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[title] => Cjepivo Moderne 96 posto učinkovito kod djece od 12 do 17 godina: nuspojave su ‘blage i umjerene težine‘, uglavnom bol na mjestu uboda i glavobolja
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Američka farmaceutska tvrtka Moderna objavila je u četvrtak da je njezino cjepivo protiv koronavirusne bolesti učinkovito 96 posto kod djece u dobi od 12 do 17 godina, prema rezultatima prvih kliničkih ispitivanja.
Dvije trećine od 3235 sudionika ispitivanja u Sjedinjenim Državama primilo je cjepivo, a trećina je dobila placebo.
Studija je "pokazala djelotvornost cjepiva protiv covida-19 od 96 posto. Cjepivo mRNA-1273 se općenito dobro podnosi, a dosad nije uočeno ništa ozbiljno što bi postavljalo pitanja oko sigurnosti cjepiva", priopćeno je iz iz tvrtke.
U okviru ispitivanja je otkriveno 12 slučajeva koronavirusa 14 dana nakon prve doze. Rezultati se temelje na praćenju ispitanika u prosjeku 35 dana nakon druge doze cjepiva.
Farmaceutska tvrtka rekla je da su nuspojave bile "blage ili umjerene težine", najčešće bolovi na mjestu uboda. Nakon druge doze nuspojave su uključivale "glavobolju, umor, bolove u mišićima i zimicu", slično onima uočenima kod odraslih koji su primili cjepivo.
"Do danas nisu utvrđeni ozbiljni razlozi za zabrinutost u pogledu sigurnosti cjepiva", kaže se.
Moderna navodi da je trenutno u "razgovorima s regulatorima u pogledu potencijalnih izmjena i dopuna svojih regulatornih prijava" kako bi se odobrilo cjepivo za ovu dobnu skupinu.
Cjepivo je trenutno odobreno samo za osobe starije od 18 godina.
Tvrtke Pfizer i BioNTech već su podnijele zahtjev za odobrenje vlastitog cjepiva za djecu od 12 do 15 godina u Sjedinjenim Državama i Europi. U srijedu je Kanada postala prva država koja je odobrila Pfizer/BioNTechovo cjepivo za ovu dobnu skupinu.
Cijepljenje tinejdžera sljedeći je korak u kampanji za konačno zaustavljanje epidemije.
Moderna je u ožujku započela ispitivanja svog cjepiva na djeci u dobi od šest mjeseci do 11 godina.
Pfizer i BioNTech objavili su u utorak kako se nadaju da će u rujnu u Sjedinjenim Državama podnijeti zahtjev za hitno odobrenje za svoje cjepivo za djecu u dobi od dvije do 11 godina.
Izvršni direktor Pfizera Albert Bourla rekao je da bi se tvrtka mogla prijaviti za odobrenje cijepljenja djece u dobi između 6 mjeseci i dvije godine "u četvrtom tromjesečju".
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Američka farmaceutska tvrtka Moderna objavila je u četvrtak da je njezino cjepivo protiv koronavirusne bolesti učinkovito 96 posto kod djece u dobi od 12 do 17 godina, prema rezultatima prvih kliničkih ispitivanja.
Dvije trećine od 3235 sudionika ispitivanja u Sjedinjenim Državama primilo je cjepivo, a trećina je dobila placebo.
Studija je "pokazala djelotvornost cjepiva protiv covida-19 od 96 posto. Cjepivo mRNA-1273 se općenito dobro podnosi, a dosad nije uočeno ništa ozbiljno što bi postavljalo pitanja oko sigurnosti cjepiva", priopćeno je iz iz tvrtke.
U okviru ispitivanja je otkriveno 12 slučajeva koronavirusa 14 dana nakon prve doze. Rezultati se temelje na praćenju ispitanika u prosjeku 35 dana nakon druge doze cjepiva.
Farmaceutska tvrtka rekla je da su nuspojave bile "blage ili umjerene težine", najčešće bolovi na mjestu uboda. Nakon druge doze nuspojave su uključivale "glavobolju, umor, bolove u mišićima i zimicu", slično onima uočenima kod odraslih koji su primili cjepivo.
"Do danas nisu utvrđeni ozbiljni razlozi za zabrinutost u pogledu sigurnosti cjepiva", kaže se.
Moderna navodi da je trenutno u "razgovorima s regulatorima u pogledu potencijalnih izmjena i dopuna svojih regulatornih prijava" kako bi se odobrilo cjepivo za ovu dobnu skupinu.
Cjepivo je trenutno odobreno samo za osobe starije od 18 godina.
Tvrtke Pfizer i BioNTech već su podnijele zahtjev za odobrenje vlastitog cjepiva za djecu od 12 do 15 godina u Sjedinjenim Državama i Europi. U srijedu je Kanada postala prva država koja je odobrila Pfizer/BioNTechovo cjepivo za ovu dobnu skupinu.
Cijepljenje tinejdžera sljedeći je korak u kampanji za konačno zaustavljanje epidemije.
Moderna je u ožujku započela ispitivanja svog cjepiva na djeci u dobi od šest mjeseci do 11 godina.
Pfizer i BioNTech objavili su u utorak kako se nadaju da će u rujnu u Sjedinjenim Državama podnijeti zahtjev za hitno odobrenje za svoje cjepivo za djecu u dobi od dvije do 11 godina.
Izvršni direktor Pfizera Albert Bourla rekao je da bi se tvrtka mogla prijaviti za odobrenje cijepljenja djece u dobi između 6 mjeseci i dvije godine "u četvrtom tromjesečju".
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11. svibanj 2024 12:52
