{"id":14713,"date":"2022-09-07T05:19:10","date_gmt":"2022-09-07T03:19:10","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=14713"},"modified":"2022-09-07T08:08:09","modified_gmt":"2022-09-07T06:08:09","slug":"regulacni-urady-schvalily-vakciny-na-omicron-bez-jedineho-testu-na-lidech","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2022\/09\/07\/regulacni-urady-schvalily-vakciny-na-omicron-bez-jedineho-testu-na-lidech\/","title":{"rendered":"Regula\u010dn\u00ed \u00fa\u0159ady schv\u00e1lily vakc\u00edny na omicron bez jedin\u00e9ho testu na lidech"},"content":{"rendered":"
<\/div>\n

L\u00e9ka\u0159i a m\u00e9dia zpochyb\u0148uj\u00ed americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) v souvislosti s jeho ned\u00e1vn\u00fdm rozhodnut\u00edm schv\u00e1lit zcela nov\u00e9 \u201ebivalentn\u00ed\u201c posilovac\u00ed d\u00e1vky vakc\u00edn proti Covid-19, kter\u00e9 nebyly nikdy testov\u00e1ny na lidech.<\/p>\n

Tot\u00e9\u017e se t\u00fdk\u00e1 i Evropsk\u00e9 l\u00e9kov\u00e9 agentury (EMA), kter\u00e1 p\u0159ed p\u00e1r t\u00fddny vydala stejn\u00e9 rozhodnut\u00ed.<\/p>\n

Argumentem je, \u017ee nov\u00e9 injekce se li\u0161\u00ed od star\u0161\u00edch tak m\u00e1lo, \u017ee nemus\u00ed podstoupit \u017e\u00e1dn\u00e9 klinick\u00e9 zkou\u0161ky na lidech.\u00a0Toto je argument regula\u010dn\u00edch \u00fa\u0159ad\u016f pot\u00e9, co oraz\u00edtkovaly nejnov\u011bj\u0161\u00ed vakc\u00edny nadsv\u011btelnou rychlost\u00ed.<\/p>\n

Komisa\u0159 FDA Robert Califf a \u0159editel Centra pro hodnocen\u00ed a v\u00fdzkum biologick\u00fdch l\u00e1tek Peter Marks uvedli, \u017ee feder\u00e1ln\u00ed agentura pou\u017eila stejn\u00fd proces pro schvalov\u00e1n\u00ed nov\u00fdch posilovac\u00edch d\u00e1vek, kter\u00fd pou\u017e\u00edv\u00e1 ke schvalov\u00e1n\u00ed nov\u00fdch ka\u017edoro\u010dn\u00edch o\u010dkov\u00e1n\u00ed proti ch\u0159ipce.<\/p>\n

„Tohle je ot\u00e1zka \u010d\u00edslo jedna, kterou si lid\u00e9 kladou,“<\/em>\u00a0\u0159ekl Califf na tiskov\u00e9 konferenci.<\/p>\n

Marks k tomu dodal, \u017ee FDA m\u00e1 \u201erozs\u00e1hl\u00e9 zku\u0161enosti z minulosti se zm\u011bnami virov\u00e9ho kmene, kter\u00e9 se uskute\u010dnily bez klinick\u00fdch \u00fadaj\u016f, jen na z\u00e1klad\u011b dostupn\u00fdch podklad\u016f\u201c.<\/p>\n

(Souvisej\u00edc\u00ed: Vlastn\u00ed intern\u00ed \u00fadaje spole\u010dnosti Moderna\u00a0ukazuj\u00ed<\/a>\u00a0, \u017ee vakc\u00edny nejsou \u00fa\u010dinn\u00e9 proti variant\u011b omikron.)<\/p>\n

Nez\u00e1visl\u00fdm m\u00e9di\u00edm bylo b\u011bhem virtu\u00e1ln\u00ed tiskov\u00e9 konference FDA zak\u00e1z\u00e1no kl\u00e1st ot\u00e1zky<\/h2>\n

Dvojice uspo\u0159\u00e1dala virtu\u00e1ln\u00ed tiskovou konferenci, na kter\u00e9 prodiskutovala tuto z\u00e1le\u017eitost.\u00a0Interaktivn\u00ed kan\u00e1l Zoom umo\u017enil m\u00e9di\u00edm \u2013 tedy jen n\u011bkter\u00fdm m\u00e9di\u00edm \u2013 kl\u00e1st ot\u00e1zky.<\/p>\n

Port\u00e1l\u00a0Just the News<\/em>\u00a0\u0159\u00edk\u00e1, \u017ee dostal p\u0159\u00edstup pouze ke stejnosm\u011brn\u00e9 verzi streamu na YouTube, kterou bylo mo\u017eno jen sledovat a neumo\u017e\u0148ovalo kl\u00e1st ot\u00e1zky.<\/p>\n

Wake Forest University<\/em>\u00a0(WFU) v Severn\u00ed Karol\u00edn\u011b mezit\u00edm dokonce ani ne\u010dekala na p\u0159\u00edm\u00fd p\u0159enos \u2013 nebo na schv\u00e1len\u00ed vakc\u00edny \u00fa\u0159adem FDA \u2013 p\u0159edt\u00edm, ne\u017e ji za\u010dala na\u0159izovat sv\u00fdm student\u016fm.<\/p>\n

Instituce se s\u00eddlem ve Winstone-Salem, kter\u00e1 je sou\u010d\u00e1st\u00ed farmaceutick\u00e9ho regionu \u201eTroj\u00faheln\u00edk\u201c ve st\u0159edn\u00ed \u010d\u00e1sti Severn\u00ed Karol\u00edny, tvrd\u00ed, \u017ee sv\u00e9 rozhodnut\u00ed na\u0159\u00eddit zcela nov\u00e9 posilovac\u00ed d\u00e1vky t\u00e9m\u011b\u0159 m\u011bs\u00edc p\u0159ed jejich skute\u010dn\u00fdm schv\u00e1len\u00edm bylo p\u0159ijato \u201ena pos\u00edlen\u00ed\u00a0kolektivn\u00ed imunity<\/a> na\u0161\u00ed komunity\u201c.<\/p>\n

Vakc\u00edna testov\u00e1na pouze na 8 my\u0161\u00edch!<\/h2>\n

Studenti a u\u010ditel\u00e9, kte\u0159\u00ed ned\u00e1vno obdr\u017eeli prvn\u00ed posilovac\u00ed d\u00e1vku vakc\u00edny, jsou spolu se v\u0161emi ostatn\u00edmi nuceni op\u011bt si vyhrnout ruk\u00e1vy pro vakc\u00ednu, kter\u00e1 byla testov\u00e1na pouze na osmi my\u0161\u00edch, na z\u00e1klad\u011b \u010deho\u017e j\u00ed FDA dala zelenou.<\/p>\n

Podle t\u00e9to skute\u010dn\u011b mal\u00e9 studie na zv\u00ed\u0159atech vakc\u00edna proti omikronu od spole\u010dnosti Pfizer \u201evygenerovala 2,6n\u00e1sobn\u00e9 zv\u00fd\u0161en\u00ed hladin neutraliza\u010dn\u00edch protil\u00e1tek\u201c ve srovn\u00e1n\u00ed s dosavadn\u00ed vakc\u00ednou spole\u010dnosti.<\/p>\n

Nedefinovan\u00e1 \u201elaboratorn\u00ed pr\u00e1ce\u201c na vakc\u00edny Moderny \u00fadajn\u011b uk\u00e1zala osmin\u00e1sobn\u00fd n\u00e1r\u016fst stejn\u00fdch hladin neutraliza\u010dn\u00edch protil\u00e1tek.<\/p>\n

Vedouc\u00ed americk\u00e9ho Centra pro kontrolu a prevenci nemoc\u00ed (CDC) Rochelle Walensky ozn\u00e1mila, \u017ee d\u016fvodem tak rychl\u00e9ho schv\u00e1len\u00ed vakc\u00edny bez pokus\u016f na lidech je to, \u017ee feder\u00e1ln\u00ed vl\u00e1da u\u017e na takov\u00e9 v\u011bci prost\u011b nem\u00e1 \u010das \u010dekat.<\/p>\n

\u201eBudeme pou\u017e\u00edvat to, co bych pova\u017eovala za potenci\u00e1ln\u011b zastaralou vakc\u00ednu,\u201c<\/em>\u00a0\u0159ekla s odkazem na sou\u010dasn\u00e9 posilovac\u00ed d\u00e1vky, o kter\u00fdch se \u0159\u00edk\u00e1, \u017ee jsou ne\u00fa\u010dinn\u00e9 proti nejnov\u011bj\u0161\u00ed podvariantu omikronu.<\/p>\n

Zd\u00e1 se, \u017ee skute\u010dn\u00fdm c\u00edlem je dostat co nejv\u00edce t\u011bchto \u201esmakul\u00e1d\u201c do ramen lid\u00ed p\u0159ed listopadov\u00fdmi dopl\u0148ovac\u00edmi volbami do americk\u00e9ho Kongresu.\u00a0Epidemiolog Vinay Prasad z Kalifornsk\u00e9 univerzity v San Francisku to potvrdil ve sv\u00e9m twitt\u011b, kdy\u017e napsal:<\/p>\n

\u201eWalensky \u0159\u00edk\u00e1, \u017ee nem\u016f\u017eeme \u010dekat na \u00fadaje z lidsk\u00fdch klinick\u00fdch zkou\u0161ek, mus\u00edme se spol\u00e9hat na my\u0161i\u2026 Toto nemohou rozhodnout politi\u010dt\u00ed kandid\u00e1ti\u2026\u00a0<\/em>M\u00e1te-li volby v listopadu, t\u011bsn\u011b p\u0159ed volbami byste schv\u00e1lili cokoli, co by mohlo sn\u00ed\u017eit po\u010det nov\u00fdch p\u0159\u00edpad\u016f covidu.\u00a0Kdo se star\u00e1 o bezpe\u010dnost a z\u00e1va\u017en\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky?\u00a0FDA mus\u00ed b\u00fdt odst\u0159ihnuta od rozhodov\u00e1n\u00ed.\u201c<\/em><\/p>\n

Z\u00e1v\u011br<\/h2>\n

\u0158editel V\u00fdboru pro korovavirovou krizi Jim Clyburn (DS.C.), osoba odpov\u011bdn\u00e1 za \u00fasp\u011b\u0161n\u00fd n\u00e1tlak na FDA, aby sn\u00ed\u017eila sv\u00e9 standardy pro covidov\u00e9 vakc\u00edny pod\u00e1van\u00e9 d\u011btem, vydal tento t\u00fdden prohl\u00e1\u0161en\u00ed, ve kter\u00e9m slav\u00ed rychl\u00e9 schv\u00e1len\u00ed nov\u00e9 posilovac\u00ed vakc\u00edny na omikron ze strany FDA .<\/p>\n

Nejnov\u011bj\u0161\u00ed zpr\u00e1vy o covidov\u00fdch vakc\u00edn\u00e1ch naleznete na str\u00e1nce\u00a0ChemicalViolence.com<\/a> .<\/p>\n

Autor: Ethan Huff, Zdroj:\u00a0naturalnews.com<\/a><\/p>\n

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

L\u00e9ka\u0159i a m\u00e9dia zpochyb\u0148uj\u00ed americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) v souvislosti s…<\/p>\n","protected":false},"author":2,"featured_media":14714,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[940,1518,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/14713"}],"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=14713"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/14713\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/14714"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=14713"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=14713"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=14713"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}