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Američka biotehnološka tvrtka Moderna u ponedjeljak je zatražila hitno odobrenje američkih regulatora za svoje cjepivo za Covid-19, nakon što su cjeloviti rezultati kasne faze provedbe kliničkih ispitivanja pokazali da je učinkovito 94,1 posto.

U priopćenju Moderne ističe se da njezino cjepivo ne izaziva nikakve ozbiljne nuspojave.

Američka uprava za hranu i lijekove (FDA) zakazala je za 17. prosinca sastanak savjetodavnog povjerenstva na kojemu će raspravljati o tome zahtjevu Moderne, čije je cjepivo drugo cjepivo visoke učinkovitosti koje ima šansu dobiti zeleno svjetlo od američkih regulatora za eventualnu distribuciju prije kraja ove godine.

Odobrenje cjepiva tvrtki Pfizer Inc i BioNTech SE, koje se u ključnim ispitivanjima pokazalo 95 posto učinkovitim, bit će na dnevnom redu sastanka vanjskih stručnjaka tjedan dana ranije. Temeljem preporuka savjetodavnog tijela, FDA će odlučivati o izdavanju odobrenja za nužnu uporabu (EUA).

Moderna, koja je također najavila da će podnijeti zahtjev za odobrenje i od regulatora u Europi, izvijestila je da je njezino cjepivo učinkovito bez obzira na dob, rasu, etničku pripadnost i spol, te da je 100 posto učinkovito u sprječavanju teških slučajeva bolesti koja je do sada u svijetu ubila gotovo 1,5 milijuna ljudi.

"Vjerujemo da imamo cjepivo vrlo visoke učinkovitosti. Sada imamo podatke koji to dokazuju", kazao je direktor Moderne Tal Zaks.

"Očekujemo da ćemo odigrati ključnu ulogu u promjeni smjera ove pandemije", dodao je.

Od ukupno 196 ljudi zaraženih covidom-19 u ispitivanju koje je obuhvatilo više od 30 tisuća dobrovoljaca, njih 185 je umjesto cjepiva dobilo placebo. Moderna je izvijestila o 30 teških slučajeva bolesti, od kojih su svi bili u skupini koja je dobila placebo.
Dionice Moderne porasle su od početka godine 700 posto.

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Američka biotehnološka tvrtka Moderna u ponedjeljak je zatražila hitno odobrenje američkih regulatora za svoje cjepivo za Covid-19, nakon što su cjeloviti rezultati kasne faze provedbe kliničkih ispitivanja pokazali da je učinkovito 94,1 posto.

U priopćenju Moderne ističe se da njezino cjepivo ne izaziva nikakve ozbiljne nuspojave.

Američka uprava za hranu i lijekove (FDA) zakazala je za 17. prosinca sastanak savjetodavnog povjerenstva na kojemu će raspravljati o tome zahtjevu Moderne, čije je cjepivo drugo cjepivo visoke učinkovitosti koje ima šansu dobiti zeleno svjetlo od američkih regulatora za eventualnu distribuciju prije kraja ove godine.

Odobrenje cjepiva tvrtki Pfizer Inc i BioNTech SE, koje se u ključnim ispitivanjima pokazalo 95 posto učinkovitim, bit će na dnevnom redu sastanka vanjskih stručnjaka tjedan dana ranije. Temeljem preporuka savjetodavnog tijela, FDA će odlučivati o izdavanju odobrenja za nužnu uporabu (EUA).

Moderna, koja je također najavila da će podnijeti zahtjev za odobrenje i od regulatora u Europi, izvijestila je da je njezino cjepivo učinkovito bez obzira na dob, rasu, etničku pripadnost i spol, te da je 100 posto učinkovito u sprječavanju teških slučajeva bolesti koja je do sada u svijetu ubila gotovo 1,5 milijuna ljudi.

"Vjerujemo da imamo cjepivo vrlo visoke učinkovitosti. Sada imamo podatke koji to dokazuju", kazao je direktor Moderne Tal Zaks.

"Očekujemo da ćemo odigrati ključnu ulogu u promjeni smjera ove pandemije", dodao je.

Od ukupno 196 ljudi zaraženih covidom-19 u ispitivanju koje je obuhvatilo više od 30 tisuća dobrovoljaca, njih 185 je umjesto cjepiva dobilo placebo. Moderna je izvijestila o 30 teških slučajeva bolesti, od kojih su svi bili u skupini koja je dobila placebo.
Dionice Moderne porasle su od početka godine 700 posto.

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Joel Saget/AFP
ilustracija

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Hrvatska i svijetčekaju zeleno svetlo

Moderna zatražila hitnu registraciju svog cjepiva za Covid-19, tvrde da je učinkovito 94,1%: Odigrat ćemo ključnu ulogu u promjeni smjera pandemije

Piše Hina

1. prosinca 2020. - 07:43

ilustracija

ilustracijaJoel Saget/AFP

Američka biotehnološka tvrtka Moderna u ponedjeljak je zatražila hitno odobrenje američkih regulatora za svoje cjepivo za Covid-19, nakon što su cjeloviti rezultati kasne faze provedbe kliničkih ispitivanja pokazali da je učinkovito 94,1 posto.

U priopćenju Moderne ističe se da njezino cjepivo ne izaziva nikakve ozbiljne nuspojave.

Američka uprava za hranu i lijekove (FDA) zakazala je za 17. prosinca sastanak savjetodavnog povjerenstva na kojemu će raspravljati o tome zahtjevu Moderne, čije je cjepivo drugo cjepivo visoke učinkovitosti koje ima šansu dobiti zeleno svjetlo od američkih regulatora za eventualnu distribuciju prije kraja ove godine.

Odobrenje cjepiva tvrtki Pfizer Inc i BioNTech SE, koje se u ključnim ispitivanjima pokazalo 95 posto učinkovitim, bit će na dnevnom redu sastanka vanjskih stručnjaka tjedan dana ranije. Temeljem preporuka savjetodavnog tijela, FDA će odlučivati o izdavanju odobrenja za nužnu uporabu (EUA).

Moderna, koja je također najavila da će podnijeti zahtjev za odobrenje i od regulatora u Europi, izvijestila je da je njezino cjepivo učinkovito bez obzira na dob, rasu, etničku pripadnost i spol, te da je 100 posto učinkovito u sprječavanju teških slučajeva bolesti koja je do sada u svijetu ubila gotovo 1,5 milijuna ljudi.

"Vjerujemo da imamo cjepivo vrlo visoke učinkovitosti. Sada imamo podatke koji to dokazuju", kazao je direktor Moderne Tal Zaks.

"Očekujemo da ćemo odigrati ključnu ulogu u promjeni smjera ove pandemije", dodao je.

Od ukupno 196 ljudi zaraženih covidom-19 u ispitivanju koje je obuhvatilo više od 30 tisuća dobrovoljaca, njih 185 je umjesto cjepiva dobilo placebo. Moderna je izvijestila o 30 teških slučajeva bolesti, od kojih su svi bili u skupini koja je dobila placebo.
Dionice Moderne porasle su od početka godine 700 posto.

#CJEPIVO PROTIV KORONAVIRUSA #MODERNA