{"id":29245,"date":"2023-06-02T01:10:32","date_gmt":"2023-06-01T23:10:32","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=29245"},"modified":"2023-06-01T14:23:35","modified_gmt":"2023-06-01T12:23:35","slug":"vitezstvi-pro-farmaceuticky-prumysl-ema-schvaluje-nove-mrna-vakciny-bez-klinickych-zkousek","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2023\/06\/02\/vitezstvi-pro-farmaceuticky-prumysl-ema-schvaluje-nove-mrna-vakciny-bez-klinickych-zkousek\/","title":{"rendered":"V\u00edt\u011bzstv\u00ed pro farmaceutick\u00fd pr\u016fmysl: EMA schvaluje nov\u00e9 mRNA vakc\u00edny bez klinick\u00fdch zkou\u0161ek"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p><strong>Covid je u konce &#8211; a\u0165 \u017eije Covid.\u00a0P\u0159inejmen\u0161\u00edm to druh\u00e9 se zd\u00e1 b\u00fdt mantrou farmaceutick\u00fdch spole\u010dnost\u00ed, kter\u00e9 cht\u011bj\u00ed sv\u011btu i nad\u00e1le \u201e\u017eehnat\u201c nov\u00fdmi experiment\u00e1ln\u00edmi vakc\u00ednami proti p\u0159ev\u00e1\u017en\u011b ne\u0161kodn\u00e9 nemoci.\u00a0U\u017e nemus\u00ed p\u0159edkl\u00e1dat d\u016fkazy o \u00fa\u010dinnosti a bezpe\u010dnosti sv\u00fdch p\u0159\u00edpravk\u016f: Evropsk\u00e1 l\u00e9kov\u00e1 agentura chce od nyn\u011bj\u0161ka obecn\u011b povolit adaptovan\u00e9 vakc\u00edny bez jak\u00fdchkoli klinick\u00fdch studi\u00ed.\u00a0Kontroverzn\u00ed postup z roku 2022 je \u201evzorem pro jin\u00e9 vakc\u00edny\u201c.<\/strong><\/p>\n<p>Na podzim lo\u0148sk\u00e9ho roku EMA kone\u010dn\u011b hodila v\u0161echny d\u016fvody p\u0159es palubu a rozhodla se pro urychlen\u00fd schvalovac\u00ed proces pro genov\u00e1 terapeutika Covid p\u0159izp\u016fsoben\u00e1 nov\u00fdm variant\u00e1m.\u00a0V t\u00e9 dob\u011b sta\u010dila\u00a0data z\u00a0<a href=\"https:\/\/report24.news\/auch-der-ema-reichen-daten-von-acht-labormaeusen-zur-mrna-impfstoff-zulassung\/\">osmi laboratorn\u00edch my\u0161\u00ed , aby agenturu p\u0159esv\u011bd\u010dila o nov\u00fdch \u201evakc\u00edn\u00e1ch\u201c.<\/a><\/p>\n<p>Gener\u00e1ln\u00ed sekret\u00e1\u0159 N\u011bmeck\u00e9 spole\u010dnosti pro imunologii tento postup dokonce tehdy chv\u00e1lil a\u00a0<a href=\"https:\/\/www.pharmazeutische-zeitung.de\/beschleunigte-zulassung-fuer-angepasste-corona-impfstoffe-134731\/\" target=\"_blank\" rel=\"noreferrer noopener\">tvrdil<\/a>\u00a0, \u017ee\u00a0<strong>klinick\u00e1 data jsou beztak irelevantn\u00ed, proto\u017ee z nich nelze odvodit \u017e\u00e1dn\u00fd ochrann\u00fd \u00fa\u010dinek (!) a kv\u016fli mal\u00e9mu po\u010dtu testovan\u00fdch osob nedojde k \u017e\u00e1dn\u00fdm vz\u00e1cn\u00fdm vedlej\u0161\u00edm \u00fa\u010dink\u016fm. b\u00fdt detekov\u00e1n.\u00a0<\/strong>(\u010cast\u00e9 vedlej\u0161\u00ed \u00fa\u010dinky asi nejsou zaj\u00edmav\u00e9.) V z\u00e1jmu lid\u00ed by se vlastn\u011b muselo vy\u017eadovat mnohem rozs\u00e1hlej\u0161\u00ed studie &#8211; a v\u00fdjime\u010dn\u011b takov\u00e9, kter\u00e9 nejsou\u00a0<a href=\"https:\/\/report24.news\/falsifizierte-daten-pfizer-impfstoff-studien-sollen-mangelhaft-bis-gefaelscht-sein\/\">zmanipulov\u00e1ny<\/a>\u00a0samotn\u00fdmi farmaceutick\u00fdmi spole\u010dnostmi .\u00a0M\u00edsto toho o nic v\u00edc ne\u017e\u00e1d\u00e1te.<\/p>\n<h3 class=\"wp-block-heading\"><span style=\"font-size: 18pt;\">O\u010dkovac\u00ed kampa\u0148 XBB na podzim<\/span><\/h3>\n<p>P\u0159esto\u017ee se n\u011bkdy masivn\u00ed vedlej\u0161\u00ed \u00fa\u010dinky vakc\u00edny st\u00e1le \u010dast\u011bji objevuj\u00ed, EMA ji\u017e\u00a0<a href=\"https:\/\/www.pharmazeutische-zeitung.de\/ema-empfiehlt-fuer-den-herbst-xbb-impfstoff-140406\/\" target=\"_blank\" rel=\"noreferrer noopener\">na podzim formuluje doporu\u010den\u00ed pro nov\u00e9 o\u010dkovac\u00ed kampan\u011b proti koronaviru<\/a>\u00a0.\u00a0Vakc\u00edny by pak m\u011bly obsahovat pouze jednu slo\u017eku: variantu XBB.\u00a0Tyto monovalentn\u00ed vakc\u00edny by se pak m\u011bly pou\u017e\u00edvat jak pro p\u0159eo\u010dkov\u00e1n\u00ed, tak pro \u201ez\u00e1kladn\u00ed imunizaci\u201c \u2013 to druh\u00e9 pr\u00fd zejm\u00e9na u d\u011bt\u00ed do \u010dty\u0159 nebo p\u011bti let.\u00a0\u017de Covid-19 nep\u0159edstavuje (a ve skute\u010dnosti\u00a0<a href=\"https:\/\/report24.news\/globaler-betrug-neue-ioannidis-studie-korrigiert-covid-sterblichkeit-fuer-2020-noch-weiter-nach-unten\/\">nikdy nep\u0159edstavuje<\/a>\u00a0) \u017e\u00e1dn\u00e9 riziko pro zdrav\u00e9 lidi, je uvedeno ve\u00a0<a href=\"https:\/\/icmra.info\/drupal\/covid-19\/8may2023\" target=\"_blank\" rel=\"noreferrer noopener\">zpr\u00e1v\u011b ICMRA<\/a>, ze kter\u00e9ho lze tyto informace zjistit, nen\u00ed v\u016fbec zm\u00edn\u011bn.\u00a0Zpr\u00e1va odkazuje na \u201e workshop o variant\u00e1ch Omicron\u201c, kde EMA a FDA spole\u010dn\u011b p\u0159edstavily nov\u00e9 o\u010dkovac\u00ed kampan\u011b.\u00a0Pro EU se tam p\u00ed\u0161e:<\/p>\n<p><em>Schvalovac\u00ed cesta pro mRNA vakc\u00edny v roce 2022 by mohla\u00a0<strong>slou\u017eit jako model pro dal\u0161\u00ed vakc\u00edny<\/strong>\u00a0, tj. schv\u00e1len\u00ed zvolen\u00e9ho slo\u017een\u00ed by\u00a0<strong>nevy\u017eadovalo generov\u00e1n\u00ed dat z klinick\u00fdch studi\u00ed s p\u0159izp\u016fsobenou vakc\u00ednou<\/strong>\u00a0za p\u0159edpokladu, \u017ee bude prok\u00e1z\u00e1na p\u0159edv\u00eddateln\u00e1 reaktogenita a imunogenicita s r\u016fzn\u00fdmi slo\u017een\u00edmi. .<\/em><\/p>\n<p>Klinick\u00e9 studie zkoumaj\u00edc\u00ed \u00fa\u010dinek a bezpe\u010dnost experiment\u00e1ln\u00edch p\u0159\u00edpravk\u016f na \u010dlov\u011bka by proto m\u011bly b\u00fdt od nyn\u011bj\u0161ka obecn\u011b zastaral\u00e9.\u00a0Dalo by se tak\u00e9 \u0159\u00edci: Nikdo nechce v\u011bd\u011bt, zda nov\u00e9 \u201ep\u0159izp\u016fsoben\u00e9\u201c vakc\u00edny o\u010dkovan\u00fdm \u0161kod\u00ed nebo dokonce zab\u00edjej\u00ed.\u00a0V\u0161echno je to o zisku.\u00a0Vzhledem k \u010detn\u00fdm nov\u00fdm \u201eo\u010dkov\u00e1n\u00edm\u201c mRNA, kter\u00e9 p\u0159ipravuj\u00ed kontroverzn\u00ed farmaceutick\u00e9 spole\u010dnosti, vyvst\u00e1v\u00e1 ot\u00e1zka, do jak\u00e9 m\u00edry lze tento pochybn\u00fd postup prohl\u00e1sit za standard.\u00a0Mo\u017en\u00e1 budou v budoucnu uvedena na trh genov\u00e1 terapeutika pro jin\u00e1 onemocn\u011bn\u00ed bez jak\u00e9hokoli p\u0159edchoz\u00edho testov\u00e1n\u00ed?\u00a0Samoz\u0159ejm\u011b, cynik by mohl \u0159\u00edct: Pokud pak je\u0161t\u011b m\u00e1te injekce, je to va\u0161e vlastn\u00ed chyba&#8230;<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-full wp-image-1185\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2021\/04\/kuryr-podpis.png\" alt=\"\" width=\"84\" height=\"24\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-19187 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO-300x36.jpg\" alt=\"\" width=\"1283\" height=\"154\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO-300x36.jpg 300w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO.jpg 699w\" sizes=\"(max-width: 1283px) 100vw, 1283px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Covid je u konce &#8211; a\u0165 \u017eije Covid.\u00a0P\u0159inejmen\u0161\u00edm to druh\u00e9 se zd\u00e1 b\u00fdt mantrou farmaceutick\u00fdch&#8230;<\/p>\n","protected":false},"author":2,"featured_media":845,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[132,41,5110,694,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/29245"}],"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=29245"}],"version-history":[{"count":1,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/29245\/revisions"}],"predecessor-version":[{"id":29246,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/29245\/revisions\/29246"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/845"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=29245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=29245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=29245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}