{"id":118684,"date":"2022-09-16T19:25:00","date_gmt":"2022-09-16T16:25:00","guid":{"rendered":"https:\/\/life.karpat.in.ua\/?p=118684"},"modified":"2022-09-16T17:36:03","modified_gmt":"2022-09-16T14:36:03","slug":"a-pfizer-es-a-moderna-vakcinainak-szabvanyos-forgalomba-hozatalat-tamogatja-az-europai-gyogyszerugynokseg","status":"publish","type":"post","link":"https:\/\/life.karpat.in.ua\/?p=118684&lang=hu","title":{"rendered":"A Pfizer \u00e9s a Moderna vakcin\u00e1inak szabv\u00e1nyos forgalomba hozatal\u00e1t t\u00e1mogatja az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) a BioNTech\/Pfizer biotechnol\u00f3giai v\u00e1llalat Comirnaty, valamint Moderna gy\u00f3gyszerc\u00e9g Spikevax nev\u0171 koronav\u00edrus elleni vakcin\u00e1j\u00e1nak jelenlegi, felt\u00e9teles forgalomba hozatali enged\u00e9ly\u00e9nek \u00e1tsorol\u00e1s\u00e1t javasolja szabv\u00e1nyos forgalomba hozatali enged\u00e9lly\u00e9 \u2013 k\u00f6z\u00f6lte az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g p\u00e9nteken.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"951\" height=\"600\" src=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/ema.jpg\" alt=\"\" class=\"wp-image-66350\" srcset=\"https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/ema.jpg 951w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/ema-300x189.jpg 300w, https:\/\/life.karpat.in.ua\/wp-content\/uploads\/2021\/08\/ema-768x485.jpg 768w\" sizes=\"auto, (max-width: 951px) 100vw, 951px\" \/><\/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 k\u00f6zlem\u00e9nye szerint a k\u00e9t vakcina forgalomba helyez\u00e9si besorol\u00e1s\u00e1nak megv\u00e1ltoztat\u00e1s\u00e1t az indokolja, hogy a leg\u00fajabb k\u00eds\u00e9rletek \u00e9s vizsg\u00e1latok megnyugtat\u00f3 adatokat szolg\u00e1ltattak az alkalmaz\u00e1sukhoz sz\u00fcks\u00e9ges kulcsfontoss\u00e1g\u00fa szempontokr\u00f3l. K\u00f6zt\u00fck arr\u00f3l, hogy az olt\u00f3anyagok milyen m\u00e9rt\u00e9kben akad\u00e1lyozz\u00e1k meg az \u00faj t\u00edpus\u00fa koronav\u00edrus-fert\u0151z\u00e9s okozta betegs\u00e9g kock\u00e1zat\u00e1t.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az \u00e9rintett olt\u00f3anyagok nagyar\u00e1ny\u00fa felhaszn\u00e1l\u00e1s\u00e1b\u00f3l rendelkez\u00e9sre \u00e1ll\u00f3, hat\u00e1soss\u00e1gra \u00e9s biztons\u00e1goss\u00e1gra vonatkoz\u00f3 adatok \u00f6sszess\u00e9ge megnyitotta az utat a szabv\u00e1nyos forgalomba hozatali enged\u00e9ly megad\u00e1sa el\u0151tt \u2013 \u00edrt\u00e1k.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Eml\u00e9keztettek, a felt\u00e9teles forgalomba hozatali enged\u00e9ly folyamatos k\u00f6telezetts\u00e9get r\u00f3 a v\u00e1llalatokra a folyamatban l\u00e9v\u0151 klinikai vizsg\u00e1latok eredm\u00e9nyeinek \u00e9s a vakcina gy\u00f3gyszer\u00e9szeti min\u0151s\u00e9g\u00e9re vonatkoz\u00f3 adatainak beny\u00fajt\u00e1s\u00e1ra. A felt\u00e9teles forgalomba hozatali enged\u00e9lyeket \u00e9vente vizsg\u00e1lj\u00e1k fel\u00fcl, \u00e9s indokolt esetben meg\u00faj\u00edtj\u00e1k. A szabv\u00e1nyos forgalomba hozatali enged\u00e9llyel rendelkez\u0151 gy\u00f3gyszerek \u00e9s olt\u00f3anyagok eset\u00e9ben nincs sz\u00fcks\u00e9g az \u00e9ves meg\u00faj\u00edt\u00e1sra \u2013 emelt\u00e9k ki.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA aj\u00e1nl\u00e1sa az \u00f6sszes megl\u00e9v\u0151 \u00e9s k\u00e9sz\u00fcl\u0151 adapt\u00e1lt Comirnaty \u00e9s Spikevax vakcin\u00e1ra kiterjed, bele\u00e9rtve a koronav\u00edrus omikron BA.1 \u00e9s BA.4\/5 jel\u0171 vari\u00e1nsai ellen kifejlesztett \u00e9s nemr\u00e9giben j\u00f3v\u00e1hagyott Comirnaty, valamint az omikron BA.1 jel\u0171 v\u00e1ltozat\u00e1t c\u00e9lz\u00f3 Spikevax vakcin\u00e1ra egyar\u00e1nt.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EMA mindk\u00e9t vakcin\u00e1t tov\u00e1bbra is szoros megfigyel\u00e9s alatt tartja, \u00e9s \u00e9rt\u00e9keli a friss adatokat \u2013 tett\u00e9k hozz\u00e1.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">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 &amp; Johnson v\u00e1llalat Jcovden nev\u0171 vakcin\u00e1j\u00e1t, valamint a Valneva eur\u00f3pai biotechnol\u00f3giai v\u00e1llalat koronav\u00edrus ellen kifejlesztett olt\u00f3anyag\u00e1t aj\u00e1nlotta haszn\u00e1latra. Az EMA jelenleg az orosz Szputnyik V, a nemzetk\u00f6zi Sanofi v\u00e1llalat Vidprevtyn nev\u0171 olt\u00f3anyag\u00e1t, a k\u00ednai Sinovac gy\u00f3gyszergy\u00e1r, a spanyolorsz\u00e1gi Hipra gy\u00f3gyszerc\u00e9g saj\u00e1t fejleszt\u00e9s\u0171, azonos nev\u0171, koronav\u00edrus elleni vakcin\u00e1j\u00e1nak, valamint n\u00e9met-d\u00e9l-koreai SK Chemicals biotechnol\u00f3giai v\u00e1llalat Skycovion nev\u0171, koronav\u00edrus ellen kifejlesztett olt\u00f3anyag\u00e1t vizsg\u00e1lja.<\/p>\n\n\n\n<p class=\"has-text-align-right wp-block-paragraph\"><strong>(MTI)<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) a BioNTech\/Pfizer biotechnol\u00f3giai v\u00e1llalat Comirnaty, valamint Moderna gy\u00f3gyszerc\u00e9g Spikevax nev\u0171 koronav\u00edrus elleni vakcin\u00e1j\u00e1nak jelenlegi, felt\u00e9teles forgalomba hozatali enged\u00e9ly\u00e9nek \u00e1tsorol\u00e1s\u00e1t javasolja szabv\u00e1nyos forgalomba hozatali enged\u00e9lly\u00e9 \u2013 k\u00f6z\u00f6lte az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g p\u00e9nteken.<\/p>\n","protected":false},"author":5,"featured_media":66350,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[41,4383,49,39],"tags":[43509,26846,27146],"class_list":["post-118684","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cikkek","category-covid-19-hu","category-hirek","category-vilag","tag-europai-gyogyszerugynokseg-ema","tag-moderna","tag-pfizer"],"_links":{"self":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/118684","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=118684"}],"version-history":[{"count":1,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/118684\/revisions"}],"predecessor-version":[{"id":118686,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/posts\/118684\/revisions\/118686"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=\/wp\/v2\/media\/66350"}],"wp:attachment":[{"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=118684"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=118684"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/life.karpat.in.ua\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=118684"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}