{"id":27785,"date":"2019-10-24T03:00:24","date_gmt":"2019-10-24T01:00:24","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=27785"},"modified":"2019-10-23T10:40:42","modified_gmt":"2019-10-23T08:40:42","slug":"first-vaccine-to-protect-against-ebola","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/first-vaccine-to-protect-against-ebola\/","title":{"rendered":"First vaccine to protect against Ebola"},"content":{"rendered":"<p class=\"tw-data-text tw-text-large tw-ta\" dir=\"ltr\" data-placeholder=\"Traducci\u00f3n\"><em><strong>EMA\u2019s human medicines committee (CHMP) has recommended granting a\u00a0conditional marketing authorisation\u00a0in the European Union for Ervebo (rVSV\u0394G-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the\u00a0Ebola\u00a0virus.<\/strong><\/em><\/p>\n<p dir=\"ltr\" data-placeholder=\"Traducci\u00f3n\"><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2018\/12\/Vacunacion.png\"><img decoding=\"async\" class=\"size-medium wp-image-10737 aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2018\/12\/Vacunacion-300x189.png\" alt=\"\" width=\"300\" height=\"189\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2018\/12\/Vacunacion-300x189.png 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2018\/12\/Vacunacion-768x485.png 768w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2018\/12\/Vacunacion.png 927w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p>&nbsp;<\/p>\n<p><em>\u201cThe\u00a0CHMP\u2019s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola. Public health authorities in countries affected by Ebola need safe and efficacious medicines to be able to respond effectively to outbreaks and save lives.\u201d<\/em><\/p>\n<h3>Background<\/h3>\n<p>Ebola virus disease is a rare but severe illness caused by the Ebola virus. Death rates in patients who have contracted the disease have varied from 25% to 90% in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. The current outbreak in the Democratic Republic of Congo (DRC) which is caused by Ebola Zaire, has shown case fatality rates of approximately 67%. More than 3,000 people have been infected with the Ebola virus during the ongoing outbreak, which was declared a\u00a0public health emergency of international concern\u00a0by the\u00a0World Health Organization (WHO)\u00a0in July 2019.<\/p>\n<h3>The vaccine<\/h3>\n<p>Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. Data from\u00a0clinical trials\u00a0and\u00a0compassionate use\u00a0programs have shown that Ervebo protects against Ebola virus disease in humans following a single dose administration.<\/p>\n<p>The clinical development of Ervebo was initiated in response to the 2014-2016 Ebola outbreak in cooperation with public health stakeholders, including national institutes of health, ministries of health in countries such as Guinea and DRC, WHO, the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, M\u00e9decins Sans Fronti\u00e8res and others.<\/p>\n<h3>Present<\/h3>\n<p>Ervebo has been tested in approximately 16,000 individuals involved in several clinical studies in Africa, Europe and the United States where it has been proven to be safe, immunogenic (i.e. able to make the immune system respond to the virus) and effective against the Zaire Ebola virus that circulated in West Africa in 2014-2016. Preliminary data suggest that it is effective in the current outbreak in DRC. Additional\u00a0efficacy and safety data are being collected through the Expanded Access Protocol and should be included in post-marketing safety reports, which are continuously reviewed by EMA.<\/p>\n<p>Ervebo was supported through EMA&#8217;s\u00a0PRIority MEdicines\u00a0(PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients&#8217; unmet medical needs. Ervebo was granted eligibility to PRIME in June 2016 for active immunisation against Ebola.<\/p>\n<p><em>\u201cEMA\u2019s positive opinion for the first vaccine against Ebola virus disease demonstrates the scientific expertise in the EU that can be mobilised to reduce the impact of deadly diseases like Ebola,\u201d<\/em> said Harald Enzmann, Chair of the\u00a0CHMP.<\/p>\n<p>Currently, there are no therapies approved for Ebola. EMA is working together with regulatory authorities around the world to support WHO and to advise on possible pathways for the development, evaluation and approval of medicines and vaccines to fight Ebola. The Agency has collaborated with WHO and African national regulatory agencies during the review of Ervebo in order to speed up WHO prequalification and approval in countries where the vaccine is mostly needed.<\/p>\n<p>Ervebo received a positive opinion for a\u00a0conditional marketing authorisation\u00a0from the\u00a0CHMP\u00a0as further information related to the manufacturing process can only be submitted in the coming months. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide\u00a0marketing authorisation.<\/p>\n<h3 dir=\"ltr\" data-placeholder=\"Traducci\u00f3n\">More information<\/h3>\n<p dir=\"ltr\" data-placeholder=\"Traducci\u00f3n\"><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/first-vaccine-protect-against-ebola\">Full news<\/a><\/p>\n<p dir=\"ltr\" data-placeholder=\"Traducci\u00f3n\"><a href=\"https:\/\/www.cde.ual.es\/en\/research\/\">R+I Section<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA\u2019s human medicines committee (CHMP) has recommended granting a\u00a0conditional marketing authorisation\u00a0in the European Union for Ervebo (rVSV\u0394G-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the\u00a0Ebola\u00a0virus. &nbsp; \u201cThe\u00a0CHMP\u2019s recommendation is the result of many years of collaborative global efforts to find and develop new medicines [&hellip;]<\/p>\n","protected":false},"author":101012,"featured_media":16452,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[346],"tags":[437,350,433,700],"class_list":{"0":"post-27785","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eu-news","8":"tag-health","9":"tag-investigacion-en","10":"tag-research","11":"tag-vaccine-en","12":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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