{"id":44787,"date":"2021-02-04T14:20:00","date_gmt":"2021-02-04T12:20:00","guid":{"rendered":"http:\/\/life.karpat.in.ua\/?p=44787"},"modified":"2021-02-04T10:00:36","modified_gmt":"2021-02-04T08:00:36","slug":"az-europai-gyogyszerugynokseg-megkezdte-a-novavax-oltoanyaganak-vizsgalatat","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=44787&lang=hu","title":{"rendered":"Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g megkezdte a Novavax olt\u00f3anyag\u00e1nak vizsg\u00e1lat\u00e1t"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) megkezdte a Novavax amerikai gy\u00f3gyszeripari v\u00e1llalat koronav\u00edrus elleni olt\u00f3anyag\u00e1nak fel\u00fclvizsg\u00e1lati elj\u00e1r\u00e1s\u00e1t &#8211; k\u00f6z\u00f6lte szerd\u00e1n az Eur\u00f3pai Uni\u00f3 gy\u00f3gyszerfel\u00fcgyeleti hat\u00f3s\u00e1g\u00e1nak szerep\u00e9t bet\u00f6lt\u0151 amszterdami sz\u00e9khely\u0171 \u00fcgyn\u00f6ks\u00e9g.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"http:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/novavax-1024x576.jpg\" alt=\"\" class=\"wp-image-44788\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/novavax-1024x576.jpg 1024w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/novavax-300x169.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/novavax-768x432.jpg 768w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/02\/novavax.jpg 1140w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA k\u00f6zlem\u00e9nye szerint a laborat\u00f3riumi vizsg\u00e1latok \u00e9s a klinikai tesztek kezdeti eredm\u00e9nyei alapj\u00e1n az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g \u00fagy d\u00f6nt\u00f6tt, hogy megind\u00edtja a g\u00f6rd\u00fcl\u0151 fel\u00fclvizsg\u00e1lati elj\u00e1r\u00e1st (rolling review). A vizsg\u00e1lat megind\u00edt\u00e1sa azt jelenti, hogy a tesztek adatait \u00e9s eredm\u00e9nyeit m\u00e9g a forgalomba hozatali enged\u00e9ly ir\u00e1nti hivatalos k\u00e9relem beny\u00fajt\u00e1sa el\u0151tt \u00e9rt\u00e9keli az \u00fcgyn\u00f6ks\u00e9g, ler\u00f6vid\u00edtve ezzel a folyamatot &#8211; k\u00f6z\u00f6lt\u00e9k.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A Novavax m\u00e9g nem ny\u00fajtott be hivatalos forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relmet az EMA-hoz. 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.<br>\u00a0\u00a0\u00a0\u00a0Az Eur\u00f3pai Bizotts\u00e1g december k\u00f6zep\u00e9n z\u00e1rta le a Novavax v\u00e1llalattal a koronav\u00edrus elleni lehets\u00e9ges olt\u00f3anyaga beszerz\u00e9s\u00e9r\u0151l folytatott megbesz\u00e9l\u00e9seket, a tervezett szerz\u0151d\u00e9s lehet\u0151v\u00e9 tenn\u00e9 az Eur\u00f3pai Uni\u00f3 sz\u00e1m\u00e1ra 100 milli\u00f3 adag, illetve ak\u00e1r tov\u00e1bbi 100 milli\u00f3 adag olt\u00f3anyag megv\u00e1s\u00e1rl\u00e1s\u00e1t.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az amerikai v\u00e1llalat janu\u00e1r v\u00e9g\u00e9n ismertetett k\u00f6zlem\u00e9nye szerint a koronav\u00edrus eredeti v\u00e1ltozat\u00e1val szemben a vakcina 95,6 sz\u00e1zal\u00e9kos, az \u00faj brit vari\u00e1nssal szemben 85,6 sz\u00e1zal\u00e9kos hat\u00e9konys\u00e1g\u00fa lehet. A c\u00e9g sz\u00e1m\u00edt\u00e1si m\u00f3dszertana alapj\u00e1n a Novavax olt\u00f3anyag\u00e1nak hat\u00e9konys\u00e1ga a vizsg\u00e1lati csoport \u00f6sszess\u00e9g\u00e9re vet\u00edtve 89,3 sz\u00e1zal\u00e9kos. Inform\u00e1ci\u00f3k szerint a Novavax olt\u00f3anyaga azonban kev\u00e9sb\u00e9 hat\u00e9kony a v\u00edrus d\u00e9l-afrikai v\u00e1ltozat\u00e1val szemben.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Eddig a Pfizer\/BioNTech, a Moderna \u00e9s AstraZeneca vakcin\u00e1i v\u00e1ltak el\u00e9rhet\u0151v\u00e9 az Eur\u00f3pai Uni\u00f3 27 tag\u00e1llam\u00e1ban. A Szputnyik V fejleszt\u0151i janu\u00e1r 20-\u00e1n k\u00e9rt\u00e9k az olt\u00f3anyag eur\u00f3pai bejegyz\u00e9s\u00e9t, a Covid-19 elleni els\u0151 orosz vakcina fokozatos szakvizsg\u00e1lat\u00e1nak folyamata febru\u00e1rban kezd\u0151dhet meg.<\/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) megkezdte a Novavax amerikai gy\u00f3gyszeripari v\u00e1llalat koronav\u00edrus elleni olt\u00f3anyag\u00e1nak fel\u00fclvizsg\u00e1lati elj\u00e1r\u00e1s\u00e1t.<\/p>\n","protected":false},"author":10,"featured_media":44788,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,49],"tags":[37442,13181],"class_list":["post-44787","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-hirek","tag-europai-gyogyszerugynokseg","tag-koronavirus-vakcina"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/44787","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=44787"}],"version-history":[{"count":0,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/44787\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/44788"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=44787"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=44787"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=44787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}