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Pfizer će od američke agencije za hranu i lijekove (FDA) zatražiti odobrenje za treću dozu cjepiva protiv COVID-a 19. Objašnjavaju kako bi treća doza u roku od 12 mjeseci značajno mogla ojačati imunitet i pomoći u zaštiti od najnovijih mutacija koronavirusa.

Zahtjev se temelji na dokazima o većem riziku ponovne infekcije šest mjeseci nakon cijepljenja, uz širenje vrlo zarazne delta varijante, javlja Reuters.

Američka uprava za hranu i lijekove, i Centri za prevenciju i kontrolu bolesti pak ustvrdili su u zajedničkoj izjavi da Amerikanci koji su u potpunosti cijepljeni trenutno ne trebaju još jednu dozu. I  dok neki znanstvenici dovode u pitanje potrebu za dodatnom trećom dozom, glavni stručnjak ovog proizvođača lijekova, Michael Dolsten ukazuje na situaciju u Izraelu  gdje je zabilježen pad učinkovitosti cjepiva, uglavnom kod ljudi koji su cijepljeni u siječnju i veljači.

Izraelci su utvrdili da je efikasnost cijepljenja u sprječavanju zaraze pala na 64 posto. No važno je znati da je to efikasnost u slučaju sprječavanja bolesti sa simptomima, dok je cjepivo i dalje vrlo učinkovito od teškog tijeka bolesti i hospitalizacije - 93 posto.

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Početkom godine, dok nije bio evidentiran delta soj u Izraelu, tamošnje Ministarstvo zdravstva objavilo da je cjepivo BioNtech/Pfizer sprečavalo COVID s efikasnošću od 95,8 posto. Pojavu simptoma poput povišene temperature i poteškoća s disanjem priječilo je u 98 posto slučajeva, dok je efikasnost u smislu sprječavanja boravka u bolnici, ozbiljnih bolesti i smrti - bila čak 99 posto.

 - Cjepivo Pfizer je vrlo učinkovito protiv delta varijante, ali nakon šest mjeseci, postoji rizik ponovne infekcije jer protutijela, kako se predviđa, polako nestaju. Mislimo da je izraelski trend točan – kazao je Dolsten.

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Izraelski liječnik priprema Pfizer/BioNTech cjepivo 
Jack Guez/AFP
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Američki regulatori već prije su najavili kako su spremni odobriti dodatne doze kada i ako znanost pokaže da su one potrebne.

Pfizerov stručnjak Dolsten je naglasio da podaci iz Izraela i Velike Britanije sugeriraju da čak i uz opadanje razine antitijela, cjepivo ostaje 95 posto učinkovito protiv teških bolesti. Kaže kako prvi podaci iz Pfizerovih studija pokazuju da treća dopunska doza stvara razinu antitijela koja je pet do deset puta veća nego nakon druge doze. Osim toga, rekao je i da su Pfizeru već pristupile mnoge europske zemlje kako bi razgovarali o dopunskim dozama, a tvrdi i da će ih neke možda početi primjenjivati i prije odobrenja SAD-a.

Ugledni znanstvenik dr. Eric Topol, profesor molekularne medicine i direktor Translacijskog instituta za istraživanje Scripps u La Jolli, kaže da bi temeljenje odluke o dodatnoj dozi samo na smanjenju broja antitijela zanemarilo ulogu drugih važnih dijelova imunološkog odgovora, uključujući i B stanice koje mogu stvoriti antitijela kada ih virus izazove.

Pfizer planira provesti dodatno ispitivanje o trećoj dozi na 10.000 sudionika da se vidi učinkovitost dopunskih doza. Dolsten je potvrdio kako Pfizer i BioNTech rade na novoj  verziji cjepiva usmjerenoj na indijsku delta varijantu, no dodao je da ne vjeruju kako trenutnu verziju cjepiva treba zamijeniti u borbi protiv indijskog mutanta SARS-CoV- 2 virusa.

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Pfizer će od američke agencije za hranu i lijekove (FDA) zatražiti odobrenje za treću dozu cjepiva protiv COVID-a 19. Objašnjavaju kako bi treća doza u roku od 12 mjeseci značajno mogla ojačati imunitet i pomoći u zaštiti od najnovijih mutacija koronavirusa.

Zahtjev se temelji na dokazima o većem riziku ponovne infekcije šest mjeseci nakon cijepljenja, uz širenje vrlo zarazne delta varijante, javlja Reuters.

Američka uprava za hranu i lijekove, i Centri za prevenciju i kontrolu bolesti pak ustvrdili su u zajedničkoj izjavi da Amerikanci koji su u potpunosti cijepljeni trenutno ne trebaju još jednu dozu. I  dok neki znanstvenici dovode u pitanje potrebu za dodatnom trećom dozom, glavni stručnjak ovog proizvođača lijekova, Michael Dolsten ukazuje na situaciju u Izraelu  gdje je zabilježen pad učinkovitosti cjepiva, uglavnom kod ljudi koji su cijepljeni u siječnju i veljači.

Izraelci su utvrdili da je efikasnost cijepljenja u sprječavanju zaraze pala na 64 posto. No važno je znati da je to efikasnost u slučaju sprječavanja bolesti sa simptomima, dok je cjepivo i dalje vrlo učinkovito od teškog tijeka bolesti i hospitalizacije - 93 posto.

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Početkom godine, dok nije bio evidentiran delta soj u Izraelu, tamošnje Ministarstvo zdravstva objavilo da je cjepivo BioNtech/Pfizer sprečavalo COVID s efikasnošću od 95,8 posto. Pojavu simptoma poput povišene temperature i poteškoća s disanjem priječilo je u 98 posto slučajeva, dok je efikasnost u smislu sprječavanja boravka u bolnici, ozbiljnih bolesti i smrti - bila čak 99 posto.

 - Cjepivo Pfizer je vrlo učinkovito protiv delta varijante, ali nakon šest mjeseci, postoji rizik ponovne infekcije jer protutijela, kako se predviđa, polako nestaju. Mislimo da je izraelski trend točan – kazao je Dolsten.

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Izraelski liječnik priprema Pfizer/BioNTech cjepivo 
Jack Guez/AFP
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Američki regulatori već prije su najavili kako su spremni odobriti dodatne doze kada i ako znanost pokaže da su one potrebne.

Pfizerov stručnjak Dolsten je naglasio da podaci iz Izraela i Velike Britanije sugeriraju da čak i uz opadanje razine antitijela, cjepivo ostaje 95 posto učinkovito protiv teških bolesti. Kaže kako prvi podaci iz Pfizerovih studija pokazuju da treća dopunska doza stvara razinu antitijela koja je pet do deset puta veća nego nakon druge doze. Osim toga, rekao je i da su Pfizeru već pristupile mnoge europske zemlje kako bi razgovarali o dopunskim dozama, a tvrdi i da će ih neke možda početi primjenjivati i prije odobrenja SAD-a.

Ugledni znanstvenik dr. Eric Topol, profesor molekularne medicine i direktor Translacijskog instituta za istraživanje Scripps u La Jolli, kaže da bi temeljenje odluke o dodatnoj dozi samo na smanjenju broja antitijela zanemarilo ulogu drugih važnih dijelova imunološkog odgovora, uključujući i B stanice koje mogu stvoriti antitijela kada ih virus izazove.

Pfizer planira provesti dodatno ispitivanje o trećoj dozi na 10.000 sudionika da se vidi učinkovitost dopunskih doza. Dolsten je potvrdio kako Pfizer i BioNTech rade na novoj  verziji cjepiva usmjerenoj na indijsku delta varijantu, no dodao je da ne vjeruju kako trenutnu verziju cjepiva treba zamijeniti u borbi protiv indijskog mutanta SARS-CoV- 2 virusa.

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Jack Guez/AFP Jack Guez/AFP
Jack Guez/AFP
Izraelski liječnik priprema Pfizer/BioNTech cjepivo 
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Svijetzahtjev Pfizera za dodatnu dozu

Izraelski slučaj mogao bi ubrzati davanje treće doze: ‘Pfizer cjepivo je vrlo učinkovito protiv delta varijante, ali nakon šest mjeseci, postoji rizik ponovne infekcije..."

Piše Anita Belak Krile
9. srpnja 2021. - 10:02
18473926
PREMIUM
Jack Guez/AFP

Pfizer će od američke agencije za hranu i lijekove (FDA) zatražiti odobrenje za treću dozu cjepiva protiv COVID-a 19. Objašnjavaju kako bi treća doza u roku od 12 mjeseci značajno mogla ojačati imunitet i pomoći u zaštiti od najnovijih mutacija koronavirusa.

Zahtjev se temelji na dokazima o većem riziku ponovne infekcije šest mjeseci nakon cijepljenja, uz širenje vrlo zarazne delta varijante, javlja Reuters.

Američka uprava za hranu i lijekove, i Centri za prevenciju i kontrolu bolesti pak ustvrdili su u zajedničkoj izjavi da Amerikanci koji su u potpunosti cijepljeni trenutno ne trebaju još jednu dozu. I  dok neki znanstvenici dovode u pitanje potrebu za dodatnom trećom dozom, glavni stručnjak ovog proizvođača lijekova, Michael Dolsten ukazuje na situaciju u Izrael...

#PFIZER#TREĆA DOZA CJEPIVA #IZRAEL#DELTA VARIJANTA#CIJEPLJENJE COVID
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14. svibanj 2024 09:59