SD Dojavi
OSMRTNICE
PRETPLATA
PREMIUM
stdClass Object ( [id] => 1097035 [title] => Europski medicinski regulator istražuje slučajeve poremećaja živčanog sustava nakon cijepljenja AstraZenecom [alias] => europski-medicinski-regulator-istrazuje-slucajeve-poremecaja-zivcanog-sustava-nakon-cijepljenja-astrazenecom [catid] => 423 [published] => 1 [introtext] => [fulltext] =>

Europski medicinski regulator objavio je u petak da istražuje rijetke slučajeve poremećaja živčanog sustava kod ljudi koji su primili cjepivo AstraZenece, dok vlasti diljem svijeta teže transparentnosti oko sigurnosti cjepiva protiv covida-19.

Odbor za sigurnost Europske agencije za lijekove (EMA), u sklopu redovitog pregleda sigurnosnih izvješća za Vaxzevriu, cjepivo AstraZenece, analizira podatke koje je ta tvrtka dostavila o slučajevima Guillain-Barreova sindroma (GBS).

Pojačana pozornost regulatora na rijetko imunološko stanje otvara nova pitanja o potencijalnim nuspojavama cjepiva protiv koronavirusa nakon što je EMA prošli mjesec otkrila moguću vezu cjepiva AstraZenece te Johnson & Johnsona s pojavom vrlo rijetkih krvnih ugrušaka.

Iako je EMA objavila da su koristi jeftinih i lako prenosivih cjepiva britansko-švedskog proizvođača u borbi protiv smrtonosne pandemije veće od bilo kakvih rizika, nekoliko europskih zemalja ograničilo je upotrebu cjepiva na starije dobne skupine ili potpuno obustavile uporabu.

Regulator je također podržao cjepivo J&J.

EMA je navela da je GBS identificiran kao moguća štetna pojava koju treba posebno pratiti tijekom uvjetnog odobrenja cjepiva, dodajući da je zatražila od AstraZenece detaljnije podatke o slučajevima.

GBS je rijetko neurološko stanje u kojemu imunološki sustav napada zaštitnu ovojnicu na živčanim vlaknima. Većina slučajeva prati bakterijsku ili virusnu infekciju.

To stanje je već u prošlosti bilo povezano s cijepljenjem - ponajviše s kampanjom cijepljenja tijekom izbijanja svinjske gripe u Sjedinjenim Državama 1976. godine, a desetljećima kasnije i s cjepivom korištenim tijekom pandemije gripe H1N1 2009. godine.

No znanstvenici su otkrili da su šanse za razvoj GBS-a nakon cijepljenja izuzetno male.

EMA je u petak također rekla da istražuje izvještaje o upali srčanog mišića nakon cijepljenja cjepivom Pfizer-BioNTech, pod nazivom Comirnaty, te cjepivom Moderne. Europski medicinski regulator navodi da trenutačno nema naznaka da su ti slučajevi posljedica primanja cjepiva.

Oba navedena cjepiva koriste novu mRNA tehnologiju za stvaranje imuniteta.

Američki centar za kontrolu i prevenciju bolesti (CDC) objavio je prošli tjedan da nije otkrio vezu između upale srčanog mišića i cjepiva protiv covida-19.

AstraZeneca, Pfizer, BioNTech i Moderna nisu odmah bili dostupni za komentar.

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Europski medicinski regulator objavio je u petak da istražuje rijetke slučajeve poremećaja živčanog sustava kod ljudi koji su primili cjepivo AstraZenece, dok vlasti diljem svijeta teže transparentnosti oko sigurnosti cjepiva protiv covida-19.

Odbor za sigurnost Europske agencije za lijekove (EMA), u sklopu redovitog pregleda sigurnosnih izvješća za Vaxzevriu, cjepivo AstraZenece, analizira podatke koje je ta tvrtka dostavila o slučajevima Guillain-Barreova sindroma (GBS).

Pojačana pozornost regulatora na rijetko imunološko stanje otvara nova pitanja o potencijalnim nuspojavama cjepiva protiv koronavirusa nakon što je EMA prošli mjesec otkrila moguću vezu cjepiva AstraZenece te Johnson & Johnsona s pojavom vrlo rijetkih krvnih ugrušaka.

Iako je EMA objavila da su koristi jeftinih i lako prenosivih cjepiva britansko-švedskog proizvođača u borbi protiv smrtonosne pandemije veće od bilo kakvih rizika, nekoliko europskih zemalja ograničilo je upotrebu cjepiva na starije dobne skupine ili potpuno obustavile uporabu.

Regulator je također podržao cjepivo J&J.

EMA je navela da je GBS identificiran kao moguća štetna pojava koju treba posebno pratiti tijekom uvjetnog odobrenja cjepiva, dodajući da je zatražila od AstraZenece detaljnije podatke o slučajevima.

GBS je rijetko neurološko stanje u kojemu imunološki sustav napada zaštitnu ovojnicu na živčanim vlaknima. Većina slučajeva prati bakterijsku ili virusnu infekciju.

To stanje je već u prošlosti bilo povezano s cijepljenjem - ponajviše s kampanjom cijepljenja tijekom izbijanja svinjske gripe u Sjedinjenim Državama 1976. godine, a desetljećima kasnije i s cjepivom korištenim tijekom pandemije gripe H1N1 2009. godine.

No znanstvenici su otkrili da su šanse za razvoj GBS-a nakon cijepljenja izuzetno male.

EMA je u petak također rekla da istražuje izvještaje o upali srčanog mišića nakon cijepljenja cjepivom Pfizer-BioNTech, pod nazivom Comirnaty, te cjepivom Moderne. Europski medicinski regulator navodi da trenutačno nema naznaka da su ti slučajevi posljedica primanja cjepiva.

Oba navedena cjepiva koriste novu mRNA tehnologiju za stvaranje imuniteta.

Američki centar za kontrolu i prevenciju bolesti (CDC) objavio je prošli tjedan da nije otkrio vezu između upale srčanog mišića i cjepiva protiv covida-19.

AstraZeneca, Pfizer, BioNTech i Moderna nisu odmah bili dostupni za komentar.

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Panoramasigurnosti cjepiva

Europski medicinski regulator istražuje slučajeve poremećaja živčanog sustava nakon cijepljenja AstraZenecom

Piše HINA
7. svibnja 2021. - 17:50
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Justin Tallis/AFP

Europski medicinski regulator objavio je u petak da istražuje rijetke slučajeve poremećaja živčanog sustava kod ljudi koji su primili cjepivo AstraZenece, dok vlasti diljem svijeta teže transparentnosti oko sigurnosti cjepiva protiv covida-19.

Odbor za sigurnost Europske agencije za lijekove (EMA), u sklopu redovitog pregleda sigurnosnih izvješća za Vaxzevriu, cjepivo AstraZenece, analizira podatke koje je ta tvrtka dostavila o slučajevima Guillain-Barreova sindroma (GBS).

Pojačana pozornost regulatora na rijetko imunološko stanje otvara nova pitanja o potencijalnim nuspojavama cjepiva protiv koronavirusa nakon što je EMA prošli mjesec otkrila moguću vezu cjepiva AstraZenece te Johnson & Johnsona s pojavom vrlo rijetkih krvnih ugrušaka.

Iako je EMA objavila da su koristi...

#ASTRA ZENECA
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12. svibanj 2024 00:20