{"id":80374,"date":"2025-06-04T00:12:59","date_gmt":"2025-06-03T22:12:59","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=80374"},"modified":"2025-06-03T13:20:32","modified_gmt":"2025-06-03T11:20:32","slug":"fda-schvalila-novou-mrna-vakcinu-moderna-bez-placebove-studie-navzdory-slibum-hhs-o-opaku","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/06\/04\/fda-schvalila-novou-mrna-vakcinu-moderna-bez-placebove-studie-navzdory-slibum-hhs-o-opaku\/","title":{"rendered":"FDA schv\u00e1lila novou mRNA vakc\u00ednu Moderna bez placebov\u00e9 studie \u2013 navzdory slib\u016fm HHS o opaku"},"content":{"rendered":"
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Nicolas Hulscher, MPH<\/p>\n

FDA p\u0159ekro\u010dila hranice \u2013 schv\u00e1lila injekci mRNA COVID-19 nov\u00e9 generace od spole\u010dnosti Moderna bez placebem kontrolovan\u00e9 studie.<\/strong>
\nToto rozhodnut\u00ed je v p\u0159\u00edm\u00e9m rozporu s ned\u00e1vn\u00fdm prohl\u00e1\u0161en\u00edm americk\u00e9ho ministerstva zdravotnictv\u00ed a soci\u00e1ln\u00edch slu\u017eeb (HHS): \u201eV\u0161echny nov\u00e9 vakc\u00edny budou p\u0159ed schv\u00e1len\u00edm podrobeny testov\u00e1n\u00ed bezpe\u010dnosti v placebem kontrolovan\u00fdch studi\u00edch \u2013 co\u017e je radik\u00e1ln\u00ed odklon od minul\u00fdch postup\u016f.\u201c<\/em><\/p>\n

FDA to ofici\u00e1ln\u011b p\u0159ehnala.<\/p>\n

Pr\u00e1v\u011b schv\u00e1lila\u00a0nejnov\u011bj\u0161\u00ed mRNA vakc\u00ednu proti COVID-19 od spole\u010dnosti Moderna \u2013\u00a0mNEXSPIKE \u2013\u00a0<\/strong>bez proveden\u00ed jedin\u00e9 placebem kontrolovan\u00e9 studie<\/strong>\u00a0, co\u017e p\u0159\u00edmo odporuje ve\u0159ejn\u00fdm uji\u0161t\u011bn\u00edm americk\u00e9ho ministerstva zdravotnictv\u00ed a soci\u00e1ln\u00edch slu\u017eeb (HHS), kter\u00e9 ned\u00e1vno uvedlo:<\/p>\n

\u201eV\u0161echny nov\u00e9 vakc\u00edny proch\u00e1zej\u00ed p\u0159ed schv\u00e1len\u00edm bezpe\u010dnostn\u00edmi testy v placebem kontrolovan\u00fdch studi\u00edch.\u201c<\/em><\/p>\n

Toto schv\u00e1len\u00ed se m\u00edsto toho z\u0159ejm\u011b \u0159\u00edd\u00ed tzv. \u201ep\u0159\u00edstupem k o\u010dkov\u00e1n\u00ed proti COVID-19 zalo\u017een\u00fdm na d\u016fkazech\u201c, kter\u00fd byl ned\u00e1vno publikov\u00e1n v\u00a0New England Journal of Medicine (NEJM)<\/strong>\u00a0\u2013 politikou, kter\u00e1 umo\u017e\u0148uje\u00a0pokra\u010dov\u00e1n\u00ed hromadn\u00fdch experiment\u016f na americk\u00e9 populaci bez d\u016fkaz\u016f o klinick\u00e9m p\u0159\u00ednosu<\/strong>\u00a0.<\/p>\n

Podle Moderny:<\/strong><\/p>\n

Americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA) schv\u00e1lil\u00a0vakc\u00ednu mNEXSPIKE\u00ae (mRNA-1283)<\/strong>\u00a0, novou vakc\u00ednu proti onemocn\u011bn\u00ed COVID-19, pro pou\u017eit\u00ed u\u00a0v\u0161ech dosp\u011bl\u00fdch ve v\u011bku 65 let a star\u0161\u00edch<\/strong>\u00a0a u osob\u00a0ve v\u011bku 12 a\u017e 64 let s alespo\u0148 jedn\u00edm z\u00e1kladn\u00edm rizikov\u00fdm faktorem<\/strong>\u00a0definovan\u00fdm CDC.<\/em><\/p>\n

Schv\u00e1len\u00ed vakc\u00edny mNEXSPIKE je zalo\u017eeno na v\u00fdsledc\u00edch randomizovan\u00e9, zaslepen\u00e9, aktivn\u011b kontrolovan\u00e9 studie f\u00e1ze 3 (identifik\u00e1tor ClinicalTrials.gov: NCT05815498), do kter\u00e9 bylo za\u0159azeno p\u0159ibli\u017en\u011b 11 400 \u00fa\u010dastn\u00edk\u016f ve v\u011bku 12 let a star\u0161\u00edch.\u00a0C\u00edlem bylo prok\u00e1zat \u201eneinferiorn\u00ed\u201c \u00fa\u010dinnost proti COVID-19<\/strong>\u00a0, po\u010d\u00ednaje 14 dny po o\u010dkov\u00e1n\u00ed vakc\u00ednou mNEXSPIKE ve srovn\u00e1n\u00ed s p\u0159edchoz\u00ed vakc\u00ednou Moderna\u00a0mRNA-1273 (Spikevax\u00ae)<\/strong>\u00a0.<\/em><\/p>\n

Spole\u010dnost Moderna pl\u00e1nuje v USA zp\u0159\u00edstupnit vakc\u00ednu mNEXSPIKE pro respira\u010dn\u00ed sez\u00f3nu 2025\u20132026,\u00a0a to spole\u010dn\u011b s vakc\u00ednami Spikevax a mRESVIA\u00ae<\/strong>\u00a0, ned\u00e1vno schv\u00e1lenou vakc\u00ednou proti RSV.<\/em><\/p>\n

Vakc\u00edna\u00a0mRNA-1283<\/strong>\u00a0je mRNA vakc\u00ednou proti COVID-19\u00a0nov\u00e9 generace<\/strong>\u00a0od spole\u010dnosti Moderna . K\u00f3duje pouze\u00a0vazebnou dom\u00e9nu receptoru (RBD)<\/strong>\u00a0a\u00a0N-termin\u00e1ln\u00ed dom\u00e9nu (NTD)<\/strong>\u00a0spike proteinu viru SARS-CoV-2, na rozd\u00edl od p\u0159edchoz\u00ed vakc\u00edny\u00a0mRNA-1273<\/strong>\u00a0, kter\u00e1 k\u00f3dovala cel\u00fd spike protein.<\/p>\n

Ofici\u00e1ln\u00ed schvalovac\u00ed dopis\u00a0FDA<\/strong>\u00a0z 30. kv\u011btna v\u0161ak obsahuje znepokojivou pas\u00e1\u017e: Kl\u00ed\u010dov\u00e1\u00a0placebem kontrolovan\u00e1 studie, kter\u00e1 by m\u011bla vyhodnotit bezpe\u010dnost a \u00fa\u010dinnost t\u00e9to nov\u00e9 vakc\u00edny, je\u0161t\u011b ani neza\u010dala.<\/strong><\/p>\n

Podle FDA spole\u010dnost Moderna nepl\u00e1nuje\u00a0zah\u00e1jit\u00a0randomizovanou, zaslepenou, placebem kontrolovanou studii\u00a0f\u00e1ze 4<\/strong>\u00a0u dosp\u011bl\u00fdch ve v\u011bku 50 a\u017e 64 let bez\u00a0rizikov\u00fdch faktor\u016f p\u0159ed\u00a0<\/strong>30. listopadu 2025.\u00a0<\/strong>V\u00fdsledky se neo\u010dek\u00e1vaj\u00ed d\u0159\u00edve ne\u017e v lednu 2027.<\/strong><\/p>\n

Studie, na n\u00ed\u017e je schv\u00e1len\u00ed zalo\u017eeno \u2013\u00a0NCT05815498<\/strong>\u00a0\u2013\u00a0nebyla placebem kontrolovan\u00e1<\/strong>\u00a0. M\u00edsto toho byl mNEXSPIKE jednodu\u0161e porovn\u00e1n s p\u0159edchoz\u00ed vakc\u00ednou spole\u010dnosti Moderna,\u00a0Spikevax (mRNA-1273)<\/strong>\u00a0, produktem, kter\u00fd\u00a0ji\u017e byl spojov\u00e1n se z\u00e1va\u017en\u00fdmi vedlej\u0161\u00edmi \u00fa\u010dinky a \u00famrt\u00edmi<\/strong>\u00a0.<\/p>\n

To znamen\u00e1, \u017ee FDA pln\u011b schv\u00e1lila mNEXSPIKE pro \u0161irok\u00e9 pou\u017eit\u00ed,\u00a0ani\u017e by kdy m\u011bla k dispozici placebo kontrolovan\u00e9 bezpe\u010dnostn\u00ed \u00fadaje pro pr\u00e1v\u011b ty populace, na kter\u00e9 je tato vakc\u00edna nyn\u00ed zam\u011b\u0159ena.<\/strong><\/p>\n

Toto rozhodnut\u00ed\u00a0je v p\u0159\u00edm\u00e9m rozporu s<\/strong>\u00a0ned\u00e1vn\u00fdm ve\u0159ejn\u00fdm prohl\u00e1\u0161en\u00edm mluv\u010d\u00edho HHS pro\u00a0Washington Post<\/em>\u00a0:<\/p>\n

\u201eV\u0161echny nov\u00e9 vakc\u00edny budou p\u0159ed schv\u00e1len\u00edm podrobeny bezpe\u010dnostn\u00edm test\u016fm v placebem kontrolovan\u00fdch studi\u00edch \u2013 co\u017e je radik\u00e1ln\u00ed odklon od p\u0159edchoz\u00edch postup\u016f.\u201c<\/strong><\/em><\/p>\n

Tento hluboce zklam\u00e1n\u00edm a nebezpe\u010dn\u00fd v\u00fdvoj nazna\u010duje, \u017ee\u00a0biofarmaceutick\u00fd komplex<\/strong>\u00a0i nad\u00e1le vykon\u00e1v\u00e1\u00a0v\u00fdznamnou kontrolu nad na\u0161imi regula\u010dn\u00edmi org\u00e1ny<\/strong>\u00a0.<\/p>\n

Pokud chceme skute\u010dn\u011b znovu nastolit zdrav\u00ed Ameriky, mus\u00edme skoncovat s t\u00edmto glob\u00e1ln\u00edm syndik\u00e1tem.<\/strong><\/em>\u2013 Nicolas Hulscher,<\/strong><\/em>
\nepidemiolog s titulem MPH a spr\u00e1vce nadace\u00a0McCullough Foundation<\/strong><\/em><\/p>\n<\/div>\n<\/div>\n

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Zdroj<\/a><\/span><\/h3>\n

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

Nicolas Hulscher, MPH FDA p\u0159ekro\u010dila hranice \u2013 schv\u00e1lila injekci mRNA COVID-19 nov\u00e9 generace od spole\u010dnosti…<\/p>\n","protected":false},"author":2,"featured_media":80375,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[1088,694,37,46],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/80374"}],"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=80374"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/80374\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/80375"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=80374"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=80374"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=80374"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}