{"id":32017,"date":"2023-07-13T01:06:15","date_gmt":"2023-07-12T23:06:15","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=32017"},"modified":"2023-07-12T14:18:38","modified_gmt":"2023-07-12T12:18:38","slug":"proc-spolecnost-pfizer-zastavila-studii-vakciny-covid","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2023\/07\/13\/proc-spolecnost-pfizer-zastavila-studii-vakciny-covid\/","title":{"rendered":"Pro\u010d spole\u010dnost Pfizer zastavila studii vakc\u00edny COVID"},"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 class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>P\u0159\u00edb\u011bh na prvn\u00ed pohled<\/strong><\/span><\/p>\n<ul>\n<li><span>V \u00fanoru 2021 zah\u00e1jila spole\u010dnost Pfizer randomizovanou, placebem kontrolovanou a zaslepenou studii s c\u00edlem prozkoumat bezpe\u010dnost injekce COVID-19 BNT162b2 u zdrav\u00fdch t\u011bhotn\u00fdch \u017een.<\/span><\/li>\n<li><span>Injekce m\u011bly b\u00fdt pod\u00e1v\u00e1ny mezi 24. a 34. t\u00fddnem t\u011bhotenstv\u00ed, p\u0159i\u010dem\u017e \u00fa\u010dastn\u00edci byli randomizov\u00e1ni 1:1, aby dostali bu\u010f injekci COVID-19, nebo placebo.<\/span><\/li>\n<li><span>Do studie se p\u016fvodn\u011b m\u011blo zapojit 4 000 \u017een, ale spole\u010dnost Pfizer zaregistrovala pouze 349 \u017een a pot\u00e9 se \u00fapln\u011b p\u0159estala \u00fa\u010dastnit.<\/span><\/li>\n<li><span>\u0160irok\u00e9 schv\u00e1len\u00ed vakc\u00edny COVID-19 pro t\u011bhotn\u00e9 \u017eeny p\u0159ed dokon\u010den\u00edm studie ze strany CDC mohlo pot\u0159ebu studie pop\u0159\u00edt.<\/span><\/li>\n<li><span>Spole\u010dnost Pfizer vysv\u011btlila, \u017ee vzhledem k tomu, \u017ee vakc\u00ednu ji\u017e dostalo tolik t\u011bhotn\u00fdch \u017een, po\u010det \u00fa\u010dastn\u00edk\u016f klesal a nebyl d\u016fvod ve studii pokra\u010dovat.<\/span><\/li>\n<\/ul>\n<p><span>Neexistuj\u00ed \u017e\u00e1dn\u00e9 \u00fadaje z randomizovan\u00fdch studi\u00ed pro pou\u017eit\u00ed injekce COVID-19 u t\u011bhotn\u00fdch \u017een a spole\u010dnost Pfizer zastavila svou t\u011bhotenskou studii.\u00a0To v\u0161ak nebr\u00e1n\u00ed americk\u00e9mu Centru pro kontrolu a prevenci nemoc\u00ed v doporu\u010dov\u00e1n\u00ed injekce COVID-19 pro ka\u017ed\u00e9ho od \u0161esti m\u011bs\u00edc\u016f v\u011bku, v\u010detn\u011b \u201elid\u00ed, kte\u0159\u00ed jsou t\u011bhotn\u00e9, koj\u00edc\u00ed, sna\u017e\u00ed se ot\u011bhotn\u011bt nyn\u00ed, nebo t\u011bch, kte\u0159\u00ed jsou\u201c. m\u016f\u017ee v budoucnu ot\u011bhotn\u011bt.&#8220;<\/span><\/p>\n<p><span>\u201eNedostatek dobr\u00fdch dat nezd\u00e1lo se, \u017ee by CDC obt\u011b\u017eoval,\u201c napsal Dr.\u00a0Martin Makary, profesor l\u00e9ka\u0159sk\u00e9 fakulty Univerzity Johnse Hopkinse v Tablet.\u00a0Spolu s t\u00fdmem v\u011bdc\u016f po\u017e\u00e1dal americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA), aby na \u0161t\u00edtek injek\u010dn\u00ed st\u0159\u00edka\u010dky vlo\u017eil pozn\u00e1mku o nedostatku \u00fadaj\u016f ze studi\u00ed o bezpe\u010dnosti u t\u011bhotn\u00fdch \u017een.\u00a0FDA odm\u00edtl s od\u016fvodn\u011bn\u00edm, \u017ee tyto informace nejsou relevantn\u00ed.<\/span><\/p>\n<p><span>T\u011bhotn\u00e9 \u017eeny v\u0161ak pot\u0159ebuj\u00ed v\u011bd\u011bt, \u017ee injek\u010dn\u00ed st\u0159\u00edka\u010dka nebyla b\u011bhem t\u011bhotenstv\u00ed testov\u00e1na \u2013 to je z\u00e1klad pro informovan\u00fd souhlas.\u00a0Pravd\u011bpodobn\u011b by v\u00e1s tak\u00e9 zaj\u00edmalo, pro\u010d spole\u010dnost Pfizer p\u0159ed\u010dasn\u011b ukon\u010dila svou t\u011bhotenskou studii a dosud nezve\u0159ejnila v\u00fdsledky.<\/span><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>Spole\u010dnost Pfizer zastavuje t\u011bhotenskou studii vakc\u00edny COVID a zadr\u017euje \u00fadaje<\/strong><\/span><\/p>\n<p><span>V \u00fanoru 2021 zah\u00e1jila spole\u010dnost Pfizer randomizovanou, zaslepenou, placebem kontrolovanou studii k vyhodnocen\u00ed bezpe\u010dnosti injekce COVID-19 (BNT162b2) u zdrav\u00fdch t\u011bhotn\u00fdch \u017een.\u00a0Injekce m\u011bly b\u00fdt pod\u00e1v\u00e1ny mezi 24. a 34. t\u00fddnem t\u011bhotenstv\u00ed, p\u0159i\u010dem\u017e \u00fa\u010dastn\u00edci byli randomizov\u00e1ni v pom\u011bru 1:1, aby dostali bu\u010f injekci COVID-19, nebo placebo.\u00a0Zat\u00edmco v\u0161ak p\u016fvodn\u011b m\u011blo b\u00fdt do studie za\u0159azeno 4 000 \u017een,5 spole\u010dnost Pfizer do studie zapsala pouze 349 \u017een a pot\u00e9 se do studie \u00fapln\u011b p\u0159estala p\u0159ihla\u0161ovat.<\/span><\/p>\n<p><span>&#8222;Nejv\u00edc znepokojiv\u00e9 je,&#8220; \u0159ekl Makary, &#8222;\u017ee v\u00fdsledky t\u011bhotenstv\u00ed \u00fa\u010dastnic studie a jejich d\u011bt\u00ed jsou dodnes, t\u00e9m\u011b\u0159 o dva roky pozd\u011bji, st\u00e1le nezn\u00e1m\u00e9.&#8220; T\u011bhotn\u00e9 a koj\u00edc\u00ed \u017eeny byly vylou\u010deny z klinick\u00fdch studi\u00ed F\u00e1ze III spole\u010dnost\u00ed Pfizer a Moderna, ale v dubnu 2021 \u0159editel CDC Dr.\u00a0Rochelle Walensky: &#8222;CDC doporu\u010duje, aby t\u011bhotn\u00e9 \u017eeny dostaly vakc\u00ednu COVID-19.&#8220;<\/span><\/p>\n<p><a href=\"https:\/\/stranapro.cz\/\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-30218 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png\" alt=\"\" width=\"1367\" height=\"164\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png 300w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-768x93.png 768w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner.png 849w\" sizes=\"(max-width: 1367px) 100vw, 1367px\" \/><\/a><\/p>\n<p><span>American College of Obstetricians and Gynecologists (ACOG) a Society for Maternal-Fetal Medicine (SMFM) brzy toto tvrzen\u00ed zopakovaly a doporu\u010dily o\u010dkov\u00e1n\u00ed t\u011bhotn\u00fdm \u017een\u00e1m, stejn\u011b jako Royal College of Obstetricians and Gynecologists ve Spojen\u00e9m kr\u00e1lovstv\u00ed.<\/span><\/p>\n<p><span>V pr\u016fb\u011bhu m\u011bs\u00edc\u016f si stovky tis\u00edc t\u011bhotn\u00fdch \u017een po cel\u00e9m sv\u011bt\u011b vyhrnuly ruk\u00e1vy, aby dostaly vakc\u00ednu, a to i p\u0159es nedostatek klinick\u00fdch studi\u00ed.\u00a0&#8222;Sd\u011blen\u00ed \u00fa\u0159ad\u016f bylo jasn\u00e9 &#8211; \u0161kody zp\u016fsoben\u00e9 infekc\u00ed COVID-19 p\u0159ev\u00e1\u017eily \u0161kody zp\u016fsoben\u00e9 mRNA vakc\u00ednou &#8211; ale pravdou bylo, \u017ee to nemohli v\u011bd\u011bt,&#8220; poznamenala Maryanne Demasi, Ph.D. , b\u00fdval\u00fd l\u00e9ka\u0159sk\u00fd v\u011bdec z University of Adelaide a b\u00fdval\u00fd report\u00e9r pro ABC News v Austr\u00e1lii.<\/span><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>Studie na zv\u00ed\u0159atech ukazuj\u00ed ztr\u00e1tu plodu a zm\u011bny skeletu<\/strong><\/span><\/p>\n<p><span>Ozna\u010den\u00ed produktu spole\u010dnosti Pfizer uv\u00e1d\u011blo: \u201eNebyly hl\u00e1\u0161eny \u017e\u00e1dn\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky vakc\u00edny na \u017eenskou plodnost, v\u00fdvoj plodu nebo postnat\u00e1ln\u00ed v\u00fdvoj.\u201c Demasi v\u0161ak ozn\u00e1mil, \u017ee \u017e\u00e1dost o svobodu informac\u00ed z roku 2021 zjistila, \u017ee toto prohl\u00e1\u0161en\u00ed bylo zalo\u017eeno na studii na zv\u00ed\u0159atech pouze 44 potkan\u016f, kter\u00e9 vykazovaly znepokojiv\u00e9 v\u00fdsledky t\u00fdkaj\u00edc\u00ed se ztr\u00e1t plodu:<\/span><\/p>\n<p><em><span>\u201eStudie zjistila, \u017ee vakc\u00edna vedla ke statisticky v\u00fdznamn\u00e9mu zdvojn\u00e1soben\u00ed fet\u00e1ln\u00edch ztr\u00e1t (9,77 % mRNA vs. 4,09 % fyziologick\u00fd roztok), ale Pfizer dosp\u011bl k z\u00e1v\u011bru, \u017ee rozd\u00edl mezi t\u011bmito dv\u011bma skupinami byl \u201ebiologicky nev\u00fdznamn\u00fd.\u201c byl.<\/span><\/em><\/p>\n<p><em><span>\u0160t\u00edtek tak\u00e9 uv\u00e1d\u00ed, \u017ee mRNA vakc\u00edna Pfizer nebyla testov\u00e1na na sv\u016fj potenci\u00e1l b\u00fdt karcinogenn\u00ed (schopnost zp\u016fsobit rakovinu), genotoxicita (schopnost po\u0161kozovat genetickou informaci) nebo naru\u0161ovat mu\u017eskou plodnost.\u201c<\/span><\/em><\/p>\n<p><span>Studie na zv\u00ed\u0159atech proveden\u00e1 spole\u010dnost\u00ed Moderna tak\u00e9 uk\u00e1zala, \u017ee zna\u010dn\u00fd po\u010det krys se narodil s kostern\u00edmi zm\u011bnami pot\u00e9, co jejich matky dostaly b\u011bhem t\u011bhotenstv\u00ed injekci COVID-19.\u00a0Podle Demasiho v\u0161ak Moderna dosp\u011bla k z\u00e1v\u011bru, \u017ee \u201ekostern\u00ed zm\u011bny jsou struktur\u00e1ln\u00ed zm\u011bny, kter\u00e9 neovliv\u0148uj\u00ed v\u00fdvoj nebo funkci vyv\u00edjej\u00edc\u00edho se embrya\u201c, a proto \u201enejsou pova\u017eov\u00e1ny za \u0161kodliv\u00e9\u201c.<\/span><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>Studie byla zastavena, proto\u017ee mnoho t\u011bhotn\u00fdch \u017een ji\u017e dost\u00e1valo injekce<\/strong><\/span><\/p>\n<p><span>Spole\u010dnost Pfizer ve\u0159ejn\u011b nevysv\u011btlila, pro\u010d byla studie u t\u011bhotn\u00fdch \u017een zastavena, ani pro\u010d nebyla zve\u0159ejn\u011bna v\u00fdsledn\u00e1 data.\u00a0Je mo\u017en\u00e9, \u017ee studie byla zastavena kv\u016fli nep\u0159\u00edzniv\u00fdm v\u00fdsledk\u016fm.\u00a0Nebylo by to poprv\u00e9.<\/span><\/p>\n<p><span>V tomto p\u0159\u00edpad\u011b se v\u0161ak zd\u00e1, \u017ee CDC obecn\u011b schv\u00e1lilo vakc\u00ednu COVID-19 pro t\u011bhotn\u00e9 \u017eeny \u2013 p\u0159ed dokon\u010den\u00edm studie \u2013 tak\u017ee studie ji\u017e nebyla nutn\u00e1, alespo\u0148 z pohledu spole\u010dnosti Pfizer.\u00a0Jak \u0159ekl Makary:<\/span><\/p>\n<p><em><span>\u201eV p\u0159\u00edpad\u011b studie vakc\u00edny COVID u t\u011bhotn\u00fdch \u017een nemusela b\u00fdt studie zastavena kv\u016fli nep\u0159\u00edzniv\u00fdm v\u00fdsledk\u016fm, ale proto, \u017ee data nebyla pot\u0159eba.\u00a0L\u00e9ka\u0159sk\u00e9 a ve\u0159ejn\u00e9 zdravotnick\u00e9 org\u00e1ny se ji\u017e rozhodly a prohl\u00e1sily vakc\u00ednu za bezpe\u010dnou a \u00fa\u010dinnou, bez ohledu na to, co data uk\u00e1\u017eou.\u00a0Pro\u010d hodnotit produkt, kdy\u017e CDC a ACOG ji\u017e v produkt v\u011b\u0159\u00ed?<\/span><\/em><\/p>\n<p><span>Demasi souhlasil.\u00a0Ve skute\u010dnosti zve\u0159ejnila e-mail od spole\u010dnosti Pfizer, ve kter\u00e9m spole\u010dnost uznala, \u017ee po\u010det \u00fa\u010dastn\u00edk\u016f studie koncem roku 2021 v\u00fdrazn\u011b poklesl, proto\u017ee zdravotnick\u00e9 \u00fa\u0159ady ji\u017e vakc\u00ednu schv\u00e1lily.\u00a0Vzhledem k tomu, \u017ee injekci ji\u017e dostalo tolik t\u011bhotn\u00fdch \u017een, nebyl d\u016fvod ve studii pokra\u010dovat, jak vl\u00e1da obhajovala.\u00a0Demasi zve\u0159ejnila e-mailovou odpov\u011b\u010f spole\u010dnosti Pfizer, kter\u00e1 zn\u00ed takto:<\/span><\/p>\n<p><em><span>\u201eVe \u010dtvrt\u00e9m \u010dtvrtlet\u00ed roku 2021 byla uzav\u0159ena studie C4591015 (placebem kontrolovan\u00e1, randomizovan\u00e1, pro pozorovatele zaslepen\u00e1 studie f\u00e1ze 2\/3 k hodnocen\u00ed bezpe\u010dnosti, sn\u00e1\u0161enlivosti a imunogenicity BNT162b2 proti COVID-19 u zdrav\u00fdch t\u011bhotn\u00fdch \u017een ve v\u011bku 18 let a star\u0161\u00edch). z\u00e1pis.\u00a0Tato studie byla vyvinuta p\u0159edt\u00edm, ne\u017e byla vakc\u00edna COVID-19 dostupn\u00e1 nebo doporu\u010den\u00e1 pro t\u011bhotn\u00e9 \u017eeny.<\/span><\/em><\/p>\n<p><em><span>B\u011bhem roku 2021 se prost\u0159ed\u00ed zm\u011bnilo a v z\u00e1\u0159\u00ed 2021 p\u0159\u00edslu\u0161n\u00e9 doporu\u010duj\u00edc\u00ed org\u00e1ny (nap\u0159. ACIP v USA) doporu\u010dily vakc\u00edny COVID-19 pro t\u011bhotn\u00e9 \u017eeny ve v\u0161ech z\u00fa\u010dastn\u011bn\u00fdch\/pl\u00e1novan\u00fdch zem\u00edch, co\u017e vedlo k v\u00fdznamn\u00e9mu poklesu po\u010dtu \u00fa\u010dastn\u00edk\u016f.<\/span><\/em><\/p>\n<p><em><span>Vzhledem k klesaj\u00edc\u00edmu po\u010dtu p\u0159ihl\u00e1\u0161en\u00fdch m\u011bla studie nedostate\u010dnou velikost vzorku k posouzen\u00ed c\u00edle prim\u00e1rn\u00ed imunogenicity a glob\u00e1ln\u00ed doporu\u010den\u00ed ji\u017e neospravedl\u0148ovala pokra\u010dov\u00e1n\u00ed t\u00e9to placebem kontrolovan\u00e9 studie.\u00a0Tento n\u00e1vrh byl ozn\u00e1men a schv\u00e1len FDA a EMA.<\/span><\/em><\/p>\n<p><a href=\"https:\/\/stranapro.cz\/\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-30218 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png\" alt=\"\" width=\"1350\" height=\"162\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png 300w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-768x93.png 768w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner.png 849w\" sizes=\"(max-width: 1350px) 100vw, 1350px\" \/><\/a><\/p>\n<p><strong>Pokud jde o nedostatek zve\u0159ejn\u011bn\u00fdch \u00fadaj\u016f, spole\u010dnost Pfizer uvedla, \u017ee je nem\u00e1:<\/strong><\/p>\n<p><em><span>\u201eSpole\u010dnost Pfizer zat\u00edm nem\u00e1 \u00fapln\u00fd soubor dat ze studie imunizace matek, C4591015.\u00a0Spole\u010dnosti Pfizer a BioNTech pl\u00e1nuj\u00ed dokon\u010dit anal\u00fdzu klinick\u00e9 studie C4591015 a sd\u00edlet ji s glob\u00e1ln\u00edmi zdravotnick\u00fdmi \u00fa\u0159ady a usilovat o zve\u0159ejn\u011bn\u00ed nebo prezentaci, jak je na\u0161\u00ed obvyklou prax\u00ed.<\/span><\/em><\/p>\n<p><em><span>Je d\u016fle\u017eit\u00e9 poznamenat, \u017ee relevantn\u00ed skute\u010dn\u00e9 d\u016fkazy podporuj\u00edc\u00ed pou\u017eit\u00ed vakc\u00edn COVID-19 u t\u011bhotn\u00fdch \u017een byly prezentov\u00e1ny a publikov\u00e1ny v n\u011bkolika \u010dtvrtlet\u00edch v mnoha \u010dasopisech a f\u00f3rech.<\/span><\/em><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>P\u0159irozen\u00e1 imunita je st\u00e1le ignorov\u00e1na<\/strong><\/span><\/p>\n<p><span>ACOG doporu\u010duje nejen o\u010dkov\u00e1n\u00ed proti COVID-19 \u201esiln\u011b\u201c t\u011bhotn\u00fdm \u017een\u00e1m, ale tak\u00e9 p\u0159eo\u010dkov\u00e1n\u00ed.\u00a0\u201eO\u010dkov\u00e1n\u00ed lze podat v kter\u00e9mkoli trimestru a je t\u0159eba se zam\u011b\u0159it na o\u010dkov\u00e1n\u00ed co nejd\u0159\u00edve, aby se optimalizovalo zdrav\u00ed matky a plodu.\u00a0Toto doporu\u010den\u00ed plat\u00ed jak pro prvn\u00ed s\u00e9rii o\u010dkov\u00e1n\u00ed, tak pro p\u0159eo\u010dkov\u00e1n\u00ed,\u201c uv\u00e1d\u00ed ACOG.<\/span><\/p>\n<p><span>V jejich informac\u00edch v\u0161ak chyb\u00ed informace o p\u0159irozen\u00e9 imunit\u011b.\u00a0V\u00fdzkum Makary a koleg\u016f, publikovan\u00fd v JAMA, uk\u00e1zal, \u017ee p\u0159irozen\u00e1 imunita v\u016f\u010di COVID-19 \u2013 dosa\u017een\u00e1 p\u0159edchoz\u00ed infekc\u00ed sp\u00ed\u0161e ne\u017e injekc\u00ed \u2013 trv\u00e1 asi dva roky, co\u017e nazna\u010duje, \u017ee trv\u00e1 d\u00e9le ne\u017e ochrana poskytovan\u00e1 o\u010dkov\u00e1n\u00edm proti COVID-19.<\/span><\/p>\n<p><span>Systematick\u00fd p\u0159ehled a metaanal\u00fdza zve\u0159ejn\u011bn\u00e1 v The Lancet tak\u00e9 zjistila, \u017ee p\u0159irozen\u00e1 imunita je p\u0159inejmen\u0161\u00edm stejn\u011b \u00fa\u010dinn\u00e1 a pravd\u011bpodobn\u011b lep\u0161\u00ed ne\u017e injekce COVID-19.\u00a0\u00dadaje z randomizovan\u00e9 studie o o\u010dkov\u00e1n\u00ed t\u011bhotn\u00fdch \u017een proveden\u00e9 spole\u010dnost\u00ed Pfizer nejsou zdravotnick\u00fdm org\u00e1n\u016fm k dispozici.\u00a0Ale m\u00edsto toho, aby hr\u00e1li na jistotu \u2013 zvl\u00e1\u0161t\u011b u lid\u00ed s p\u0159irozenou imunitou \u2013 p\u0159esto v\u0161em doporu\u010duj\u00ed nechat se o\u010dkovat.<\/span><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>V\u011bdci varuj\u00ed t\u011bhotn\u00e9 \u017eeny p\u0159ed o\u010dkov\u00e1n\u00edm COVID<\/strong><\/span><\/p>\n<p><span>Ne ka\u017ed\u00fd souhlas\u00ed s t\u00edm, \u017ee zdravotnick\u00e9 \u00fa\u0159ady \u017e\u00e1daj\u00ed t\u011bhotn\u00e9 \u017eeny, aby byly o\u010dkov\u00e1ny.\u00a0\u201eGlob\u00e1ln\u00ed distribuce t\u011bchto experiment\u00e1ln\u00edch vakc\u00edn proti COVID-19 je nejv\u011bt\u0161\u00edm poru\u0161en\u00edm l\u00e9ka\u0159sk\u00e9 etiky v historii medic\u00edny, mo\u017en\u00e1 i v historii lidstva,\u201c \u0159ekl Dr.\u00a0James Thorp, odborn\u00edk na fet\u00e1ln\u00ed medic\u00ednu, Tuckeru Carlsonovi.<\/span><\/p>\n<p><span>Thorp a jeho kolegov\u00e9 zve\u0159ejnili p\u0159edtiskovou studii, ve kter\u00e9 zjistili do o\u010d\u00ed bij\u00edc\u00ed rizika pro t\u011bhotn\u00e9 \u017eeny a jejich nenarozen\u00e9 d\u011bti.\u00a0V\u00fdsledky byly tak z\u00e1va\u017en\u00e9, \u017ee v\u011bdci dosp\u011bli k z\u00e1v\u011bru, \u017ee t\u011bhotn\u00e9 \u017eeny by nem\u011bly dost\u00e1vat o\u010dkov\u00e1n\u00ed proti COVID-19, dokud nebude dokon\u010den dal\u0161\u00ed v\u00fdzkum.<\/span><\/p>\n<p><span>&#8222;Dokud nebudou randomizov\u00e1ny, prospektivn\u00ed studie dokumentuj\u00ed bezpe\u010dnost v t\u011bhotenstv\u00ed a dlouhodob\u00e9 sledov\u00e1n\u00ed u potomk\u016f, doporu\u010duje se glob\u00e1ln\u00ed moratorium na pou\u017e\u00edv\u00e1n\u00ed vakc\u00edn COVID-19 v t\u011bhotenstv\u00ed,&#8220; uvedli.\u00a0Ve srovn\u00e1n\u00ed s vakc\u00ednou proti ch\u0159ipce je o\u010dkov\u00e1n\u00ed proti COVID-19 spojeno s v\u00fdznamn\u00fdm n\u00e1r\u016fstem ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f (AE), v\u010detn\u011b:<\/span><\/p>\n<ul>\n<li><span>menstrua\u010dn\u00ed abnormality<\/span><\/li>\n<li><span>potrat<\/span><\/li>\n<li><span>Chromozom\u00e1ln\u00ed abnormality plodu<\/span><\/li>\n<li><span>malformace plodu<\/span><\/li>\n<li><span>Fet\u00e1ln\u00ed cystick\u00e9 hygromy<\/span><\/li>\n<li><span>Poruchy srdce plodu<\/span><\/li>\n<li><span>Fet\u00e1ln\u00ed srde\u010dn\u00ed arytmie<\/span><\/li>\n<li><span>Z\u00e1stava srdce plodu<\/span><\/li>\n<li><span>Fet\u00e1ln\u00ed vaskul\u00e1rn\u00ed misperfuze<\/span><\/li>\n<li><span>Abnormality r\u016fstu plodu<\/span><\/li>\n<li><span>Abnorm\u00e1ln\u00ed sledov\u00e1n\u00ed plodu<\/span><\/li>\n<li><span>Fet\u00e1ln\u00ed tromb\u00f3za placenty<\/span><\/li>\n<li><span>N\u00edzk\u00e1 hladina plodov\u00e9 vody<\/span><\/li>\n<li><span>Smrt plodu\/mrtv\u00e9 narozen\u00ed<\/span><\/li>\n<\/ul>\n<p><span>Podle internisty a kardiologa Dr.\u00a0Petera McCullougha, data tak\u00e9 odhalila 27n\u00e1sobn\u011b zv\u00fd\u0161en\u00e9 riziko potratu a v\u00edce ne\u017e dvojn\u00e1sobn\u00e9 zv\u00fd\u0161en\u00e9 riziko nep\u0159\u00edzniv\u00fdch n\u00e1sledk\u016f plodu v \u0161esti r\u016fzn\u00fdch kategori\u00edch.<\/span><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>Studie NIH potvrzuje menstrua\u010dn\u00ed zm\u011bny po o\u010dkov\u00e1n\u00ed<\/strong><\/span><\/p>\n<p><span>Podle studie zve\u0159ejn\u011bn\u00e9 v \u010dasopise Obstetrics &amp; Gynecology a financovan\u00e9 N\u00e1rodn\u00edm institutem d\u011btsk\u00e9ho zdrav\u00ed a lidsk\u00e9ho rozvoje (NICHD) a \u00da\u0159adem pro v\u00fdzkum zdrav\u00ed \u017een N\u00e1rodn\u00edho institutu zdrav\u00ed (NIH) do\u0161lo po COVID-19 k opo\u017ed\u011bn\u00e9 menstruaci. potvrzeno o\u010dkov\u00e1n\u00ed.<\/span><\/p>\n<p><span>Studie se z\u00fa\u010dastnilo 3959 lid\u00ed ve v\u011bku od 18 do 45 let.\u00a0Ti, kte\u0159\u00ed nedostali injekci COVID-19, nezaznamenali ve \u010dtvrt\u00e9m cyklu studie \u017e\u00e1dn\u00e9 v\u00fdznamn\u00e9 zm\u011bny ve srovn\u00e1n\u00ed s prvn\u00edmi t\u0159emi cykly.\u00a0Nicm\u00e9n\u011b ty, kter\u00e9 dostaly vakc\u00ednu COVID-19, m\u011bly del\u0161\u00ed menstrua\u010dn\u00ed cykly, obvykle o m\u00e9n\u011b ne\u017e jeden den, kdy\u017e dostaly vakc\u00ednu.<\/span><\/p>\n<p><span>Evropsk\u00e1 unie mezit\u00edm doporu\u010dila p\u0159idat k mRNA-COVID-19 jako vedlej\u0161\u00ed \u00fa\u010dinek \u201esiln\u00e9 menstrua\u010dn\u00ed krv\u00e1cen\u00ed\u201c.\u00a0Makary poznamenal:<\/span><\/p>\n<p><em><span>\u201eTady v USA \u017e\u00e1dn\u00e1 takov\u00e1 aktualizace zna\u010den\u00ed produkt\u016f neexistuje.\u00a0Tento nedostatek pokory se tak\u00e9 uk\u00e1zal, kdy\u017e bylo zdrav\u00fdm mlad\u00fdm \u017een\u00e1m s neuv\u011b\u0159iteln\u00fdm absolutismem \u0159e\u010deno, \u017ee vakc\u00edna proti COVID nem\u016f\u017ee ovlivnit plodnost.\u00a0Spr\u00e1vn\u00e1 odpov\u011b\u010f m\u011bla zn\u00edt: Nemysl\u00edme si, \u017ee to ovliv\u0148uje plodnost, ale nem\u00e1me na tuto ot\u00e1zku dobr\u00e9 \u00fadaje.\u201c<\/span><\/em><\/p>\n<p class=\"has-medium-font-size\"><span style=\"font-size: 18pt;\"><strong>\u00da\u0159edn\u00edci vol\u00ed \u201ep\u0159\u00edsn\u00fd paternalismus\u201c p\u0159ed informovan\u00fdm souhlasem<\/strong><\/span><\/p>\n<p><span>Vzhledem k nedostatku \u00fadaj\u016f pro zranitelnou populaci &#8211; t\u011bhotn\u00e9 a koj\u00edc\u00ed \u017eeny &#8211; m\u011bli zdravotn\u00edci varovat.\u00a0Kdy\u017e se projevila \u00fa\u010dinnost p\u0159irozen\u00e9 imunity, m\u011bli b\u00fdt lid\u00e9 informov\u00e1ni a varov\u00e1ni o mo\u017en\u00fdch rizic\u00edch o\u010dkov\u00e1n\u00ed proti COVID-19.\u00a0T\u00edmto zp\u016fsobem mohli u\u010dinit informovan\u00e9 rozhodnut\u00ed p\u0159edt\u00edm, ne\u017e souhlasili s injekc\u00ed, kter\u00e1 by mohla m\u00edt v\u00e1\u017en\u00e9 \u00fa\u010dinky na reprodukci.<\/span><\/p>\n<p><span>V roce 2021 Institut pro \u010dist\u00e9 a aplikovan\u00e9 znalosti (IPAK) v\u011b\u0159il, \u017ee \u00fadaje jsou dostate\u010dn\u011b p\u0159esv\u011bd\u010div\u00e9 na to, aby st\u00e1hly o\u010dkov\u00e1n\u00ed zraniteln\u00fdm skupin\u00e1m obyvatelstva, jako jsou t\u011bhotn\u00e9 \u017eeny, ale zdravotni\u010dt\u00ed \u00fa\u0159edn\u00edci se m\u00edsto toho rozhodli pro pokusn\u00e9 kr\u00e1l\u00edky pro netestovanou experiment\u00e1ln\u00ed vakc\u00ednu.<\/span><\/p>\n<p><span>\u201eP\u0159i absenci dobr\u00fdch dat si organizovan\u00e1 medic\u00edna vybrala cestu p\u0159\u00edsn\u00e9ho paternalismu.\u00a0Ale podle m\u00fdch zku\u0161enost\u00ed l\u00e9ka\u0159e je mnohem lep\u0161\u00ed pacienta \u0159\u00e1dn\u011b informovat, ne\u017e potla\u010dovat jeho ot\u00e1zky,\u201c \u0159ekl Makary.\u00a0Pokud a a\u017e Pfizer \u00fadaje zve\u0159ejn\u00ed, je mo\u017en\u00e9, \u017ee zdravotn\u00ed \u00fa\u0159edn\u00edci budou m\u00edt co vysv\u011btlit, pokud \u00fadaje nebudou p\u0159\u00edzniv\u00e9.\u00a0Makary pokra\u010doval:<\/span><\/p>\n<p><em><span>\u201eJe mo\u017en\u00e9, \u017ee t\u011bhotensk\u00e1 studie proveden\u00e1 spole\u010dnost\u00ed Pfizer by byla pro vakc\u00ednu pozitivn\u00ed a uk\u00e1zala, \u017ee p\u0159\u00ednosy p\u0159eva\u017euj\u00ed nad \u0161kodami, ale spole\u010dnost Pfizer \u00fadaje nezve\u0159ejnila.\u00a0Mo\u017en\u00e1 data nebyla p\u0159\u00edzniv\u00e1, nebo si Pfizer mo\u017en\u00e1 uv\u011bdomil, \u017ee bez dat zv\u00edt\u011bzil nad l\u00e9ka\u0159sk\u00fdm za\u0159\u00edzen\u00edm, tak pro\u010d riskovat sd\u00edlen\u00ed v\u00fdsledk\u016f placebem kontrolovan\u00e9 studie?\u201c<\/span><\/em><\/p>\n<p><a href=\"https:\/\/media.mercola.com\/ImageServer\/Public\/2023\/July\/PDF\/why-pfizer-stopped-covid-vax-pregnancy-trial-pdf.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><span>\u010cl\u00e1nek ve form\u00e1tu PDF<\/span><\/a><\/p>\n<p><strong><span style=\"font-size: 18pt;\">Prameny:<\/span><\/strong><\/p>\n<ul>\n<li><sup><span>1,\u00a0<\/span><\/sup>\u00a0<sup><span>5,\u00a0<\/span><\/sup>\u00a0<sup><span>6,\u00a0<\/span><\/sup>\u00a0<sup><span>7,\u00a0<\/span><\/sup>\u00a0<sup><span>21,\u00a0<\/span><\/sup>\u00a0<sup><span>29,\u00a0<\/span><\/sup>\u00a0<sup><span>32,\u00a0<\/span><\/sup>\u00a0<sup><span>33\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.tabletmag.com\/sections\/news\/articles\/was-covid-vaccine-safe-pregnant-women\" target=\"_blank\" rel=\"noreferrer noopener\"><span>tablet 21. \u010dervna 2023<\/span><\/a><\/li>\n<li><sup><span>2,\u00a0<\/span><\/sup>\u00a0<sup><span>3,\u00a0<\/span><\/sup>\u00a0<sup><span>13\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/vaccines\/recommendations\/pregnancy.html\" target=\"_blank\" rel=\"noreferrer noopener\"><span>USA\u00a0CDC, vakc\u00edny proti COVID-19 b\u011bhem t\u011bhotenstv\u00ed nebo kojen\u00ed 20. \u0159\u00edjna 2022<\/span><\/a><\/li>\n<li><sup><span>4\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT04754594\" target=\"_blank\" rel=\"noreferrer noopener\"><span>ClinicalTrials.gov, k vyhodnocen\u00ed bezpe\u010dnosti, sn\u00e1\u0161enlivosti a imunogenicity BNT162b2 proti COVID-19 u zdrav\u00fdch t\u011bhotn\u00fdch \u017een ve v\u011bku 18 let [\u2026]<\/span><\/a><\/li>\n<li><sup><span>8,\u00a0<\/span><\/sup>\u00a0<sup><span>10,\u00a0<\/span><\/sup>\u00a0<sup><span>11\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/maryannedemasi.substack.com\/p\/exclusive-whatever-happened-to-pfizers\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Substack, Maryanne Demasi hl\u00e1s\u00ed 23. \u00fanora 2023<\/span><\/a><\/li>\n<li><sup><span>9\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.cbsnews.com\/news\/covid-19-vaccine-pregnancy-cdc-guidelines-walensky\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Zpr\u00e1vy CBS 27. dubna 2021<\/span><\/a><\/li>\n<li><sup><span>12,\u00a0<\/span><\/sup>\u00a0<sup><span>14,\u00a0<\/span><\/sup>\u00a0<sup><span>15\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/palexander.substack.com\/p\/whatever-happened-to-pfizers-covid\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Substack, Alexander COVID News 25. \u00fanora 2023<\/span><\/a><\/li>\n<li><sup><span>16,\u00a0<\/span><\/sup>\u00a0<sup><span>17\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.acog.org\/covid-19\/covid-19-vaccines-and-pregnancy-conversation-guide-for-clinicians\" target=\"_blank\" rel=\"noreferrer noopener\"><span>ACOG, vakc\u00edny proti COVID-19 a t\u011bhotenstv\u00ed: Pr\u016fvodce konverzac\u00ed<\/span><\/a><\/li>\n<li><sup><span>18\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2788894\" target=\"_blank\" rel=\"noreferrer noopener\"><span>JAMA.\u00a02022;327(11):1085-1087.\u00a0doi: 10.1001\/jama.2022.1393<\/span><\/a><\/li>\n<li><sup><span>19\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/twitter.com\/MartyMakary\/status\/1489365806060236803?s=20\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Twitter, Marty Makary 3. \u00fanora 2022<\/span><\/a><\/li>\n<li><sup><span>20\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(22)02465-5\/fulltext\" target=\"_blank\" rel=\"noreferrer noopener\"><span>The Lancet 11. b\u0159ezna 2023<\/span><\/a><\/li>\n<li><sup><span>22\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/rumble.com\/v2awx7a-dr.-james-thorp-obgyn-on-tucker-carlson-harms-of-the-covid-vaccine-for-preg.html\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Rumble 27. \u00fanora 2023, 1:00<\/span><\/a><\/li>\n<li><sup><span>23,\u00a0<\/span><\/sup>\u00a0<sup><span>24,\u00a0<\/span><\/sup>\u00a0<sup><span>25\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/doi.org\/10.20944\/preprints202209.0430.v1\" target=\"_blank\" rel=\"noreferrer noopener\"><span>P\u0159edtisky 2022, 2022090430<\/span><\/a><\/li>\n<li><sup><span>26\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/petermcculloughmd.substack.com\/p\/covid-19-vaccines-remain-pregnancy?r=14jb45\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Substack, Courageous Discourse 2. b\u0159ezna 2023<\/span><\/a><\/li>\n<li><sup><span>27\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/journals.lww.com\/greenjournal\/Fulltext\/9900\/Association_Between_Menstrual_Cycle_Length_and.357.aspx\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Porodnictv\u00ed a gynekologie: 5. ledna 2022 \u2013 Ro\u010dn\u00edk \u2013 Vyd\u00e1n\u00ed \u2013 10.1097<\/span><\/a><\/li>\n<li><sup><span>28\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-24-27-october-2022\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Evropsk\u00e1 l\u00e9kov\u00e1 agentura 28. \u0159\u00edjna 2022<\/span><\/a><\/li>\n<li><sup><span>30,\u00a0<\/span><\/sup>\u00a0<sup><span>31\u00a0<\/span><\/sup>\u00a0<a href=\"https:\/\/cf5e727d-d02d-4d71-89ff-9fe2d3ad957f.filesusr.com\/ugd\/adf864_2bd97450072f4364a65e5cf1d7384dd4.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><span>Science, Public Health Policy, and the Law Volume 4:130-143 November 2021<\/span><\/a><\/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: 8pt;\"><a href=\"https:\/\/articles.mercola.com\/sites\/articles\/archive\/2023\/07\/11\/why-pfizer-stopped-covid-vax-pregnancy-trial.aspx?ui=9c61c0428e2c408fdaa52e1f8a2e29b3c347424cdbd5be591509cf14340e9789&amp;sd=20210104&amp;cid_source=dnl&amp;cid_medium=email&amp;cid_content=art1HL&amp;cid=20230711&amp;mid=DM1426448&amp;rid=1852131632\" target=\"_blank\" rel=\"nofollow noopener\">ZDROJ<\/a><\/span><\/h3>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/stranapro.cz\/\"><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-30218 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png\" alt=\"\" width=\"1375\" height=\"165\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-300x36.png 300w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner-768x93.png 768w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/06\/PRO-banner.png 849w\" sizes=\"(max-width: 1375px) 100vw, 1375px\" \/><\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>P\u0159\u00edb\u011bh na prvn\u00ed pohled V \u00fanoru 2021 zah\u00e1jila spole\u010dnost Pfizer randomizovanou, placebem kontrolovanou a zaslepenou&#8230;<\/p>\n","protected":false},"author":2,"featured_media":15695,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[23,315,839,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/32017"}],"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=32017"}],"version-history":[{"count":1,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/32017\/revisions"}],"predecessor-version":[{"id":32018,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/32017\/revisions\/32018"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/15695"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=32017"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=32017"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=32017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}