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[title] => Pfizer i BioNTech tvrde: cjepivo protiv korone je 100% učinkovito u adolescenata 4 mjeseca nakon druge doze, traže odobrenje za hitnu upotrebu
[alias] => pfizer-i-biontech-tvrde-cjepivo-protiv-korone-je-100-ucinkovito-u-adolescenata-4-mjeseca-nakon-druge-doze-traze-odobrenje-za-hitnu-upotrebu
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Tvrtke Pfizer i BioNTech u ponedjeljak su izvijestile da je njihovo cjepivo protiv covida-19 pokazalo stopostotnu učinkovitost u djece u dobi od 12 do 15 godina, četiri mjeseca nakon davanja druge doze.
Tvrtke su objavile da bi novi podaci, utemeljeni na ispitivanju na 2228 sudionika, mogli pomoći njihovu zahtjevu za potpunim odobrenjem primjene cjepiva u Sjedinjenim Državama i u svijetu.
U cijepljenih ispitanika čije je stanje praćeno najmanje šest mjeseci nakon davanja druge doze nisu uočeni ozbiljni sigurnosni problemi, stoji u objavi tvrtke.
"Budući da globalna zdravstvena zajednica radi na povećanju broja cijepljenih ljudi u cijelome svijetu, dodatni podaci koje iznosimo pridonose i dodatnom povjerenju u sigurnost i učinkovitost našeg cjepiva među adolescentima", rekao je izvršni direktor Pfizera Albert Bourla.
"Rezultati našeg ispitivanja osobito su važni u trenutku kada u nekim regijama svjedočimo stopi porasta zaraze covidom-19 upravo u ovoj dobnoj skupini, a istodobno je proces cijepljenja protiv covida usporen. Radujemo se što ove podatke možemo podijeliti s FDA-om i ostalim regulatornim tijelima", kazao je.
Cjepivo je u svibnju u Sjedinjenim Državama dobilo "odobrenje za hitnu upotrebu" za adolescente, a Pfizer i BioNTech uskoro planiraju zatražiti i puno odobrenje.
Ono je trenutačno u potpunosti odobreno samo za osobe starije od 16 godina.
Među 2228 sudionika, koliko ih je sudjelovalo u ispitivanju, bilo je 30 potvrđenih simptomatskih slučajeva covida bez dokaza o prethodnoj infekciji.
Važno je istaknuti da su svi slučajevi evidentirani u skupini koja je primila placebo pa iz tvrtki kažu da rezultati upućuju na stopostotnu djelotvornost cjepiva.
Zamijećeno je da je učinkovitost bila ujednačeno visoka bez obzira na spol, rasu, razinu pretilosti ili status komorbiditeta.
Glavni sigurnosni problem u ovoj dobnoj skupini je manji rizik od miokarditisa, upale srčanog mišića povezane s cjepivom koja je zamijećena u muškoj populaciji.
No takvi su slučajevi vrlo rijetki, a dosadašnji podaci su pokazali da je korist od cijepljenja i dalje znatno veća od rizika.
Stručnjaci ističu da i covid može uzrokovati miokarditis te dodaju da se u slučaju obolijevanja od covida on javlja češće i obično je riječ o težem obliku ove bolesti.
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Tvrtke Pfizer i BioNTech u ponedjeljak su izvijestile da je njihovo cjepivo protiv covida-19 pokazalo stopostotnu učinkovitost u djece u dobi od 12 do 15 godina, četiri mjeseca nakon davanja druge doze.
Tvrtke su objavile da bi novi podaci, utemeljeni na ispitivanju na 2228 sudionika, mogli pomoći njihovu zahtjevu za potpunim odobrenjem primjene cjepiva u Sjedinjenim Državama i u svijetu.
U cijepljenih ispitanika čije je stanje praćeno najmanje šest mjeseci nakon davanja druge doze nisu uočeni ozbiljni sigurnosni problemi, stoji u objavi tvrtke.
"Budući da globalna zdravstvena zajednica radi na povećanju broja cijepljenih ljudi u cijelome svijetu, dodatni podaci koje iznosimo pridonose i dodatnom povjerenju u sigurnost i učinkovitost našeg cjepiva među adolescentima", rekao je izvršni direktor Pfizera Albert Bourla.
"Rezultati našeg ispitivanja osobito su važni u trenutku kada u nekim regijama svjedočimo stopi porasta zaraze covidom-19 upravo u ovoj dobnoj skupini, a istodobno je proces cijepljenja protiv covida usporen. Radujemo se što ove podatke možemo podijeliti s FDA-om i ostalim regulatornim tijelima", kazao je.
Cjepivo je u svibnju u Sjedinjenim Državama dobilo "odobrenje za hitnu upotrebu" za adolescente, a Pfizer i BioNTech uskoro planiraju zatražiti i puno odobrenje.
Ono je trenutačno u potpunosti odobreno samo za osobe starije od 16 godina.
Među 2228 sudionika, koliko ih je sudjelovalo u ispitivanju, bilo je 30 potvrđenih simptomatskih slučajeva covida bez dokaza o prethodnoj infekciji.
Važno je istaknuti da su svi slučajevi evidentirani u skupini koja je primila placebo pa iz tvrtki kažu da rezultati upućuju na stopostotnu djelotvornost cjepiva.
Zamijećeno je da je učinkovitost bila ujednačeno visoka bez obzira na spol, rasu, razinu pretilosti ili status komorbiditeta.
Glavni sigurnosni problem u ovoj dobnoj skupini je manji rizik od miokarditisa, upale srčanog mišića povezane s cjepivom koja je zamijećena u muškoj populaciji.
No takvi su slučajevi vrlo rijetki, a dosadašnji podaci su pokazali da je korist od cijepljenja i dalje znatno veća od rizika.
Stručnjaci ističu da i covid može uzrokovati miokarditis te dodaju da se u slučaju obolijevanja od covida on javlja češće i obično je riječ o težem obliku ove bolesti.
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17. svibanj 2024 06:39
