{"id":21437,"date":"2023-01-19T05:19:52","date_gmt":"2023-01-19T04:19:52","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=21437"},"modified":"2023-01-19T05:19:52","modified_gmt":"2023-01-19T04:19:52","slug":"vysoky-predstavitel-fda-zada-okamzite-ukonceni-ockovani-proti-covidu-a-miliony-zatim-padaji-mrtvi-k-zemi","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2023\/01\/19\/vysoky-predstavitel-fda-zada-okamzite-ukonceni-ockovani-proti-covidu-a-miliony-zatim-padaji-mrtvi-k-zemi\/","title":{"rendered":"Vysok\u00fd p\u0159edstavitel FDA \u017e\u00e1d\u00e1 okam\u017eit\u00e9 ukon\u010den\u00ed o\u010dkov\u00e1n\u00ed proti covidu. A miliony zat\u00edm padaj\u00ed mrtv\u00ed k zemi"},"content":{"rendered":"
<\/div>\n

\u00a0Vysok\u00fd p\u0159edstavitel americk\u00e9ho regula\u010dn\u00edho \u00fa\u0159adu pro l\u00e9ky a potraviny FDA vyzval k okam\u017eit\u00e9mu zastaven\u00ed o\u010dkov\u00e1n\u00ed proti onemocn\u011bn\u00ed Covid-19 v USA z d\u016fvodu alarmuj\u00edc\u00edho po\u010dtu lid\u00ed trp\u00edc\u00edch z\u00e1va\u017en\u00fdmi ne\u017e\u00e1douc\u00edmi reakcemi n mRNA \u201evakc\u00edny\u201c.<\/span><\/p>\n

Dr.\u00a0Paul Offit, \u010dlen poradn\u00edho v\u00fdboru pro vakc\u00edny americk\u00e9 FDA, napsal \u010dl\u00e1nek v presti\u017en\u00edm medic\u00ednsk\u00e9m \u010dasopise\u00a0<\/span>New England Journal of Medicine<\/span><\/em>\u00a0, ve kter\u00e9m vyzval k ukon\u010den\u00ed masov\u00e9ho o\u010dkov\u00e1n\u00ed, zejm\u00e9na t\u011bch, jejich\u017e onemocn\u011bn\u00ed ohro\u017euje jen m\u00e1lo.<\/span><\/p>\n

V \u010dl\u00e1nku s n\u00e1zvem \u201eBivalentn\u00ed vakc\u00edny proti Covid-19 \u2013 varovn\u00fd p\u0159\u00edb\u011bh\u201c Dr.\u00a0Offit prohla\u0161uje, \u017ee posilovac\u00ed d\u00e1vky vakc\u00edn by m\u011bly b\u00fdt pod\u00e1v\u00e1ny pouze lidem, kte\u0159\u00ed pot\u0159ebuj\u00ed ochranu p\u0159ed z\u00e1va\u017en\u00fdm pr\u016fb\u011bhem onemocn\u011bn\u00ed.<\/span><\/p>\n

(\u00a0<\/span>Pozn\u00e1mka redakce:<\/span><\/strong>\u00a0Podle n\u00e1s jsou tyto vakc\u00edny jed a nem\u011bly by b\u00fdt pod\u00e1v\u00e1ny nikomu. Av\u0161ak i takov\u00e1 \u010d\u00e1ste\u010dn\u00e1 zm\u011bna n\u00e1zoru u d\u0159\u00edve tvrd\u00e9ho zast\u00e1nce covidov\u00e9ho o\u010dkov\u00e1n\u00ed se cen\u00ed.)<\/span><\/p>\n

\u201eV\u011b\u0159\u00edm, \u017ee bychom se m\u011bli p\u0159estat sna\u017eit p\u0159edch\u00e1zet v\u0161em symptomatick\u00fdm infekc\u00edm u zdrav\u00fdch, mlad\u00fdch lid\u00ed t\u00edm, \u017ee jim budeme pod\u00e1vat posiluj\u00edc\u00ed d\u00e1vky pro kmeny viru, kter\u00e9 o n\u011bkolik m\u011bs\u00edc\u016f pozd\u011bji zmiz\u00ed,\u201c<\/span><\/em>\u00a0varuje Dr.\u00a0Offit.<\/span><\/p>\n

Str\u00e1nka\u00a0<\/span>Summit.news<\/span><\/a>\u00a0uv\u00e1d\u00ed:<\/span><\/p>\n

Dr.\u00a0Offit, kter\u00fd je profesorem vakcinologie a profesorem pediatrie na Pensylv\u00e1nsk\u00e9 univerzit\u011b, podrobn\u011b popisuje proces, kter\u00fd vedl k tomu, \u017ee bivalentn\u00ed mRNA \u201evakc\u00edny\u201c se v USA doporu\u010dovaly v\u0161em lidem star\u0161\u00edm p\u011bti let, bez relevantn\u00edch dat ze studi\u00ed na lidech.\u00a0O\u010dividn\u011b je z toho velmi ne\u0161\u0165astn\u00fd.<\/span><\/p>\n

Dr.\u00a0Offit odhaluje praktiky schvalov\u00e1n\u00ed covidov\u00fdch vakc\u00edn<\/span><\/h2>\n

Dne 28. \u010dervna 2022 p\u0159edlo\u017eili v\u00fdzkumn\u00edci Pfizer-BioNTech a Moderna \u00fadaje o sv\u00fdch bivalentn\u00edch vakc\u00edn\u00e1ch Poradn\u00edmu v\u00fdboru pro vakc\u00edny a p\u0159\u00edbuzn\u00e9 biologick\u00e9 produkty FDA (jeho\u017e je \u010dlenem).<\/span><\/p>\n

V\u00fdsledky byly podpr\u016fm\u011brn\u00e9.\u00a0Bivalentn\u00ed posilovac\u00ed d\u00e1vky vedly k hladin\u00e1m neutralizuj\u00edc\u00edch protil\u00e1tek proti BA.1, kter\u00e9 byly jen 1,5 a\u017e 1,75kr\u00e1t vy\u0161\u0161\u00ed ne\u017e hladiny dosa\u017een\u00e9 p\u0159i monovalentn\u00edch posilovac\u00edch d\u00e1vk\u00e1ch.<\/span><\/p>\n

P\u0159edchoz\u00ed zku\u0161enosti s vakc\u00ednami spole\u010dnost\u00ed nazna\u010dovaly, \u017ee tento rozd\u00edl pravd\u011bpodobn\u011b nebude klinicky v\u00fdznamn\u00fd.\u00a0Bezpe\u010dnostn\u00ed \u00fadaje byly uspokojuj\u00edc\u00ed.<\/span><\/p>\n

V dob\u011b prezentace test\u016f pro FDA ji\u017e varianta BA.1 ve Spojen\u00fdch st\u00e1tech ani v Evrop\u011b necirkulovala, byla nahrazena imunitn\u011b vyh\u00fdbav\u00fdmi a naka\u017eliv\u011bj\u0161\u00edmi subvarianty omikronu.\u00a0Ale zima byla za rohem a poradn\u00ed v\u00fdbor\u00a0<\/span>FDA<\/span><\/a>\u00a0\u00a0c\u00edtil nal\u00e9havost reakce na tyto imunit\u011b se vyh\u00fdbaj\u00edc\u00ed kmeny.<\/span><\/p>\n

N\u00e1sledovala s\u00e9rie rychl\u00fdch politick\u00fdch rozhodnut\u00ed.<\/span><\/p>\n

Dne 29. \u010dervna 2022, den po setk\u00e1n\u00ed poradn\u00edho v\u00fdboru, Bidenova administrativa souhlasila s n\u00e1kupem 105 milion\u016f d\u00e1vek bivalentn\u00ed vakc\u00edny Pfizer-BioNTech s obsahem mRNA proti variant\u00e1m BA.4 a BA.5.<\/span><\/p>\n

O m\u011bs\u00edc pozd\u011bji, 29. \u010dervence 2022, administrativa souhlasila s n\u00e1kupem dal\u0161\u00edch 66 milion\u016f d\u00e1vek bivalentn\u00ed vakc\u00edny Moderna s \u00famyslem nab\u00eddnout ob\u011b vakc\u00edny na podzim a v zim\u011b.<\/span><\/p>\n

Dne 1. z\u00e1\u0159\u00ed 2022 FDA st\u00e1hla sv\u00e9 povolen\u00ed k nouzov\u00e9mu pou\u017eit\u00ed pro posilovac\u00ed d\u00e1vky monovalentn\u00ed o\u010dkovac\u00ed l\u00e1tky a CDC doporu\u010dilo p\u0159eo\u010dkov\u00e1n\u00ed bivalentn\u00ed vakc\u00ednou pro v\u0161echny ve v\u011bku 12 let nebo star\u0161\u00ed.<\/span><\/p>\n

Dne 12. \u0159\u00edjna 2022 CDC roz\u0161\u00ed\u0159ilo toto doporu\u010den\u00ed tak, aby zahrnovalo v\u0161echny ve v\u011bku p\u011bt let nebo star\u0161\u00edch.\u00a0Pro toto rozhodnut\u00ed CDC v\u0161ak neexistuj\u00ed \u017e\u00e1dn\u00e1 data z klinick\u00fdch zkou\u0161ek, v\u010detn\u011b \u00fadaj\u016f o imunogenit\u011b.<\/span><\/p>\n

Dne 24. \u0159\u00edjna 2022 David Ho a kolegov\u00e9 zve\u0159ejnili v\u00fdsledky studie zkoumaj\u00edc\u00ed hladiny neutraliza\u010dn\u00edch protil\u00e1tek proti variant\u00e1m omikronu BA.4 a BA.5 po pod\u00e1n\u00ed monovalentn\u00ed nebo bivalentn\u00ed posilovac\u00ed d\u00e1vky.\u00a0Mezi t\u011bmito dv\u011bma skupinami nena\u0161li \u201e\u017e\u00e1dn\u00fd v\u00fdznamn\u00fd rozd\u00edl v neutralizaci \u017e\u00e1dn\u00e9 varianty SARS-CoV-2\u201c, v\u010detn\u011b BA.4 a BA.5.<\/span><\/p>\n

O den pozd\u011bji Dan Barouch a kolegov\u00e9 zve\u0159ejnili v\u00fdsledky podobn\u00e9 studie a zjistili, \u017ee \u201etitry BA.5 (neutraliza\u010dn\u00edch protil\u00e1tek) byly srovnateln\u00e9 po posilovac\u00edch d\u00e1vk\u00e1ch monovalentn\u00edch a bivalentn\u00edch mRNA vakc\u00edn\u201c.<\/span><\/p>\n

Barouch a kolegov\u00e9 tak\u00e9 nezaznamenali \u017e\u00e1dn\u00e9 v\u00fdrazn\u00e9 rozd\u00edly v odpov\u011bd\u00edch CD4+ nebo CD8+ T-bun\u011bk mezi \u00fa\u010dastn\u00edky ve skupin\u011b s monovalentn\u00ed posilovac\u00ed d\u00e1vkou a \u00fa\u010dastn\u00edky ve skupin\u011b s bivalentn\u00ed posilovac\u00ed d\u00e1vkou.<\/span><\/p>\n

Ani jedna v\u00fdzkumn\u00e1 skupina nezjistila, \u017ee bivalentn\u00ed posilovac\u00ed d\u00e1vky vyvol\u00e1vaj\u00ed lep\u0161\u00ed imunitn\u00ed reakce.\u00a0<\/span><\/strong>V\u00fdsledky jsou nyn\u00ed zve\u0159ejn\u011bny v medic\u00ednsk\u00e9m \u017eurn\u00e1lu.<\/span><\/p>\n

Pravd\u011bpodobn\u00fdm d\u016fvodem selh\u00e1n\u00ed bivalentn\u00edch vakc\u00edn je imprinting, vysv\u011btluje Dr.\u00a0Offit.<\/span><\/h2>\n

Imunitn\u00ed syst\u00e9m lid\u00ed o\u010dkovan\u00fdch bivalentn\u00ed \u201evakc\u00ednou\u201c, z nich\u017e v\u0161ichni byli d\u0159\u00edve o\u010dkov\u00e1ni p\u016fvodn\u00ed \u201evakc\u00ednou\u201c, byl p\u0159ipraven reagovat na p\u016fvodn\u00ed kmen SARS-CoV-2.\u00a0Proto pravd\u011bpodobn\u011b reagovali sp\u00ed\u0161e na epitopy sd\u00edlen\u00e9 BA.4 a BA.5 a p\u016fvodn\u00ed kmen viru, ne\u017e na nov\u00e9 varianty BA.4 a BA.5.<\/span><\/p>\n

Kdy\u017e byly dostupn\u00e9 epidemiologick\u00e9 \u00fadaje, vykazovaly velmi slabou ochranu.<\/span><\/p>\n

Dne 22. listopadu 2022 CDC zve\u0159ejnilo \u00fadaje o \u00fa\u010dinnosti mRNA \u201evakc\u00edn\u201c proti kmen\u016fm viru BA.4 a BA.5 k prevenci symptomatick\u00e9 infekce do dvou m\u011bs\u00edc\u016f po pod\u00e1n\u00ed posilovac\u00ed d\u00e1vky.<\/span><\/p>\n

U lid\u00ed, kte\u0159\u00ed dostali monovalentn\u00ed vakc\u00ednu p\u0159ed dv\u011bma a\u017e t\u0159emi m\u011bs\u00edci, se dodate\u010dn\u00e1 ochrana spojen\u00e1 s bivalentn\u00ed posilovac\u00ed d\u00e1vkou pohybovala od 28% do 31%.\u00a0Pro ty, kte\u0159\u00ed dostali monovalentn\u00ed vakc\u00ednu p\u0159ed v\u00edce ne\u017e osmi m\u011bs\u00edci, byla dodate\u010dn\u00e1 ochrana v rozsahu od 43% do 56%.<\/span><\/p>\n

Vzhledem k v\u00fdsledk\u016fm p\u0159edchoz\u00edch studi\u00ed je pravd\u011bpodobn\u00e9, \u017ee toto m\u00edrn\u00e9 zv\u00fd\u0161en\u00ed ochrany proti pravd\u011bpodobn\u011b obecn\u011b m\u00edrn\u00e9mu onemocn\u011bn\u00ed bude m\u00edt kr\u00e1tk\u00e9 trv\u00e1n\u00ed.<\/span><\/p>\n

M\u00edra proo\u010dkovanosti populace bivalentn\u00ed vakc\u00ednou byla n\u00edzk\u00e1 (lid\u00e9 o ni nejevili z\u00e1jem) a varianty viru, proti kter\u00fdm byla zam\u011b\u0159ena, rychle mizely z cirkulace v populaci.<\/span><\/p>\n

K 15. listopadu 2022 ji dostalo jen asi 10% populace, pro kterou byla bivalentn\u00ed vakc\u00edna doporu\u010dena.<\/span><\/p>\n

Do prosince 2022 kmen BA.4 ji\u017e necirkuloval a BA.5 p\u0159edstavoval m\u00e9n\u011b ne\u017e 25% cirkuluj\u00edc\u00edch kmen\u016f SARS-CoV-2, p\u0159i\u010dem\u017e byl \u010d\u00e1ste\u010dn\u011b nahrazen kmeny, kter\u00e9 se vyh\u00fdbaj\u00ed imunit\u011b z\u00edskan\u00e9 z o\u010dkov\u00e1n\u00ed, jako nap\u0159\u00edklad kmeny BQ.1, BQ.1.1 , BF.7, XBB a XBB.1.<\/span><\/p>\n

Pro\u010d se Dr.\u00a0Offit oz\u00fdv\u00e1 a\u017e te\u010f?<\/span><\/h2>\n

Je chv\u00e1lyhodn\u00e9, \u017ee Dr.\u00a0Offit prolomil ml\u010den\u00ed, vyjad\u0159uje zd\u011b\u0161en\u00ed nad \u0161patn\u00fdm postupem a nedostatkem \u00fadaj\u016f a vyz\u00fdv\u00e1 k ukon\u010den\u00ed kampan\u011b masov\u00e9ho o\u010dkov\u00e1n\u00ed.<\/span><\/p>\n

Jeho ozv\u00e1n\u00ed se je obzvl\u00e1\u0161\u0165 v\u00fdznamn\u00e9, proto\u017ee poukazuje na selh\u00e1n\u00ed centr\u00e1ln\u00ed strategie biologick\u00e9 bezpe\u010dnosti USA spo\u010d\u00edvaj\u00edc\u00ed v pokusu pou\u017e\u00edt rychlokva\u0161en\u00e9 mRNA \u201evakc\u00edny\u201c k realizaci bleskurychl\u00e9 reakce na vznikaj\u00edc\u00ed biologickou hrozbu.<\/span><\/p>\n

Je tedy pravd\u011bpodobn\u00e9, \u017ee z\u00e1v\u011brem Dr.\u00a0Offita budou siln\u011b odporovat ti, kte\u0159\u00ed jsou do o\u010dkovac\u00ed strategie siln\u011b zainteresovan\u00ed \u2013 finan\u010dn\u011b, psychologicky a politicky.<\/span><\/p>\n

Fakt, \u017ee to Dr.\u00a0Offit d\u011bl\u00e1 a\u017e nyn\u00ed a neuzn\u00e1v\u00e1 jak\u00e9koli bezpe\u010dnostn\u00ed probl\u00e9my covidov\u00fdch vakc\u00edn, je ji\u017e m\u00e9n\u011b chv\u00e1lyhodn\u00e9.\u00a0P\u0159esto mu jeho sponzo\u0159i pravd\u011bpodobn\u011b nepod\u011bkuj\u00ed.\u00a0Ka\u017edop\u00e1dn\u011b se vydal spr\u00e1vn\u00fdm sm\u011brem, tak\u017ee by za to m\u011bl z\u00edskat uzn\u00e1n\u00ed.<\/span><\/p>\n

St\u00e1le v\u0161ak \u010dek\u00e1me na potvrzen\u00ed, \u017ee p\u0159\u00ednos t\u011bchto vakc\u00edn nebyl nikdy p\u0159\u00edzniv\u00fd pro lidi s n\u00edzk\u00fdm rizikem onemocn\u011bn\u00ed, kte\u0159\u00ed je nikdy nepot\u0159ebovali a tak\u00e9, \u017ee jejich bezpe\u010dnostn\u00ed profil je mnohem hor\u0161\u00ed, ne\u017e farmaceutick\u00e9 firmy a regula\u010dn\u00ed org\u00e1ny p\u0159esv\u011bd\u010dovaly ve\u0159ejnost.<\/span><\/p>\n

Port\u00e1l CNN\u00a0<\/span>uv\u00e1d\u00ed<\/span><\/a>\u00a0, \u017ee Dr.\u00a0Offit je \u201erozzloben\u00fd\u201c, proto\u017ee spole\u010dnost Moderna minul\u00fd rok nezahrnula nep\u0159\u00edzniv\u00e9 \u00fadaje o infek\u010dnosti ve sv\u00e9m pod\u00e1n\u00ed pro FDA.<\/span><\/p>\n

\u201eByl jsem rozzloben\u00fd, kdy\u017e jsem zjistil, \u017ee existuj\u00ed \u00fadaje, kter\u00e9 jsou relevantn\u00ed pro na\u0161e rozhodnut\u00ed a kter\u00e9 jsme nem\u011bli mo\u017enost vid\u011bt,\u201c<\/span><\/em>\u00a0\u0159ekl Dr.\u00a0Offit.<\/span><\/p>\n

\u201e\u00dadaje, kter\u00e9 nebyly p\u0159edlo\u017eeny odborn\u00edkem, se zab\u00fdvaly skute\u010dn\u00fdmi infekcemi \u2013 kdo chytil Covid-19 a kdo ne.\u00a0Bylo zji\u0161t\u011bno, \u017ee 1,9 % \u00fa\u010dastn\u00edk\u016f studie, kte\u0159\u00ed obdr\u017eeli p\u016fvodn\u00ed posilovac\u00ed d\u00e1vku, se nakazili.\u00a0Mezi t\u011bmi, kdo dostali aktualizovanou bivalentn\u00ed posilovac\u00ed d\u00e1vku \u2013 tu, o kter\u00e9 v\u011bdci doufali, \u017ee bude fungovat l\u00e9pe \u2013 se infikovalo dokonce vy\u0161\u0161\u00ed procento, a\u017e 3,2%.\u201c<\/span><\/em><\/p>\n

Pokud farmaceutick\u00e9 firmy zatajily tak podstatn\u00e9 informace, co\u017e je\u0161t\u011b dal\u0161\u00ed v\u00e1m zatajili, Dr.\u00a0Offit?<\/span><\/p>\n

Autor: Sean Adl-Tabatabai, Zdroj:\u00a0<\/span>newspunch.com<\/span><\/a><\/p>\n

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\u00a0Vysok\u00fd p\u0159edstavitel americk\u00e9ho regula\u010dn\u00edho \u00fa\u0159adu pro l\u00e9ky a potraviny FDA vyzval k okam\u017eit\u00e9mu zastaven\u00ed o\u010dkov\u00e1n\u00ed…<\/p>\n","protected":false},"author":2,"featured_media":7750,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,213,651,538],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/21437"}],"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=21437"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/21437\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/7750"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=21437"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=21437"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=21437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}