{"id":10383,"date":"2022-05-09T01:40:23","date_gmt":"2022-05-08T23:40:23","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=10383"},"modified":"2022-05-08T15:02:55","modified_gmt":"2022-05-08T13:02:55","slug":"pote-co-americka-agentura-fda-omezila-pouziti-vakciny-jj-kvuli-poruse-krevni-srazlivosti-odbornici-hlasi-ockovani-od-pfizer-a-moderna-predstavuje-podobne-riziko","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2022\/05\/09\/pote-co-americka-agentura-fda-omezila-pouziti-vakciny-jj-kvuli-poruse-krevni-srazlivosti-odbornici-hlasi-ockovani-od-pfizer-a-moderna-predstavuje-podobne-riziko\/","title":{"rendered":"Pot\u00e9, co americk\u00e1 agentura FDA omezila pou\u017eit\u00ed vakc\u00edny J&J kv\u016fli poru\u0161e krevn\u00ed sr\u00e1\u017elivosti, odborn\u00edci hl\u00e1s\u00ed: O\u010dkov\u00e1n\u00ed od Pfizer a Moderna p\u0159edstavuje podobn\u00e9 riziko!"},"content":{"rendered":"
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Americk\u00fd \u00da\u0159ad pro potraviny a l\u00e9\u010diva (FDA) ve \u010dtvrtek p\u0159\u00edsn\u011b omezil pou\u017e\u00edv\u00e1n\u00ed vakc\u00edny Johnson & Johnson’s COVID-19 kv\u016fli riziku poruchy krevn\u00ed sr\u00e1\u017elivosti, ale odborn\u00edci tvrd\u00ed, \u017ee Pfizer a Moderna \u010del\u00ed podobn\u00fdm rizik\u016fm.<\/span><\/p>\n

Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) ve \u010dtvrtek vydal p\u0159\u00edsn\u00e1 omezen\u00ed pou\u017e\u00edv\u00e1n\u00ed vakc\u00edny Johnson & Johnson (J&J) COVID-19 s odkazem na riziko krv\u00e1civ\u00e9 poruchy, kterou agentura ozna\u010dila za \u201evz\u00e1cnou a potenci\u00e1ln\u011b \u017eivot ohro\u017euj\u00edc\u00ed\u201c. „ur\u010deno.<\/span><\/p>\n

Ve \u010dtvrte\u010dn\u00edm prohl\u00e1\u0161en\u00ed FDA uvedl, \u017ee riziko vzniku tromb\u00f3zy s trombocytopenick\u00fdm syndromem (TTS) po pod\u00e1n\u00ed vakc\u00edny u p\u0159\u00edjemc\u016f vakc\u00edny vy\u017eaduje omezen\u00ed schv\u00e1len\u00e9ho pou\u017eit\u00ed vakc\u00edny.<\/span><\/p>\n

FDA uvedl, \u017ee identifikoval 60 p\u0159\u00edpad\u016f tromb\u00f3zy souvisej\u00edc\u00ed s vakc\u00ednou s trombocytopenick\u00fdm syndromem, v\u010detn\u011b dev\u00edti \u00famrt\u00ed, z asi 18 milion\u016f podan\u00fdch d\u00e1vek – a\u010dkoli tento stav je pravd\u011bpodobn\u011b nedostate\u010dn\u011b hl\u00e1\u0161en.<\/span><\/p>\n

Podle FDA jsou TTS z vakc\u00edny J&J nejv\u00edce ohro\u017eeny \u017eeny ve v\u011bku 30 a\u017e 49 let, p\u0159i\u010dem\u017e p\u0159ibli\u017en\u011b osm p\u0159\u00edpad\u016f na 1 milion podan\u00fdch d\u00e1vek vakc\u00edny.<\/span><\/p>\n

Podle nejnov\u011bj\u0161\u00edch \u00fadaj\u016f ze Syst\u00e9mu hl\u00e1\u0161en\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f vakc\u00edn (VAERS) bylo mezi 14. prosincem 2020 a 29. dubnem 2022 ve Spojen\u00fdch st\u00e1tech hl\u00e1\u0161eno 13 873 poruch krv\u00e1civosti po o\u010dkov\u00e1n\u00ed proti COVID-19.<\/span><\/p>\n

Z toho bylo 6 227 zpr\u00e1v p\u0159ips\u00e1no spole\u010dnosti Pfizer, 4 943 zpr\u00e1v spole\u010dnosti Moderna a 2 662 zpr\u00e1v spole\u010dnosti J&J.<\/span><\/p>\n

K 29. dubnu bylo ve Spojen\u00fdch st\u00e1tech pod\u00e1no 575 milion\u016f d\u00e1vek vakc\u00edny COVID-19, v\u010detn\u011b 339 milion\u016f d\u00e1vek od spole\u010dnosti Pfizer, 217 milion\u016f d\u00e1vek od spole\u010dnosti Moderna a 19 milion\u016f d\u00e1vek od spole\u010dnosti J&J.<\/span><\/p>\n

Agentura uvedla, \u017ee \u201ezn\u00e1m\u00e9 a potenci\u00e1ln\u00ed p\u0159\u00ednosy\u201c vakc\u00edny J&J v prevenci COVID-19 p\u0159eva\u017euj\u00ed nad zn\u00e1m\u00fdmi a potenci\u00e1ln\u00edmi riziky pro osoby ve v\u011bku 18 let a star\u0161\u00ed, \u201epro kter\u00e9 nejsou jin\u00e9 schv\u00e1len\u00e9 nebo schv\u00e1len\u00e9 vakc\u00edny proti COVID-19 dostupn\u00e9 nebo klinicky dostupn\u00e9. \u201enejsou zp\u016fsobil\u00ed\u201c nebo \u201ekte\u0159\u00ed si vyberou vakc\u00ednu proti COVID-19 od spole\u010dnosti Janssen, proto\u017ee by jinak vakc\u00ednu proti COVID-19 nedostali.\u201c<\/span><\/p>\n

Agentura popsala TTS jako \u201esyndrom vz\u00e1cn\u00fdch a potenci\u00e1ln\u011b \u017eivot ohro\u017euj\u00edc\u00edch krevn\u00edch sra\u017eenin spojen\u00fdch s n\u00edzk\u00fdm po\u010dtem krevn\u00edch desti\u010dek s n\u00e1stupem p\u0159\u00edznak\u016f p\u0159ibli\u017en\u011b jeden a\u017e dva t\u00fddny po pod\u00e1n\u00ed vakc\u00edny Janssen [J&J] COVID-19.<\/span><\/p>\n

Aktualizovan\u00e1 omezen\u00ed povolen\u00ed k nouzov\u00e9mu pou\u017eit\u00ed (EUA) vakc\u00edny prod\u00e1van\u00e9 pod zna\u010dkou Janssen se vztahuj\u00ed tak\u00e9 na posilovac\u00ed d\u00e1vky, uvedla CNN.<\/span><\/p>\n

Mezi lidi, kte\u0159\u00ed st\u00e1le mohou dostat vakc\u00ednu Janssen, pat\u0159\u00ed:<\/span><\/p>\n

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  • Jedinci, kte\u0159\u00ed m\u011bli z\u00e1va\u017enou alergickou reakci na mRNA vakc\u00edny Pfizer\/BioNTech nebo Moderna.<\/span><\/li>\n
  • Jednotlivci, kte\u0159\u00ed maj\u00ed osobn\u00ed obavy z mRNA vakc\u00edn a necht\u011bj\u00ed se nechat o\u010dkovat, pokud si nemohou vybrat vakc\u00ednu Janssen.<\/span><\/li>\n
  • Jednotlivci, kte\u0159\u00ed maj\u00ed omezen\u00fd p\u0159\u00edstup k mRNA vakc\u00edn\u00e1m COVID-19.<\/span><\/li>\n<\/ul>\n

    P\u0159\u00edznaky TTS zahrnuj\u00ed du\u0161nost, bolest na hrudi, otoky nohou, p\u0159etrv\u00e1vaj\u00edc\u00ed bolesti b\u0159icha, neurologick\u00e9 p\u0159\u00edznaky (jako je bolest hlavy nebo rozmazan\u00e9 vid\u011bn\u00ed) nebo \u010derven\u00e9 skvrny t\u011bsn\u011b pod k\u016f\u017e\u00ed zvan\u00e9 \u201epetechie\u201c, kter\u00e9 se objevuj\u00ed za m\u00edstem vpichu.<\/span><\/p>\n

    Odborn\u00edci se ptaj\u00ed na na\u010dasov\u00e1n\u00ed a pro\u010d pr\u00e1v\u011b J&J?<\/span><\/strong><\/p>\n

    Peter Marks, MD, Ph.D., \u0159editel Centra pro biologick\u00e9 hodnocen\u00ed a v\u00fdzkum FDA, uvedl, \u017ee omezen\u00ed schv\u00e1len\u00e9ho pou\u017eit\u00ed vakc\u00edny Janssen demonstruje robustnost na\u0161ich syst\u00e9m\u016f bezpe\u010dnostn\u00edho dohledu a n\u00e1\u0161 z\u00e1vazek zajistit, aby v\u011bda a data podporovaly na\u0161i p\u0159\u00edru\u010dku. rozhodnut\u00ed\u201c.<\/span><\/p>\n

    Marks \u0159ekl:<\/span><\/p>\n

    \u201ePozorn\u011b jsme sledovali vakc\u00ednu Janssen proti COVID-19 a vznik TTS po jej\u00edm pod\u00e1n\u00ed a pou\u017eili jsme aktu\u00e1ln\u00ed informace z na\u0161ich syst\u00e9m\u016f bezpe\u010dnostn\u00edho dohledu k revizi EEA.<\/span><\/p>\n

    „Agentura bude i nad\u00e1le sledovat bezpe\u010dnost vakc\u00edny Janssen COVID-19 a v\u0161ech ostatn\u00edch vakc\u00edn a stejn\u011b jako b\u011bhem pandemie d\u016fkladn\u011b vyhodnot\u00ed nov\u00e9 bezpe\u010dnostn\u00ed informace.“<\/span><\/p>\n

    Brian Hooker, Ph.D., PE, hlavn\u00ed v\u011bdeck\u00fd pracovn\u00edk organizace Children’s Health Defense a profesor biologie na Simpsonov\u011b univerzit\u011b, v\u0161ak vid\u00ed novinky jinak.<\/span><\/p>\n

    Zd\u00e1 se, \u017ee FDA mluv\u00ed na rovinu skute\u010dnosti, \u017ee spike protein m\u016f\u017ee zp\u016fsobit sra\u017eeniny, a roz\u0161\u00ed\u0159en\u00fdm zpr\u00e1v\u00e1m o sra\u017eenin\u00e1ch t\u00edm, \u017ee potrestal Janssena, kter\u00fd se b\u011bhem pandemie stal \u201eml\u00e1ti\u010dem\u201c v\u00fdrobc\u016f vakc\u00edn proti COVID-19, \u201c \u0159\u00edk\u00e1 Hooker.<\/span><\/p>\n

    „Domn\u00edv\u00e1m se, \u017ee je to \u010d\u00e1ste\u010dn\u011b zp\u016fsobeno omezen\u00fdm pou\u017e\u00edv\u00e1n\u00edm vakc\u00edny Janssen v USA ve srovn\u00e1n\u00ed s Pfizer a Moderna,“ dodal.<\/span><\/p>\n

    Hooker \u0159ekl, \u017ee FDA m\u016f\u017ee omezit pou\u017eit\u00ed vakc\u00edny J&J, ani\u017e by to podstatn\u011b ovlivnilo celkovou distribuci vakc\u00edny, \u201ea p\u0159itom se zd\u00e1, \u017ee \u0159e\u0161\u00ed nes\u010detn\u00e9 mno\u017estv\u00ed ne\u017e\u00e1douc\u00edch p\u0159\u00edhod zp\u016fsoben\u00fdch v\u0161emi typy vakc\u00edn COVID-19\u201c.<\/span><\/p>\n

    Ve \u010dtvrtek CNN uvedla, \u017ee pouze 7,7 % lid\u00ed pova\u017eovan\u00fdch za pln\u011b o\u010dkovan\u00e9 dostalo vakc\u00ednu J&J.<\/span><\/p>\n

    Dr\u00a0Pierre Kory, zakladatel a prezident Front Line COVID-19 Critical Care Alliance, \u0159ekl The Defender:<\/span><\/p>\n

    Moje jedin\u00e1 hypot\u00e9za je, \u017ee tato akce je pokusem FDA tvrdit, \u017ee p\u0159ijala alespo\u0148 n\u011bjak\u00e1 opat\u0159en\u00ed na ochranu bezpe\u010dnosti ve\u0159ejnosti, jak\u00fdsi \u201esign\u00e1l ctnosti\u201c.<\/span><\/p>\n

    „Jako horliv\u00fd pozorovatel jejich akc\u00ed b\u011bhem pandemie pova\u017euji toto opat\u0159en\u00ed za hrub\u011b nedostate\u010dn\u00e9 a promy\u0161len\u00fd pokus zajistit pokra\u010dov\u00e1n\u00ed imunizace podobn\u011b nebezpe\u010dn\u00fdmi vakc\u00ednami.“<\/span><\/p>\n

    Dr\u00a0Meryl Nass zpochybnila na\u010dasov\u00e1n\u00ed omezen\u00ed EUA FDA.<\/span><\/p>\n

    „Pro\u010d FDA pr\u00e1v\u011b p\u0159ehodila smrteln\u00fd sp\u00edna\u010d na vakc\u00ednu Janssen, kdy\u017e v\u011bd\u011bla o probl\u00e9mech s tromb\u00f3zou od jej\u00edho po\u010d\u00e1tku?“ zeptal se Nass.<\/span><\/p>\n

    Nass pro The Defender \u0159ekl, \u017ee FDA mo\u017en\u00e1 v\u011bd\u011bla o probl\u00e9mu s tromb\u00f3zou je\u0161t\u011b p\u0159ed uveden\u00edm vakc\u00edny Janssen na trh, \u201eproto\u017ee platforma adenovirov\u00fdch vektor\u016f je ji\u017e v\u00edce ne\u017e 15 let zn\u00e1m\u00e1 jako n\u00e1chyln\u00e1 k tromb\u00f3ze\u201c.<\/span><\/p>\n

    Kory, kter\u00fd poznamenal, \u017ee v\u0161echny vakc\u00edny COVID-19 m\u011bly vysokou m\u00edru ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f, tak\u00e9 zpochybnil na\u010dasov\u00e1n\u00ed nov\u00fdch omezen\u00ed.<\/span><\/p>\n

    \u201eNa\u010dasov\u00e1n\u00ed t\u00e9to akce pova\u017euji za iracion\u00e1ln\u00ed a alarmuj\u00edc\u00ed vzhledem k rozs\u00e1hl\u00fdm \u00fadaj\u016fm z cel\u00e9ho sv\u011bta, z nich\u017e velk\u00e1 \u010d\u00e1st je cenzurov\u00e1na v m\u00e9di\u00edch a l\u00e9ka\u0159sk\u00fdch \u010dasopisech, \u017ee v\u0161echny vakc\u00edny COVID-19, nejen Janssen, jsou ji\u017e dlouho nep\u0159ijateln\u00e9 a vykazuj\u00ed \u010detn\u00e9 sign\u00e1ly toxicity krom\u011b poruch koagulace obsa\u017een\u00e9 v \u010detn\u00fdch farmakovigilan\u010dn\u00edch datab\u00e1z\u00edch a zpr\u00e1v\u00e1ch o epidemiologick\u00fdch \u00fadaj\u00edch a \u00fadaj\u00edch o ve\u0159ejn\u00e9m zdrav\u00ed,\u201c \u0159ekl Kory.<\/span><\/p>\n

    V dubnu 2021 ameri\u010dt\u00ed a evrop\u0161t\u00ed zdravotn\u00edci zkoumali, zda vakc\u00edny COVID-19 spole\u010dnosti J&J zp\u016fsobily krevn\u00ed sra\u017eeniny.<\/span><\/p>\n

    Ji\u017e nyn\u00ed v\u0161ak p\u0159ib\u00fdvalo d\u016fkaz\u016f, \u017ee vakc\u00edny Pfizer a Moderna mohou zp\u016fsobit podobn\u00e9 ne\u017e\u00e1douc\u00ed reakce.\u00a0Americk\u00e9 \u00fa\u0159ady byly na toto riziko upozorn\u011bny ji\u017e v prosinci 2020.<\/span><\/p>\n

    Centra pro kontrolu a prevenci nemoc\u00ed (CDC) v prosinci 2021 doporu\u010dila vakc\u00edny Pfizer a Moderna mRNA-COVID p\u0159ed vakc\u00ednou J&J kv\u016fli riziku krevn\u00edch sra\u017eenin, a\u010dkoli data uk\u00e1zala, \u017ee vakc\u00edny Pfizer a Moderna tak\u00e9 zp\u016fsobuj\u00ed poruchy krv\u00e1cen\u00ed.<\/span><\/p>\n

    V lednu 2021, kr\u00e1tce po uveden\u00ed vakc\u00edny Pfizer na trh v USA, The Defender informoval o \u00famrt\u00ed 56let\u00e9ho floridsk\u00e9ho l\u00e9ka\u0159e, u kter\u00e9ho se po pod\u00e1n\u00ed vakc\u00edny od Pfizeru rozvinula porucha krv\u00e1cen\u00ed a o 12 dn\u00ed pozd\u011bji zem\u0159el.<\/span><\/p>\n

    Ochr\u00e1nce tak\u00e9 uvedl \u010detn\u00e1 dal\u0161\u00ed \u00famrt\u00ed souvisej\u00edc\u00ed s poruchami krv\u00e1cen\u00ed, ke kter\u00fdm do\u0161lo po vakc\u00edn\u00e1ch Moderna a J&J.<\/span><\/p>\n

    Vakc\u00edna J&J z\u00edskala EUA 27. \u00fanora 2021.<\/span><\/p>\n

    Dne 13. dubna 2021 FDA a CDC pozastavily pou\u017e\u00edv\u00e1n\u00ed vakc\u00edny, aby pro\u0161et\u0159ily \u0161est hl\u00e1\u0161en\u00fdch p\u0159\u00edpad\u016f TTS.<\/span><\/p>\n

    \u00da\u0159ady zru\u0161ily pozastaven\u00ed pouh\u00fdch 10 dn\u00ed pot\u00e9, co potvrdily, \u017ee celkem 15 p\u0159\u00edpad\u016f TTS bylo hl\u00e1\u0161eno VAERS, v\u010detn\u011b \u0161esti p\u016fvodn\u011b hl\u00e1\u0161en\u00fdch p\u0159\u00edpad\u016f, z p\u0159ibli\u017en\u011b 8 milion\u016f podan\u00fdch d\u00e1vek.<\/span><\/p>\n<\/div>\n<\/div>\n

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    ZDROJ: FDA OMEZUJE POU\u017d\u00cdV\u00c1N\u00cd VAKC\u00cdNY J&J PROTI PORUCH\u00c1M SR\u00c1\u017dLIVOSTI KRVE, ALE ODBORN\u00cdCI TVRD\u00cd, \u017dE PFIZER, Z\u00c1B\u011aRY MODERNA P\u0158EDSTAVUJ\u00cd PODOBN\u00c9 RIZIKO<\/a><\/span><\/h3>\n

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

    Americk\u00fd \u00da\u0159ad pro potraviny a l\u00e9\u010diva (FDA) ve \u010dtvrtek p\u0159\u00edsn\u011b omezil pou\u017e\u00edv\u00e1n\u00ed vakc\u00edny Johnson &…<\/p>\n","protected":false},"author":2,"featured_media":5887,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[213,315,651,21],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/10383"}],"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=10383"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/10383\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/5887"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=10383"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=10383"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=10383"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}