\nProcesul de “revizuire continu\u0103” prin care va trece vaccinul Sinovac permite autorit\u0103\u0163ilor de reglementare din UE s\u0103 evalueze datele pe m\u0103sur\u0103 ce devin disponibile p\u00e2n\u0103 c\u00e2nd exist\u0103 suficiente dovezi pentru a depunerea unei cereri formale de autorizare condi\u0163ionat\u0103 de introducere pe pia\u0163\u0103.<\/p>\n
\nEMA nu a precizat un interval de timp pentru o decizie final\u0103, dar a spus c\u0103 procesul ar trebui s\u0103 “dureze mai pu\u0163in timp dec\u00e2t \u00een \u200b\u200bmod normal”.<\/p>\n
\nAgen\u0163ia are, de asemenea, evalu\u0103ri \u00een curs de desf\u0103\u015furare a altor trei vaccinuri, inclusiv vaccinul Sputnik, vaccinul ARNm CureVac \u015fi vaccinul pe baz\u0103 de proteine \u200b\u200bNovavax. Vaccinul Sinovac folose\u015fte un virus inactivat.<\/p>\n
\n\u201eEMA va evalua conformitatea vaccinului cu standardele obi\u015fnuite ale UE pentru eficacitate, siguran\u0163\u0103 \u015fi calitate\u201d, a precizat EMA.<\/p>\n
\nSinovac a \u00eenregistrat rate de eficacitate diferite \u00een studiile desf\u0103\u015furate \u00een mai multe \u0163\u0103ri, care variaz\u0103 \u00eentre 51% \u015fi 82%. Acesta a fost aprobat de autorit\u0103\u0163ile de reglementare chineze, \u00eempreun\u0103 cu alte trei vaccinuri autohtone.<\/p>\n
\nSe a\u015fteapt\u0103 ca Organiza\u0163ia Mondial\u0103 a S\u0103n\u0103t\u0103\u0163ii s\u0103 ia o decizie cu privire la vaccin la sf\u00e2r\u015fitul acestei s\u0103pt\u0103m\u00e2ni.<\/p>\n","protected":false},"excerpt":{"rendered":"
Agen\u0163ia European\u0103 a Medicamentului a \u00eenceput o evaluarea vaccinului chinez Sinovac, a anun\u0163at mar\u0163i autoritatea de reglementare a medicamentelor. Datele preliminare din studiile de laborator arat\u0103 c\u0103 vaccinul produce un r\u0103spuns imun, a precizat EMA \u00eentr-un comunicat de pres\u0103.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[510],"tags":[48174,14930],"class_list":["post-193695","post","type-post","status-publish","format-standard","hentry","category-actualitate","tag-ema","tag-vaccin"],"_links":{"self":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/193695","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=193695"}],"version-history":[{"count":0,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/193695\/revisions"}],"wp:attachment":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=193695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=193695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=193695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}