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Pfizer Inc i BioNTech objavili su u četvrtak da je njihovo cjepivo protiv covida-19 učinkovito oko 91 posto u sprječavanju bolesti pri čemu se pozivaju na ažurirane podatke o cijepljenima  od kojih su neki primili cjepivo prije šest mjeseci.

Cjepivo je bilo 100 posto učinkovito u sprječavanju oboljenja među sudionicima u Južnoj Africi gdje dominira nova varijanta virusa B1351 iako je broj sudionika u ispitivanju relativno malen - njih 800.

Novi podatak o 91,3 postotnoj efikasnosti niži je od 95 posto kako je bilo prvotno objavljeno u studenom na ispitivanju koje je obuhvatilo 44.000 ljudi, no virus je od tada mutirao i danas kruži više varijanata covida-19. 

Albert Bourla, glavni direktor Pfizera, rekao je da novi dopunjeni podaci uključuju više od 12.000 ljudi koji su potpuno cijepljeni najmanje šest te je proizvođač stekao osnovu da može zatražiti konačno odobrenje američkog regulatora. 

Cjepivo se sada koristi na temelju privremenog odobrenja koje je dala Američka agencija za hranu i lijekova (FDA).

Rezultati ispitivanja "daju prve kliničke rezultate da cjepivo može učinkovito štititi od varijanata bolesti koje trenutačno cirkuliraju, a što je kritičan faktor da bi se stekao kolektivni imunitet i okončala ova pandemija za stanovništvo cijelog svijeta", kaže Ugur Sahin, ravnatelj BioNTecha.

Stručnjaci strahuju da bi nove varijante covida-19 iz Južne Afrike i Brazila mogle biti otpornije na postojeća cjepiva i liječenje. Više od 300 slučajeva južnoafričke varijante detektirano je u više od 25 američkih saveznih država, prema saveznim podacima.

Cjepivo je 100 posto učinkovito u sprječavanju teških oblika bolesti kako ih definiraju Američki centri za kontrolu i prevenciju bolesti, odnosno učinkovito je 95,3 posto prema definiciji FDA-e.

U kliničkim ispitivanjima nije bilo ozbiljnih razloga za zabrinutost u sigurnost cjepiva tijekom šest mjeseci otkako su primatelji dobili  prvu dozu, navode dva proizvođača.

Dodaju da je to cjepivo općenito jednako učinkovito bez obzira na dob, rasu, spol, etničku pripadnost primatelja i bez obzira na postojeće medicinske uvjete primatelja cjepiva. 

Ispitivanje je obuhvatilo više od 900 potvrđenih slučajeva covida-19 kojih je većina primila placebo.

Objava današnjih ažuriranih rezultata slijedila je nakon odvojene studije koja je potvrdila da je cjepivo sigurno i  učinkovito među djecom od 12 do 15 godina čime je  utrt put da proizvođač zatraži i u SAD-u i u Europi odobrenje za cijepljenje te dobne skupine idućih tjedana.

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Pfizer Inc i BioNTech objavili su u četvrtak da je njihovo cjepivo protiv covida-19 učinkovito oko 91 posto u sprječavanju bolesti pri čemu se pozivaju na ažurirane podatke o cijepljenima  od kojih su neki primili cjepivo prije šest mjeseci.

Cjepivo je bilo 100 posto učinkovito u sprječavanju oboljenja među sudionicima u Južnoj Africi gdje dominira nova varijanta virusa B1351 iako je broj sudionika u ispitivanju relativno malen - njih 800.

Novi podatak o 91,3 postotnoj efikasnosti niži je od 95 posto kako je bilo prvotno objavljeno u studenom na ispitivanju koje je obuhvatilo 44.000 ljudi, no virus je od tada mutirao i danas kruži više varijanata covida-19. 

Albert Bourla, glavni direktor Pfizera, rekao je da novi dopunjeni podaci uključuju više od 12.000 ljudi koji su potpuno cijepljeni najmanje šest te je proizvođač stekao osnovu da može zatražiti konačno odobrenje američkog regulatora. 

Cjepivo se sada koristi na temelju privremenog odobrenja koje je dala Američka agencija za hranu i lijekova (FDA).

Rezultati ispitivanja "daju prve kliničke rezultate da cjepivo može učinkovito štititi od varijanata bolesti koje trenutačno cirkuliraju, a što je kritičan faktor da bi se stekao kolektivni imunitet i okončala ova pandemija za stanovništvo cijelog svijeta", kaže Ugur Sahin, ravnatelj BioNTecha.

Stručnjaci strahuju da bi nove varijante covida-19 iz Južne Afrike i Brazila mogle biti otpornije na postojeća cjepiva i liječenje. Više od 300 slučajeva južnoafričke varijante detektirano je u više od 25 američkih saveznih država, prema saveznim podacima.

Cjepivo je 100 posto učinkovito u sprječavanju teških oblika bolesti kako ih definiraju Američki centri za kontrolu i prevenciju bolesti, odnosno učinkovito je 95,3 posto prema definiciji FDA-e.

U kliničkim ispitivanjima nije bilo ozbiljnih razloga za zabrinutost u sigurnost cjepiva tijekom šest mjeseci otkako su primatelji dobili  prvu dozu, navode dva proizvođača.

Dodaju da je to cjepivo općenito jednako učinkovito bez obzira na dob, rasu, spol, etničku pripadnost primatelja i bez obzira na postojeće medicinske uvjete primatelja cjepiva. 

Ispitivanje je obuhvatilo više od 900 potvrđenih slučajeva covida-19 kojih je većina primila placebo.

Objava današnjih ažuriranih rezultata slijedila je nakon odvojene studije koja je potvrdila da je cjepivo sigurno i  učinkovito među djecom od 12 do 15 godina čime je  utrt put da proizvođač zatraži i u SAD-u i u Europi odobrenje za cijepljenje te dobne skupine idućih tjedana.

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AFP
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Svijetnova saznanja

Cjepivo Pfizera i BioNTecha učinkovito je 91 posto, a štiti i protiv južnoafričkog soja

Piše Hina
1. travnja 2021. - 14:26

Pfizer Inc i BioNTech objavili su u četvrtak da je njihovo cjepivo protiv covida-19 učinkovito oko 91 posto u sprječavanju bolesti pri čemu se pozivaju na ažurirane podatke o cijepljenima  od kojih su neki primili cjepivo prije šest mjeseci.

Cjepivo je bilo 100 posto učinkovito u sprječavanju oboljenja među sudionicima u Južnoj Africi gdje dominira nova varijanta virusa B1351 iako je broj sudionika u ispitivanju relativno malen - njih 800.

Novi podatak o 91,3 postotnoj efikasnosti niži je od 95 posto kako je bilo prvotno objavljeno u studenom na ispitivanju koje je obuhvatilo 44.000 ljudi, no virus je od tada mutirao i danas kruži više varijanata covida-19. 

Albert Bourla, glavni direktor Pfizera, rekao je da novi dopunjeni podaci uključuju više od 12.000 ljudi...

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15. svibanj 2024 04:28