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[title] => Pfizer pokrenuo proces odobrenja cjepiva protiv Covida za djecu od šest mjeseci do četiri godine starosti
[alias] => pfizer-pokrenuo-proces-odobrenja-cjepiva-protiv-covida-za-djecu-od-sest-mjeseci-do-cetiri-godine-starosti
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Pfizer je pokrenuo proces u kojemu traži hitno odobrenje primjene cjepiva Pfizer/BioNTech protiv covida 19 i za djecu u dobi od šest mjeseci do navršene 4 godine, objavila je u utorak farmaceutska tvrtka.
Odobri li ga američka agencija za lijekove (FDA), to će cjepivo postati prvo u SAD-u za tu dobnu skupinu.
Zahtjev se u prvoj fazi odnosi na seriju od dvije doze, no s vremenom će se morati računati i na treću, objašnjavaju u priopćenju tvrtke Pfizer i BioNTech.
"Mislimo da će za djecu u dobi od šest mjeseci do četiri godine biti potrebne dvije doze kako bi se postigla visoka razina zaštite od sadašnjih i budućih varijanti virusa", dodao je u priopćenju šef Pfizera Albert Bourla.
Budu li sada odobrene dvije doze, roditelji će imati priliku započeti cijepljenje djeteta protiv covida u očekivanju mogućega odobrenja treće doze, dodao je.
Pfizer navodi da je zahtjev predan "nakon poziva" američke agencije za lijekove, koja očito ne želi gubiti vrijeme i želi ubrzati proces.
Zahtjev će biti u potpunosti finaliziran za nekoliko dana, dodaju iz Pfizera, a cjepivo za tu dobnu skupinu možda će biti dostupno za nekoliko tjedana.
FDA je najavila da će se njihovo stručno povjerenstvo zaduženo za ispitivanje podataka sastati 15. veljače.
Za djecu te dobi farmaceutska tvrtka se odlučila za dozu od samo 3 mikrograma po injekciji (u usporedbi s 30 za odrasle i 10 za dobnu skupinu od 5 do 11 godina), kako bi se ograničile nuspojave. No, pokazalo se da tako smanjena doza ne izaziva željeni imunološki odgovor kod djece u dobio od 2 do 4 godine, objavio je Pfizer u prosincu.
Tvrtka je stoga željela ispitati i primjenu treće doze cjepiva za tu dobnu skupinu te je dopunila protokole svojih kliničkih ispitivanja.
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Pfizer je pokrenuo proces u kojemu traži hitno odobrenje primjene cjepiva Pfizer/BioNTech protiv covida 19 i za djecu u dobi od šest mjeseci do navršene 4 godine, objavila je u utorak farmaceutska tvrtka.
Odobri li ga američka agencija za lijekove (FDA), to će cjepivo postati prvo u SAD-u za tu dobnu skupinu.
Zahtjev se u prvoj fazi odnosi na seriju od dvije doze, no s vremenom će se morati računati i na treću, objašnjavaju u priopćenju tvrtke Pfizer i BioNTech.
"Mislimo da će za djecu u dobi od šest mjeseci do četiri godine biti potrebne dvije doze kako bi se postigla visoka razina zaštite od sadašnjih i budućih varijanti virusa", dodao je u priopćenju šef Pfizera Albert Bourla.
Budu li sada odobrene dvije doze, roditelji će imati priliku započeti cijepljenje djeteta protiv covida u očekivanju mogućega odobrenja treće doze, dodao je.
Pfizer navodi da je zahtjev predan "nakon poziva" američke agencije za lijekove, koja očito ne želi gubiti vrijeme i želi ubrzati proces.
Zahtjev će biti u potpunosti finaliziran za nekoliko dana, dodaju iz Pfizera, a cjepivo za tu dobnu skupinu možda će biti dostupno za nekoliko tjedana.
FDA je najavila da će se njihovo stručno povjerenstvo zaduženo za ispitivanje podataka sastati 15. veljače.
Za djecu te dobi farmaceutska tvrtka se odlučila za dozu od samo 3 mikrograma po injekciji (u usporedbi s 30 za odrasle i 10 za dobnu skupinu od 5 do 11 godina), kako bi se ograničile nuspojave. No, pokazalo se da tako smanjena doza ne izaziva željeni imunološki odgovor kod djece u dobio od 2 do 4 godine, objavio je Pfizer u prosincu.
Tvrtka je stoga željela ispitati i primjenu treće doze cjepiva za tu dobnu skupinu te je dopunila protokole svojih kliničkih ispitivanja.
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11. svibanj 2024 04:42
