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[title] => Pfizer i BioNTech počeli testirati cjepivo protiv Covid-19 na trudnicama: ispitivanja će se odvijati u devet država, u SAD-u su već primile prvu dozu
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Pfizer Inc i BioNTech započeli su međunarodnu studiju s 4000 sudionica kako bi procijenili sigurnost i učinkovitost svog cjepiva protiv covida-19 u zdravih trudnica, priopćile su tvrtke u četvrtak.
Trudnice su pod većim rizikom od razvoja teškog oblika covida-19, a mnogi su zdravstveni djelatnici rekli da neke žene u visoko rizičnim profesijama uzimaju cjepiva protiv koronavirusa čak i bez dokaza da je ono za njih sigurno.
Prošli tjedan američki Nacionalni institut za zdravlje pozvao je na veće uključivanje trudnica i dojilja u istraživanje cjepiva protiv covida-19.
Bioetičari, stručnjaci za cjepiva i zdravlje majki godinama su tvrdili da bi trudnice trebale biti rano uključene u ispitivanja pandemijskih cjepiva, tako da ne bi trebale čekati dugo nakon što im se dokaže učinkovitost za opću populaciju.
Ipak, trudnice su isključene iz velikih američkih ispitivanja za dobivanje odobrenja za hitnu uporabu cjepiva protiv covida-19.
Proizvođači lijekova rekli su da prvo trebaju osigurati sigurnija i učinkovitija cjepiva za opću populaciju.
U Sjedinjenim Američkim Državama regulatori zahtijevaju od proizvođača lijekova da provedu sigurnosne studije na trudnim životinjama prije testiranja cjepiva na trudnicama kako bi bili sigurni da ne štete fetusu te da ne mogu dovesti do pobačaja.
Tvrtke su rekle da te studije nisu otkrile nove rizike.
Trudnice u SAD-u već su dobile prve doze cjepiva, rekle su tvrtke.
Nova studija testirat će trudnice u dobi od 18 godina i više u SAD-u, Kanadi, Argentini, Brazilu, Čileu, Mozambiku, JAR-u, Velikoj Britaniji i Španjolskoj.
Žene će primiti cjepivo između 24 i 34 tjedna turdnoće, a uzet će dvije doze u razmaku od 21 dan, kao što se radilo i u većem kliničkom ispitivanju.
Ubrzo nakon porođaja sudionice koje dobiju placebo u ispitivanju imat će priliku dobiti pravo cjepivo, rekle su tvrtke.
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[cleanTitle] => Pfizer i BioNTech počeli testirati cjepivo protiv Covid-19 na trudnicama: ispitivanja će se odvijati u devet država, u SAD-u su već primile prvu dozu
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Pfizer Inc i BioNTech započeli su međunarodnu studiju s 4000 sudionica kako bi procijenili sigurnost i učinkovitost svog cjepiva protiv covida-19 u zdravih trudnica, priopćile su tvrtke u četvrtak.
Trudnice su pod većim rizikom od razvoja teškog oblika covida-19, a mnogi su zdravstveni djelatnici rekli da neke žene u visoko rizičnim profesijama uzimaju cjepiva protiv koronavirusa čak i bez dokaza da je ono za njih sigurno.
Prošli tjedan američki Nacionalni institut za zdravlje pozvao je na veće uključivanje trudnica i dojilja u istraživanje cjepiva protiv covida-19.
Bioetičari, stručnjaci za cjepiva i zdravlje majki godinama su tvrdili da bi trudnice trebale biti rano uključene u ispitivanja pandemijskih cjepiva, tako da ne bi trebale čekati dugo nakon što im se dokaže učinkovitost za opću populaciju.
Ipak, trudnice su isključene iz velikih američkih ispitivanja za dobivanje odobrenja za hitnu uporabu cjepiva protiv covida-19.
Proizvođači lijekova rekli su da prvo trebaju osigurati sigurnija i učinkovitija cjepiva za opću populaciju.
U Sjedinjenim Američkim Državama regulatori zahtijevaju od proizvođača lijekova da provedu sigurnosne studije na trudnim životinjama prije testiranja cjepiva na trudnicama kako bi bili sigurni da ne štete fetusu te da ne mogu dovesti do pobačaja.
Tvrtke su rekle da te studije nisu otkrile nove rizike.
Trudnice u SAD-u već su dobile prve doze cjepiva, rekle su tvrtke.
Nova studija testirat će trudnice u dobi od 18 godina i više u SAD-u, Kanadi, Argentini, Brazilu, Čileu, Mozambiku, JAR-u, Velikoj Britaniji i Španjolskoj.
Žene će primiti cjepivo između 24 i 34 tjedna turdnoće, a uzet će dvije doze u razmaku od 21 dan, kao što se radilo i u većem kliničkom ispitivanju.
Ubrzo nakon porođaja sudionice koje dobiju placebo u ispitivanju imat će priliku dobiti pravo cjepivo, rekle su tvrtke.
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[absoluteURL] => https://slobodnadalmacija.hr/vijesti/svijet/pfizer-i-biontech-poceli-testirati-cjepivo-protiv-covida-19-na-trudnicama-ispitivanja-ce-se-odvijati-u-devet-drzava-u-sad-u-su-vec-primile-prvu-dozu-1078658
[emailLink] => /component/mailto/?tmpl=component&template=site&link=516f0abba6009a1cdbbe9586f07c2f57dc7cb85a
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[socialLink] => https%3A%2F%2Fslobodnadalmacija.hr%2Fvijesti%2Fsvijet%2Fpfizer-i-biontech-poceli-testirati-cjepivo-protiv-covida-19-na-trudnicama-ispitivanja-ce-se-odvijati-u-devet-drzava-u-sad-u-su-vec-primile-prvu-dozu-1078658
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19. svibanj 2024 04:32
