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Europski regulatori odgodili su sastanak na kojem se očekuje odobrenje korištenja cjepiva tvrtki Moderna i Pfizer/BioNTech, čime je potencijalno još jednom usporena mogućnost cijepljenja građana EU protiv novog koronavirusa, moguće sve do iduće godine, prenosi Jutarnji list.

Kako piše Financial Times, Europska agencija za lijekove (EMA) priopćila je kako će svoje mišljenje o cjepivu američke tvrtke Pfizer i njemačke biotehnološke kompanije BioNTech, za koje je utvrđena 95-postotna učinkovitost, iznijeti tek 29. prosinca, pa je malo vjerojatno da bi distribucija cjepiva mogla početi prije siječnja.

Naime, nakon njihovog mišljenja svaka država članica Europske unije mora posebno dozvoliti cijepljenje. Sve to moglo bi potrajati danima. Situacija je još gora kada je u pitanju cjepivo Moderne, o kojoj će EMA odlučivati tek 12. siječnja. Samo donedavno vjerovalo se da je američka Moderna najdulje dogurala u razvoju cjepiva protiv covida-19.

Značajna je to odgoda, jer je prvotno planirano da se odluka o oba cjepiva donese 22. prosinca. Pfizer i BioNTech svoje su cjepivo finalizirali u ponedjeljak nakon kompleksnih kliničkih istraživanja na mnoštvu ispitanika, a svi podaci dostavljeni su EMA-i.

- Za kompaniju koja je locirana u srcu Europe, ovo je velika prekretnica i radimo na tomu da osiguramo dostatne zalihe cjepiva za čitav svijet - kazao je Ugur Sahin, suosnivač i izvršni direktor BioNTecha. 

FT navodi i kako su se u Njemačkoj već pojavile najave kako bi cijepljenje moglo početi već ovog mjeseca, no ministar zdravstva Jens Spahn to je odbacio rekavši kako će procjepljivanje sanovništva moći početi najranije u siječnju 2021.

Njemački plan predviđa da će mobilni zdravstveni timovi najprije cijepiti ljude u bolnicama i domovima za starije. 

Treće najavljivano cjepivo, ono koje zajedno razvijaju kompanija AstraZeneca i sveučilište Oxford u najnepovoljnijoj je situaciji jer će na analizu ići tek u siječnju. Dužnosnici članica EU pritišću EMA-u da se prikloni mišljenjima britanskih i američkih regulatornih tijela jer će, primjerice, Velika Britanija Pfizer/BioNTech cjepivo odobriti vjerojatno već ovog tjedna, dok će do sredine prosinca to učiniti i američka FDA.

Iz Agencije su odgovorili kako bi mogli eventualno dati uvjetno odobrenje za prodaju i ranije ako se nesporno dokaže da je cjepivo učinkovito i neopasno.

Europska komisija u tom bi slučaju brzo donijela odluku i dala uvjetno odobrenje za prodaju u svim zemljama članica EU i EEA.

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Chandan Khanna/AFP
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Europski regulatori odgodili su sastanak na kojem se očekuje odobrenje korištenja cjepiva tvrtki Moderna i Pfizer/BioNTech, čime je potencijalno još jednom usporena mogućnost cijepljenja građana EU protiv novog koronavirusa, moguće sve do iduće godine, prenosi Jutarnji list.

Kako piše Financial Times, Europska agencija za lijekove (EMA) priopćila je kako će svoje mišljenje o cjepivu američke tvrtke Pfizer i njemačke biotehnološke kompanije BioNTech, za koje je utvrđena 95-postotna učinkovitost, iznijeti tek 29. prosinca, pa je malo vjerojatno da bi distribucija cjepiva mogla početi prije siječnja.

Naime, nakon njihovog mišljenja svaka država članica Europske unije mora posebno dozvoliti cijepljenje. Sve to moglo bi potrajati danima. Situacija je još gora kada je u pitanju cjepivo Moderne, o kojoj će EMA odlučivati tek 12. siječnja. Samo donedavno vjerovalo se da je američka Moderna najdulje dogurala u razvoju cjepiva protiv covida-19.

Značajna je to odgoda, jer je prvotno planirano da se odluka o oba cjepiva donese 22. prosinca. Pfizer i BioNTech svoje su cjepivo finalizirali u ponedjeljak nakon kompleksnih kliničkih istraživanja na mnoštvu ispitanika, a svi podaci dostavljeni su EMA-i.

- Za kompaniju koja je locirana u srcu Europe, ovo je velika prekretnica i radimo na tomu da osiguramo dostatne zalihe cjepiva za čitav svijet - kazao je Ugur Sahin, suosnivač i izvršni direktor BioNTecha. 

FT navodi i kako su se u Njemačkoj već pojavile najave kako bi cijepljenje moglo početi već ovog mjeseca, no ministar zdravstva Jens Spahn to je odbacio rekavši kako će procjepljivanje sanovništva moći početi najranije u siječnju 2021.

Njemački plan predviđa da će mobilni zdravstveni timovi najprije cijepiti ljude u bolnicama i domovima za starije. 

Treće najavljivano cjepivo, ono koje zajedno razvijaju kompanija AstraZeneca i sveučilište Oxford u najnepovoljnijoj je situaciji jer će na analizu ići tek u siječnju. Dužnosnici članica EU pritišću EMA-u da se prikloni mišljenjima britanskih i američkih regulatornih tijela jer će, primjerice, Velika Britanija Pfizer/BioNTech cjepivo odobriti vjerojatno već ovog tjedna, dok će do sredine prosinca to učiniti i američka FDA.

Iz Agencije su odgovorili kako bi mogli eventualno dati uvjetno odobrenje za prodaju i ranije ako se nesporno dokaže da je cjepivo učinkovito i neopasno.

Europska komisija u tom bi slučaju brzo donijela odluku i dala uvjetno odobrenje za prodaju u svim zemljama članica EU i EEA.

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Chandan Khanna/AFP
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Joel Saget/AFP Chandan Khanna/AFP
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SvijetZAPELO

Jesmo li se prerano poveselili cijepljenju još do kraja ove godine? Europska agencija za lijekove odgodila odluke o odobrenju

Piše PSD.
1. prosinca 2020. - 19:45
15433574
PREMIUM
Joel Saget/AFP

Europski regulatori odgodili su sastanak na kojem se očekuje odobrenje korištenja cjepiva tvrtki Moderna i Pfizer/BioNTech, čime je potencijalno još jednom usporena mogućnost cijepljenja građana EU protiv novog koronavirusa, moguće sve do iduće godine, prenosi Jutarnji list.

Kako piše Financial Times, Europska agencija za lijekove (EMA) priopćila je kako će svoje mišljenje o cjepivu američke tvrtke Pfizer i njemačke biotehnološke kompanije BioNTech, za koje je utvrđena 95-postotna učinkovitost, iznijeti tek 29. prosinca, pa je malo vjerojatno da bi distribucija cjepiva mogla početi prije siječnja.

Naime, nakon njihovog mišljenja svaka država članica Europske unije mora posebno dozvoliti cijepljenje. Sve to moglo bi potrajati danima. Situacija je još gora kada...

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17. svibanj 2024 05:42