta. Konkr\u00e9tn\u011b to znamenalo o \u010dty\u0159i hospitalizace s ch\u0159ipkou m\u00e9n\u011b ve skupin\u011b s mRNA mezi des\u00edtkami tis\u00edc \u00fa\u010dastn\u00edk\u016f studie. To je st\u0159\u00edzliv\u00e1 realita, kter\u00e1 se skr\u00fdv\u00e1 za hojn\u011b citovan\u00fdmi marketingov\u00fdmi \u010d\u00edsly.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">M\u00e1lo pozornosti se v\u0161ak dostalo faktu, \u017ee ve stejn\u00e9 studii (P304), kter\u00e9 se z\u00fa\u010dastnilo v\u00edce ne\u017e 40 000 dosp\u011bl\u00fdch ve v\u011bku 50 let a star\u0161\u00edch, se u 449 osob ve skupin\u011b s mRNA vyskytla alespo\u0148 jedna z\u00e1va\u017en\u00e1 ne\u017e\u00e1douc\u00ed p\u0159\u00edhoda, ve srovn\u00e1n\u00ed s 389 \u00fa\u010dastn\u00edky v kontroln\u00ed skupin\u011b \u2013 rozd\u00edl je 60 p\u0159\u00edpad\u016f. Mezi tyto p\u0159\u00edhody pat\u0159ily hospitalizace, \u017eivot ohro\u017euj\u00edc\u00ed stavy, trval\u00e1 posti\u017een\u00ed nebo \u00famrt\u00ed.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Statistick\u00e9 \u017eonglov\u00e1n\u00ed s daty<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Rozd\u00edl v z\u00e1va\u017en\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch byl statisticky v\u00fdznamn\u00fd. Jin\u00fdmi slovy, je vysoce nepravd\u011bpodobn\u00e9, \u017ee by k n\u011bmu do\u0161lo n\u00e1hodou. P\u0159esto FDA popsala ne\u017e\u00e1douc\u00ed \u00fa\u010dinky sv\u00e9mu vlastn\u00edmu poradn\u00edmu panelu VRBPAC jako \u201erovnom\u011brn\u011b rozlo\u017een\u00e9\u201c. Jak mohla k tomuto z\u00e1v\u011bru doj\u00edt?<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Kl\u00ed\u010dov\u00fdm bodem je slou\u010den\u00ed dat. M\u00edsto pouh\u00e9ho hodnocen\u00ed v\u00fdsledk\u016f studie P304 \u2013 studie, kter\u00e1 testovala p\u0159esn\u00e9 slo\u017een\u00ed vakc\u00edny, o jej\u00ed\u017e schv\u00e1len\u00ed se nakonec \u017e\u00e1dalo \u2013 FDA tyto v\u00fdsledky zkombinovala s v\u00fdsledky t\u0159\u00ed dal\u0161\u00edch studi\u00ed f\u00e1ze 3.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Celkem se t\u011bchto studi\u00ed z\u00fa\u010dastnilo t\u00e9m\u011b\u0159 72 000 \u00fa\u010dastn\u00edk\u016f. Zkoumaly v\u0161ak r\u016fzn\u00e9 formulace mRNA, r\u016fzn\u00e9 srovn\u00e1vac\u00ed vakc\u00edny, r\u016fzn\u00e9 v\u011bkov\u00e9 skupiny, n\u011bkolik zem\u00ed a r\u016fzn\u00e1 obdob\u00ed sledov\u00e1n\u00ed. Kombinac\u00ed t\u011bchto heterogenn\u00edch dat bezpe\u010dnostn\u00ed sign\u00e1l ze studie P304 prakticky zmizel v celkov\u00e9m souboru dat.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Zvl\u00e1\u0161t\u011b pozoruhodn\u00e9: V dodatku k vlastn\u00edmu informa\u010dn\u00edmu dokumentu FDA sama uzn\u00e1v\u00e1, \u017ee rozd\u00edly mezi jednotliv\u00fdmi studiemi by mohly v\u00e9st k odchylk\u00e1m v bezpe\u010dnosti, kter\u00e9 by v souhrnn\u00e9 anal\u00fdze nemusely b\u00fdt pln\u011b patrn\u00e9. Nicm\u00e9n\u011b zvolila pr\u00e1v\u011b tento p\u0159\u00edstup.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Dvoj\u00ed metr<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Obzvl\u00e1\u0161t\u011b pozoruhodn\u00e1 je odli\u0161n\u00e1 metodologie FDA.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Pro posouzen\u00ed \u00fa\u010dinnosti se agentura spol\u00e9hala v\u00fdhradn\u011b na studii P304. To se zd\u00e1 rozumn\u00e9, jeliko\u017e d\u0159\u00edv\u011bj\u0161\u00ed studie p\u0159inesly slab\u0161\u00ed v\u00fdsledky \u2013 alespo\u0148 v jednom p\u0159\u00edpad\u011b dokonce prok\u00e1zaly negativn\u00ed \u00fa\u010dinnost. Pokud by tyto d\u0159\u00edv\u011bj\u0161\u00ed studie byly tak\u00e9 zahrnuty do posouzen\u00ed \u00fa\u010dinnosti, \u010dasto uv\u00e1d\u011bn\u00e1 \u00fa\u010dinnost 26,6 procenta by byla v\u00fdrazn\u011b ni\u017e\u0161\u00ed.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Kdy\u017e v\u0161ak tat\u00e1\u017e studie P304 vyk\u00e1zala nep\u0159\u00edzniv\u00fd bezpe\u010dnostn\u00ed sign\u00e1l, FDA n\u00e1hle zm\u011bnila svou metodologii a uch\u00fdlila se k celkov\u00e9mu hodnocen\u00ed v\u0161ech studi\u00ed.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Z hlediska \u00fa\u010dinnosti byla pou\u017eita pouze nejp\u0159\u00edzniv\u011bj\u0161\u00ed studie, zat\u00edmco z hlediska bezpe\u010dnosti byl zvolen postup, kter\u00fd siln\u00fd sign\u00e1l zeslabil. Nejde o n\u00e1hodn\u00e9, ale o z\u00e1m\u011brn\u00e9 metodologick\u00e9 rozhodnut\u00ed \u2013 rozhodnut\u00ed, kter\u00e9 si podle kritik\u016f mus\u00ed FDA vysv\u011btlit.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">M\u00edra \u00famrtnosti, kter\u00e1 vyvol\u00e1v\u00e1 ot\u00e1zky<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Obavy se neomezuj\u00ed pouze na z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Ve studii P304 zem\u0159elo 40 \u00fa\u010dastn\u00edk\u016f ve skupin\u011b s mRNA ve srovn\u00e1n\u00ed s 34 v kontroln\u00ed skupin\u011b.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">P\u0159edchoz\u00ed studie P303 tak\u00e9 prok\u00e1zala vy\u0161\u0161\u00ed po\u010det \u00famrt\u00ed ve skupin\u00e1ch s mRNA ve v\u0161ech t\u0159ech d\u00edl\u010d\u00edch studi\u00edch:<\/span><\/p>\n<ul>\n<li><span dir=\"auto\">Podstudie 1: p\u011bt \u00famrt\u00ed ve skupin\u011b s mRNA ve srovn\u00e1n\u00ed s jedn\u00edm v kontroln\u00ed skupin\u011b<\/span><\/li>\n<li><span dir=\"auto\">Podstudie 2: t\u0159i \u00famrt\u00ed versus dv\u011b<\/span><\/li>\n<li><span dir=\"auto\">Podstudie 3: t\u0159i \u00famrt\u00ed oproti jednomu<\/span><\/li>\n<\/ul>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">V prvn\u00ed \u010d\u00e1sti studie vlastn\u00ed v\u00fdzkumn\u00edci spole\u010dnosti Moderna vyhodnotili jedno z p\u011bti \u00famrt\u00ed ve skupin\u011b s mRNA jako mo\u017en\u00e9 souvisej\u00edc\u00ed s o\u010dkov\u00e1n\u00edm \u2013 konkr\u00e9tn\u011b s tou samou vakc\u00ednou, kter\u00e1 byla od t\u00e9 doby schv\u00e1lena.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">FDA se v\u0161ak ve sv\u00e9 ve\u0159ejn\u00e9 komunikaci tomuto opakuj\u00edc\u00edmu se vzorci konkr\u00e9tn\u011b nezab\u00fdvala.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Floridsk\u00fd gener\u00e1ln\u00ed chirurg vzn\u00e1\u0161\u00ed z\u00e1va\u017en\u00e1 obvin\u011bn\u00ed<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Anal\u00fdza Maryanne Demasi nez\u016fstala bez odezvy.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Joseph Ladapo, hlavn\u00ed chirurg americk\u00e9ho st\u00e1tu Florida, se k jejich zji\u0161t\u011bn\u00edm ve\u0159ejn\u011b vyj\u00e1d\u0159il. Prohl\u00e1sil syst\u00e9m regulace o\u010dkov\u00e1n\u00ed za \u201enefunk\u010dn\u00ed\u201c a ozna\u010dil za nep\u0159ijateln\u00e9 zva\u017eovat 60 dal\u0161\u00edch z\u00e1va\u017en\u00fdch vedlej\u0161\u00edch \u00fa\u010dink\u016f oproti pouh\u00fdm \u010dty\u0159em zabr\u00e1n\u011bn\u00fdm hospitalizac\u00edm v d\u016fsledku ch\u0159ipky.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">To, \u017ee vysoce postaven\u00fd \u00fa\u0159edn\u00edk zdravotnictv\u00ed otev\u0159en\u011b kritizuje FDA, je extr\u00e9mn\u011b neobvykl\u00e9 a podtrhuje citlivost t\u00e9to debaty.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Kdo vlastn\u011b ovl\u00e1d\u00e1 ty regul\u00e1tory?<\/span><\/h3>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">\u00dast\u0159edn\u00ed ot\u00e1zka, kterou si Maryanne Demasi klade na konci sv\u00e9 anal\u00fdzy, jde daleko za hranice t\u00e9to jedin\u00e9 vakc\u00edny:<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Pokud FDA p\u0159ijme statistick\u00e9 metody hodnocen\u00ed v\u00fdrobce, a t\u00edm oslab\u00ed nebo zataj\u00ed relevantn\u00ed bezpe\u010dnostn\u00ed sign\u00e1l \u2013 kdo nakonec ochr\u00e1n\u00ed populaci p\u0159ed potenci\u00e1ln\u00edmi riziky?<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">Kritici tvrd\u00ed, \u017ee bezpe\u010dnostn\u00ed sign\u00e1ly pozorovan\u00e9 ve studii nebyly vyvr\u00e1ceny, ale sp\u00ed\u0161e statisticky oslabeny kombinac\u00ed velmi odli\u0161n\u00fdch studi\u00ed. Proto ji nepova\u017euj\u00ed za v\u011bdeckou anal\u00fdzu, ale sp\u00ed\u0161e za v\u00fdpo\u010detn\u00ed oslaben\u00ed n\u00e1padn\u00e9ho bezpe\u010dnostn\u00edho sign\u00e1lu.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span dir=\"auto\">To pro n\u011b vyvol\u00e1v\u00e1 z\u00e1sadn\u00ed ot\u00e1zku: Pln\u00ed dozorov\u00fd org\u00e1n st\u00e1le sv\u016fj skute\u010dn\u00fd \u00fakol \u2013 nebo st\u00e1le v\u00edce ztr\u00e1c\u00ed svou roli nez\u00e1visl\u00e9ho kontroln\u00edho org\u00e1nu?<\/span><\/p>\n<\/div>\n<\/div>\n<div class=\"elementor-element elementor-element-8c57238 quelle dc-has-condition dc-condition-empty elementor-widget elementor-widget-heading\" data-id=\"8c57238\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n<div class=\"elementor-widget-container\">\n<h3 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-size: 10pt;\"><a href=\"https:\/\/blog.maryannedemasi.com\/p\/fdas-botched-review-of-modernas-flu\" target=\"_blank\" rel=\"nofollow noopener\"><span dir=\"auto\">Zdroj<\/span><\/a><\/span><\/h3>\n<p>&nbsp;<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky, kter\u00e9 se objevily ve schvalovac\u00ed studii nov\u00e9 mRNA vakc\u00edny proti ch\u0159ipce od&#8230;<\/p>\n","protected":false},"author":2,"featured_media":113162,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1208,573,694,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/113161"}],"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=113161"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/113161\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/113162"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=113161"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=113161"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=113161"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}