Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g (EMA) megkezdte a Johnson and Johnson gy\u00f3gyszeripari v\u00e1llalata, a Janssen vakcin\u00e1j\u00e1val v\u00e9gzett olt\u00e1sokat k\u00f6vet\u0151en jelentett nagyon ritka v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9ses estek kivizsg\u00e1l\u00e1s\u00e1t – k\u00f6z\u00f6lte az uni\u00f3s gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g p\u00e9nteken.<\/p>\n
K\u00f6zlem\u00e9ny\u00e9ben kiemelte: mostan\u00e1ig n\u00e9gy alkalommal jelentettek tromboemb\u00f3li\u00e1s esem\u00e9nyeket, azaz \u00e9relz\u00e1r\u00f3d\u00e1s vesz\u00e9ly\u00e9vel j\u00e1r\u00f3 v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9st azokn\u00e1l, akiket a Janssen vakcin\u00e1j\u00e1val beoltottak. Elmondt\u00e1k, hogy a n\u00e9gy szokatlan v\u00e9ralvad\u00e1ssal j\u00e1r\u00f3 esetb\u0151l egy a klinikai vizsg\u00e1lat szakasz\u00e1ban meg nem nevezett helysz\u00ednen, h\u00e1rom pedig a vakcina bead\u00e1s\u00e1t k\u00f6vet\u0151en fordult el\u0151 az Egyes\u00fclt \u00c1llamokban. Az egyik eset hal\u00e1los kimenetel\u0171 volt – tett\u00e9k hozz\u00e1.<\/p>\n
Kiemelt\u00e9k: kivizsg\u00e1l\u00e1sra v\u00e1r, hogy van-e okozati \u00f6sszef\u00fcgg\u00e9s a Janssen olt\u00f3anyaga \u00e9s a kissz\u00e1m\u00fa v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9ses eset k\u00f6z\u00f6tt. Az \u00fcgyn\u00f6ks\u00e9g illet\u00e9kes kock\u00e1zat\u00e9rt\u00e9kel\u0151 bizotts\u00e1ga (PRAC) megkezdte az esetek fel\u00fclvizsg\u00e1lat\u00e1t annak meg\u00e1llap\u00edt\u00e1s\u00e1ra, hogy sz\u00fcks\u00e9g-e a vakcina term\u00e9kinform\u00e1ci\u00f3j\u00e1nak friss\u00edt\u00e9se.<\/p>\n
A Janssen koronav\u00edrus elleni olt\u00f3anyag\u00e1t jelenleg csak az Egyes\u00fclt \u00c1llamokban alkalmazz\u00e1k, a vakcina m\u00e1rcius 11-\u00e9n kapott ideiglenes forgalombahozatali enged\u00e9lyt az Eur\u00f3pai Uni\u00f3ban. Az olt\u00f3anyag bevezet\u00e9se m\u00e9g egyetlen EU-tag\u00e1llamban sem kezd\u0151d\u00f6tt el, alkalmaz\u00e1sa Eur\u00f3p\u00e1ban a k\u00f6vetkez\u0151 hetekben v\u00e1rhat\u00f3. Az Eur\u00f3pai Bizotts\u00e1g okt\u00f3ber 8-\u00e1n k\u00f6t\u00f6tt meg\u00e1llapod\u00e1st a Johnson & Johnson v\u00e1llalattal 200 milli\u00f3 adag olt\u00f3anyag beszerz\u00e9s\u00e9r\u0151l, tov\u00e1bbi 200 milli\u00f3 d\u00f3zis v\u00e1s\u00e1rl\u00e1s\u00e1nak lehet\u0151s\u00e9g\u00e9vel.<\/p>\n
A Janssen \u00e1ltal kifejlesztett olt\u00f3anyag arra a technol\u00f3giai platformra t\u00e1maszkodik, amelyet m\u00e1r haszn\u00e1ltak a gy\u00f3gyszergy\u00e1r ebola elleni olt\u00f3anyag\u00e1nak, valamint a Zika-, az RSV- \u00e9s a HIV-v\u00edrus elleni vakcin\u00e1k kifejleszt\u00e9s\u00e9hez \u00e9s gy\u00e1rt\u00e1s\u00e1hoz. Az 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 tartoz\u00f3 T-sejteket termel ellene. A vakcin\u00e1ban tal\u00e1lhat\u00f3 adenov\u00edrus nem k\u00e9pes szaporodni, \u00e9s nem okoz betegs\u00e9get.<\/p>\n
Az Eur\u00f3pai Gy\u00f3gyszer\u00fcgyn\u00f6ks\u00e9g szerd\u00e1n tette k\u00f6zz\u00e9 az AstraZeneca brit-sv\u00e9d gy\u00f3gyszergy\u00e1rt\u00f3 \u00e9s az Oxfordi Egyetem Vaxzevria n\u00e9vre keresztelt olt\u00f3anyag\u00e1val kapcsolatban felvet\u0151d\u00f6tt v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9ses esetek kivizsg\u00e1l\u00e1s\u00e1nak r\u00e9szeredm\u00e9ny\u00e9t. Az \u00fcgyn\u00f6ks\u00e9g arra a k\u00f6vetkeztet\u00e9sre jutott, hogy lehets\u00e9ges az \u00f6sszef\u00fcgg\u00e9s a v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9ssel \u00f6sszef\u00fcgg\u0151 rendelleness\u00e9gek kor\u00e1bban jelzett nagyon ritka esetei \u00e9s az AstraZeneca olt\u00f3anyaga k\u00f6z\u00f6tt, a vakcina el\u0151nyei azonban tov\u00e1bbra is fel\u00fclm\u00falj\u00e1k a lehets\u00e9ges mell\u00e9khat\u00e1sok kock\u00e1zatait. Mint k\u00f6z\u00f6lt\u00e9k: a v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9s esetleges vesz\u00e9ly\u00e9t fel kell t\u00fcntetni a vakcina „nagyon ritka mell\u00e9khat\u00e1sak\u00e9nt”.<\/p>\n
Az \u00fcgyn\u00f6ks\u00e9g nem javasolt semmif\u00e9le korl\u00e1toz\u00e1st az olt\u00f3anyag alkalmaz\u00e1sa tekintet\u00e9ben a 18 \u00e9vesekn\u00e9l id\u0151sebbek eset\u00e9ben. A vakcina tov\u00e1bbi vizsg\u00e1lata folytat\u00f3dik.<\/p>","protected":false},"excerpt":{"rendered":"
Az EMA megkezdte a Janssen-vakcin\u00e1val v\u00e9gezett olt\u00e1sokat k\u00f6vet\u0151en jelentett v\u00e9rr\u00f6gk\u00e9pz\u0151d\u00e9ses esetek kivizsg\u00e1l\u00e1s\u00e1t. Mostan\u00e1ig n\u00e9gy alkalommal jeleztek tromboemb\u00f3li\u00e1s esem\u00e9nyeket. A Janssen vakcin\u00e1j\u00e1t jelenleg csak az US\u00c1-ban alkalmazz\u00e1k, bevezet\u00e9se az EU-ban a k\u00f6vetkez\u0151 hetekben v\u00e1rhat\u00f3.<\/p>","protected":false},"author":5,"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-13751","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\/13751","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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/comments?post=13751"}],"version-history":[{"count":0,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/posts\/13751\/revisions"}],"wp:attachment":[{"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/media?parent=13751"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/categories?post=13751"},{"taxonomy":"cikk_cimkek","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/cikk_cimkek?post=13751"},{"taxonomy":"content_flags","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/content_flags?post=13751"},{"taxonomy":"content_icons","embeddable":true,"href":"https:\/\/erdmost.hu\/en\/wp-json\/wp\/v2\/content_icons?post=13751"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}