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[title] => Američka Moderna se pohvalila da je daleko odmakla u razvoju cjepiva protiv koronavirusa: uskoro će ga testirati na 30 tisuća ljudi
[alias] => americka-moderna-se-pohvalila-da-je-daleko-odmakla-u-razvoju-cjepiva-protiv-koronavirusa-uskoro-ce-ga-testirati-na-30-tisuca-ljudi
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Ako se pokaže da je Modernino eksperimentalno cjepivo protiv covida-19 učinkovito barem 70 posto, američka farmaceutska tvrtka planira zatražiti prijevremeno odobrenje za njegovo ograničeno korištenje kod visoko rizičnih skupina, rekao je glavni direktor tvrtke Stephane Bancel.
Modernin kandidat za cjepivo, mRNA-1273, blizu je cilja i planira ga se testirati na 30.000 ljudi.
Tvrtka bi međutim mogla proglasiti pobjedu i prije dovršetka te treće faze kliničkih ispitivanja ako uspije dokazati da su ljudi koji su se cijepili prošli mnogo bolje u ispitivanju od onih koji nisu.
Cjepiva moraju pokazati da su barem 50 posto učinkovitija od placeba da bi došla u obzir za razmatranje za odobrenje.
Da bi se to dokazalo, kako su objasnili vladini dužnosnici, mora se zabilježiti barem 150 zaraženih u skupini koja je dobila cjepivo i barem dvostruko više u placebo skupini.
Ako se cjepivo pokaže posebno učinkovitim, odobrenje se može dobiti brže.
Neovisni odbor za provjeru sigurnosti cjepiva prvi će put razmotriti Modernine podatke kada se 53 ispitanika zarazi koronavirusom. Moderna to očekuje u studenom, ili možda već u listopadu.
Ako je većina ljudi koja se razboljela dobila placebo, to bi značilo da cjepivo štiti one koji su se njime cijepili i mogao bi biti dovoljan dokaz za odobrenje.
Ako se cjepivo pokaže učinkovitim 70, 80 ili 90 posto, razmislit ćemo o tome da zatražimo odobrenje, rekao je Bancel u telefonskom intervjuu za Reuters, dodajući da bi u tom slučaju mogli zaštititi puno života među onima koji su izloženi najvećem riziku. To su zdravstveni djelatnici i stariji.
Ako se cjepivo ne pokaže učinkovitim nakon 53 zaraženih, stručni odbor razmotrit će podatke nakon što se zarazi 106 ispitanika te naposljetku nakon što se 151 ispitanik zarazi virusom.
Moderna, koja još nije razvila nijedno cjepivo za tržište, dobila je gotovo milijardu američkih dolara od američke vlade za razvoj cjepiva. Sklopila je i dogovor o prodaji cjepiva vladi u vrijednosti od 1,5 milijarda dolara.
Farmaceutska tvrtka Pfizer u utorak je objavila da je već okupila više od 29.000 ljudi za ispitivanje svojeg eksperimentalnog cjepiva od ukupno planiranih 44.000 dragovoljaca. Cjepivo razvija s njemačkim partnerom BioNTech.
Očekuju da će dovoljno podataka o učinkovitosti cjepiva imati do kraja listopada.
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Ako se pokaže da je Modernino eksperimentalno cjepivo protiv covida-19 učinkovito barem 70 posto, američka farmaceutska tvrtka planira zatražiti prijevremeno odobrenje za njegovo ograničeno korištenje kod visoko rizičnih skupina, rekao je glavni direktor tvrtke Stephane Bancel.
Modernin kandidat za cjepivo, mRNA-1273, blizu je cilja i planira ga se testirati na 30.000 ljudi.
Tvrtka bi međutim mogla proglasiti pobjedu i prije dovršetka te treće faze kliničkih ispitivanja ako uspije dokazati da su ljudi koji su se cijepili prošli mnogo bolje u ispitivanju od onih koji nisu.
Cjepiva moraju pokazati da su barem 50 posto učinkovitija od placeba da bi došla u obzir za razmatranje za odobrenje.
Da bi se to dokazalo, kako su objasnili vladini dužnosnici, mora se zabilježiti barem 150 zaraženih u skupini koja je dobila cjepivo i barem dvostruko više u placebo skupini.
Ako se cjepivo pokaže posebno učinkovitim, odobrenje se može dobiti brže.
Neovisni odbor za provjeru sigurnosti cjepiva prvi će put razmotriti Modernine podatke kada se 53 ispitanika zarazi koronavirusom. Moderna to očekuje u studenom, ili možda već u listopadu.
Ako je većina ljudi koja se razboljela dobila placebo, to bi značilo da cjepivo štiti one koji su se njime cijepili i mogao bi biti dovoljan dokaz za odobrenje.
Ako se cjepivo pokaže učinkovitim 70, 80 ili 90 posto, razmislit ćemo o tome da zatražimo odobrenje, rekao je Bancel u telefonskom intervjuu za Reuters, dodajući da bi u tom slučaju mogli zaštititi puno života među onima koji su izloženi najvećem riziku. To su zdravstveni djelatnici i stariji.
Ako se cjepivo ne pokaže učinkovitim nakon 53 zaraženih, stručni odbor razmotrit će podatke nakon što se zarazi 106 ispitanika te naposljetku nakon što se 151 ispitanik zarazi virusom.
Moderna, koja još nije razvila nijedno cjepivo za tržište, dobila je gotovo milijardu američkih dolara od američke vlade za razvoj cjepiva. Sklopila je i dogovor o prodaji cjepiva vladi u vrijednosti od 1,5 milijarda dolara.
Farmaceutska tvrtka Pfizer u utorak je objavila da je već okupila više od 29.000 ljudi za ispitivanje svojeg eksperimentalnog cjepiva od ukupno planiranih 44.000 dragovoljaca. Cjepivo razvija s njemačkim partnerom BioNTech.
Očekuju da će dovoljno podataka o učinkovitosti cjepiva imati do kraja listopada.
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17. svibanj 2024 07:06
