{"id":84571,"date":"2025-07-30T00:12:27","date_gmt":"2025-07-29T22:12:27","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=84571"},"modified":"2025-07-29T10:03:46","modified_gmt":"2025-07-29T08:03:46","slug":"americka-agentura-pripousti-vazne-selhani-ockovani-u-mladych-muzu","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/07\/30\/americka-agentura-pripousti-vazne-selhani-ockovani-u-mladych-muzu\/","title":{"rendered":"Americk\u00e1 agentura p\u0159ipou\u0161t\u00ed v\u00e1\u017en\u00e9 selh\u00e1n\u00ed o\u010dkov\u00e1n\u00ed u mlad\u00fdch mu\u017e\u016f"},"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-widget_type=\"theme-post-content.default\">\n<div class=\"elementor-widget-container\">\n<p><strong><span dir=\"auto\">mRNA vakc\u00edna proti COVID-19 p\u0159edstavuje p\u0159etrv\u00e1vaj\u00edc\u00ed riziko myokarditidy se zn\u00e1mkami dlouhodob\u00e9ho po\u0161kozen\u00ed srdce, zejm\u00e9na u mlad\u00fdch mu\u017e\u016f \u2013 revidovan\u00e9 celost\u00e1tn\u00ed bezpe\u010dnostn\u00ed varov\u00e1n\u00ed je opodstatn\u011bn\u00e9.<\/span><\/strong><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Pozad\u00ed: Dlouho odkl\u00e1dan\u00e9 z\u00fa\u010dtov\u00e1n\u00ed<\/span><\/h3>\n<p><span dir=\"auto\">Ve vz\u00e1cn\u00e9 a st\u0159\u00edzliv\u00e9\u00a0<\/span><a href=\"https:\/\/www.youtube.com\/watch?v=68QzzWGc4mI\" target=\"_blank\" rel=\"noreferrer noopener\" data-type=\"link\" data-id=\"https:\/\/www.youtube.com\/watch?v=68QzzWGc4mI\"><span dir=\"auto\">prezentaci<\/span><\/a><span dir=\"auto\">\u00a0Dr. Vinay Prasad \u2013 nov\u011b jmenovan\u00fd \u0159editel CBER a hlavn\u00ed l\u00e9ka\u0159sk\u00fd a v\u011bdeck\u00fd pracovn\u00edk americk\u00e9ho \u00da\u0159adu pro kontrolu potravin a l\u00e9\u010div (FDA) \u2013 odhalil aktualizovan\u00e9 bezpe\u010dnostn\u00ed varov\u00e1n\u00ed agentury t\u00fdkaj\u00edc\u00ed se myokarditidy spojen\u00e9 se v\u0161emi mRNA vakc\u00ednami proti COVID-19 pro celou skupinu. Varov\u00e1n\u00ed, vydan\u00e9 25. \u010dervna 2025, odr\u00e1\u017e\u00ed rostouc\u00ed intern\u00ed i extern\u00ed obavy z p\u0159etrv\u00e1vaj\u00edc\u00edho po\u0161kozen\u00ed srdce a p\u0159edstavuje kritick\u00fd zlom ve vl\u00e1dn\u00ed politice bezpe\u010dnosti vakc\u00edn.<\/span><\/p>\n<p><span dir=\"auto\">Dr. Prasad zd\u016fraznil, \u017ee nov\u00e9 ozna\u010den\u00ed vyvinuli v\u011bdci z FDA a kone\u010dn\u00e9 schv\u00e1len\u00ed prob\u011bhlo p\u0159ed jeho n\u00e1stupem do funkce. Varov\u00e1n\u00ed obsahuje dv\u011b kl\u00ed\u010dov\u00e1 zji\u0161t\u011bn\u00ed:<\/span><\/p>\n<ul>\n<li><strong><span dir=\"auto\">P\u0159etrv\u00e1vaj\u00edc\u00ed riziko<\/span><\/strong><span dir=\"auto\">\u00a0: Hrub\u00fd v\u00fdskyt myokarditidy 27 p\u0159\u00edpad\u016f na milion (1 z 37 000) u mu\u017e\u016f ve v\u011bku 12\u201324 let na z\u00e1klad\u011b \u00fadaj\u016f o l\u00e9kov\u00e9 form\u011b za obdob\u00ed 2023\u20132024.<\/span><\/li>\n<li><strong><span dir=\"auto\">D\u016fkazy po\u0161kozen\u00ed srdce<\/span><\/strong><span dir=\"auto\">\u00a0: P\u0159etrv\u00e1vaj\u00edc\u00ed pozdn\u00ed gadoliniov\u00e9 zes\u00edlen\u00ed (LGE) na magnetick\u00e9 rezonanci srdce u v\u011bt\u0161iny hospitalizovan\u00fdch p\u0159\u00edpad\u016f myokarditidy po o\u010dkov\u00e1n\u00ed \u2013 indik\u00e1tor nebenign\u00edho, potenci\u00e1ln\u011b nevratn\u00e9ho po\u0161kozen\u00ed.<\/span><\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">D\u016fle\u017eit\u00e9 poznatky: Dlouhodob\u00e9 po\u0161kozen\u00ed srdce nesm\u00ed b\u00fdt ignorov\u00e1no<\/span><\/h3>\n<ul>\n<li><strong><span dir=\"auto\">Perzistence LGE<\/span><\/strong><span dir=\"auto\">\u00a0: Ve studii financovan\u00e9 FDA z roku 2024 se u 60 % hospitalizovan\u00fdch pacient\u016f s myokarditidou vyvolanou vakc\u00ednou projevovala LGE i p\u011bt m\u011bs\u00edc\u016f po o\u010dkov\u00e1n\u00ed. Glob\u00e1ln\u00ed p\u0159ehled literatury dokonce zjistil m\u00edru perzistence 72 %.<\/span><\/li>\n<li><strong><span dir=\"auto\">Klinick\u00fd v\u00fdznam<\/span><\/strong><span dir=\"auto\">\u00a0: LGE se nepova\u017euje za benign\u00ed n\u00e1lez \u2013 v jin\u00fdch kardiologick\u00fdch kontextech je spojov\u00e1n se \u0161patnou progn\u00f3zou, jako je srde\u010dn\u00ed selh\u00e1n\u00ed a \u00famrt\u00ed.<\/span><\/li>\n<li><strong><span dir=\"auto\">Podcen\u011bn\u00e1 rizika<\/span><\/strong><span dir=\"auto\">\u00a0: Americk\u00e9 syst\u00e9my sledov\u00e1n\u00ed, jako je Vaccine Safety Datalink (VSD), podcenily incidenci kv\u016fli zpo\u017ed\u011bn\u00edm v postupech k\u00f3dov\u00e1n\u00ed a hl\u00e1\u0161en\u00ed; v n\u011bkter\u00fdch studi\u00edch bylo skute\u010dn\u00e9 riziko u mlad\u00fdch mu\u017e\u016f po druh\u00e9 d\u00e1vce p\u0159ibli\u017en\u011b 1 z 2 000\u20133 000.<\/span><\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Znepokojiv\u00fd p\u0159\u00edb\u011bh o odkladu a pop\u00edr\u00e1n\u00ed<\/span><\/h3>\n<p><span dir=\"auto\">Prezentace odhalila \u010detn\u00e9 nedostatky v ran\u00e9 komunikaci o bezpe\u010dnosti:<\/span><\/p>\n<ul>\n<li><strong><span dir=\"auto\">V\u010dasn\u00e9 potla\u010den\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0: Navzdory varov\u00e1n\u00edm Izraele a \u00fadaj\u016fm americk\u00e9ho ministerstva obrany z po\u010d\u00e1tku roku 2021 CDC a FDA sign\u00e1l myokarditidy v dubnu 2021 pop\u0159ely.<\/span><\/li>\n<li><strong><span dir=\"auto\">Politick\u00e9 vm\u011b\u0161ov\u00e1n\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0: Intern\u00ed e-maily ukazuj\u00ed, \u017ee B\u00edl\u00fd d\u016fm za Bidena zve\u0159ejnil argumenty bagatelizuj\u00edc\u00ed riziko jen n\u011bkolik dn\u00ed po intern\u00edm potvrzen\u00ed CDC\/FDA.<\/span><\/li>\n<li><strong><span dir=\"auto\">Blokovan\u00e1 upozorn\u011bn\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0: Pl\u00e1novan\u00e9 upozorn\u011bn\u00ed na myokarditidu od s\u00edt\u011b CDC Health Alert Network bylo zablokov\u00e1no a zve\u0159ejn\u011bno pouze na webov\u00fdch str\u00e1nk\u00e1ch.<\/span><\/li>\n<\/ul>\n<p><span dir=\"auto\">Tato odhalen\u00ed vyvol\u00e1vaj\u00ed v\u00e1\u017en\u00e9 ot\u00e1zky ohledn\u011b politizace monitorov\u00e1n\u00ed bezpe\u010dnosti vakc\u00edn v dob\u011b masivn\u00edch imuniza\u010dn\u00edch kampan\u00ed.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Promarn\u011bn\u00e9 p\u0159\u00edle\u017eitosti k omezen\u00ed \u0161kod<\/span><\/h3>\n<p><span dir=\"auto\">Na rozd\u00edl od USA reagovali evrop\u0161t\u00ed regul\u00e1to\u0159i mnohem rozhodn\u011bji:<\/span><\/p>\n<ul>\n<li><strong><span dir=\"auto\">Del\u0161\u00ed intervaly mezi d\u00e1vkami<\/span><\/strong><span dir=\"auto\">\u00a0: Rok p\u0159ed zaveden\u00edm CDC zavedly evropsk\u00e9 \u00fa\u0159ady del\u0161\u00ed intervaly mezi d\u00e1vkami.<\/span><\/li>\n<li><strong><span dir=\"auto\">V\u011bkov\u00e1 omezen\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0: N\u011bkolik zem\u00ed EU v\u00fdrazn\u011b omezilo pou\u017e\u00edv\u00e1n\u00ed mRNA vakc\u00edn u mlad\u00fdch lid\u00ed \u2013 USA to v\u0161ak neud\u011blaly.<\/span><\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">V\u00edce ne\u017e jen statistiky: dopad na re\u00e1ln\u00fd sv\u011bt<\/span><\/h3>\n<ul class=\"wp-block-list\">\n<li><strong><span dir=\"auto\">\u00dadaje CDC (2022)<\/span><\/strong><span dir=\"auto\">\u00a0:<\/span><\/li>\n<\/ul>\n<ul>\n<li><span dir=\"auto\">25 % posti\u017een\u00fdch dosp\u00edvaj\u00edc\u00edch muselo b\u00fdt p\u0159ijato na jednotku intenzivn\u00ed p\u00e9\u010de.<\/span><\/li>\n<li><span dir=\"auto\">V\u00edce ne\u017e 30 % m\u011blo o n\u011bkolik m\u011bs\u00edc\u016f pozd\u011bji omezenou fyzickou aktivitu.<\/span><\/li>\n<li><span dir=\"auto\">17 % se po 90 dnech pln\u011b nezotavilo.<\/span><\/li>\n<li><em><span dir=\"auto\">V \u010dasopise New England Journal of Medicine<\/span><\/em><span dir=\"auto\">\u00a0byl zdokumentov\u00e1n nejm\u00e9n\u011b jeden smrteln\u00fd p\u0159\u00edpad\u00a0\u2013 je pravd\u011bpodobn\u00e9, \u017ee jich bude v\u00edce.<\/span><\/li>\n<li><strong><span dir=\"auto\">Subklinick\u00e9 a fat\u00e1ln\u00ed spektrum<\/span><\/strong><span dir=\"auto\">\u00a0: Myokarditida se li\u0161\u00ed z\u00e1va\u017enost\u00ed, od m\u00edrn\u00e9 a\u017e po fat\u00e1ln\u00ed. Obzvl\u00e1\u0161t\u011b alarmuj\u00edc\u00ed: I p\u0159i m\u00edrn\u00fdch p\u0159\u00edznac\u00edch je LGE pova\u017eov\u00e1na za negativn\u00ed prognostick\u00fd znak.<\/span><\/li>\n<\/ul>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Nov\u00fd postoj FDA: Vy\u017eaduj\u00ed se randomizovan\u00e9 kontrolovan\u00e9 studie, d\u016fv\u011bra je podrobena zkou\u0161ce<\/span><\/h3>\n<p><span dir=\"auto\">Vzhledem k klesaj\u00edc\u00ed d\u016fv\u011b\u0159e ve\u0159ejnosti a m\u011bn\u00edc\u00edmu se pom\u011bru rizik a p\u0159\u00ednos\u016f nyn\u00ed FDA vyz\u00fdv\u00e1 k:<\/span><\/p>\n<ul>\n<li><strong><span dir=\"auto\">Randomizovan\u00e9 kontrolovan\u00e9 studie (RCT)<\/span><\/strong><span dir=\"auto\">\u00a0pro budouc\u00ed posilova\u010de mRNA u zdrav\u00fdch Ameri\u010dan\u016f mlad\u0161\u00edch 65 let.<\/span><\/li>\n<li><strong><span dir=\"auto\">Individu\u00e1ln\u00ed doporu\u010den\u00ed d\u00e1vkov\u00e1n\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0na z\u00e1klad\u011b anamn\u00e9zy infekce a rizikov\u00e9ho profilu \u2013 zejm\u00e9na u mlad\u00fdch mu\u017e\u016f.<\/span><\/li>\n<li><strong><span dir=\"auto\">Transparentn\u00ed monitorov\u00e1n\u00ed zabezpe\u010den\u00ed<\/span><\/strong><span dir=\"auto\">\u00a0s pr\u016fb\u011b\u017en\u00fdmi aktualizacemi \u0161t\u00edtk\u016f, jakmile jsou k dispozici nov\u00e1 data.<\/span><\/li>\n<\/ul>\n<p><span dir=\"auto\">Poselstv\u00ed je jasn\u00e9: \u00c9ra plo\u0161n\u00e9 o\u010dkovac\u00ed politiky skon\u010dila. FDA op\u011bt bere svou regula\u010dn\u00ed roli v\u00e1\u017en\u011b \u2013 opo\u017ed\u011bn\u011b, ale odhodlan\u011b.<\/span><\/p>\n<h3 class=\"wp-block-heading\"><span dir=\"auto\">Z\u00e1v\u011br zku\u0161ebn\u00edho centra<\/span><\/h3>\n<p><span dir=\"auto\">Aktualizace ozna\u010den\u00ed myokarditidy z \u010dervna 2025 p\u0159edstavuje zlomov\u00fd bod. Je to tich\u00e9 p\u0159izn\u00e1n\u00ed, \u017ee feder\u00e1ln\u00ed agentury po l\u00e9ta ignorovaly nebo bagatelizovaly legitimn\u00ed bezpe\u010dnostn\u00ed sign\u00e1ly \u2013 pravd\u011bpodobn\u011b pod politick\u00fdm tlakem.<\/span><\/p>\n<p><span dir=\"auto\">FDA nyn\u00ed m\u011bn\u00ed sv\u016fj kurz \u2013 zakl\u00e1d\u00e1 se na v\u011bd\u011b a zam\u011b\u0159uje se na transparentnost. To ale nesta\u010d\u00ed. Nyn\u00ed je zapot\u0159eb\u00ed odpov\u011bdnost:<\/span><\/p>\n<ul>\n<li><strong><span dir=\"auto\">Pro\u010d byla v\u010dasn\u00e1 varov\u00e1n\u00ed potla\u010dena?<\/span><\/strong><\/li>\n<li><strong><span dir=\"auto\">Pro\u010d byly ignorov\u00e1ny osv\u011bd\u010den\u00e9 strategie zm\u00edr\u0148ov\u00e1n\u00ed rizik?<\/span><\/strong><\/li>\n<li><strong><span dir=\"auto\">A p\u0159edev\u0161\u00edm: Kdo je zodpov\u011bdn\u00fd za d\u016fsledky tohoto zpo\u017ed\u011bn\u00ed?<\/span><\/strong><\/li>\n<\/ul>\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-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:\/\/www.trialsitenews.com\/a\/fda-issues-class-wide-myocarditis-warning-for-mrna-covid-19-vaccines-amid-mounting-evidence-of-persistent-cardiac-injury-4fdf3fe2\" 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>mRNA vakc\u00edna proti COVID-19 p\u0159edstavuje p\u0159etrv\u00e1vaj\u00edc\u00ed riziko myokarditidy se zn\u00e1mkami dlouhodob\u00e9ho po\u0161kozen\u00ed srdce, zejm\u00e9na u&#8230;<\/p>\n","protected":false},"author":2,"featured_media":42959,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[694,213,839,37,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/84571"}],"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=84571"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/84571\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/42959"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=84571"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=84571"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=84571"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}