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Europski medicinski regulator ponovio je u srijedu svoju potporu cjepivu AstraZenece i naveo da nijedna dobna ili spolna skupina te ona s poviješću bolesti nije posebno sklonija krvnim ugrušcima nakon primanja tog cjepiva.
No, iako je Europska agencija za lijekove (EMA) ponovila da su koristi cjepiva veće od rizika, upozorila je da ljudi trebaju biti svjesni "daleke mogućnosti" pojave rijetkih krvnih ugrušaka i da moraju hitno potražiti liječničku pomoć u slučaju pojave simptoma.
"Uzročna veza s cjepivom nije dokazana, ali je moguća i nastavlja se daljnja analiza", priopćila je EMA.
EMA je objavila novo priopćenje nakon sastanka s panelom neovisnih vanjskih stručnjaka u ponedjeljak.
Oglasila se nakon što je nekoliko zemalja, uključujući Kanadu, Njemačku, Francusku i Španjolsku ograničilo cijepljenje AstraZenecom nakon napisa o pojavi krvnih ugrušaka nakon cijepljenja.
Istrage EMA-e i nekoliko nacionalnih tijela u Europskoj uniji nastavljaju se nakon što su prvotne istrage procijenile da je cjepivo sigurno za uporabu.
Visok udio među prijavljenim slučajevima krvnih ugrušaka odnosi se na mlade i sredovječne žene, ali to nije navelo EMA-u da zaključi da je ova skupina posebno izložena riziku od cijepljenja AstraZenecom.
Žene su općenito sklonije cerebralnoj venskoj trombozi (CVST) nego muškarci i dvostruko više žena nego muškaraca je već primilo cjepivo AstraZenece u EU-u, rekao je šef EMA-e za nadzor sigurnosti Peter Arlett.
"Zbog toga je u ovoj fazi vrlo teško odvojiti zašto su prevladavali izvještaji o vrlo rijetkoj, potencijalnoj nuspojavi osobito među mlađim ženama", dodao je Arlett.
EMA je analizirala 62 takva slučaja na globalnoj razini i konzultirala se s regulatorima iz Indije, Brazila i Velike Britanije, a 44 od tih slučajeva zabilježeni su u Europskom gospodarskom prostoru (EEA).
Europski medicinski regulator analizirao je 14 smrtnih slučajeva, iako nisu svi bili povezani s cerebralnom venskom trombozom, naveo je Arlett. Oko 9,2 milijuna ljudi u EEA-u primilo je dozu cjepiva AstraZenece do 22. ožujka.
Arlett je priznao da je stopa incidencije zgrušavanja krvi viša od one koja se obično očekuje mlađima i sredovječnima. Iako nije kvantificirao razliku, rekao je da to ne opravdava promjenu preporuke.
"Ako pogledamo pojedince ispod 60 godina, vidimo više slučajeva CVST-a nego što bismo očekivali vidjeti iz pozadinske stope", rekao je Arlett.
Njemačko tijelo za nadzor cjepiva PEI objavilo je u utorak da je registriralo 31 slučaj CVST-a što je rezultiralo s devet smrtnih slučajeva među 2,7 milijuna ljudi koji su primili cjepivo AstraZenece.
EMA je navela da nekoliko naknadnih slučajeva u Njemačkoj nije bilo uključeno u analizu.
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[cleanTitle] => EMA potvrdila potporu AstraZeneci: ‘Nijedna dobna ili spolna skupina nije posebno sklonija krvnim ugrušcima nakon primanja cjepiva‘
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Europski medicinski regulator ponovio je u srijedu svoju potporu cjepivu AstraZenece i naveo da nijedna dobna ili spolna skupina te ona s poviješću bolesti nije posebno sklonija krvnim ugrušcima nakon primanja tog cjepiva.
No, iako je Europska agencija za lijekove (EMA) ponovila da su koristi cjepiva veće od rizika, upozorila je da ljudi trebaju biti svjesni "daleke mogućnosti" pojave rijetkih krvnih ugrušaka i da moraju hitno potražiti liječničku pomoć u slučaju pojave simptoma.
"Uzročna veza s cjepivom nije dokazana, ali je moguća i nastavlja se daljnja analiza", priopćila je EMA.
EMA je objavila novo priopćenje nakon sastanka s panelom neovisnih vanjskih stručnjaka u ponedjeljak.
Oglasila se nakon što je nekoliko zemalja, uključujući Kanadu, Njemačku, Francusku i Španjolsku ograničilo cijepljenje AstraZenecom nakon napisa o pojavi krvnih ugrušaka nakon cijepljenja.
Istrage EMA-e i nekoliko nacionalnih tijela u Europskoj uniji nastavljaju se nakon što su prvotne istrage procijenile da je cjepivo sigurno za uporabu.
Visok udio među prijavljenim slučajevima krvnih ugrušaka odnosi se na mlade i sredovječne žene, ali to nije navelo EMA-u da zaključi da je ova skupina posebno izložena riziku od cijepljenja AstraZenecom.
Žene su općenito sklonije cerebralnoj venskoj trombozi (CVST) nego muškarci i dvostruko više žena nego muškaraca je već primilo cjepivo AstraZenece u EU-u, rekao je šef EMA-e za nadzor sigurnosti Peter Arlett.
"Zbog toga je u ovoj fazi vrlo teško odvojiti zašto su prevladavali izvještaji o vrlo rijetkoj, potencijalnoj nuspojavi osobito među mlađim ženama", dodao je Arlett.
EMA je analizirala 62 takva slučaja na globalnoj razini i konzultirala se s regulatorima iz Indije, Brazila i Velike Britanije, a 44 od tih slučajeva zabilježeni su u Europskom gospodarskom prostoru (EEA).
Europski medicinski regulator analizirao je 14 smrtnih slučajeva, iako nisu svi bili povezani s cerebralnom venskom trombozom, naveo je Arlett. Oko 9,2 milijuna ljudi u EEA-u primilo je dozu cjepiva AstraZenece do 22. ožujka.
Arlett je priznao da je stopa incidencije zgrušavanja krvi viša od one koja se obično očekuje mlađima i sredovječnima. Iako nije kvantificirao razliku, rekao je da to ne opravdava promjenu preporuke.
"Ako pogledamo pojedince ispod 60 godina, vidimo više slučajeva CVST-a nego što bismo očekivali vidjeti iz pozadinske stope", rekao je Arlett.
Njemačko tijelo za nadzor cjepiva PEI objavilo je u utorak da je registriralo 31 slučaj CVST-a što je rezultiralo s devet smrtnih slučajeva među 2,7 milijuna ljudi koji su primili cjepivo AstraZenece.
EMA je navela da nekoliko naknadnih slučajeva u Njemačkoj nije bilo uključeno u analizu.
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17. svibanj 2024 05:16
