{"id":45896,"date":"2021-02-13T16:22:00","date_gmt":"2021-02-13T14:22:00","guid":{"rendered":"http:\/\/life.karpat.in.ua\/?p=45896"},"modified":"2021-02-13T12:33:59","modified_gmt":"2021-02-13T10:33:59","slug":"az-europai-gyogyszerugynokseg-megkezdte-a-curevac-oltoanyaganak-vizsgalatat","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=45896&lang=hu","title":{"rendered":"Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g megkezdte a CureVac olt\u00f3anyag\u00e1nak vizsg\u00e1lat\u00e1t"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) Hum\u00e1ngy\u00f3gyszer Bizotts\u00e1ga (CHMP) megkezdte a n\u00e9met CureVac gy\u00f3gyszerv\u00e1llalat koronav\u00edrus elleni olt\u00f3anyag\u00e1nak folyamatos fel\u00fclvizsg\u00e1lat\u00e1t (rolling review).<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"796\" height=\"448\" src=\"http:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/curevac.jpg\" alt=\"\" class=\"wp-image-45897\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/curevac.jpg 796w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/curevac-300x169.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/curevac-768x432.jpg 768w\" sizes=\"auto, (max-width: 796px) 100vw, 796px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">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 p\u00e9nteki k\u00f6zlem\u00e9nye szerint a bizotts\u00e1g d\u00f6nt\u00e9se a szakvizsg\u00e1lat megkezd\u00e9s\u00e9r\u0151l a laborat\u00f3riumi kutat\u00e1sok \u00e9s a feln\u0151ttekn\u00e9l v\u00e9gzett korai klinikai vizsg\u00e1latok el\u0151zetes, kedvez\u0151nek mutatkoz\u00f3 eredm\u00e9nyein alapul.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA megkezdi a vakcina biztons\u00e1goss\u00e1g\u00e1nak, ellen\u00e1ll\u00f3k\u00e9pess\u00e9g\u00e9nek \u00e9s a koronav\u00edrus elleni hat\u00e9konys\u00e1g\u00e1nak felm\u00e9r\u00e9s\u00e9t, illetve a klinikai vizsg\u00e1latok rendelkez\u00e9sre \u00e1ll\u00f3 adatainak ki\u00e9rt\u00e9kel\u00e9s\u00e9t, hogy meg\u00e1llap\u00edtsa, az olt\u00f3anyag megfelel-e a gy\u00f3gyszermin\u0151s\u00e9g szok\u00e1sos norm\u00e1inak. A folyamatos szakvizsg\u00e1lat addig folytat\u00f3dik, am\u00edg elegend\u0151 bizony\u00edt\u00e9k nem \u00e1ll rendelkez\u00e9sre a hivatalos forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relem beny\u00fajt\u00e1s\u00e1hoz &#8211; k\u00f6z\u00f6lt\u00e9k. A vakcina eur\u00f3pai uni\u00f3s forgalmaz\u00e1s\u00e1t a beny\u00fajt\u00e1st k\u00f6vet\u0151 vizsg\u00e1lat eredm\u00e9nye alapj\u00e1n az EMA pozit\u00edv aj\u00e1nl\u00e1s\u00e1val az Eur\u00f3pai Bizotts\u00e1gnak kell hivatalosan enged\u00e9lyeznie.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az uni\u00f3s gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g ez id\u00e1ig a Pfizer amerikai gy\u00f3gyszergy\u00e1rt\u00f3 \u00e9s partnere, a BioNTech n\u00e9met biotechnol\u00f3giai c\u00e9g \u00e1ltal kifejlesztett vakcin\u00e1t, a Moderna amerikai biotechnol\u00f3giai v\u00e1llalat olt\u00f3anyag\u00e1t, illetve az AstraZeneca gy\u00f3gyszeripari v\u00e1llalat \u00e9s az Oxfordi Egyetem \u00e1ltal az \u00faj t\u00edpus\u00fa koronav\u00edrus ellen k\u00f6z\u00f6sen kifejlesztett olt\u00f3anyag\u00e1t aj\u00e1nlotta uni\u00f3s alkalmaz\u00e1sra.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A folyamat felgyors\u00edt\u00e1sa \u00e9rdek\u00e9ben a gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g kor\u00e1bban megkezdte a Johnson &amp; Johnson \u00e9s a Novavax amerikai gy\u00f3gyszeripari v\u00e1llalatok \u00e1ltal fejlesztett olt\u00f3anyagok folyamatos \u00e9rt\u00e9kel\u00e9s\u00e9t is.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az Eur\u00f3pai Bizotts\u00e1g november k\u00f6zep\u00e9n k\u00f6t\u00f6tt szerz\u0151d\u00e9st a n\u00e9met CureVac gy\u00f3gyszerv\u00e1llalattal, az els\u0151 k\u00f6rben 225 milli\u00f3 adag koronav\u00edrus elleni olt\u00f3anyag v\u00e1s\u00e1rl\u00e1s\u00e1r\u00f3l, fenntartva tov\u00e1bbi 180 milli\u00f3 adag ig\u00e9nyl\u00e9s\u00e9nek lehet\u0151s\u00e9g\u00e9t a vakcina biztons\u00e1goss\u00e1g\u00e1nak \u00e9s hat\u00e9konys\u00e1g\u00e1nak bizony\u00edt\u00e1s\u00e1t k\u00f6vet\u0151en.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A CureVac olt\u00f3anyaga a h\u00edrviv\u0151 RNS (mRNS) technol\u00f3gi\u00e1n alapul, amely lipid-nanor\u00e9szecsk\u00e9k seg\u00edts\u00e9g\u00e9vel juttatja be a sejtekbe az mRNS-t. Az alapelv az mRNS molekula inform\u00e1ci\u00f3s adathordoz\u00f3k\u00e9nt val\u00f3 alkalmaz\u00e1sa, melynek seg\u00edts\u00e9g\u00e9vel az emberi szervezet saj\u00e1t maga tudja el\u0151\u00e1ll\u00edtani az egyes betegs\u00e9gek lek\u00fczd\u00e9s\u00e9hez sz\u00fcks\u00e9ges hat\u00f3anyagokat.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MTI<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) Hum\u00e1ngy\u00f3gyszer Bizotts\u00e1ga (CHMP) megkezdte a n\u00e9met CureVac gy\u00f3gyszerv\u00e1llalat koronav\u00edrus elleni olt\u00f3anyag\u00e1nak folyamatos fel\u00fclvizsg\u00e1lat\u00e1t.<\/p>\n","protected":false},"author":10,"featured_media":45897,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,49],"tags":[37442],"class_list":["post-45896","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-hirek","tag-europai-gyogyszerugynokseg"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/45896","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\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=45896"}],"version-history":[{"count":0,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/45896\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/45897"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=45896"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=45896"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=45896"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}