Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) Hum\u00e1ngy\u00f3gyszer Bizotts\u00e1ga (CHMP) megkezdte az orosz fejleszt\u00e9s\u0171 Szputnyik V olt\u00f3anyag folyamatos fel\u00fclvizsg\u00e1lat\u00e1t – er\u0151s\u00edtette meg 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.<\/p>\n
Az EMA k\u00f6zlem\u00e9nye szerint az olt\u00f3anyag uni\u00f3s k\u00e9relmez\u0151je az R-Pharm moszkvai sz\u00e9khely\u0171 gy\u00f3gyszergy\u00e1r n\u00e9metorsz\u00e1gi le\u00e1nyv\u00e1llalata. Az uni\u00f3s \u00fcgyn\u00f6ks\u00e9g k\u00f6z\u00f6lte, a szakvizsg\u00e1lat megkezd\u00e9s\u00e9r\u0151l hozott d\u00f6nt\u00e9s 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. A kutat\u00e1sok \u00e9s vizsg\u00e1latok alapj\u00e1n k\u00e9sz\u00fclt tanulm\u00e1nyok azt mutatj\u00e1k, hogy a Szputnyik V kiv\u00e1ltja a sz\u00fcks\u00e9ges antitestek \u00e9s immunsejtek termel\u00e9s\u00e9t, ez \u00e1ltal hozz\u00e1j\u00e1rulhat a koronav\u00edrus elleni v\u00e9delemhez.<\/p>\n
Az EMA \u00e9rt\u00e9kelni fogja a rendelkez\u00e9sre \u00e1ll\u00f3 adatokat annak eld\u00f6nt\u00e9s\u00e9re, hogy az olt\u00f3anyag el\u0151nyei fel\u00fclm\u00falj\u00e1k-e a kock\u00e1zatokat. \u00c9rt\u00e9kelni fogja azt is, hogy a vakcina megfelel-e a hat\u00e9konys\u00e1g, a biztons\u00e1g \u00e9s a min\u0151s\u00e9g uni\u00f3s szabv\u00e1nyainak. 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 – k\u00f6z\u00f6lt\u00e9k.<\/p>\n
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
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 brit-sv\u00e9d 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
A Johnson & Johnson csoportba tartoz\u00f3 Janssen Pharmaceutica-Cilag NV gy\u00f3gyszeripari v\u00e1llalat febru\u00e1r k\u00f6zep\u00e9n ny\u00fajtotta be az \u00faj t\u00edpus\u00fa koronav\u00edrus ellen kifejlesztett olt\u00f3anyag\u00e1nak enged\u00e9lyeztet\u00e9si k\u00e9relm\u00e9t az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9ghez. Az EMA v\u00e1rhat\u00f3an m\u00e1rcius 11-\u00e9n foglal \u00e1ll\u00e1st az olt\u00f3anyag uni\u00f3s aj\u00e1nl\u00e1s\u00e1r\u00f3l. A folyamat felgyors\u00edt\u00e1sa \u00e9rdek\u00e9ben a gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g kor\u00e1bban megkezdte a Novavax amerikai, valamint a CureVac n\u00e9met gy\u00f3gyszeripari v\u00e1llalatok \u00e1ltal fejlesztett olt\u00f3anyagok folyamatos \u00e9rt\u00e9kel\u00e9s\u00e9t is.<\/p>\n
A Szputnyik V olt\u00f3anyagban \u00e1rtalmatlan\u00edtott adenov\u00edrussal juttatj\u00e1k be a koronav\u00edrusra jellemz\u0151 t\u00fcskefeh\u00e9rj\u00e9t a szervezetbe. Az immunrendszer ezt k\u00f6vet\u0151en idegen anyagk\u00e9nt kezeli ezt a feh\u00e9rj\u00e9t, \u00e9s term\u00e9szetes v\u00e9dekez\u00e9sk\u00e9nt antitesteket \u00e9s a feh\u00e9rv\u00e9rsejtek csoportj\u00e1hoz T-sejteket termel ellene. A vakcin\u00e1ban tal\u00e1lhat\u00f3 adenov\u00edrus nem k\u00e9pes szaporodni, \u00e9s nem okoz betegs\u00e9get – k\u00f6z\u00f6lte az uni\u00f3s gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g.<\/p>","protected":false},"excerpt":{"rendered":"
Az eddigi kutat\u00e1sok \u00e9s vizsg\u00e1latok alapj\u00e1n k\u00e9sz\u00fclt tanulm\u00e1nyok azt mutatj\u00e1k, hogy a Szputnyik V kiv\u00e1ltja a sz\u00fcks\u00e9ges antitestek \u00e9s immunsejtek termel\u00e9s\u00e9t. Az \u00fcgyn\u00f6ks\u00e9g a rendelkez\u00e9sre \u00e1ll\u00f3 adatok vizsg\u00e1lat\u00e1t k\u00f6vet\u0151en d\u00f6nt arr\u00f3l, hogy a vakcina el\u0151nyei fel\u00fclm\u00falj\u00e1k-e a kock\u00e1zatokat.<\/p>","protected":false},"author":8,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"cikk_cimkek":[104],"content_flags":[],"content_icons":[],"class_list":["post-12766","post","type-post","status-publish","format-standard","hentry","category-erdmost","cikk_cimkek-koronavirus"],"acf":[],"_links":{"self":[{"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/posts\/12766","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/comments?post=12766"}],"version-history":[{"count":0,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/posts\/12766\/revisions"}],"wp:attachment":[{"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/media?parent=12766"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/categories?post=12766"},{"taxonomy":"cikk_cimkek","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/cikk_cimkek?post=12766"},{"taxonomy":"content_flags","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/content_flags?post=12766"},{"taxonomy":"content_icons","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/content_icons?post=12766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}