{"id":5372,"date":"2024-08-17T06:53:30","date_gmt":"2024-08-17T06:53:30","guid":{"rendered":"https:\/\/regtechafrica.com\/healthcare\/?p=5372"},"modified":"2024-08-17T06:53:30","modified_gmt":"2024-08-17T06:53:30","slug":"global-bavarian-nordic-seeks-eu-approval-to-expand-mpox-vaccine-use-to-adolescents","status":"publish","type":"post","link":"https:\/\/regtechafrica.com\/healthcare\/global-bavarian-nordic-seeks-eu-approval-to-expand-mpox-vaccine-use-to-adolescents\/","title":{"rendered":"Global: Bavarian Nordic Seeks EU Approval to Expand Mpox Vaccine Use to Adolescents"},"content":{"rendered":"<p>Mpox, recently declared a global public health emergency by the World Health Organization (WHO), poses a significant threat to children and adolescents, who are particularly vulnerable to the disease.<\/p>\n<p>In response to this growing concern, Danish biotech company Bavarian Nordic announced on Friday that it has submitted data to the European Union&#8217;s drug regulator seeking approval to extend the use of its mpox and smallpox vaccine to adolescents aged 12 to 17 years.<\/p>\n<p>The urgency of this request is underscored by recent developments in global health. On Thursday, officials confirmed a new strain of the mpox virus in Sweden, linking it to a burgeoning outbreak in Africa, signaling the virus&#8217;s spread beyond the continent.<\/p>\n<p>&#8220;Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa,&#8221; Bavarian Nordic CEO Paul Chaplin stated. &#8220;This highlights the importance and urgency of broadening access to vaccines and therapies for this vulnerable population.&#8221;<\/p>\n<p>The European Medicines Agency&#8217;s (EMA) review of the submitted data could lead to an extension of the vaccine&#8217;s marketing authorization to include adolescents by the fourth quarter of this year. Additionally, Bavarian Nordic is preparing to conduct a clinical trial to assess the vaccine&#8217;s safety in children aged 2 to 12 years, potentially broadening its use further.<\/p>\n<p>This upcoming trial, partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is set to begin later this year in the Democratic Republic of Congo and Uganda.<\/p>\n<p>Since the current outbreak began in January 2023, the Democratic Republic of Congo has reported 27,000 cases and more than 1,100 deaths, primarily among children.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mpox, recently declared a global public health emergency by the World Health Organization (WHO), poses a significant threat to children and adolescents, who are particularly vulnerable to the disease. In&hellip;<\/p>\n","protected":false},"author":1,"featured_media":5377,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[78],"tags":[],"class_list":["post-5372","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/regtechafrica.com\/healthcare\/wp-content\/uploads\/2024\/08\/Mpox-Vaccine.jpg?fit=1920%2C1080&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5372","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/comments?post=5372"}],"version-history":[{"count":1,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5372\/revisions"}],"predecessor-version":[{"id":5378,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/5372\/revisions\/5378"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media\/5377"}],"wp:attachment":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media?parent=5372"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/categories?post=5372"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/tags?post=5372"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}