{"id":119482,"date":"2026-10-27T00:24:10","date_gmt":"2026-10-26T23:24:10","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=119482"},"modified":"2026-10-26T14:51:29","modified_gmt":"2026-10-26T13:51:29","slug":"smrtelna-myokarditida-po-ockovani-fda-nereaguje-na-varovani-vlastnich-expertu","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2026\/10\/27\/smrtelna-myokarditida-po-ockovani-fda-nereaguje-na-varovani-vlastnich-expertu\/","title":{"rendered":"Smrteln\u00e1 myokarditida po o\u010dkov\u00e1n\u00ed: FDA nereaguje na varov\u00e1n\u00ed vlastn\u00edch expert\u016f"},"content":{"rendered":"
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Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) vy\u0161et\u0159oval \u00famrt\u00ed nezletil\u00fdch po o\u010dkov\u00e1n\u00ed proti COVID-19. Jeho bezpe\u010dnostn\u00ed experti vyhodnotili sedm p\u0159\u00edpad\u016f jako p\u0159\u00edpady, kter\u00e9 mohou nebo pravd\u011bpodobn\u011b souvisej\u00ed s o\u010dkov\u00e1n\u00edm, a v prosinci 2025 doporu\u010dili v\u00fdslovn\u00e9 varov\u00e1n\u00ed p\u0159ed fat\u00e1ln\u00ed myokarditidou. I po v\u00edce ne\u017e deseti m\u011bs\u00edc\u00edch toto varov\u00e1n\u00ed st\u00e1le chyb\u00ed. Ani za vl\u00e1dy ministra zdravotnictv\u00ed a soci\u00e1ln\u00edch slu\u017eeb Roberta F. Kennedyho Jr. nebyl po\u017eadovan\u00fd dodatek k informac\u00edm o p\u0159\u00edpravku dosud proveden.<\/span><\/strong><\/p>\n

Intern\u00ed e-mail ze dne 5. prosince 2025 postavil americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) do obt\u00ed\u017en\u00e9 situace. Dr. Meghna Alimchandani z divize pro bezpe\u010dnost l\u00e9\u010div FDA doporu\u010dila Vinayovi Prasadovi, tehdej\u0161\u00edmu vedouc\u00edmu t\u00fdmu pro v\u00fdvoj vakc\u00edn, aby varov\u00e1n\u00ed t\u00fdkaj\u00edc\u00ed se injekc\u00ed mRNA genu COVID-19 byla upravena tak, aby zahrnovala riziko fat\u00e1ln\u00ed myokarditidy. Jej\u00ed t\u00fdm pl\u00e1noval prezentovat zji\u0161t\u011bn\u00ed p\u0159\u00edslu\u0161n\u00e9mu panelu FDA 11. prosince. Po\u017eadovan\u00e9 zn\u011bn\u00ed v\u0161ak dodnes nen\u00ed zahrnuto v aktu\u00e1ln\u00edch informac\u00edch o p\u0159edepisov\u00e1n\u00ed l\u00e9k\u016f ani pro Pfizer, ani pro Modernu. Americk\u00fd sen\u00e1tor Ron Johnson <\/span>zve\u0159ejnil e-mail v \u010dervnu leto\u0161n\u00edho roku.<\/span><\/a><\/p>\n

T\u00e9m\u011b\u0159 sto mrtv\u00fdch nezletil\u00fdch<\/span><\/h3>\n

Doporu\u010den\u00ed n\u00e1sledovalo po vy\u0161et\u0159ov\u00e1n\u00ed 96 hl\u00e1\u0161en\u00fdch \u00famrt\u00ed nezletil\u00fdch osob, kter\u00e9 zem\u0159ely mezi lety 2021 a 2024 po pod\u00e1n\u00ed genov\u00e9 injekce COVID-19. Kontrolo\u0159i FDA zpo\u010d\u00e1tku identifikovali deset p\u0159\u00edpad\u016f, u kter\u00fdch spat\u0159ovali mo\u017enou nebo pravd\u011bpodobnou souvislost s vakc\u00ednou. Po dal\u0161\u00edm p\u0159ezkoum\u00e1n\u00ed zb\u00fdvalo sedm p\u0159\u00edpad\u016f: dva byly odborn\u00edky klasifikov\u00e1ny jako pravd\u011bpodobn\u011b souvisej\u00edc\u00ed s o\u010dkov\u00e1n\u00edm a p\u011bt jako p\u0159\u00edpady, kter\u00e9 mohly souviset s o\u010dkov\u00e1n\u00edm. Myokarditida hr\u00e1la roli v p\u011bti z t\u011bchto sedmi \u00famrt\u00ed. V \u017e\u00e1dn\u00e9m p\u0159\u00edpad\u011b nebylo mo\u017en\u00e9 stanovit definitivn\u00ed kauz\u00e1ln\u00ed souvislost a jin\u00e9 p\u0159\u00ed\u010diny \u00famrt\u00ed nebylo mo\u017en\u00e9 d\u016fsledn\u011b vylou\u010dit. Nicm\u00e9n\u011b zji\u0161t\u011bn\u00ed byla dostate\u010dn\u00e1 k tomu, aby odpov\u011bdn\u00ed bezpe\u010dnostn\u00ed experti doporu\u010dili dal\u0161\u00ed varov\u00e1n\u00ed.<\/span><\/p>\n

Riziko myokarditidy bylo americk\u00fdm \u00fa\u0159ad\u016fm zn\u00e1mo mnohem d\u0159\u00edve. Server Report24 je\u0161t\u011b v z\u00e1\u0159\u00ed <\/span>informoval<\/span><\/a> o tom, jak Izrael ji\u017e na za\u010d\u00e1tku roku 2021 hl\u00e1sil mezin\u00e1rodn\u00edm zdravotnick\u00fdm org\u00e1n\u016fm neobvykl\u00e9 p\u0159\u00edpady myokarditidy u mlad\u0161\u00edch osob o\u010dkovan\u00fdch vakc\u00ednou Pfizer. Odpov\u00eddaj\u00edc\u00ed informace obdr\u017eely i FDA a CDC. Navzdory tomu FDA v kv\u011btnu 2021 roz\u0161\u00ed\u0159ila povolen\u00ed k nouzov\u00e9mu pou\u017eit\u00ed vakc\u00edny Pfizer i na d\u011bti ve v\u011bku 12 a\u017e 15 let. Ofici\u00e1ln\u00ed varov\u00e1n\u00ed bylo vyd\u00e1no a\u017e koncem \u010dervna.<\/span><\/p>\n

Zn\u00e1m\u00e9 nebezpe\u010d\u00ed<\/span><\/h3>\n

V \u010dervnu 2025, za nov\u00e9 Trumpovy administrativy, FDA <\/span>zp\u0159\u00edsnila<\/span><\/a> sv\u00e1 bezpe\u010dnostn\u00ed varov\u00e1n\u00ed pro spole\u010dnosti Pfizer a Moderna. Agentura citovala anal\u00fdzy, kter\u00e9 ukazuj\u00ed, \u017ee u dosp\u00edvaj\u00edc\u00edch mu\u017e\u016f a mlad\u00fdch dosp\u011bl\u00fdch ve v\u011bku 12 a\u017e 24 let bylo do jednoho t\u00fddne od pod\u00e1n\u00ed d\u00e1vky zaznamen\u00e1no p\u0159ibli\u017en\u011b 27 p\u0159\u00edpad\u016f myokarditidy nebo perikarditidy na milion d\u00e1vek vakc\u00edn mRNA 2023\/24. V\u00fdrobci byli tak\u00e9 povinni uznat p\u0159etrv\u00e1vaj\u00edc\u00ed abnormality pozorovan\u00e9 na magnetick\u00e9 rezonanci srdce. N\u00e1sledn\u00e1 vy\u0161et\u0159en\u00ed p\u0159ibli\u017en\u011b p\u011bt m\u011bs\u00edc\u016f po o\u010dkov\u00e1n\u00ed odhalila u n\u011bkter\u00fdch pacient\u016f p\u0159etrv\u00e1vaj\u00edc\u00ed abnormality srde\u010dn\u00edho svalu. Pro v\u011bt\u0161inu posti\u017een\u00fdch to znamen\u00e1, \u017ee budou muset \u017e\u00edt s celo\u017eivotn\u00edmi zdravotn\u00edmi omezen\u00edmi.<\/span><\/p>\n

Pohled na aktu\u00e1ln\u00ed informace o produktu zd\u016fraz\u0148uje probl\u00e9m s ozna\u010dov\u00e1n\u00edm. Spole\u010dnost Pfizer uzn\u00e1v\u00e1 zv\u00fd\u0161en\u00e9 riziko myokarditidy a perikarditidy u vakc\u00edny <\/span>Comiraty<\/span><\/a> a uv\u00e1d\u00ed, \u017ee n\u011bkte\u0159\u00ed posti\u017een\u00ed jedinci vy\u017eadovali intenzivn\u00ed p\u00e9\u010di. Z\u00e1rove\u0148 informace uv\u00e1d\u011bj\u00ed, \u017ee p\u0159\u00edznaky obvykle odezn\u00ed b\u011bhem n\u011bkolika dn\u00ed p\u0159i konzervativn\u00ed l\u00e9\u010db\u011b. Ve verzi ze srpna 2026 chyb\u00ed v\u00fdslovn\u00e9 varov\u00e1n\u00ed p\u0159ed fat\u00e1ln\u00edmi n\u00e1sledky. Situace je podobn\u00e1 u vakc\u00edny <\/span>Spikevax<\/span><\/a> od spole\u010dnosti Moderna . Oba v\u00fdrobci uv\u00e1d\u011bj\u00ed myokarditidu jako uzn\u00e1van\u00fd vedlej\u0161\u00ed \u00fa\u010dinek, ale po\u017eadovan\u00fd dodatek, o kter\u00fd bylo po\u017e\u00e1d\u00e1no v prosinci, nebyl zahrnut.<\/span><\/p>\n

Ticho v lese<\/span><\/h3>\n

Americk\u00fd sen\u00e1tor Ron Johnson proto cht\u011bl v\u011bd\u011bt, co se stalo v r\u00e1mci FDA. Ve sv\u00e9m <\/span>dopise<\/span><\/a> ze 16. \u010dervna 2026 ministrovi zdravotnictv\u00ed Kennedymu a dal\u0161\u00edm \u00fa\u0159edn\u00edk\u016fm agentury po\u017eadoval informace o tom, zda se konzultace pl\u00e1novan\u00e1 na 11. prosince v\u016fbec uskute\u010dnila. Pokud bylo doporu\u010den\u00ed zam\u00edtnuto, m\u011bla by FDA poskytnout vysv\u011btlen\u00ed. Johnson si tak\u00e9 vy\u017e\u00e1dal dokumenty t\u00fdkaj\u00edc\u00ed se intern\u00ed komunikace agentury ohledn\u011b podez\u0159el\u00fdch \u00famrt\u00ed souvisej\u00edc\u00edch s o\u010dkov\u00e1n\u00edm. Kdo a z jak\u00fdch d\u016fvod\u016f nakonec varov\u00e1n\u00ed odlo\u017eil, z dosud zve\u0159ejn\u011bn\u00fdch dokument\u016f nen\u00ed jasn\u00e9.<\/span><\/p>\n

Ministr zdravotnictv\u00ed Robert F. Kennedy Jr. sl\u00edbil d\u016fkladn\u00fd p\u0159ezkum politiky o\u010dkov\u00e1n\u00ed proti COVID-19 a v\u011bt\u0161\u00ed transparentnost, pokud jde o bezpe\u010dnost vakc\u00edn. Jeho FDA ji\u017e zp\u0159\u00edsnila varov\u00e1n\u00ed p\u0159ed myokarditidou a zah\u00e1jila dal\u0161\u00ed vy\u0161et\u0159ov\u00e1n\u00ed potenci\u00e1ln\u00edch po\u0161kozen\u00ed zdrav\u00ed vakc\u00ednou. Absence aktualizace o mo\u017en\u00fdch fat\u00e1ln\u00edch d\u016fsledc\u00edch je proto o to matouc\u00ed. Koneckonc\u016f, doporu\u010den\u00ed vzniklo v r\u00e1mci vlastn\u00edho bezpe\u010dnostn\u00edho odd\u011blen\u00ed FDA. Investigativn\u00ed novin\u00e1\u0159 Paul D. Thacker se k t\u00e9to ot\u00e1zce nyn\u00ed vr\u00e1til a <\/span>informoval<\/span><\/a> o intern\u00edch sporech kolem bezpe\u010dnosti vakc\u00edn. Ve\u0159ejn\u011b srozumiteln\u00e9 vysv\u011btlen\u00ed, pro\u010d FDA dosud toto varov\u00e1n\u00ed nep\u0159ijala, zat\u00edm chyb\u00ed.<\/span><\/p>\n

FDA po\u017eaduje, aby v\u00fdrobci vakc\u00edn poskytovali podrobn\u00e9 informace o zn\u00e1m\u00fdch rizic\u00edch a vedlej\u0161\u00edch \u00fa\u010dinc\u00edch. Nyn\u00ed sama dlu\u017e\u00ed vysv\u011btlen\u00ed: Pro\u010d se v\u00fdslovn\u00e9 varov\u00e1n\u00ed p\u0159ed potenci\u00e1ln\u011b smrtelnou myokarditidou nedostalo do informac\u00ed o p\u0159\u00edpravku v\u00edce ne\u017e deset m\u011bs\u00edc\u016f, p\u0159esto\u017ee jej\u00ed vlastn\u00ed bezpe\u010dnostn\u00ed experti p\u0159esn\u011b to doporu\u010duj\u00ed?<\/span><\/p>\n

\"\"<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) vy\u0161et\u0159oval \u00famrt\u00ed nezletil\u00fdch po o\u010dkov\u00e1n\u00ed proti COVID-19….<\/p>\n","protected":false},"author":2,"featured_media":119483,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,2340,37,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/119482"}],"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=119482"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/119482\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/119483"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=119482"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=119482"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=119482"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}