{"id":79267,"date":"2025-05-21T00:13:12","date_gmt":"2025-05-20T22:13:12","guid":{"rendered":"https:\/\/www.infokuryr.cz\/n\/?p=79267"},"modified":"2025-05-20T10:40:20","modified_gmt":"2025-05-20T08:40:20","slug":"ivo-zvardon-testovani-bezpecnosti-vakcin","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2025\/05\/21\/ivo-zvardon-testovani-bezpecnosti-vakcin\/","title":{"rendered":"Ivo Zvardo\u0148: Testov\u00e1n\u00ed bezpe\u010dnosti vakc\u00edn"},"content":{"rendered":"
<\/div>\n

Bezpe\u010dnost d\u011btsk\u00fdch vakc\u00edn se jev\u00ed jako jedno z hork\u00fdch t\u00e9mat sou\u010dasnosti. V posledn\u00ed dob\u011b se zd\u00e1, \u017ee st\u00e1le v\u00edce rodi\u010d\u016f se intenzivn\u011bji zaj\u00edm\u00e1 o vakc\u00edny, kter\u00e9 maj\u00ed b\u00fdt jejich d\u00edt\u011bti pod\u00e1ny, a st\u00e1le kles\u00e1 jejich ochota nechat sv\u00e9 d\u011bti pediatrem nao\u010dkovat.<\/strong><\/p>\n

Zast\u00e1nci o\u010dkov\u00e1n\u00ed \u2013 v\u011bt\u0161inou farmaceutick\u00e9 spole\u010dnosti nebo m\u00e9dia pracuj\u00edc\u00ed v jejich prosp\u011bch \u2013 r\u00e1di zmi\u0148uj\u00ed, \u017ee vakc\u00edny jsou d\u016fkladn\u011b testov\u00e1ny, a tud\u00ed\u017e jsou pro na\u0161e d\u011bti bezpe\u010dn\u00e9. Zde bych se na to r\u00e1d pod\u00edval, abych toto dogma vyvr\u00e1til.<\/p>\n

1.Placebo testy<\/h2>\n

Zlat\u00fdm standardem v medic\u00edn\u011b pro testov\u00e1n\u00ed v\u0161ech farmaceutick\u00fdch v\u00fdrobk\u016f jsou dvojit\u011b zaslepen\u00e9 placebo studie. Ty se prov\u00e1d\u011bj\u00ed obvykle s pou\u017eit\u00edm inertn\u00edho soln\u00e9ho roztoku. Experiment\u00e1ln\u00ed skupina dostane testovan\u00fd p\u0159\u00edpravek, kontroln\u00ed skupina dostane placebo, a v\u00fdsledky se pak porovn\u00e1vaj\u00ed. Jednodu\u0161e \u0159e\u010deno, pokud experiment\u00e1ln\u00ed skupina z\u00edsk\u00e1 v\u00edce pozitivn\u00edch v\u00fdsledk\u016f a m\u00e9n\u011b vedlej\u0161\u00edch \u00fa\u010dink\u016f, m\u016f\u017ee b\u00fdt v\u00fdrobek uveden na trh.<\/p>\n

Tyto placebo testy se prov\u00e1d\u011bj\u00ed u v\u0161ech l\u00e9k\u016f a farmaceutick\u00fdch v\u00fdrobk\u016f, kter\u00e9 maj\u00ed b\u00fdt uvedeny na trh. Bohu\u017eel \u2013 a toto je \u0161okuj\u00edc\u00ed \u2013 vakc\u00edny jsou v tomto v\u00fdjimka, a v\u00fdrobci nemaj\u00ed povinnost prov\u00e1d\u011bt skute\u010dn\u00e9 placebo testy. Pokud tak v\u016fbec \u010din\u00ed, prov\u00e1d\u011bj\u00ed a naz\u00fdvaj\u00ed placebo testy studie, b\u011bhem nich\u017e kontroln\u00ed skupina dostane bu\u010f jinou vakc\u00ednu (obvykle star\u0161\u00ed verzi od stejn\u00e9ho v\u00fdrobce), nebo hlin\u00edkov\u00e9 adjuvans.<\/p>\n

Experiment\u00e1ln\u00ed skupina tedy dostane vakc\u00ednu, kontroln\u00ed skupina dostane jinou (v\u011bt\u0161inou star\u0161\u00ed, m\u00e9n\u011b bezpe\u010dnou) vakc\u00ednu, co\u017e t\u00e9m\u011b\u0159 zaru\u010duje pozitivn\u00ed v\u00fdsledek pro nov\u00fd v\u00fdrobek.<\/p>\n

Pro ty, kte\u0159\u00ed by t\u00edm mohli b\u00fdt \u0161okov\u00e1ni a necht\u011bj\u00ed v\u011b\u0159it, \u017ee je takov\u00e9 chov\u00e1n\u00ed p\u0159\u00edpustn\u00e9, pod\u00edvejme se na n\u00e1sleduj\u00edc\u00ed p\u0159\u00edklady 4 r\u016fzn\u00fdch vakc\u00edn, kter\u00e9 se b\u011b\u017en\u011b pod\u00e1vaj\u00ed d\u011btem ve vysp\u011bl\u00fdch zem\u00edch:<\/p>\n

–Prevnar 13<\/b>\u00a0(v\u00fdrobce: Pfizer) \u2013 o\u010dkov\u00e1n\u00ed proti streptokoku pneumoniae<\/p>\n

B\u011bhem placebov\u00fdch studi\u00ed dost\u00e1vala experiment\u00e1ln\u00ed skupina novou vakc\u00ednu Prevnar 13 a kontroln\u00ed skupina star\u0161\u00ed verzi \u2013 Prevnar 7 (tak\u00e9: Prevnar).<\/p>\n

Bezpe\u010dnost vakc\u00edny Prevnar 13 byla hodnocena ve 13 klinick\u00fdch studi\u00edch, v nich\u017e 4 729 kojenc\u016f dostalo alespo\u0148 jednu d\u00e1vku vakc\u00edny Prevnar 13 a 2 760 kojenc\u016f a batolat dostalo alespo\u0148 jednu d\u00e1vku aktivn\u00ed kontroln\u00ed vakc\u00edny Prevnar.<\/em><\/p>\n

(zdroj: p\u0159\u00edbalov\u00fd let\u00e1k v\u00fdrobce).<\/em><\/p>\n

Pro informaci, z\u00e1va\u017en\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky u vakc\u00edny Prevnar 13 byly zji\u0161t\u011bny u 8,2 % testovan\u00fdch (!), nicm\u00e9n\u011b ve srovn\u00e1n\u00ed s \u201eplacebem\u201c Prevnar 7 je rozd\u00edl nepatrn\u00fd (Prevnar 7 m\u00e1 7,2 % z\u00e1va\u017en\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f), tak\u017ee v\u00fdrobce m\u016f\u017ee tvrdit, \u017ee mezi p\u0159\u00edjemci vakc\u00edny Prevnar 13 a kontroln\u00ed skupinou nen\u00ed v\u00fdznamn\u00fd rozd\u00edl v ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch a \u017ee vakc\u00edna je bezpe\u010dn\u00e1.<\/p>\n

Z\u00e1va\u017en\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky hl\u00e1\u0161en\u00e9 po o\u010dkov\u00e1n\u00ed u kojenc\u016f a batolat se vyskytly v 8,2 % u p\u0159\u00edjemc\u016f vakc\u00edny Prevnar 13 a v 7,2 % u p\u0159\u00edjemc\u016f vakc\u00edny Prevnar.<\/em><\/p>\n

(zdroj: p\u0159\u00edbalov\u00fd let\u00e1k v\u00fdrobce).<\/em><\/p>\n

–M-M-R-II<\/b>\u00a0(v\u00fdrobce: Merck) \u2013 o\u010dkov\u00e1n\u00ed proti spalni\u010dk\u00e1m, p\u0159\u00edu\u0161nic\u00edm a zard\u011bnk\u00e1m.<\/p>\n

Nebyla provedena \u017e\u00e1dn\u00e1 placebo studie.<\/p>\n

–Gardasil 9<\/b>\u00a0(v\u00fdrobce: Merck) \u2013 o\u010dkov\u00e1n\u00ed proti 9 typ\u016fm lidsk\u00e9ho papilomaviru<\/p>\n

V kontroln\u00ed skupin\u011b bylo pou\u017eito placebo ve form\u011b star\u0161\u00ed vakc\u00edny Gardasil 4.<\/p>\n

–Engerix B<\/b>\u00a0(v\u00fdrobce: GlaxoSmithKline) \u2013 o\u010dkov\u00e1n\u00ed proti vir\u016fm hepatitidy B<\/p>\n

Nebyla provedena \u017e\u00e1dn\u00e1 placebo studie.<\/p>\n

2. Dlouhodob\u00e9 studie bezpe\u010dnosti<\/h2>\n

A\u010d se to m\u016f\u017ee zd\u00e1t p\u0159ekvapiv\u00e9, farmaceutick\u00e9 spole\u010dnosti prov\u00e1d\u011bj\u00ed pouze v\u00fdzkum kr\u00e1tkodob\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f po pod\u00e1n\u00ed vakc\u00edny, nikoli v\u00fdzkum mo\u017en\u00fdch dlouhodob\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f.<\/p>\n

Pod\u00edvejme se op\u011bt na 3 r\u016fzn\u00e9 vakc\u00edny:<\/p>\n

–Engerix B<\/b><\/p>\n

D\u00e9lka studi\u00ed vedlej\u0161\u00edch \u00fa\u010dink\u016f po o\u010dkov\u00e1n\u00ed:\u00a04 dny!<\/b><\/p>\n

(zdroj: p\u0159\u00edbalov\u00fd let\u00e1k v\u00fdrobce)<\/p>\n

–Prevnar 13<\/b><\/p>\n

D\u00e9lka studi\u00ed ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f po o\u010dkov\u00e1n\u00ed:\u00a06 m\u011bs\u00edc\u016f<\/b><\/p>\n

(zdroj: p\u0159\u00edbalov\u00fd let\u00e1k v\u00fdrobce).<\/p>\n

–M-M-R-II<\/b><\/p>\n

D\u00e9lka studi\u00ed vedlej\u0161\u00edch \u00fa\u010dink\u016f po o\u010dkov\u00e1n\u00ed:\u00a042 dn\u00ed<\/b>.<\/p>\n

(zdroj: p\u0159\u00edbalov\u00fd let\u00e1k v\u00fdrobce).<\/p>\n

Jak vid\u00edme, dlouhodob\u00e9 studie ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f trvaj\u00edc\u00ed jen n\u011bkolik m\u011bs\u00edc\u016f nebo dokonce dn\u016f jsou sm\u011b\u0161n\u00e9 a o\u010dividn\u011b jsou prov\u00e1d\u011bny s c\u00edlem zakr\u00fdt mo\u017en\u00e9 ne\u017e\u00e1douc\u00ed \u00fa\u010dinky, kter\u00e9 se objev\u00ed pozd\u011bji po pod\u00e1n\u00ed vakc\u00edny. Znovu se nab\u00edz\u00ed ot\u00e1zka, jak je mo\u017en\u00e9, \u017ee regula\u010dn\u00ed org\u00e1ny umo\u017e\u0148uj\u00ed v\u00fdrobc\u016fm prov\u00e1d\u011bt tak nedbal\u00e9 studie.<\/p>\n

Dokonce i p\u0159i takov\u00fdch na m\u00edru \u0161it\u00fdch, velmi kr\u00e1tk\u00fdch studi\u00edch ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f hl\u00e1s\u00ed v\u00fdrobci u r\u016fzn\u00fdch vakc\u00edn spoustu ne\u017e\u00e1douc\u00edch \u00fa\u010dink\u016f. Doporu\u010duji v\u0161em, aby si p\u0159e\u010detli p\u0159\u00edbalov\u00e9 let\u00e1ky v\u00fdrobc\u016f a dozv\u011bd\u011bli se v\u00edce o r\u016fzn\u00fdch hl\u00e1\u0161en\u00fdch ne\u017e\u00e1douc\u00edch \u00fa\u010dinc\u00edch zaznamenan\u00fdch b\u011bhem t\u011bchto kr\u00e1tk\u00fdch zku\u0161ebn\u00edch obdob\u00ed.<\/p>\n

Na z\u00e1v\u011br o bezpe\u010dnosti vakc\u00edn bych se cht\u011bl kr\u00e1tce dotknout hlin\u00edku (Al3+). Negativn\u00ed \u00fa\u010dinky Al na lidsk\u00fd mozek a n\u00e1sledn\u011b jeho pod\u00edl na neurologick\u00fdch onemocn\u011bn\u00edch byly prok\u00e1z\u00e1ny v mnoha studi\u00edch, p\u0159esto se dnes pou\u017e\u00edv\u00e1 v adjuvansech v\u011bt\u0161iny d\u011btsk\u00fdch vakc\u00edn. Adjuvans je l\u00e1tka, kter\u00e1 zesiluje reakci imunitn\u00edho syst\u00e9mu proti pod\u00e1van\u00e9mu antigenu, a zvy\u0161uje tak jeho \u00fa\u010dinnost. Je op\u011bt \u0161okuj\u00edc\u00ed, \u017ee pro mno\u017estv\u00ed hlin\u00edku ve vakc\u00edn\u00e1ch nejsou zdravotnick\u00fdmi org\u00e1ny stanoveny \u017e\u00e1dn\u00e9 limity. Je tedy na rozhodnut\u00ed v\u00fdrobce, jak\u00e9 mno\u017estv\u00ed Al ve sv\u00e9m v\u00fdrobku pou\u017eije. Na\u0161e regula\u010dn\u00ed org\u00e1ny tvrd\u00ed, \u017ee hlin\u00edk ve vakc\u00edn\u00e1ch je bezpe\u010dn\u00fd, ani\u017e by uvedly, jak\u00e1 je jeho bezpe\u010dn\u00e1 hladina, a ani\u017e by stanovily maxim\u00e1ln\u00ed mno\u017estv\u00ed Al ve vakc\u00edn\u00e1ch. Do dne\u0161n\u00edho dne nebyly provedeny \u017e\u00e1dn\u00e9 komplexn\u00ed studie o tom, jak\u00e9 je bezpe\u010dn\u00e9 mno\u017estv\u00ed hlin\u00edku v d\u00e1vce vakc\u00edny.<\/p>\n

Farmaceutick\u00e9 spole\u010dnosti ji\u017e dlouho tvrd\u00ed, \u017ee jejich vakc\u00edny jsou bezpe\u010dn\u00e9 (navzdory mnoha skand\u00e1l\u016fm v historii tohoto odv\u011btv\u00ed), a vyu\u017e\u00edvaj\u00ed k tomu na\u0161e st\u00e1tn\u00ed zdravotn\u00ed \u00fa\u0159ady a mocn\u00e1 masm\u00e9dia s bezohledn\u00fdmi novin\u00e1\u0159i, kte\u0159\u00ed jsou na jejich v\u00fdplatn\u00edch listin\u00e1ch. Stalo se tak\u00e9 zvykem kritizovat nebo zesm\u011b\u0161\u0148ovat ty, kte\u0159\u00ed podrobuj\u00ed jejich produkty kritick\u00e9 anal\u00fdze. Jsou ozna\u010dov\u00e1ni za v\u00e1hav\u00e9 skupiny nebo konspira\u010dn\u00ed teoretiky, kte\u0159\u00ed pravd\u011bpodobn\u011b podkop\u00e1vaj\u00ed zdrav\u00ed na\u0161\u00ed spole\u010dnosti t\u00edm, \u017ee odm\u00edtaj\u00ed vakc\u00edny, kter\u00e9 jsou podle v\u0161eho dobr\u00e9 pro na\u0161e d\u011bti.<\/p>\n

Sta\u010d\u00ed v\u0161ak pochopit, jak \u0161patn\u011b jsou u vakc\u00edn prov\u00e1d\u011bny dva v\u00fd\u0161e zm\u00edn\u011bn\u00e9 z\u00e1klady testov\u00e1n\u00ed bezpe\u010dnosti farmaceutick\u00fdch v\u00fdrobk\u016f \u2013 placebo testy a dlouhodob\u00e9 studie bezpe\u010dnosti \u2013 a vid\u00edme, \u017ee ani jedno z toho nen\u00ed prov\u00e1d\u011bno \u0159\u00e1dn\u011b, co\u017e vyvol\u00e1v\u00e1 u rodi\u010d\u016f zcela pochopiteln\u00e9 v\u00e1h\u00e1n\u00ed.<\/p>\n

Vzhledem k v\u00fd\u0161e uveden\u00fdm z\u00e1va\u017en\u00fdm z\u00e1m\u011brn\u00fdm nedostatk\u016fm v bezpe\u010dnostn\u00edch postupech p\u0159i o\u010dkov\u00e1n\u00ed a s ohledem na n\u00e1r\u016fst neurologick\u00fdch a autoimunitn\u00edch onemocn\u011bn\u00ed se zd\u00e1 b\u00fdt obt\u00ed\u017en\u00e9 tvrdit, \u017ee vakc\u00edny jsou bezpe\u010dn\u00e9 a mohou b\u00fdt pod\u00e1v\u00e1ny na\u0161im d\u011btem bez opr\u00e1vn\u011bn\u00fdch obav.<\/p>\n

D\u011bkuji v\u00e1m za p\u0159e\u010dten\u00ed a pros\u00edm,\u00a0kontaktujte m\u011b<\/a>, pokud si chcete o tomto t\u00e9matu vym\u011bnit n\u00e1zory.<\/p>\n

Ivo Zvardo\u0148<\/em><\/a><\/p>\n

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

Bezpe\u010dnost d\u011btsk\u00fdch vakc\u00edn se jev\u00ed jako jedno z hork\u00fdch t\u00e9mat sou\u010dasnosti. V posledn\u00ed dob\u011b se…<\/p>\n","protected":false},"author":2,"featured_media":66737,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[6],"tags":[839,651,21],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/79267"}],"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=79267"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/79267\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/66737"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=79267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=79267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=79267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}