{"id":18923,"date":"2026-09-25T13:22:48","date_gmt":"2026-09-25T13:22:48","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=18923"},"modified":"2026-09-25T13:22:48","modified_gmt":"2026-09-25T13:22:48","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-celldemic-vaccin-contre-la-grippe-zoonotique-h5n1-antigene-de-surface-inactive-avec-adjuvant-prepare-su","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=18923","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Celldemic, vaccin contre la grippe zoonotique (H5N1) (antig\u00e8ne de surface, inactiv\u00e9, avec adjuvant, pr\u00e9par\u00e9 sur cultures cellulaires), Date d\u2019autorisation : 19\/04\/2024, R\u00e9vision : 1, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Celldemic est un vaccin destin\u00e9 \u00e0 la pr\u00e9vention de la grippe A (H5N1), dite \u00ab grippe aviaire \u00bb, chez l\u2019adulte et l\u2019enfant \u00e0 partir de 6 mois. Il contient de petites quantit\u00e9s de prot\u00e9ines issues d\u2019une souche H5N1 du virus de la grippe A, inactiv\u00e9e pour ne pas provoquer la maladie. Le vaccin inclut \u00e9galement un adjuvant destin\u00e9 \u00e0 renforcer la r\u00e9ponse immunitaire. Il n\u2019est disponible que sur prescription m\u00e9dicale et son utilisation doit suivre les recommandations officielles.<\/p>\n<p>Le sch\u00e9ma vaccinal recommand\u00e9 est de deux injections \u00e0 3 semaines d\u2019intervalle, administr\u00e9es en g\u00e9n\u00e9ral dans le muscle du haut du bras chez l\u2019adulte et l\u2019enfant, et dans la cuisse chez les nourrissons de 6 \u00e0 12 mois. Le m\u00e9canisme d\u2019action repose sur la stimulation du syst\u00e8me immunitaire qui produit des anticorps dirig\u00e9s contre la souche H5N1 contenue dans le vaccin, afin de mieux prot\u00e9ger en cas d\u2019exposition ult\u00e9rieure au virus.<\/p>\n<p>L\u2019efficacit\u00e9 de Celldemic a \u00e9t\u00e9 \u00e9valu\u00e9e dans un essai principal portant sur environ 3 200 adultes recevant soit deux doses de vaccin, soit un placebo \u00e0 3 semaines d\u2019intervalle. Trois semaines apr\u00e8s la deuxi\u00e8me dose, 67 % des personnes vaccin\u00e9es pr\u00e9sentaient un taux d\u2019anticorps jug\u00e9 suffisant contre la souche H5N1 incluse, contre 1 % dans le groupe placebo. Six mois apr\u00e8s la vaccination, environ 12 % des personnes vaccin\u00e9es avaient encore un niveau d\u2019anticorps consid\u00e9r\u00e9 comme ad\u00e9quat, contre environ 1 % dans le groupe placebo. Un autre essai men\u00e9 chez environ 330 enfants \u00e2g\u00e9s de 6 mois \u00e0 17 ans a montr\u00e9 qu\u2019environ 96 % d\u2019entre eux pr\u00e9sentaient des taux d\u2019anticorps suffisants trois semaines apr\u00e8s la deuxi\u00e8me dose.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents chez les adultes et les enfants de 6 ans et plus (plus de 1 personne sur 10) sont la douleur au site d\u2019injection, la fatigue, les c\u00e9phal\u00e9es, un malaise g\u00e9n\u00e9ral, les douleurs musculaires et articulaires. Chez les enfants de 6 ans et plus, une perte d\u2019app\u00e9tit et des naus\u00e9es sont \u00e9galement tr\u00e8s fr\u00e9quentes. La liste compl\u00e8te des effets ind\u00e9sirables et des contre-indications figure dans la notice du m\u00e9dicament. Aucun autre pays, institution ou autorit\u00e9 de sant\u00e9 sp\u00e9cifique n\u2019est mentionn\u00e9 dans la source. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/celldemic\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Celldemic est un vaccin destin\u00e9 \u00e0 la pr\u00e9vention de la grippe A (H5N1), dite \u00ab grippe aviaire \u00bb, chez l\u2019adulte et l\u2019enfant \u00e0 partir de 6 mois. Il contient de [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"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":"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":"","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-4)","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-4)","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-4)","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":[7],"tags":[257,227,226],"class_list":["post-18923","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18923","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=18923"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18923\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=18923"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18923"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18923"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}