{"id":75235,"date":"2021-10-13T08:27:00","date_gmt":"2021-10-13T05:27:00","guid":{"rendered":"http:\/\/life.karpat.in.ua\/?p=75235"},"modified":"2021-10-12T19:29:25","modified_gmt":"2021-10-12T16:29:25","slug":"a-curevac-visszavonta-vakcinajanak-ideiglenes-forgalomba-hozatali-engedely-iranti-kerelmet","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=75235&lang=hu","title":{"rendered":"A CureVac visszavonta vakcin\u00e1j\u00e1nak ideiglenes forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relm\u00e9t"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) kedden abbahagyta a CureVac gy\u00f3gyszerv\u00e1llalat vakcin\u00e1j\u00e1nak folyamatos fel\u00fclvizsg\u00e1lat\u00e1t (rolling review), miut\u00e1n a c\u00e9g visszavonta a koronav\u00edrus ellen kifejlesztett CVnCoV nev\u0171 olt\u00f3anyag\u00e1nak ideiglenes forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relm\u00e9t.<\/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\/10\/curevac-1024x576.jpg\" alt=\"\" class=\"wp-image-75236\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/10\/curevac-1024x576.jpg 1024w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/10\/curevac-300x169.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/10\/curevac-768x432.jpg 768w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/10\/curevac.jpg 1200w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/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 \u00fcgyn\u00f6ks\u00e9g keddi k\u00f6zlem\u00e9nye szerint a n\u00e9met CureVac gy\u00f3gyszerv\u00e1llalat a visszal\u00e9p\u00e9s\u00e9t azzal indokolta, hogy er\u0151fesz\u00edt\u00e9seit egy m\u00e1sik, szint\u00e9n koronav\u00edrus elleni vakcinafejleszt\u00e9si programra \u00f6sszpontos\u00edtja.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relem visszavon\u00e1sa azt jelenti, hogy az EMA felhagy a vakcin\u00e1ra vonatkoz\u00f3 adatok fel\u00fclvizsg\u00e1lat\u00e1val, \u00e9s nem z\u00e1rja le a folyamatot. A gy\u00f3gyszerv\u00e1llalat a j\u00f6v\u0151ben az olt\u00f3anyag \u00fajabb folyamatos fel\u00fclvizsg\u00e1lat\u00e1t kezdem\u00e9nyezheti &#8211; k\u00f6z\u00f6lt\u00e9k.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az Eur\u00f3pai Bizotts\u00e1g 2020 november k\u00f6zep\u00e9n k\u00f6t\u00f6tt szerz\u0151d\u00e9st a CureVac gy\u00f3gyszergy\u00e1rt\u00f3val, 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. A CureVac febru\u00e1rban ny\u00fajtott be k\u00e9relmet olt\u00f3anyag\u00e1nak vizsg\u00e1lat\u00e1ra. A n\u00e9met c\u00e9g j\u00fanius k\u00f6zep\u00e9n jelentette be, hogy vakcin\u00e1ja csup\u00e1n 47 sz\u00e1zal\u00e9kban hat\u00e9kony a koronav\u00edrus ellen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az amszterdami sz\u00e9khely\u0171 uni\u00f3s gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g ez id\u00e1ig a Pfizer\/BioNTech Comirnaty, az AstraZeneca Vaxzevira, a Moderna Spikevax, valamint a Johnson &amp; Johnson v\u00e1llalatok koronav\u00edrus elleni vakcin\u00e1j\u00e1t javasolta haszn\u00e1latra. Ezeket az olt\u00f3anyagokat az Eur\u00f3pai Bizotts\u00e1g enged\u00e9lyezte. Az \u00fcgyn\u00f6ks\u00e9g emellett vizsg\u00e1lja a Szputnyik V-t, a Sanofi v\u00e1llalat Vidprevtyn nev\u0171 olt\u00f3anyag\u00e1t, a Sinovac, valamint a Novavax gy\u00f3gyszergy\u00e1rak vakcin\u00e1it.<\/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) kedden abbahagyta a CureVac gy\u00f3gyszerv\u00e1llalat vakcin\u00e1j\u00e1nak folyamatos fel\u00fclvizsg\u00e1lat\u00e1t (rolling review), miut\u00e1n a c\u00e9g visszavonta a koronav\u00edrus ellen kifejlesztett CVnCoV nev\u0171 olt\u00f3anyag\u00e1nak ideiglenes forgalomba hozatali enged\u00e9ly ir\u00e1nti k\u00e9relm\u00e9t.<\/p>\n","protected":false},"author":10,"featured_media":75236,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,49],"tags":[56901,1228,13181],"class_list":["post-75235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-hirek","tag-curevac","tag-koronavirus","tag-koronavirus-vakcina"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/75235","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=75235"}],"version-history":[{"count":0,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/75235\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/75236"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=75235"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=75235"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=75235"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}