{"id":55286,"date":"2021-05-05T13:21:00","date_gmt":"2021-05-05T10:21:00","guid":{"rendered":"http:\/\/life.karpat.in.ua\/?p=55286"},"modified":"2021-05-05T01:25:09","modified_gmt":"2021-05-04T22:25:09","slug":"megkezdte-az-ema-a-kinai-sinovac-oltas-felulvizsgalatat","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=55286&lang=hu","title":{"rendered":"Megkezdte az EMA a k\u00ednai Sinovac-olt\u00e1s fel\u00fclvizsg\u00e1lat\u00e1t"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Megkezdte az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) a k\u00ednai Sinovac Life Sciences biotechnol\u00f3giai v\u00e1llalat \u00e1ltal a koronav\u00edrus ellen kifejlesztett, inaktiv\u00e1lt v\u00edrust (Vero Cell) tartalmaz\u00f3 vakcina folyamatos fel\u00fclvizsg\u00e1lat\u00e1t (rolling review) \u2013 k\u00f6z\u00f6lte az Eur\u00f3pai Uni\u00f3 gy\u00f3gyszerfel\u00fcgyeleti hat\u00f3s\u00e1g\u00e1nak szerep\u00e9t bet\u00f6lt\u0151, amszterdami sz\u00e9khely\u0171 uni\u00f3s \u00fcgyn\u00f6ks\u00e9g kedden.<\/strong><\/p>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"aligncenter size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"http:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346-1024x576.jpg\" alt=\"\" class=\"wp-image-55287\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346-1024x576.jpg 1024w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346-300x169.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346-768x432.jpg 768w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346-1536x864.jpg 1536w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/05\/vakcina-oltas-covid19-2021-427346.jpg 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g k\u00f6zlem\u00e9nye szerint d\u00f6nt\u00e9se a szakvizsg\u00e1lat megkezd\u00e9s\u00e9r\u0151l a laborat\u00f3riumi kutat\u00e1sok \u00e9s a klinikai vizsg\u00e1latok el\u0151zetes, kedvez\u0151nek mutatkoz\u00f3 eredm\u00e9nyein alapul. A tanulm\u00e1nyok azt sugallj\u00e1k, hogy az inaktiv\u00e1lt v\u00edrust tartalmaz\u00f3 vakcina olyan antitestek termel\u00e9s\u00e9t v\u00e1ltja ki, amelyek a SARS-CoV-2-t, azaz a Covid-19-et okoz\u00f3 v\u00edrust t\u00e1madj\u00e1k meg, \u00e9s el\u0151seg\u00edthetik a betegs\u00e9g elleni v\u00e9dekez\u00e9st.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA Hum\u00e1ngy\u00f3gyszer Bizotts\u00e1ga (CHMP) elj\u00e1r\u00e1sa sor\u00e1n \u00e9rt\u00e9kelni fogja a vakcina hat\u00e9konys\u00e1g\u00e1ra \u00e9s biztons\u00e1goss\u00e1g\u00e1ra, valamint min\u0151s\u00e9g\u00e9re vonatkoz\u00f3 adatokat, hogy megbizonyosodjanak r\u00f3la, hogy az olt\u00f3anyag el\u0151nyei fel\u00fclm\u00falj\u00e1k-e az esetleges kock\u00e1zatokat. A folyamatos fel\u00fclvizsg\u00e1lat addig folytat\u00f3dik, am\u00edg elegend\u0151 bizony\u00edt\u00e9k nem \u00e1ll rendelkez\u00e9sre a forgalomba hozatali enged\u00e9ly hivatalos k\u00e9relm\u00e9nek bead\u00e1s\u00e1hoz.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA k\u00f6z\u00f6lni fogja a vakcin\u00e1r\u00f3l kialak\u00edtott v\u00e9lem\u00e9ny\u00e9t, illetve azt, ha a gy\u00e1rt\u00f3 beny\u00fajtja az olt\u00f3anyag forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relm\u00e9t \u2013 k\u00f6z\u00f6lt\u00e9k.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA t\u00e1j\u00e9koztat\u00e1sa szerint az olt\u00f3anyag el\u0151seg\u00edti, hogy a v\u00e9d\u0151olt\u00e1s ut\u00e1n az emberi szervezet immunrendszere az inaktiv\u00e1lt v\u00edrust idegen anyagk\u00e9nt azonos\u00edtsa, \u00e9s term\u00e9szetes v\u00e9dekez\u00e9sk\u00e9nt antitesteket termeljen ellene. Ha az oltott szem\u00e9ly k\u00e9s\u0151bb kapcsolatba ker\u00fcl a koronav\u00edrussal, immunrendszere felismeri a v\u00edrust, \u00e9s k\u00e9szen \u00e1ll arra, hogy v\u00e9delmet ny\u00fajtson a koronav\u00edrus ellen. Az inaktiv\u00e1lt v\u00edrus nem okozhat betegs\u00e9get \u2013 tett\u00e9k hozz\u00e1.<\/p>\n\n\n\n<p class=\"has-text-align-right wp-block-paragraph\"><strong><a href=\"https:\/\/kitekinto.hu\/2021\/05\/04\/europai-ugyek\/az-ema-megkezdte-a-kinai-sinovac-oltas-felulvizsgalatat\/191719\/\" target=\"_blank\" rel=\"noreferrer noopener\">(kitekinto.hu)<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Megkezdte az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) a k\u00ednai Sinovac Life Sciences biotechnol\u00f3giai v\u00e1llalat \u00e1ltal a koronav\u00edrus ellen kifejlesztett, inaktiv\u00e1lt v\u00edrust (Vero Cell) tartalmaz\u00f3 vakcina folyamatos fel\u00fclvizsg\u00e1lat\u00e1t (rolling review) \u2013 k\u00f6z\u00f6lte az Eur\u00f3pai Uni\u00f3 gy\u00f3gyszerfel\u00fcgyeleti hat\u00f3s\u00e1g\u00e1nak szerep\u00e9t bet\u00f6lt\u0151, amszterdami sz\u00e9khely\u0171 uni\u00f3s \u00fcgyn\u00f6ks\u00e9g kedden.<\/p>\n","protected":false},"author":12,"featured_media":55287,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4000,41,4383,594,11,39],"tags":[43509,48579],"class_list":["post-55286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actual-hu","category-cikkek","category-covid-19-hu","category-egeszseg","category-kiemelt-tema","category-vilag","tag-europai-gyogyszerugynokseg-ema","tag-kinai-vakcinak"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/55286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=55286"}],"version-history":[{"count":0,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/55286\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/55287"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=55286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=55286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=55286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}