{"id":9104,"date":"2024-05-10T18:12:15","date_gmt":"2024-05-10T16:12:15","guid":{"rendered":"https:\/\/syva.es\/lagence-federale-belge-du-medicament-afmps-autorise-a-son-tour-lutilisation-du-vaccin-contre-le-btv3-developpe-par-les-laboratoires-syva\/"},"modified":"2024-05-10T19:03:55","modified_gmt":"2024-05-10T17:03:55","slug":"lagence-federale-belge-du-medicament-afmps-autorise-a-son-tour-lutilisation-du-vaccin-contre-le-btv3-developpe-par-les-laboratoires-syva","status":"publish","type":"post","link":"https:\/\/syva.es\/fr\/lagence-federale-belge-du-medicament-afmps-autorise-a-son-tour-lutilisation-du-vaccin-contre-le-btv3-developpe-par-les-laboratoires-syva\/","title":{"rendered":"L\u2019agence f\u00e9d\u00e9rale belge du m\u00e9dicament (AFMPS) autorise \u00e0 son tour l\u2019utilisation du vaccin contre le BTV3 d\u00e9velopp\u00e9 par les laboratoires Syva."},"content":{"rendered":"<p><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Alors que les v\u00e9t\u00e9rinaires n\u00e9erlandais ont commenc\u00e9 d\u00e8s ce lundi \u00e0 vacciner massivement, les autorit\u00e9s de la sant\u00e9 v\u00e9t\u00e9rinaire belges ont autoris\u00e9 ce mercredi 8 mai, l\u2019utilisation du vaccin contre le BTV3 des Laboratoires Syva en vertu de l&rsquo;article 110, paragraphe 2, du r\u00e8glement (UE) 2019\/6.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Cette proc\u00e9dure d\u2019utilisation d\u2019urgence d\u2019un vaccin dans une situation exceptionnelle, permet aux autorit\u00e9s comp\u00e9tentes au sein de l\u2019Union Europ\u00e9enne et dans chaque pays concern\u00e9 par un risque d\u2019\u00e9pid\u00e9mie, de d\u00e9roger \u00e0 l\u2019autorisation de mise sur le march\u00e9 classique. Cela, afin de permettre une action rapide de pr\u00e9vention face \u00e0 un risque imminent de voir une maladie comme la fi\u00e8vre catarrhale ovine (FCO), impacter fortement la sant\u00e9 et le bien-\u00eatre des animaux. Comme ce fut le cas aux Pays-Bas de septembre 2023 \u00e0 janvier 2024, causant de nombreuses mortalit\u00e9s et une maladie s\u00e9v\u00e8re dans les troupeaux de moutons, ainsi que de graves sympt\u00f4mes chez les vaches avec des cons\u00e9quences \u00e9conomiques importantes, mais \u00e9galement, comme le soulignaient certains t\u00e9moignages de v\u00e9t\u00e9rinaires n\u00e9erlandais, un impact social et psychologique consid\u00e9rable au sein des communaut\u00e9s d\u2019\u00e9leveurs et des v\u00e9t\u00e9rinaires, qu\u2019il ne faut pas sous-estimer.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Comme nous vous l\u2019avions d\u00e9j\u00e0 signal\u00e9 dans notre pr\u00e9c\u00e9dent communiqu\u00e9 de presse, un appel au niveau europ\u00e9en avait \u00e9t\u00e9 lanc\u00e9 en d\u00e9cembre 2023, par AnimalHealthEurope.<\/span> <span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Suite \u00e0 cela et notre d\u00e9cision de donner la priorit\u00e9 au d\u00e9veloppement d\u2019une solution rapide, s\u00fbre et efficace pour prot\u00e9ger les millions de vaches et de moutons, des contacts se sont \u00e9tablis avec les responsables des principaux pays concern\u00e9s par des foyers de BTV3. Depuis l\u2019annonce de l\u2019autorisation d\u2019usage de notre vaccin, et le premier million de doses livr\u00e9es aux Pays-Bas, nos \u00e9quipes ont vu le rythme des contacts et des discussions s\u2019acc\u00e9l\u00e9rer.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">C\u2019est ainsi que l\u2019Agence F\u00e9d\u00e9rale Belge des M\u00e9dicaments et des Produits de Sant\u00e9, AFMPS \u2013 FAGG, s\u2019est attach\u00e9e \u00e0 analyser de tr\u00e8s pr\u00e8s les donn\u00e9es et les \u00e9tudes r\u00e9alis\u00e9es et qui font partie du dossier d\u2019enregistrement que nous leur avons soumis.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Sur base de diff\u00e9rents rapports officiels, qui monitorent l\u2019activit\u00e9 des culico\u00efdes, les insectes piqueurs et vecteurs du BTV3, le haut degr\u00e9 de certitude que des foyers de grande ampleur de la FCO risquent d\u2019\u00e9clater d\u00e8s la fin juin, et le fait qu\u2019il n\u2019existe actuellement aucun vaccin disponible pour cette souche tr\u00e8s agressive de BTV, les autorit\u00e9s sanitaires belges ont d\u00e9cid\u00e9 d\u2019acc\u00e9l\u00e9rer l\u2019analyse du dossier.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">L\u2019agence f\u00e9d\u00e9rale sanitaire Belge, AFMPS, analysant en d\u00e9tail le dossier, a estim\u00e9 que les r\u00e9sultats disponibles issus des \u00e9tudes cliniques effectu\u00e9es, comportent suffisamment de donn\u00e9es sur la s\u00e9curit\u00e9, la qualit\u00e9 et l\u2019efficacit\u00e9 du vaccin des laboratoires Syva, pour autoriser son utilisation chez les ovins et les bovins, et permettre de vacciner le plus rapidement possible avant la saison d\u2019activit\u00e9 des moucherons vecteurs du virus.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Suite \u00e0 cette autorisation d\u2019utiliser notre vaccin, toutes nos \u00e9quipes se sont engag\u00e9es \u00e0 mettre encore une fois tout en \u0153uvre pour assurer la production des lots de vaccin et des emballages indispensables pour \u00eatre en conformit\u00e9 avec les conditions d\u2019utilisation en Belgique.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Nous tenons \u00e0 remercier une nouvelle fois nos \u00e9quipes pour leur engagement sans faille depuis des mois, depuis que nous avons d\u00e9cid\u00e9 de relever ce remarquable d\u00e9fi sanitaire.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Nous sommes reconnaissants aux autorit\u00e9s belges de nous faire confiance et de nous permettre d&rsquo;apporter cette solution qui donne du sens \u00e0 ce que nous faisons chaque jour avec les \u00e9leveurs et les v\u00e9t\u00e9rinaires belges.<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Plus d\u2019information :<\/span><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><a href=\"https:\/\/syva.es\/las-autoridades-holandesas-aprueban-el-uso-de-la-vacuna-contra-el-serotipo-3-de-la-lengua-azul-desarrollada-por-laboratorios-syva\/\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Communiqu\u00e9 de presse Syva du 26 avril 2024<\/span><\/a><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><a href=\"https:\/\/www.afmps.be\/fr\/news\/vaccin_contre_la_fievre_catarrhale_ovine_de_serotype_3_en_belgique_evaluation_acceleree_des\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">Communiqu\u00e9 de L&rsquo;AFMPS du 7 mai 2024<\/span><\/a><\/p>\n<p class=\"cvGsUA direction-ltr align-justify para-style-body\"><a href=\"https:\/\/www.afmps.be\/fr\/news\/vaccin_contre_le_virus_de_la_fievre_catarrhale_ovine_de_serotype_3_autorisation_dutilisation\"><span class=\"OYPEnA text-decoration-none text-strikethrough-none\">communiqu\u00e9 de l&rsquo;AFMPS de 8 mai 2024<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Alors que les v\u00e9t\u00e9rinaires n\u00e9erlandais ont commenc\u00e9 d\u00e8s ce lundi \u00e0 vacciner massivement, les autorit\u00e9s de la sant\u00e9 v\u00e9t\u00e9rinaire belges ont autoris\u00e9 ce mercredi 8 mai, l\u2019utilisation du vaccin contre le BTV3 des Laboratoires Syva en vertu de l&rsquo;article 110, paragraphe 2, du r\u00e8glement (UE) 2019\/6.<\/p>\n","protected":false},"author":4,"featured_media":9097,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[444],"tags":[],"class_list":["post-9104","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-classifiee"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>L\u2019agence f\u00e9d\u00e9rale belge du m\u00e9dicament (AFMPS) autorise \u00e0 son tour l\u2019utilisation du vaccin contre le BTV3 d\u00e9velopp\u00e9 par les laboratoires Syva. - Syva<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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