{"id":7334,"date":"2022-01-05T07:48:44","date_gmt":"2022-01-05T06:48:44","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=7334"},"modified":"2022-01-05T07:48:44","modified_gmt":"2022-01-05T06:48:44","slug":"omikron-stoupa-nyni-je-ockovaci-strategie-fda-zpochybnovana","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2022\/01\/05\/omikron-stoupa-nyni-je-ockovaci-strategie-fda-zpochybnovana\/","title":{"rendered":"Omikron stoup\u00e1, nyn\u00ed je o\u010dkovac\u00ed strategie FDA zpochyb\u0148ov\u00e1na"},"content":{"rendered":"
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USA:<\/strong> Varianta Omicron je p\u0159evl\u00e1daj\u00edc\u00edm kmenem COVID-19 ve Spojen\u00fdch st\u00e1tech, co\u017e vedlo k pozastaven\u00ed distribuce n\u011bkter\u00fdch ne\u00fa\u010dinn\u00fdch terapi\u00ed monoklon\u00e1ln\u00edmi protil\u00e1tkami. Ale tlak na vakc\u00edny, kter\u00e9 jsou i proti t\u00e9to variant\u011b ne\u00fa\u010dinn\u00e9, v nezmen\u0161en\u00e9 m\u00ed\u0159e pokra\u010duje.<\/span><\/p>\n

Prvn\u00ed p\u0159\u00edpad Omikronu ve Spojen\u00fdch st\u00e1tech byl hl\u00e1\u0161en 1. prosince 2021.\u00a0K 25. prosinci 2021 Centers for Disease Control and Prevention (CDC) odhaduje, \u017ee Omikron je zodpov\u011bdn\u00fd za 58,6 % infekc\u00ed SARS-CoV-2 ve Spojen\u00fdch st\u00e1tech.<\/span><\/p>\n

Rychl\u00fd v\u00fdskyt Omikronu je zn\u00e1mkou zv\u00fd\u0161en\u00e9 p\u0159enositelnosti varianty a ne\u00fa\u010dinnosti vakc\u00edn proti tomuto kmeni.<\/span><\/p>\n

Prevalence omikronov\u00e9 varianty p\u0159im\u011bla \u00da\u0159ad n\u00e1m\u011bstka ministra zdravotnictv\u00ed USA (HHS) k p\u0159i\u0159azen\u00ed dvou b\u011b\u017en\u011b pou\u017e\u00edvan\u00fdch kombinac\u00ed terapie monoklon\u00e1ln\u00edmi protil\u00e1tkami – Bamlanivimab \/ Etesevimab (Eli Lilly) a REGN10933 \/ REGN10987 (Regeneron) – do region\u016f V zem\u00edch, kde je varianta Omikron roz\u0161\u00ed\u0159ena z v\u00edce ne\u017e 80 %.<\/span><\/p>\n

Podle HHS \u201ese neo\u010dek\u00e1v\u00e1, \u017ee by tyto dva produkty byly \u00fa\u010dinn\u00e9 u pacient\u016f infikovan\u00fdch variantou Omikron…\u201c.<\/span><\/p>\n

Monoklon\u00e1ln\u00ed protil\u00e1tky jsou syntetick\u00e9.\u00a0Mohou nahradit vakc\u00ednou indukovan\u00e9 nebo p\u0159irozen\u011b vytvo\u0159en\u00e9 protil\u00e1tky v reakci na infekci.\u00a0Obvykle jsou vyhrazeny pro pacienty, kte\u0159\u00ed jsou vystaveni vysok\u00e9mu riziku z\u00e1va\u017en\u00fdch komplikac\u00ed ze zn\u00e1m\u00e9 nebo pravd\u011bpodobn\u00e9 infekce.<\/span><\/p>\n

Pokud jsou odhady CDC pro variantu Omikron spr\u00e1vn\u00e9, m\u011blo by toto rozhodnut\u00ed smysl, proto\u017ee se uk\u00e1zalo, \u017ee tyto protil\u00e1tkov\u00e9 terapie maj\u00ed pouze n\u00edzk\u00fd neutraliza\u010dn\u00ed \u00fa\u010dinek proti variant\u011b Omikron ve srovn\u00e1n\u00ed s p\u016fvodn\u00edm kmenem Wuhan.<\/span><\/p>\n

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Tabulka 1 p\u0159evzat\u00e1 z Gruell et al.<\/span><\/figcaption><\/figure>\n<\/div>\n

Omikron se tak\u00e9 vyh\u00fdb\u00e1 vakcina\u010dn\u00edm protil\u00e1tk\u00e1m<\/span><\/strong><\/p>\n

Cameroni a kol.\u00a0zjistili, \u017ee s\u00e9ra od lid\u00ed pln\u011b o\u010dkovan\u00fdch vakc\u00ednou Pfizer vykazovala 44n\u00e1sobn\u00fd pokles neutralizace proti Omikronu ve srovn\u00e1n\u00ed s p\u016fvodn\u00edm kmenem Wuhan.<\/span><\/p>\n

Tento d\u011bsiv\u00fd pokles nen\u00ed p\u0159ekvapiv\u00fd.\u00a0Varianta SARS-CoV-2 Omikron m\u00e1 alespo\u0148 37 aminokyselinov\u00fdch substituc\u00ed v spike proteinu, 15 z nich v dom\u00e9n\u011b v\u00e1zaj\u00edc\u00ed receptor (RBD).<\/span><\/p>\n

RBD spike proteinu je hlavn\u00edm c\u00edlem protil\u00e1tek indukovan\u00fdch mRNA vakc\u00ednou.<\/span><\/p>\n

P\u0159edpokl\u00e1dan\u00e1 schopnost spole\u010dnosti Omicron vyhnout se ochran\u011b zprost\u0159edkovan\u00e9 vakc\u00ednou je potvrzena v t\u00e9to ran\u00e9 studii, ve kter\u00e9 \u00fa\u010dinnost vakc\u00edny Pfizer proti symptomatick\u00e9 infekci klesla na 34 % – 37 % b\u011bhem 15 t\u00fddn\u016f po druh\u00e9 d\u00e1vce.<\/span><\/p>\n

Pro srovn\u00e1n\u00ed, dv\u011b d\u00e1vky vakc\u00edny Pfizer byly 25 t\u00fddn\u016f po druh\u00e9 d\u00e1vce st\u00e1le 63,5% \u00fa\u010dinn\u00e9 proti variant\u011b Delta.\u00a0Tento \u010dl\u00e1nek, rovn\u011b\u017e v p\u0159edti\u0161t\u011bn\u00e9 verzi, obsahuje anal\u00fdzu dat z d\u00e1nsk\u00fdch n\u00e1rodn\u00edch registr\u016f.\u00a0Ukazuje, \u017ee \u00fa\u010dinnost vakc\u00edn Pfizer i Moderna proti variant\u011b Omikron se b\u011bhem 60 a\u017e 90 dn\u016f bl\u00ed\u017eila nule a pot\u00e9 se dostala do z\u00e1porn\u00fdch hodnot:<\/span><\/p>\n

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\"\"<\/figure>\n<\/div>\n

Negativn\u00ed \u00fa\u010dinnost znamen\u00e1, \u017ee vakc\u00edna zp\u016fsobuje zv\u00fd\u0161en\u00e9 riziko infekce.<\/span><\/p>\n

I kdy\u017e se jedn\u00e1 o malou p\u0159edb\u011b\u017enou anal\u00fdzu, kter\u00e1 je\u0161t\u011b nebyla potvrzena v\u011bt\u0161\u00edmi studiemi, vyvol\u00e1v\u00e1 d\u016fle\u017eit\u00e9 ot\u00e1zky, zejm\u00e9na s ohledem na skute\u010dnost, \u017ee negativn\u00ed dopad se zd\u00e1 b\u00fdt tak velk\u00fd.<\/span><\/p>\n

FDA a CDC nesouhlas\u00ed mezi sebou a sami se sebou<\/span><\/strong><\/p>\n

Dne 29. \u0159\u00edjna 2021 americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) roz\u0161\u00ed\u0159il nouzov\u00e9 schv\u00e1len\u00ed vakc\u00edny COVID-19 spole\u010dnosti Pfizer-BioNTech pro prevenci COVID-19 na d\u011bti ve v\u011bku 5\u201311 let.<\/span><\/p>\n

Toto rozhodnut\u00ed je v\u011bdecky, empiricky, logicky a eticky neospravedlniteln\u00e9, jak zde vysv\u011btluje Toby Rogers, Ph.D.\u00a0Tvrzen\u00ed spole\u010dnosti Pfizer, \u017ee vakc\u00edna byla v t\u00e9to v\u011bkov\u00e9 skupin\u011b \u00fa\u010dinn\u00e1 z 90,7 %, je zalo\u017eeno na celkem 19 d\u011btech (t\u0159i ve skupin\u011b 1450 o\u010dkovan\u00fdch osob a 16 ve skupin\u011b 736 p\u0159\u00edjemc\u016f placeba), u kter\u00fdch se b\u011bhem kr\u00e1tk\u00e9 studie rozvinuly m\u00edrn\u00e9 p\u0159\u00edznaky.<\/span><\/p>\n

\u017d\u00e1dn\u00e9 d\u00edt\u011b ve studii nezem\u0159elo ani nemuselo b\u00fdt hospitalizov\u00e1no kv\u016fli COVID.\u00a0P\u0159i absenci v\u00fdznamn\u00fdch klinick\u00fdch v\u00fdsledk\u016f nelze prov\u00e9st \u017e\u00e1dn\u00fd smyslupln\u00fd v\u00fdpo\u010det \u00fa\u010dinnosti vakc\u00edny.<\/span><\/p>\n

Na z\u00e1klad\u011b t\u011bchto v\u00fdsledk\u016f by spole\u010dnost Pfizer nem\u011bla uva\u017eovat o schv\u00e1len\u00ed sv\u00e9ho produktu v t\u00e9to v\u011bkov\u00e9 skupin\u011b.\u00a0Studie spole\u010dnosti Pfizer v podstat\u011b prok\u00e1zala, \u017ee vakc\u00edna COVID v\u00fdrobce l\u00e9ku, pokud je spr\u00e1vn\u011b d\u00e1vkov\u00e1na a ve srovn\u00e1n\u00ed s placebem, by v randomizovan\u00e9 studii mal\u00fdch d\u011bt\u00ed sn\u00ed\u017eila riziko vzniku p\u0159\u00edznak\u016f nachlazen\u00ed o p\u0159ibli\u017en\u011b 2 %.<\/span><\/p>\n

M\u00edsto toho, s odvahou FDA jasn\u011b demonstrovanou ka\u017ed\u00e9mu bystr\u00e9mu pozorovateli, se agentura rozhodla odvodit preventivn\u00ed \u00fa\u010dinek proti hospitalizac\u00edm a \u00famrt\u00edm na z\u00e1klad\u011b hladin protil\u00e1tek, kter\u00e9 indikovaly ochranu u 16-25let\u00fdch.<\/span><\/p>\n

Krom\u011b skok\u016f v logice a zjevn\u00e9ho nez\u00e1jmu o v\u011bdeckou p\u0159\u00edsnost \u2013 pro\u010d by l\u00e9ka\u0159sk\u00fd regul\u00e1tor jednodu\u0161e p\u0159edpokl\u00e1dal, \u017ee stejn\u00e9 hladiny protil\u00e1tek u 5let\u00e9ho a 25let\u00e9ho vedou ke stejn\u00e9mu riziku hospitalizace, resp. smrt na COVID bez toho, existuje n\u011bjak\u00fd d\u016fkaz o tom?\u00a0– Tento neopodstatn\u011bn\u00fd p\u0159edpoklad umo\u017enil spole\u010dnosti Pfizer a FDA vyhnout se vhodn\u00e9mu a nezbytn\u00e9mu opat\u0159en\u00ed: proveden\u00ed v\u011bt\u0161\u00ed a del\u0161\u00ed studie.<\/span><\/p>\n

P\u0159ijet\u00ed v\u00edce \u00fa\u010dastn\u00edk\u016f a \u010dek\u00e1n\u00ed na smyslupln\u00e9 klinick\u00e9 v\u00fdsledky by samoz\u0159ejm\u011b mo\u017en\u00e1 tak\u00e9 objasnilo rizika intervence.<\/span><\/p>\n

A\u010dkoli se CDC a FDA rozhodly povolit spole\u010dnosti Pfizer tento monument\u00e1ln\u00ed p\u0159edpoklad ve sv\u00e9 neefektivn\u00ed studii, FDA ji\u017e dlouho nal\u00e9h\u00e1 na ve\u0159ejnost, aby nepou\u017e\u00edvala hladiny protil\u00e1tek jako m\u011b\u0159\u00edtko imunity.<\/span><\/p>\n

CDC tak\u00e9 opakuje tento postoj ve shrnut\u00ed sv\u00e9ho COVID-19 Science Brief, ironicky zve\u0159ejn\u011bn\u00e9ho ve stejn\u00fd den, kdy FDA ud\u011blil Pfizer nouzov\u00e9 schv\u00e1len\u00ed pro d\u011bti: \u201eV sou\u010dasn\u00e9 dob\u011b nejsou k dispozici dostate\u010dn\u00e9 \u00fadaje ke stanoven\u00ed prahov\u00e9 hodnoty titru protil\u00e1tek, kter\u00e1 ukazuje, kdy \u010dlov\u011bk je chr\u00e1n\u011bn p\u0159ed infekc\u00ed.“<\/span><\/p>\n

Z\u00e1v\u011br<\/span><\/strong><\/p>\n

Na\u0161e zem\u011b dnes \u010del\u00ed nov\u00e9mu kmeni Omikron rezistentn\u00edmu na protil\u00e1tky a nelze p\u0159ehl\u00e9dnout nejednotn\u00fd a rozporupln\u00fd p\u0159\u00edstup na\u0161ich l\u00e9ka\u0159sk\u00fdch autorit.<\/span><\/p>\n

P\u0159im\u011b\u0159en\u011b jste odrazovali pacienty a poskytovatele p\u00e9\u010de od n\u011bkter\u00fdch intervenc\u00ed, kter\u00e9 pravd\u011bpodobn\u011b nebudou fungovat.\u00a0Pro\u010d by se m\u011bly pou\u017e\u00edvat infuze monoklon\u00e1ln\u00edch protil\u00e1tek, kter\u00e9 p\u0159in\u00e1\u0161ej\u00ed mal\u00fd u\u017eitek a pouze rizika?<\/span><\/p>\n

Na druhou stranu, sou\u010dasn\u00e9 formulace vakc\u00edn jsou tak\u00e9 st\u00e1le m\u00e9n\u011b \u00fa\u010dinn\u00e9, zejm\u00e9na proti Omicron, ale tlak na o\u010dkov\u00e1n\u00ed za ka\u017edou cenu pokra\u010duje.<\/span><\/p>\n

Terapie monoklon\u00e1ln\u00edmi protil\u00e1tkami jsou nav\u00edc obvykle vyhrazeny pro ty, kte\u0159\u00ed jsou po infekci v nejvy\u0161\u0161\u00edm riziku v\u00e1\u017en\u00e9ho onemocn\u011bn\u00ed, pokud byla prok\u00e1z\u00e1na expozice viru, zat\u00edmco o\u010dkov\u00e1n\u00ed se pou\u017e\u00edv\u00e1 jako preventivn\u00ed opat\u0159en\u00ed pro \u0161irokou ve\u0159ejnost a nov\u011b i pro mal\u00e9 d\u011bti, co\u017e je nejmen\u0161\u00ed Riziko hospitalizace a \u00famrt\u00ed na infekci SARS-CoV-2.<\/span><\/p>\n

Jin\u00fdmi slovy, z hlediska rizika a p\u0159\u00ednosu je logi\u010dt\u011bj\u0161\u00ed pokra\u010dovat v infuz\u00edch monoklon\u00e1ln\u00edch protil\u00e1tek, i kdy\u017e jsou okrajov\u011b \u00fa\u010dinn\u00e9, a okam\u017eit\u011b ukon\u010dit o\u010dkov\u00e1n\u00ed d\u011bt\u00ed.<\/span><\/p>\n

Z\u00e1hadn\u00fd postoj CDC a FDA lze p\u0159i\u010d\u00edst pouze jejich systematick\u00e9mu pop\u00edr\u00e1n\u00ed jak\u00e9koli mo\u017enosti vedlej\u0161\u00edch \u00fa\u010dink\u016f vakc\u00edny, navzdory rozs\u00e1hl\u00fdm a hromad\u00edc\u00edm se d\u016fkaz\u016fm o opaku.<\/span><\/p>\n<\/div>\n<\/div>\n

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ZDROJ: AS OMICRON SURGES, O\u010cKOVAC\u00cd STRATEGIE FDA ZPOCHYBN\u011aNA<\/a><\/span><\/h3>\n

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

USA: Varianta Omicron je p\u0159evl\u00e1daj\u00edc\u00edm kmenem COVID-19 ve Spojen\u00fdch st\u00e1tech, co\u017e vedlo k pozastaven\u00ed distribuce…<\/p>\n","protected":false},"author":2,"featured_media":7053,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1037,1088,213,1518,37],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/7334"}],"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=7334"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/7334\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/7053"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=7334"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=7334"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=7334"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}