{"id":115154,"date":"2022-08-19T22:32:00","date_gmt":"2022-08-19T19:32:00","guid":{"rendered":"https:\/\/life.karpat.in.ua\/?p=115154"},"modified":"2022-08-19T18:33:59","modified_gmt":"2022-08-19T15:33:59","slug":"az-ema-megkezdte-a-skycovion-nevu-oltoanyag-vizsgalatat","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=115154&lang=hu","title":{"rendered":"Az EMA megkezdte a Skycovion nev\u0171 olt\u00f3anyag vizsg\u00e1lat\u00e1t"},"content":{"rendered":"\n

Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) megkezdte a n\u00e9met-d\u00e9l-koreai SK Chemicals biotechnol\u00f3giai v\u00e1llalat Skycovion nev\u0171, koronav\u00edrus ellen kifejlesztett vakcin\u00e1j\u00e1ra vonatkoz\u00f3 felt\u00e9teles forgalombahozatali enged\u00e9ly ir\u00e1nti k\u00e9relem vizsg\u00e1lat\u00e1t \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 cs\u00fct\u00f6rt\u00f6k\u00f6n.<\/strong><\/p>\n\n\n\n

A k\u00f6zlem\u00e9ny szerint a k\u00e9relmez\u0151 v\u00e1llalat elegend\u0151 adatot ny\u00fajtott be arr\u00f3l, hogy a vakcina milyen ar\u00e1nyban v\u00e1ltja ki a koronav\u00edrus-fert\u0151z\u00e9st okoz\u00f3 SARS-CoV-2 eredeti t\u00f6rzse elleni antitestek termel\u00e9s\u00e9t. A v\u00e1llalat adatokat ny\u00fajtott be a vakcina biztons\u00e1goss\u00e1g\u00e1r\u00f3l \u00e9s min\u0151s\u00e9g\u00e9r\u0151l is \u2013 k\u00f6z\u00f6lt\u00e9k.<\/p>\n\n\n

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\"\"<\/figure>\n<\/div>\n\n\n

Az adatok fel\u00fclvizsg\u00e1lat\u00e1t k\u00f6vet\u0151en az EMA Hum\u00e1ngy\u00f3gyszer Bizotts\u00e1ga (CHMP) v\u00e9lem\u00e9nyt ad ki arr\u00f3l, hogy a gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g javasolja-e majd az olt\u00f3anyag uni\u00f3s felt\u00e9teles forgalombahozatali enged\u00e9ly\u00e9nek megad\u00e1s\u00e1t. Az Eur\u00f3pai Bizotts\u00e1g ezt k\u00f6vet\u0151en hozhat majd jogilag k\u00f6telez\u0151 \u00e9rv\u00e9ny\u0171 hat\u00e1rozatot a vakcina ideiglenes forgalomba helyez\u00e9s\u00e9r\u0151l \u2013 \u00edrt\u00e1k.<\/p>\n\n\n\n

Az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g t\u00e1j\u00e9koztat\u00e1sa szerint a vakcina a SARS-CoV-2 koronav\u00edrus fel\u00fclet\u00e9n tal\u00e1lhat\u00f3 t\u00fcskefeh\u00e9rje laborat\u00f3riumban teny\u00e9sztett v\u00e1ltozat\u00e1t tartalmazza. Beolt\u00e1st k\u00f6vet\u0151en a szervezet immunrendszere a t\u00fcskefeh\u00e9rj\u00e9t idegenk\u00e9nt azonos\u00edtja, \u00e9s antitesteket termel ellene. Ha az oltott szem\u00e9ly k\u00e9s\u0151bb kapcsolatba ker\u00fcl a koronav\u00edrussal, immunrendszere felismeri a v\u00edrusfeh\u00e9rj\u00e9t, \u00e9s k\u00e9szen \u00e1ll arra, hogy v\u00e9delmet ny\u00fajtson a koronav\u00edrus ellen. A vakcina \u00fagynevezett adjuv\u00e1nst is tartalmaz, amely el\u0151seg\u00edti a vakcin\u00e1ra adott immunv\u00e1lasz er\u0151s\u00edt\u00e9s\u00e9t.<\/p>\n\n\n\n

Az uni\u00f3s gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g ez id\u00e1ig a Pfizer\/BioNTech Comirnaty, az AstraZeneca Vaxzevira, a Moderna Spikevax, a Novavax Nuvaxovid nev\u0171, valamint a Johnson & Johnson v\u00e1llalatok koronav\u00edrus elleni vakcin\u00e1it, valamint a Valneva eur\u00f3pai biotechnol\u00f3giai v\u00e1llalat koronav\u00edrus ellen kifejlesztett olt\u00f3anyag\u00e1t aj\u00e1nlotta haszn\u00e1latra. Az EMA jelenleg a Szputnyik V, a Sanofi v\u00e1llalat Vidprevtyn nev\u0171 olt\u00f3anyag\u00e1t, valamint a Sinovac gy\u00f3gyszergy\u00e1rak olt\u00f3anyagait vizsg\u00e1lja.<\/p>\n\n\n\n

(MTI)<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) megkezdte a n\u00e9met-d\u00e9l-koreai SK Chemicals biotechnol\u00f3giai v\u00e1llalat Skycovion nev\u0171, koronav\u00edrus ellen kifejlesztett vakcin\u00e1j\u00e1ra vonatkoz\u00f3 felt\u00e9teles forgalombahozatali enged\u00e9ly ir\u00e1nti k\u00e9relem vizsg\u00e1lat\u00e1t.<\/p>\n","protected":false},"author":12,"featured_media":87695,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,594,49,592,39],"tags":[],"class_list":["post-115154","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-egeszseg","category-hirek","category-tarsadalom","category-vilag"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/115154","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=115154"}],"version-history":[{"count":1,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/115154\/revisions"}],"predecessor-version":[{"id":115155,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/115154\/revisions\/115155"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/87695"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=115154"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=115154"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=115154"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}