{"id":12344,"date":"2022-07-13T01:07:32","date_gmt":"2022-07-12T23:07:32","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=12344"},"modified":"2022-07-12T16:40:14","modified_gmt":"2022-07-12T14:40:14","slug":"unikle-dokumenty-odhaluji-ze-vladni-urednici-tlacili-na-regulacni-organy-eu-aby-urychlily-schvaleni-vakciny-pfizer","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2022\/07\/13\/unikle-dokumenty-odhaluji-ze-vladni-urednici-tlacili-na-regulacni-organy-eu-aby-urychlily-schvaleni-vakciny-pfizer\/","title":{"rendered":"Unikl\u00e9 dokumenty odhaluj\u00ed, \u017ee vl\u00e1dn\u00ed \u00fa\u0159edn\u00edci tla\u010dili na regula\u010dn\u00ed org\u00e1ny EU, aby urychlily schv\u00e1len\u00ed vakc\u00edny Pfizer"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p><strong>Informace, kter\u00e9 vy\u0161ly najevo jsou natolik skand\u00e1ln\u00ed, \u017ee v norm\u00e1ln\u00edm sv\u011bt\u011b by musel zodpov\u011bdn\u00fd politik (v tomto p\u0159\u00edpad\u011b p\u016fjde z\u0159ejm\u011b o v\u00edce politik\u016f, v \u010dele se \u0161\u00e9fkou EK) nejen rezignovat, ale tak\u00e9 stanout p\u0159ed soudem. To se samoz\u0159ejm\u011b nestane, tak\u017ee velk\u00e1 p\u0159\u00edtelkyn\u011b \u0161\u00e9fa Pfizeru Bourly \u2013 Ursula von der Leyenov\u00e1 \u2013 se jist\u011b nemus\u00ed ni\u010deho ob\u00e1vat. Pat\u0159ila toti\u017e k t\u011bm, kdo na l\u00e9kov\u00e9ho regul\u00e1tora EU \u2013 EMA \u2013 tla\u010dili nejv\u00edc, aby do\u0161lo k rychl\u00e9mu nouzov\u00e9mu schv\u00e1len\u00ed experiment\u00e1ln\u00edch mRNA p\u0159\u00edpravk\u016f.<\/strong><\/p>\n<p>A nejde o jedin\u00e9 skand\u00e1ln\u00ed zji\u0161t\u011bn\u00ed, op\u011bt se hovo\u0159ilo o rozd\u00edlech v kvalit\u011b jednotliv\u00fdch \u0161ar\u017e\u00ed, o nich\u017e od sam\u00e9ho za\u010d\u00e1tku v\u011bd\u011bla i EMA, jak vypl\u00fdv\u00e1 z unikl\u00fdch e-mail\u016f.<\/p>\n<p><a href=\"https:\/\/childrenshealthdefense.org\/defender\/european-medicines-agency-eu-pfizer-vaccine\/\">Podle unikl\u00fdch<\/a>\u00a0dokument\u016f z Evropsk\u00e9 l\u00e9kov\u00e9 agentury vyv\u00edjeli vl\u00e1dn\u00ed \u00fa\u0159edn\u00edci USA a EU n\u00e1tlak na evropsk\u00e9 l\u00e9kov\u00e9 agentury, aby urychlily schv\u00e1len\u00ed vakc\u00edny COVID-19 spole\u010dnosti Pfizer-BioNTech navzdory bezpe\u010dnostn\u00edm obav\u00e1m.<\/p>\n<p>Dokumenty, o kter\u00fdch jako prvn\u00ed informoval Trial Site News, zahrnuj\u00ed e-maily, prezentaci v PowerPointu a d\u016fv\u011brnou zpr\u00e1vu spole\u010dnosti Pfizer z 10.\u201325. listopadu 2020 \u2013 jen n\u011bkolik t\u00fddn\u016f p\u0159edt\u00edm, ne\u017e evropsk\u00e9, britsk\u00e9 a americk\u00e9 regula\u010dn\u00ed org\u00e1ny na obrovsk\u00fd n\u00e1tlak schv\u00e1lily vakc\u00ednu pro nouzov\u00e9 pou\u017eit\u00ed.<\/p>\n<p><span style=\"font-size: 18pt;\"><strong>Mezi kl\u00ed\u010dov\u00e1 odhalen\u00ed v dokumentech pat\u0159\u00ed:<\/strong><\/span><\/p>\n<ul>\n<li>Sp\u011bch se schv\u00e1len\u00edm vakc\u00edny, kter\u00fd byl siln\u011b prosazov\u00e1n vl\u00e1dn\u00edmi \u00fa\u0159edn\u00edky v USA a Evrop\u011b.<\/li>\n<li>Tlak na evropsk\u00e9 regula\u010dn\u00ed org\u00e1ny, aby schv\u00e1lily vakc\u00ednu Pfizer navzdory obav\u00e1m odborn\u00edk\u016f o bezpe\u010dnost vakc\u00edny.<\/li>\n<li>V\u00fdznamn\u00e9 rozd\u00edly v \u00fa\u010dinnosti mRNA mezi experiment\u00e1ln\u00edmi \u0161ar\u017eemi vakc\u00edny a komer\u010dn\u00edmi \u0161ar\u017eemi vakc\u00edny COVID-19 spole\u010dnosti Pfizer-BioNTech, co\u017e vyvol\u00e1v\u00e1 obavy o bezpe\u010dnost.<\/li>\n<li>\u201e\u017d\u00e1dn\u00fd velk\u00fd z\u00e1jem\u201c ze strany FDA o tyto nesrovnalosti.<\/li>\n<li>Sn\u00ed\u017een\u00ed p\u0159ijateln\u00e9ho prahu integrity mRNA t\u011bsn\u011b p\u0159ed schv\u00e1len\u00edm vakc\u00edny Pfizer-BioNTech ve Spojen\u00e9m kr\u00e1lovstv\u00ed, USA a EU.<\/li>\n<li>P\u0159\u00edm\u00fd lobbing gener\u00e1ln\u00edho \u0159editele spole\u010dnosti Pfizer Alberta Bourly u p\u0159edsedkyn\u011b Evropsk\u00e9 komise a vysok\u00e9ho regul\u00e1tora FDA.<\/li>\n<\/ul>\n<p><span style=\"font-size: 18pt;\"><strong>Politi\u010dt\u00ed \u010dinitel\u00e9 nal\u00e9hali na to, aby bylo schv\u00e1len\u00ed vakc\u00edny Pfizer \u201eurychleno\u201c<\/strong><\/span><\/p>\n<p>V e-mailu ze 16. listopadu 2020 od Marca Cavaleriho, tehdej\u0161\u00edho vedouc\u00edho strategie EMA pro biologick\u00e9 zdravotn\u00ed hrozby a vakc\u00edny, st\u00e1lo, \u017ee \u201eAlex Azar a vl\u00e1da USA\u201c \u201etvrd\u011b tla\u010dili\u201c na EMA.<\/p>\n<p>V t\u00e9 dob\u011b byl Azar ve veden\u00ed americk\u00e9ho ministerstva zdravotnictv\u00ed a soci\u00e1ln\u00edch slu\u017eeb, kter\u00e9 dohl\u00ed\u017e\u00ed na FDA.<\/p>\n<p>V e-mailu ze dne 19. listopadu 2020 se Noel Wathion, tehdej\u0161\u00ed z\u00e1stupce v\u00fdkonn\u00e9ho \u0159editele EMA, odvol\u00e1val na \u201eTC\u201c \u2013 zkratku pro telekonferenci \u2013 \u201es komisa\u0159kou\u201c, p\u0159i\u010dem\u017e odkazoval na komisa\u0159ku EU Ursulu von der Leyen, kter\u00e1 na schv\u00e1len\u00ed vakc\u00edny tla\u010dila.<\/p>\n<p>B\u011bhem hovoru, kter\u00fd Wathion popsal jako \u201edocela napjat\u00fd, n\u011bkdy dokonce trochu trapn\u00fd\u201c,<strong>\u00a0von der Leyenov\u00e1 varovala l\u00e9kovou agenturu EMA<\/strong>\u00a0p\u0159ed t\u00edm, co by se mohlo st\u00e1t, \u201epokud nebudou spln\u011bna o\u010dek\u00e1v\u00e1n\u00ed\u201c, a vyzvala ke schv\u00e1len\u00ed vakc\u00edny Pfizer \u2013 BioNTech,<strong>\u00a0\u201ebez ohledu na to, zda jsou tato o\u010dek\u00e1v\u00e1n\u00ed realistick\u00e1 nebo ne\u201c.<\/strong><\/p>\n<p><span style=\"font-size: 18pt;\"><strong>Ve stejn\u00e9m e-mailu Wathion napsal:<\/strong><\/span><\/p>\n<p>\u201ePolitick\u00e9 d\u016fsledky se zdaj\u00ed b\u00fdt p\u0159\u00edli\u0161 vysok\u00e9, a\u010dkoli \u201atechnick\u00e1 \u00farove\u0148\u2018 \u2026 by mohla ospravedlnit takov\u00e9 zpo\u017ed\u011bn\u00ed, aby byl v\u00fdsledek v\u011bdeck\u00e9ho p\u0159ezkumu co nejspolehliv\u011bj\u0161\u00ed.\u00a0\u2026\u00a0A\u010dkoli v\u00edme, \u017ee a\u0165 ud\u011bl\u00e1me cokoli, EMA bude m\u00edt v p\u0159\u00edpad\u011b zpo\u017ed\u011bn\u00ed o n\u011bkolik t\u00fddn\u016f\u00a0<strong>velk\u00fd probl\u00e9m<\/strong>\u00a0<strong>odpov\u00eddat na ot\u00e1zky a kritiku z r\u016fzn\u00fdch stran<\/strong>.\u201c<\/p>\n<p>Mezi \u201er\u016fzn\u00e9 strany\u201c, o kter\u00fdch Wathion hovo\u0159il, pat\u0159ila Evropsk\u00e1 komise, Evropsk\u00fd parlament, m\u00e9dia a \u0161irok\u00e1 ve\u0159ejnost.<\/p>\n<p>Wathion d\u00e1le napsal: \u201emysl\u00edm, \u017ee je t\u0159eba zv\u00e1\u017eit zodpov\u011bdnost.\u201c<\/p>\n<p>V pozd\u011bj\u0161\u00edm e-mailu z 22. listopadu 2020 Wathion zd\u016fraznil tlak, kter\u00e9mu agentura \u010delila, aby vydala povolen\u00ed pro vakc\u00ednu Pfizer-BioNTech, a napsal:<\/p>\n<p>\u201ePravd\u011bpodobnost, \u017ee FDA (a tak\u00e9 MHRA) vyd\u00e1 podm\u00edne\u010dn\u00e9 schv\u00e1len\u00ed (EUA) p\u0159ed vyd\u00e1n\u00edm povolen\u00ed, je extr\u00e9mn\u011b vysok\u00e1. Tak\u017ee se na to mus\u00edme p\u0159ipravit.\u201c<\/p>\n<p>Ve stejn\u00e9m e-mailu v\u0161ak Wathion vyj\u00e1d\u0159il obavy, \u017ee takov\u00e1 p\u0159\u00edprava by mohla b\u00fdt na \u00fakor \u0159\u00e1dn\u00e9ho v\u011bdeck\u00e9ho hodnocen\u00ed vakc\u00edny Pfizer.<\/p>\n<p>\u201eUrychlujeme proces, jak je to jen mo\u017en\u00e9, ale mus\u00edme tak\u00e9 zajistit, aby na\u0161e v\u011bdeck\u00e9 hodnocen\u00ed bylo co nejspolehliv\u011bj\u0161\u00ed,\u201c napsal Wathion.<\/p>\n<p>Wathion tak\u00e9 \u0159ekl, \u017ee \u201elaick\u00e1 ve\u0159ejnost a m\u00e9dia nepochop\u00ed nuance mezi EUA nebo CMA na jedn\u00e9 stran\u011b a plnou akreditac\u00ed na stran\u011b druh\u00e9 (tzn. nepochop\u00ed rozd\u00edl mezi podm\u00edn\u011bn\u00fdm a skute\u010dn\u00fdm schv\u00e1len\u00edm). \u201ePro n\u011b je \u201aschv\u00e1len\u00ed\u2018 prost\u011b \u201eschv\u00e1len\u00ed.\u201c<\/p>\n<p>M\u00e9dia skute\u010dn\u011b \u010dasto hovo\u0159\u00ed o vakc\u00edn\u00e1ch Pfizer, Moderna a Johnson &amp; Johnson COVID-19 jako o \u201eschv\u00e1len\u00fdch\u201c, i kdy\u017e jsou ve skute\u010dnosti pod\u00e1v\u00e1ny v r\u00e1mci EUA, tedy podm\u00edne\u010dn\u00e9ho schv\u00e1len\u00ed v USA.<\/p>\n<p>Wathion c\u00edtil, \u017ee je pot\u0159eba \u201ep\u0159ej\u00edt od kontroly \u0161kod k proaktivn\u00edmu \u0159\u00edzen\u00ed o\u010dek\u00e1v\u00e1n\u00ed\u201c, s odkazem na mo\u017enost, \u017ee by regula\u010dn\u00ed org\u00e1ny USA a Spojen\u00e9ho kr\u00e1lovstv\u00ed vydaly EUA p\u0159edt\u00edm, ne\u017e EMA vyd\u00e1 sv\u016fj vlastn\u00ed CMA.<\/p>\n<p><span style=\"font-size: 18pt;\"><strong>Vedly obavy o integritu a konzistenci \u0161ar\u017e\u00ed vakc\u00edn k ni\u017e\u0161\u00edm standard\u016fm?<\/strong><\/span><\/p>\n<p>Dal\u0161\u00ed unikl\u00e9 dokumenty odhaluj\u00ed\u00a0<strong>nesrovnalosti v konzistenci \u0161ar\u017e\u00ed vakc\u00edn<\/strong>\u00a0spole\u010dnosti Pfizer a dal\u0161\u00ed bezpe\u010dnostn\u00ed probl\u00e9my.<\/p>\n<p>E-mail od Cavaleriho ze dne 10. listopadu 2020 nazna\u010duje, \u017ee v t\u00e9 dob\u011b si FDA byla v\u011bdoma n\u011bkter\u00fdch probl\u00e9m\u016f s CMC, kter\u00e9 je t\u0159eba \u0159e\u0161it, a \u017ee se ob\u00e1vala, \u017ee \u201eCMC by mohla skon\u010dit s obt\u00ed\u017eemi\u201c.<\/p>\n<p>Ve stejn\u00e9m e-mailu uvedl, \u017ee FDA by mohla vydat sv\u00e9 EUA do V\u00e1noc 2020 a zeptal se, zda by EMA mohla vydat sv\u00e9 vlastn\u00ed CMA (schv\u00e1len\u00ed) ve stejnou dobu.<\/p>\n<p><strong>\u201eProbl\u00e9my\u201c, na kter\u00e9 Cavaleri odkazoval, se t\u00fdkaly v\u00fdznamn\u00e9ho rozd\u00edlu v integrit\u011b mRNA mezi klinick\u00fdmi \u0161ar\u017eemi a pl\u00e1novan\u00fdmi komer\u010dn\u00edmi \u0161ar\u017eemi vakc\u00edny Pfizer-BioNTech.<\/strong><\/p>\n<p>V e-mailu ze dne 23. listopadu 2020 se Evdokia Korakianiti, v\u011bdeck\u00fd administr\u00e1tor v EMA, zab\u00fdval t\u011bmito probl\u00e9my a napsal:<\/p>\n<p>\u201eProbl\u00e9m: Mezi klinick\u00fdmi \u0161ar\u017eemi (~78% integrita mRNA), na kter\u00fdch byla provedena prozat\u00edmn\u00ed anal\u00fdza, a navrhovan\u00fdmi komer\u010dn\u00edmi \u0161ar\u017eemi (~55 %) byl pozorov\u00e1n v\u00fdznamn\u00fd rozd\u00edl v % integrity RNA\/zkr\u00e1cen\u00fdch druh\u016f.<\/p>\n<p>\u201eSpole\u010dnost tvrd\u00ed, \u017ee \u00fa\u010dinnost l\u00e9ku z\u00e1vis\u00ed na expresi dodan\u00e9 RNA, co\u017e vy\u017eaduje dostate\u010dn\u011b neporu\u0161enou molekulu RNA.\u201c<\/p>\n<p>To m\u00e1 dosud nespecifikovan\u00e9 d\u016fsledky pro bezpe\u010dnost produktu, jak Korakianiti pozd\u011bji vysv\u011btlil ve stejn\u00e9m e-mailu:<\/p>\n<p>\u201eP\u0159\u00ed\u010dina ni\u017e\u0161\u00ed integrity % RNA v [sic] komer\u010dn\u00edch \u0161ar\u017e\u00edch dosud nebyla identifikov\u00e1na.\u00a0Potenci\u00e1ln\u00ed d\u016fsledky pro bezpe\u010dnost a \u00fa\u010dinnost t\u00e9to ztr\u00e1ty integrity RNA v komer\u010dn\u00edch \u0161ar\u017e\u00edch oproti klinick\u00fdm \u0161ar\u017e\u00edm mus\u00ed b\u00fdt je\u0161t\u011b definov\u00e1ny.\u201c<\/p>\n<p>D\u016fv\u011brn\u00e1 43str\u00e1nkov\u00e1 zpr\u00e1va spole\u010dnosti Pfizer, kter\u00e1 je tak\u00e9 sou\u010d\u00e1st\u00ed unikl\u00fdch dokument\u016f, vrh\u00e1 v\u00edce sv\u011btla na v\u00fdznam tohoto rozporu.<\/p>\n<p>Podle zpr\u00e1vy Acuitas Therapeutics, spole\u010dnosti, kter\u00e1 vyvinula platformu lipid\u016f a nano\u010d\u00e1stic pou\u017e\u00edvanou vakc\u00ednami Pfizer-BioNTech a Moderna COVID-19, m\u011bla \u201eminim\u00e1ln\u00ed pr\u00e1h\u201c pro integritu mRNA \u201easi 70 %\u201c stanovenou.<\/p>\n<p><span style=\"font-size: 18pt;\"><strong>Zpr\u00e1va uv\u00e1d\u00ed:<\/strong><\/span><\/p>\n<p>\u201e\u00da\u010dinnost produktu z\u00e1vis\u00ed na expresi dodan\u00e9 RNA, kter\u00e1 vy\u017eaduje dostate\u010dn\u011b intaktn\u00ed molekulu RNA.\u201c<\/p>\n<p>V odpov\u011bdi na Korakianitiho e-mail ze dne 24. listopadu 2020 Veronika Jekerle, vedouc\u00ed odd\u011blen\u00ed kvality l\u00e9\u010div EMA, popsala tyto obavy jako sou\u010d\u00e1st \u201e\u0159ady v\u011bt\u0161\u00edch obav, kter\u00e9 p\u0159etrv\u00e1vaj\u00ed, kter\u00e9 se t\u00fdkaj\u00ed p\u0159\u00ednosu\/rizika vakc\u00edny a \u00fa\u010dinnosti \u010di bezpe\u010dnosti\u201c.<\/p>\n<p>Jekerle \u0159ekl, \u017ee tyto obavy sd\u00edl\u00ed v\u011bt\u0161ina \u010dlensk\u00fdch st\u00e1t\u016f EU.<\/p>\n<p>Jekerle v\u0161ak nazna\u010dil, \u017ee \u201eschv\u00e1len\u00ed by mohlo b\u00fdt mo\u017en\u00e9 do konce roku, pokud budou vy\u0159e\u0161eny tyto obavy + GMP [spr\u00e1vn\u00e1 v\u00fdrobn\u00ed praxe].\u201c<\/p>\n<p>Ve zjevn\u00e9m rozporu, mo\u017en\u00e1 odr\u00e1\u017eej\u00edc\u00edm zm\u011bnu postoje od EMA, e-mail od Cavaleriho z 23. listopadu 2020 uv\u00e1d\u00ed: \u201e..<strong>.probl\u00e9m obsahu mRNA nen\u00ed pova\u017eov\u00e1n za d\u016fle\u017eit\u00fd.\u201c<\/strong><\/p>\n<p>Stejn\u00fd e-mail tak\u00e9 siln\u011b nazna\u010doval, \u017ee FDA to c\u00edt\u00ed stejn\u011b, proto\u017ee Cavaleri napsal, \u017ee \u201eze strany FDA nebyl velk\u00fd z\u00e1jem\u201c.<\/p>\n<p>E-mail od Jekerleho z 25. listopadu 2020\u00a0<strong>potvrdil nez\u00e1jem n\u011bkolika regula\u010dn\u00edch agentur, v\u010detn\u011b FDA, o ot\u00e1zku integrity mRNA.<\/strong><\/p>\n<p>Jekerle napsal:<\/p>\n<p>\u201eFDA a Health Canada [HC] uvedly, \u017ee bezpe\u010dnostn\u00ed obavy spojen\u00e9 s variabiln\u00edmi typy mRNA\/proteinu jsou sp\u00ed\u0161e teoretick\u00e9ho charakteru\u2026<\/p>\n<p>FDA\/HC\/EMA souhlasily s t\u00edm, \u017ee slad\u011bn\u00ed specifikac\u00ed integrity % mRNA je kritick\u00e9, aby se zabr\u00e1nilo tomu, \u017ee jedna oblast [sic] obdr\u017e\u00ed ve\u0161ker\u00fd suboptim\u00e1ln\u00ed materi\u00e1l\u2026 Specifikace by m\u011bly b\u00fdt klinicky kvalifikovan\u00e9.\u201c<\/p>\n<p>Zd\u00e1 se, \u017ee v\u00fd\u0161e uveden\u00e1 pas\u00e1\u017e nazna\u010duje, \u017ee<strong>\u00a0ur\u010dit\u00e9 \u0161ar\u017ee vakc\u00edny by byly \u201esuboptim\u00e1ln\u00ed\u201c kv\u016fli t\u00e9to nesrovnalosti v integrit\u011b mRNA.<\/strong><\/p>\n<p>Jekerleho e-mail z 25. listopadu 2020 tak\u00e9 odhalil dal\u0161\u00ed potenci\u00e1ln\u00ed bezpe\u010dnostn\u00ed obavy \u2013 konkr\u00e9tn\u011b, \u017ee \u201e\u017dadatel pr\u00e1v\u011b dnes informoval FDA a n\u00e1s\/MHRA o probl\u00e9mu s viditeln\u00fdmi \u010d\u00e1sticemi v l\u00e9kov\u00e9m produktu (zd\u00e1 se, \u017ee jde o slo\u017eky lipidov\u00fdch nano\u010d\u00e1stic).\u201c<\/p>\n<p>Jin\u00fdmi slovy, spole\u010dnost Pfizer, \u201e\u017eadatel\u201c, ozn\u00e1mila sv\u00e9 obavy regula\u010dn\u00edm org\u00e1n\u016fm a\u017e 25. listopadu 2020 \u2013<strong>\u00a0t\u011bsn\u011b p\u0159edt\u00edm, ne\u017e regula\u010dn\u00ed org\u00e1ny USA, Spojen\u00e9ho kr\u00e1lovstv\u00ed a EU ud\u011blily spole\u010dnosti Pfizer nouzov\u00e9 a podm\u00edn\u011bn\u00e9 schv\u00e1len\u00ed.<\/strong><\/p>\n<p>MHRA schv\u00e1lila vakc\u00ednu Pfizer dne 2. prosince 2020.<\/p>\n<p>Zd\u00e1 se, \u017ee obavy ohledn\u011b nesrovnalost\u00ed v integrit\u011b mRNA nebyly vy\u0159e\u0161eny zm\u011bnou p\u0159\u00edslu\u0161n\u00e9ho produktu, ale zm\u011bnou specifikace pro p\u0159ijatelnou integritu RNA.\u00a0Unikl\u00e1 powerpointov\u00e1 prezentace odkazuj\u00edc\u00ed na sch\u016fzku mezi EMA a Pfizer 26. listopadu 2020, kter\u00e1 se konala jen den po Jekerleho e-mailu, zn\u00ed:<\/p>\n<p>\u201e\u2026my [EMA] revidujeme specifikaci integrity RNA pro l\u00e9\u010divou l\u00e1tku na &gt;=60 %, pro uvol\u0148ov\u00e1n\u00ed l\u00e9\u010diva na &gt;=55 % a pro trvanlivost l\u00e9\u010diva na &gt;=50 %.\u201c<\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" class=\"jetpack-lazy-image jetpack-lazy-image--handled aligncenter\" src=\"https:\/\/i0.wp.com\/childrenshealthdefense.org\/wp-content\/uploads\/trial-site-news-pp-1.png?w=800&amp;ssl=1\" alt=\"\" data-recalc-dims=\"1\" data-lazy-loaded=\"1\" \/><\/figure>\n<\/div>\n<p>Tyto zm\u011bny byly provedeny navzdory skute\u010dnosti, \u017ee stejn\u00fd sn\u00edmek zmi\u0148oval\u00a0<strong>\u201enejistoty ohledn\u011b bezpe\u010dnosti produktu a \u00fa\u010dinnosti komer\u010dn\u00edho produktu\u201c.<\/strong><\/p>\n<p>Dal\u0161\u00ed sn\u00edmek ve stejn\u00e9 prezentaci uv\u00e1d\u00ed:<\/p>\n<p>\u201eZkr\u00e1cen\u00e9 a modifikovan\u00e9 druhy RNA by m\u011bly b\u00fdt pova\u017eov\u00e1ny za kontaminanty souvisej\u00edc\u00ed s produktem.\u00a0Krom\u011b toho by se m\u011bla \u0159e\u0161it mo\u017enost p\u0159elo\u017een\u00fdch protein\u016f jin\u00fdch ne\u017e zam\u00fd\u0161len\u00fd spike protein (S1S2) vypl\u00fdvaj\u00edc\u00ed ze zkr\u00e1cen\u00fdch a\/nebo modifikovan\u00fdch druh\u016f mRNA a m\u011bly by b\u00fdt poskytnuty relevantn\u00ed \u00fadaje o charakterizaci protein\u016f pro p\u0159evl\u00e1daj\u00edc\u00ed druhy, jsou-li k dispozici.\u201c<\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><img decoding=\"async\" class=\"jetpack-lazy-image jetpack-lazy-image--handled aligncenter\" src=\"https:\/\/i0.wp.com\/childrenshealthdefense.org\/wp-content\/uploads\/trial-site-news-pp-2.png?w=800&amp;ssl=1\" alt=\"\" data-recalc-dims=\"1\" data-lazy-loaded=\"1\" \/><\/figure>\n<\/div>\n<p><span style=\"font-size: 18pt;\"><strong>Farmaceuti\u010dt\u00ed mana\u017ee\u0159i lobuj\u00ed za rychl\u00e9 schv\u00e1len\u00ed<\/strong><\/span><\/p>\n<p>Unikl\u00e9 dokumenty odhalily intenzivn\u00ed lobbov\u00e1n\u00ed ze strany p\u0159edn\u00edch farmaceutick\u00fdch a politick\u00fdch osobnost\u00ed ve prosp\u011bch rychl\u00e9ho schv\u00e1len\u00ed vakc\u00edny, p\u0159esto\u017ee odborn\u00edci EMA v\u011b\u0159\u00ed, \u017ee je zapot\u0159eb\u00ed d\u016fkladn\u011bj\u0161\u00ed v\u011bdeck\u00e9 posouzen\u00ed vakc\u00edny Pfizer-BioNTech.<\/p>\n<p>Nap\u0159\u00edklad dal\u0161\u00ed e-mail od Cavaleriho konkr\u00e9tn\u011b zmi\u0148uje\u00a0<strong>p\u0159\u00edm\u00fd lobbing spole\u010dnosti Pfizer u Dr.\u00a0Petera Markse, \u0159editele Centra pro biologick\u00e9 hodnocen\u00ed a v\u00fdzkum FDA.<\/strong><\/p>\n<p>Cavaleri napsal:<\/p>\n<p>\u201eGener\u00e1ln\u00ed \u0159editel spole\u010dnosti Pfizer lobboval u Petera Markse a \u0159ekl mu, \u017ee EMA chce data d\u0159\u00edve!\u201c<\/p>\n<p>Stejn\u00fd e-mail zm\u00ednil, \u017ee<strong>\u00a0\u201ekolegov\u00e9\u201c v EMA \u201etvrd\u011b tla\u010d\u00ed na zkr\u00e1cen\u00ed \u010dasov\u00e9 osy pro testov\u00e1n\u00ed\u201c vakc\u00edny Pfizer.<\/strong><\/p>\n<p>Podle Trial Site News by takov\u00e9 lobov\u00e1n\u00ed \u201emohlo b\u00fdt interpretov\u00e1no jako vysoce kontroverzn\u00ed\u201c.<\/p>\n<p>\u201eZjevn\u00fd p\u0159\u00edstup spole\u010dnosti Pfizer k feder\u00e1ln\u00edm regula\u010dn\u00edm org\u00e1n\u016fm p\u0159inejmen\u0161\u00edm vyvol\u00e1v\u00e1 z\u00e1va\u017en\u00e9 ot\u00e1zky,\u201c uvedl Trial Site News a \u201eotev\u00edr\u00e1 mo\u017enost znepokojiv\u00fdch propletenc\u016f mezi pr\u016fmyslem a \u00fadajn\u011b nez\u00e1vislou v\u011bdeckou feder\u00e1ln\u00ed agenturou.\u201c<\/p>\n<p>Zpr\u00e1vy ze zku\u0161ebn\u00edho webu tak\u00e9 odkazovaly na<strong>\u00a0nez\u00e1visl\u00e9 poslance EP, kte\u0159\u00ed v \u00fanoru 2022 vyzvali von der Leyenovou, aby odstoupila pot\u00e9, co vy\u0161lo najevo, \u017ee si vym\u011bnila soukrom\u00e9 textov\u00e9 zpr\u00e1vy s Bourlou.<\/strong><\/p>\n<p>Zat\u00edmco \u201ebyla zve\u0159ejn\u011bna jen mal\u00e1 \u010d\u00e1st t\u011bchto text\u016f\u201c, podle Trial Site News,<strong>\u00a0\u201ety, kter\u00e9 byly zve\u0159ejn\u011bny, odhalily, \u017ee jednostrann\u011b vyjednala \u010d\u00e1sti panevropsk\u00e9 dohody o vakc\u00edn\u011b s Bourlou p\u0159es s\u00e9rii SMS!\u201c<\/strong><\/p>\n<p><a href=\"https:\/\/uncutnews.ch\/durchgesickerte-dokumente-enthuellen-dass-regierungsbeamte-die-eu-regulierungsbehoerden-unter-druck-setzten-um-die-zulassung-des-pfizer-impfstoffs-zu-beschleunigen\/\">ZDROJ<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Informace, kter\u00e9 vy\u0161ly najevo jsou natolik skand\u00e1ln\u00ed, \u017ee v norm\u00e1ln\u00edm sv\u011bt\u011b by musel zodpov\u011bdn\u00fd politik&#8230;<\/p>\n","protected":false},"author":2,"featured_media":12345,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[2794,41,315,2793,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/12344"}],"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=12344"}],"version-history":[{"count":1,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/12344\/revisions"}],"predecessor-version":[{"id":12346,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/12344\/revisions\/12346"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/12345"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=12344"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=12344"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=12344"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}