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[title] => Američki institut izrazio zabrinutost: AstraZeneca je u ispitivanju možda koristila zastarjele podatke, to dovodi u pitanje učinkovitost cjepiva
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Rezultati američkog ispitivanja cjepiva proizvođača AstraZeneca možda su dobiveni korištenjem zastarjelih podataka, objavili je jutros američki nacionalni institut za alergije i zarazne bolesti (NIAD), javlja AP.
AstraZeneca je u ponedjeljak objavila da se cjepivo protiv covida-19 razvijeno u suradnji sa Sveučilištem Oxford pokazalo 79 posto učinkovito u prevenciji simptomatske bolesti u velikom ispitivanju u Sjedinjenim Državama, Čileu i Peruu.
"DSMB je izrazio zabrinutost da je AstraZeneca možda uključila zastarjele podatke iz tog ispitivanja, koji su možda pružili necjelovit prikaz podataka o učinkovitosti", rekla je američka agencija, referirajući se na neovisni Odbor za sigurnost podataka (DSMB).
"Tražimo od tvrtke da surađuje s DSMB-om u preispitivanju podataka o učinkovitosti i osigura da se što prije objave najtočniji, najnoviji podaci o učinkovitosti", navodi se.
Taj je zahtjev doveo u pitanje plan tvrtke da sljedećih mjeseci traži hitno američko odobrenje za upotrebu cjepiva.
Odbor za sigurnost podataka jučer je izrazio zabrinutost zbog toga što je AstraZeneca možda pružila nepotpun prikaz podataka o djelotvornosti cjepiva zbog korištenja zastarjelih podataka iz ispitivanja cjepiva u SAD-u.
Naime, jučer je iz AstraZenece priopćeno kako njihovo cjepivo protiv Covida-19 pruža snažnu zaštitu za odrasle osobe svih dobnih skupina. Otkrića iz tog američkog istraživanja mogla bi pomoći da se ponovno izgradi povjerenje javnosti u to cjepivo te da se dođe na korak bliže njegovu odobrenju u SAD-u.
U studiji koja je uključivala 30.000 ljudi, pokazalo se da je cjepivo bilo 79% učinkovito u prevenciji simptomatskih slučajeva Covida-19, a to se odnosilo i na osobe starije životne dobi, unatoč prvotnim sumnjama u djelotvornost cjepiva za one starije od 65 godina. Među cijepljenima nije bilo težih oblika bolesti ili hospitalizacija. U skupini osoba koje su dobile placebo bio je manji broj takvih slučajeva, no sve se podudara s nalazima iz Velike Britanije koji kažu da cjepivo u svakom slučaju štiti od teških oblika bolesti.
AstraZeneca je također priopćila kako nisu pronađene ozbiljne nuspojave cjepiva, uključujući i povećani rizik od stvaranja krvnih ugrušaka, zbog čega su neke europske zemlje prošlog tjedna obustavile cijepljenje cjepivom tog proizvođača.
Stručnjaci AstraZenece objavili su i kako vjeruju da je cjepivo djelotvorno kada se radi o novim varijantama koronavirusa.
AstraZeneca u narednim tjednima namjerava zatražiti dozvolu od Američke agencije za hranu i lijekove, a vladini će savjetnici zatim javno raspravljati o dokazima prije nego što agencija donese odluku. Nakon temeljitog pregleda od strane neovisnih savjetodavnih odbora, Agencija za hranu i lijekove mogla bi donijeti odobrenje i smjernice za upotrebu tog cjepiva u SAD-u, javlja AP.
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Rezultati američkog ispitivanja cjepiva proizvođača AstraZeneca možda su dobiveni korištenjem zastarjelih podataka, objavili je jutros američki nacionalni institut za alergije i zarazne bolesti (NIAD), javlja AP.
AstraZeneca je u ponedjeljak objavila da se cjepivo protiv covida-19 razvijeno u suradnji sa Sveučilištem Oxford pokazalo 79 posto učinkovito u prevenciji simptomatske bolesti u velikom ispitivanju u Sjedinjenim Državama, Čileu i Peruu.
"DSMB je izrazio zabrinutost da je AstraZeneca možda uključila zastarjele podatke iz tog ispitivanja, koji su možda pružili necjelovit prikaz podataka o učinkovitosti", rekla je američka agencija, referirajući se na neovisni Odbor za sigurnost podataka (DSMB).
"Tražimo od tvrtke da surađuje s DSMB-om u preispitivanju podataka o učinkovitosti i osigura da se što prije objave najtočniji, najnoviji podaci o učinkovitosti", navodi se.
Taj je zahtjev doveo u pitanje plan tvrtke da sljedećih mjeseci traži hitno američko odobrenje za upotrebu cjepiva.
Odbor za sigurnost podataka jučer je izrazio zabrinutost zbog toga što je AstraZeneca možda pružila nepotpun prikaz podataka o djelotvornosti cjepiva zbog korištenja zastarjelih podataka iz ispitivanja cjepiva u SAD-u.
Naime, jučer je iz AstraZenece priopćeno kako njihovo cjepivo protiv Covida-19 pruža snažnu zaštitu za odrasle osobe svih dobnih skupina. Otkrića iz tog američkog istraživanja mogla bi pomoći da se ponovno izgradi povjerenje javnosti u to cjepivo te da se dođe na korak bliže njegovu odobrenju u SAD-u.
U studiji koja je uključivala 30.000 ljudi, pokazalo se da je cjepivo bilo 79% učinkovito u prevenciji simptomatskih slučajeva Covida-19, a to se odnosilo i na osobe starije životne dobi, unatoč prvotnim sumnjama u djelotvornost cjepiva za one starije od 65 godina. Među cijepljenima nije bilo težih oblika bolesti ili hospitalizacija. U skupini osoba koje su dobile placebo bio je manji broj takvih slučajeva, no sve se podudara s nalazima iz Velike Britanije koji kažu da cjepivo u svakom slučaju štiti od teških oblika bolesti.
AstraZeneca je također priopćila kako nisu pronađene ozbiljne nuspojave cjepiva, uključujući i povećani rizik od stvaranja krvnih ugrušaka, zbog čega su neke europske zemlje prošlog tjedna obustavile cijepljenje cjepivom tog proizvođača.
Stručnjaci AstraZenece objavili su i kako vjeruju da je cjepivo djelotvorno kada se radi o novim varijantama koronavirusa.
AstraZeneca u narednim tjednima namjerava zatražiti dozvolu od Američke agencije za hranu i lijekove, a vladini će savjetnici zatim javno raspravljati o dokazima prije nego što agencija donese odluku. Nakon temeljitog pregleda od strane neovisnih savjetodavnih odbora, Agencija za hranu i lijekove mogla bi donijeti odobrenje i smjernice za upotrebu tog cjepiva u SAD-u, javlja AP.
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17. svibanj 2024 10:47
