{"id":85884,"date":"2025-08-20T00:17:26","date_gmt":"2025-08-19T22:17:26","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=85884"},"modified":"2025-08-19T10:26:30","modified_gmt":"2025-08-19T08:26:30","slug":"netestovane-sarze-mrna-chybejici-data-nulova-transparentnost-svycarsko-ockovane-naslepo","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/08\/20\/netestovane-sarze-mrna-chybejici-data-nulova-transparentnost-svycarsko-ockovane-naslepo\/","title":{"rendered":"Netestovan\u00e9 \u0161ar\u017ee mRNA, chyb\u011bj\u00edc\u00ed data, nulov\u00e1 transparentnost: \u0160v\u00fdcarsko o\u010dkovan\u00e9 naslepo"},"content":{"rendered":"
<\/div>\n

Swissmedic a \u201eJak \u0161patn\u00e1 je moje \u0161ar\u017ee?\u201c \u2013 Velk\u00e9 ticho<\/span><\/strong><\/p>\n

Ve \u0160v\u00fdcarsku byla b\u011bhem o\u010dkovac\u00ed kampan\u011b proti COVID-19 ve velk\u00e9m m\u011b\u0159\u00edtku aplikov\u00e1na vakc\u00edna, jej\u00ed\u017e v\u00fdrobn\u00ed proces \u2013 zn\u00e1m\u00fd jako\u00a0<\/span>proces P2<\/span><\/strong>\u00a0\u2013 nebyl\u00a0<\/span>nikdy ofici\u00e1ln\u011b schv\u00e1len<\/span><\/strong>\u00a0. Obzvl\u00e1\u0161t\u011b zr\u00e1dn\u00e9 je, \u017ee tyto vakc\u00edny byly\u00a0<\/span>up\u0159ednost\u0148ov\u00e1ny pro vysoce rizikov\u00e9 skupiny<\/span><\/strong>\u00a0, tj. ty, kter\u00e9 by pot\u0159ebovaly zvl\u00e1\u0161tn\u00ed ochranu. P\u0159esto existuj\u00ed spolehliv\u00e9 \u00fadaje o \u00fa\u010dinnosti, bezpe\u010dnosti nebo mo\u017en\u00fdch rozd\u00edlech v kvalit\u011b mezi v\u00fdrobn\u00edmi procesy\u00a0<\/span>P1 a P2<\/span><\/strong>\u00a0?\u00a0<\/span>\u017d\u00e1dn\u00e9.<\/span><\/strong><\/p>\n

P\u0159esto\u017ee nez\u00e1visl\u00e1 vy\u0161et\u0159ovac\u00ed skupina m\u011bla 20denn\u00ed lh\u016ftu na zodpov\u011bzen\u00ed kl\u00ed\u010dov\u00fdch ot\u00e1zek t\u00fdkaj\u00edc\u00edch se projektu\u00a0<\/span>\u201eJak \u0161patn\u00e1 je moje \u0161ar\u017ee?\u201c<\/span><\/em>\u00a0, nechal odpov\u011bdn\u00fd regula\u010dn\u00ed org\u00e1n\u00a0<\/span>Swissmedic<\/span><\/strong>\u00a0lh\u016ftu\u00a0<\/span>bez koment\u00e1\u0159e<\/span><\/strong>\u00a0. Transparentnost op\u011bt chyb\u00ed \u2013 stejn\u011b jako vy\u0161et\u0159ov\u00e1n\u00ed potenci\u00e1ln\u00edch zdravotn\u00edch rizik. Tato\u00a0<\/span>dokumentace, 6.95.1<\/span><\/strong>\u00a0, vyu\u017e\u00edv\u00e1\u00a0<\/span>ofici\u00e1ln\u00ed studie, intern\u00ed protokoly a regula\u010dn\u00ed dokumenty<\/span><\/strong>\u00a0k dolo\u017een\u00ed, pro\u010d je tvrzen\u00ed, \u017ee P2 je ekvivalentn\u00ed P1,\u00a0<\/span>v\u011bdecky neudr\u017eiteln\u00e9<\/span><\/strong>\u00a0.\u00a0<\/span>Zdroj<\/span><\/a><\/p>\n

Stru\u010dn\u00fd p\u0159ehled dokumentace<\/span><\/h2>\n

Dokument\u00a0<\/span>PDF<\/span><\/a>\u00a0s n\u00e1zvem\u00a0<\/span>\u201eJak \u0161patn\u00e1 je moje \u0161ar\u017ee?\u201c<\/span><\/em>\u00a0je v\u00fdsledkem m\u011bs\u00edc\u016f v\u00fdzkumu schvalov\u00e1n\u00ed a distribuce mRNA vakc\u00edn proti COVID-19 ve \u0160v\u00fdcarsku. T\u00fdk\u00e1 se zejm\u00e9na v\u00fdrobn\u00edho procesu\u00a0<\/span>P2<\/span><\/strong>\u00a0spole\u010dnosti\u00a0<\/span>BioNTech<\/span><\/strong>\u00a0, kter\u00fd \u2013 podle regula\u010dn\u00edch dokument\u016f \u2013\u00a0<\/span>nem\u00e1 stejn\u00fd z\u00e1klad jako p\u016fvodn\u011b klinicky testovan\u00fd proces P1<\/span><\/strong>\u00a0. P\u0159esto byla vakc\u00edna P2\u00a0<\/span>dod\u00e1na a injek\u010dn\u011b aplikov\u00e1na ve velk\u00e9m m\u011b\u0159\u00edtku,<\/span><\/strong>\u00a0ani\u017e by spole\u010dnost Swissmedic\u00a0zve\u0159ejnila\u00a0<\/span>samostatn\u00e9 schv\u00e1len\u00ed<\/span><\/strong>\u00a0nebo\u00a0<\/span>komplexn\u00ed posouzen\u00ed rizik .<\/span><\/strong><\/p>\n

Kl\u00ed\u010dov\u00e1 sd\u011blen\u00ed:<\/span><\/h3>\n
    \n
  • Vakc\u00edna P2 nebyla schv\u00e1lena<\/span><\/strong>\u00a0\u2013 a p\u0159esto byla pou\u017eita.<\/span><\/li>\n
  • Neexistuj\u00ed \u017e\u00e1dn\u00e9 \u00fapln\u00e9 \u00fadaje<\/span><\/strong>\u00a0o \u00fa\u010dinnosti a bezpe\u010dnosti l\u00e1tky P2.<\/span><\/li>\n
  • Ofici\u00e1ln\u00ed dokumenty<\/span><\/strong>\u00a0ukazuj\u00ed, \u017ee Swissmedic o rozd\u00edlech v\u011bd\u011bl, ale nekonal.<\/span><\/li>\n
  • Rizikov\u00e9 skupiny<\/span><\/strong>\u00a0dost\u00e1valy P2 i p\u0159es nedostatek d\u016fkaz\u016f o ekvivalentn\u00ed bezpe\u010dnosti.<\/span><\/li>\n
  • \u017d\u00e1dosti o transparentnost byly ignorov\u00e1ny<\/span><\/strong>\u00a0a kl\u00ed\u010dov\u00e9 ot\u00e1zky nebyly zodpov\u011bzeny.<\/span><\/li>\n<\/ul>\n

    Role Swissmedicu \u2013 regul\u00e1tora, nebo komplice?<\/span><\/h2>\n

    Podle p\u016fvodn\u00edch dokument\u016f ze spis\u016f Swissmedic a protokol\u016f BioNTech citovan\u00fdch v dokumentaci nebyl<\/strong>\u00a0tzv. v\u00fdrobn\u00ed proces\u00a0<\/span>P2<\/span><\/strong>\u00a0p\u016fvodn\u011b p\u0159edm\u011btem schvalovac\u00edch studi\u00ed, ale sp\u00ed\u0161e pr\u016fmyslov\u011b efektivn\u011bj\u0161\u00ed proces pro hromadnou v\u00fdrobu.\u00a0V\u00fdznamn\u00e9 rozd\u00edly<\/strong>\u00a0mezi t\u011bmito procesy byly ji\u017e n\u011bkolikr\u00e1t zm\u00edn\u011bny v odborn\u00e9 literatu\u0159e a v p\u0159\u00edloh\u00e1ch ke schv\u00e1len\u00ed\u00a0\u2013 v\u010detn\u011b:<\/span><\/p>\n

      \n
    • Integrita RNA<\/span><\/li>\n
    • \u010cistota lipidov\u00fdch nano\u010d\u00e1stic<\/span><\/li>\n
    • Kontaminace DNA<\/span><\/li>\n
    • Distribuce \u00fa\u010dinn\u00fdch l\u00e1tek v t\u011ble<\/span><\/li>\n<\/ul>\n

      Spole\u010dnost Swissmedic se nicm\u00e9n\u011b rozhodla neprovedit\u00a0<\/span>nov\u00e9, \u00fapln\u00e9 hodnocen\u00ed vakc\u00edny P2 , p\u0159esto\u017ee ta nakonec t\u00e9m\u011b\u0159 \u00fapln\u011b\u00a0<\/span><\/strong>nahradila<\/span><\/strong>\u00a0vakc\u00ednu P1\u00a0.<\/span><\/p>\n

      Probl\u00e9my s kvalitou a rizika \u0161ar\u017e\u00ed \u2013 situace s daty<\/span><\/h2>\n

      \u00dast\u0159edn\u00edm aspektem dokumentace je ot\u00e1zka\u00a0<\/span>kvality a bezpe\u010dnosti \u0161ar\u017e\u00ed<\/span><\/strong>\u00a0. Mezin\u00e1rodn\u00ed projekt\u00a0<\/span>\u201eJak \u0161patn\u00e1 je moje \u0161ar\u017ee?\u201c<\/span><\/em>\u00a0dokumentuje celosv\u011btov\u011b\u00a0<\/span>zv\u00fd\u0161enou m\u00edru ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f a \u00famrt\u00ed<\/span><\/strong>\u00a0, soust\u0159ed\u011bn\u00fdch u ur\u010dit\u00fdch \u0161ar\u017e\u00ed vakc\u00edn \u2013 toto pozorov\u00e1n\u00ed\u00a0<\/span>nen\u00ed dostate\u010dn\u011b zohledn\u011bno v ofici\u00e1ln\u00edch bezpe\u010dnostn\u00edch \u00fadaj\u00edch<\/span><\/strong>\u00a0.<\/span><\/p>\n

      Skupina po\u017e\u00e1dala spole\u010dnost Swissmedic o zve\u0159ejn\u011bn\u00ed:<\/span><\/p>\n

        \n
      1. Kter\u00e9 \u0161ar\u017ee byly dod\u00e1ny do \u0160v\u00fdcarska<\/span><\/li>\n
      2. Zda existuj\u00ed specifick\u00e1 posouzen\u00ed rizik pro ur\u010dit\u00e9 \u0161ar\u017ee<\/span><\/li>\n
      3. Kter\u00e9 v\u00fdrobn\u00ed procesy byly pou\u017eity pro kter\u00e9 skupiny<\/span><\/li>\n<\/ol>\n

        Odpov\u011b\u010f:\u00a0<\/span>\u017d\u00e1dn\u00e1.<\/span><\/strong><\/p>\n

        Riziko m\u00edsto ochrany pro zraniteln\u00e9?<\/span><\/h2>\n

        Dokumentace nazna\u010duje, \u017ee\u00a0<\/span>zraniteln\u00e9 skupiny<\/span><\/strong>\u00a0\u2013 senio\u0159i, osoby s ji\u017e existuj\u00edc\u00edmi onemocn\u011bn\u00edmi a t\u011bhotn\u00e9 \u017eeny \u2013 byly\u00a0<\/span>konkr\u00e9tn\u011b o\u010dkov\u00e1ny d\u00e1vkami P2<\/span><\/strong>\u00a0. Toto o\u010dkov\u00e1n\u00ed bylo provedeno na z\u00e1klad\u011b p\u0159edpokladu, \u017ee P2 je \u201eekvivalentn\u00ed\u201c. Pro to v\u0161ak neexistuj\u00ed \u017e\u00e1dn\u00e9 d\u016fkazy. Naopak: Intern\u00ed protokoly ukazuj\u00ed, \u017ee i v r\u00e1mci expertn\u00edch v\u00fdbor\u016f\u00a0<\/span>panovala nejistota<\/span><\/strong>\u00a0ohledn\u011b toho, zda je P2 skute\u010dn\u011b identick\u00fd s P1 \u2013 zejm\u00e9na s ohledem na stabilitu mRNA, imunitn\u00ed odpov\u011bdi a syst\u00e9movou distribuci.<\/span><\/p>\n

        Odm\u00edtl informace, pop\u0159el odpov\u011bdnost<\/span><\/h2>\n

        Dokumentace pe\u010dliv\u011b dokumentuje\u00a0<\/span>odm\u00edtnut\u00ed Swissmedicu komunikovat<\/span><\/strong>\u00a0. Navzdory opakovan\u00fdm a p\u0159esn\u00fdm \u017e\u00e1dostem agentura odm\u00edt\u00e1 vydat jasn\u00e9 prohl\u00e1\u0161en\u00ed \u2013 m\u00edsto toho nech\u00e1v\u00e1 odhalen\u00ed mezer na nez\u00e1visl\u00fdch skupin\u00e1ch. Tento nedostatek transparentnosti podkop\u00e1v\u00e1 ve\u0161ker\u00e9 etick\u00e9 standardy, kter\u00e9 by se daly o\u010dek\u00e1vat od regula\u010dn\u00edho org\u00e1nu pro l\u00e9\u010diva v demokracii.<\/span><\/p>\n

        Z\u00e1v\u011br \u2013 Ozn\u00e1men\u00e9 regula\u010dn\u00ed selh\u00e1n\u00ed?<\/span><\/h2>\n

        P\u0159\u00edpad vyvol\u00e1v\u00e1 z\u00e1va\u017en\u00e9 ot\u00e1zky:<\/span><\/p>\n

          \n
        • Byl\u00a0<\/span>neschv\u00e1len\u00fd p\u0159\u00edpravek<\/span><\/strong>\u00a0v\u011bdom\u011b pod\u00e1n milion\u016fm lid\u00ed?<\/span><\/li>\n
        • Bylo\u00a0<\/span>nebezpe\u010d\u00ed z\u00e1m\u011brn\u011b bagatelizov\u00e1no<\/span><\/strong>\u00a0, aby neohrozilo o\u010dkovac\u00ed kampa\u0148?<\/span><\/li>\n
        • Pro\u010d\u00a0nejsou zve\u0159ej\u0148ov\u00e1ny\u00a0<\/span>d\u016fle\u017eit\u00e9 \u00fadaje t\u00fdkaj\u00edc\u00ed se bezpe\u010dnosti ?<\/span><\/strong><\/li>\n
        • Kdo je zodpov\u011bdn\u00fd za\u00a0<\/span>p\u0159\u00edpadn\u00e9 \u0161kody<\/span><\/strong>\u00a0?<\/span><\/li>\n<\/ul>\n

          Dokumentace\u00a0<\/span>6.95.1<\/span><\/em>\u00a0zpochyb\u0148uje nejen Swissmedic, ale cel\u00fd syst\u00e9m schvalov\u00e1n\u00ed v p\u0159\u00edpad\u011b pandemie. Je to ponau\u010den\u00ed o souh\u0159e mezi \u00fa\u0159ady, pr\u016fmyslem a politikou \u2013\u00a0<\/span>a z\u00e1rove\u0148 v\u00fdzva k opravdov\u00e9 transparentnosti a odpov\u011bdnosti.<\/span><\/strong><\/p>\n

          \"\"<\/p>\n

          \"\"<\/p>\n

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

          Swissmedic a \u201eJak \u0161patn\u00e1 je moje \u0161ar\u017ee?\u201c \u2013 Velk\u00e9 ticho Ve \u0160v\u00fdcarsku byla b\u011bhem o\u010dkovac\u00ed…<\/p>\n","protected":false},"author":2,"featured_media":85885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[213,467,651],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/85884"}],"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=85884"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/85884\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/85885"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=85884"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=85884"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=85884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}