{"id":59125,"date":"2020-12-22T11:00:01","date_gmt":"2020-12-22T10:00:01","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=59125"},"modified":"2021-11-05T14:41:52","modified_gmt":"2021-11-05T13:41:52","slug":"european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\/","title":{"rendered":"European Commission authorises first safe and effective vaccine against COVID-19"},"content":{"rendered":"<p><strong>The European Commission has granted a conditional marketing authorisation (CMA) for the COVID\u201119 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.<\/strong><\/p>\n<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920.jpg\"><img decoding=\"async\" class=\"aligncenter wp-image-59133\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920-300x200.jpg\" alt=\"European Commission authorises first safe and effective vaccine against COVID-19\" width=\"517\" height=\"344\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920-300x200.jpg 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920-1024x683.jpg 1024w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920-768x512.jpg 768w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920-1536x1025.jpg 1536w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920.jpg 1920w\" sizes=\"(max-width: 517px) 100vw, 517px\" \/><\/a><\/p>\n<blockquote><p>The President of the European Commission, Ursula\u00a0<strong>von der Leyen<\/strong>, said:<em>\u00a0\u201cToday we add an important chapter to a European success story. We approved the first safe and effective vaccine against COVID-19. More vaccines will come soon. Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions. The upcoming European vaccination days will also be a great moment of unity. This is a good way to end this difficult year, and to start turning the page on this pandemic. We are all in this together.\u201d<\/em><\/p><\/blockquote>\n<p>EMA\u2019s human medicines committee\u00a0has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and\u00a0efficacy of the vaccine are now available to recommend a formal\u00a0conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.<\/p>\n<p>\u201cToday\u2019s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,\u201d said Emer Cooke, Executive Director of EMA. \u201cWe have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.<\/p>\n<p>\u201cOur thorough evaluation means that we can confidently assure EU citizens of the safety and\u00a0efficacy\u00a0of this vaccine and that it meets necessary quality standards.\u00a0However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.\u201d<\/p>\n<p>Efficacy\u00a0was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection. The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95%\u00a0efficacy\u00a0in the\u00a0clinical trial.<\/p>\n<p>Comirnaty is given as two injections into the arm, at least 21 days apart.\u00a0The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the Member States, through the\u00a0EU pharmacovigilance system\u00a0and additional studies by the company and by European authorities.<\/p>\n<h3>More information<\/h3>\n<p><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/es\/ip_20_2466\" target=\"_blank\" rel=\"noopener\">European Commission<\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-first-covid-19-vaccine-authorisation-eu\" target=\"_blank\" rel=\"noopener\">Eurpoean Medicines Agency<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has granted a conditional marketing authorisation (CMA) for the COVID\u201119 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency [&hellip;]<\/p>\n","protected":false},"author":101012,"featured_media":59133,"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":[4093,346,4092,4088],"tags":[2448,779,700],"class_list":{"0":"post-59125","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-diseases","8":"category-eu-news","9":"category-health","10":"category-market","11":"tag-covid","12":"tag-eu-en","13":"tag-vaccine-en","14":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Commission authorises first safe and effective vaccine against COVID-19 | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cde.ual.es\/en\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission authorises first safe and effective vaccine against COVID-19 | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"The European Commission has granted a conditional marketing authorisation (CMA) for the COVID\u201119 vaccine developed by BioNTech and Pfizer, making it the first COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.cde.ual.es\/en\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\/\" \/>\n<meta property=\"og:site_name\" content=\"CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/cdeuniversidadalmeria\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-22T10:00:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-11-05T13:41:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/12\/injection-5722329_1920.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1281\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"BECACDE1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@cdeualmeria\" \/>\n<meta name=\"twitter:site\" content=\"@cdeualmeria\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"BECACDE1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/\"},\"author\":{\"name\":\"BECACDE1\",\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/#\\\/schema\\\/person\\\/bf2f837cf3353e2161fe1087adbd728f\"},\"headline\":\"European Commission authorises first safe and effective vaccine against COVID-19\",\"datePublished\":\"2020-12-22T10:00:01+00:00\",\"dateModified\":\"2021-11-05T13:41:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/\"},\"wordCount\":507,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.cde.ual.es\\\/wp-content\\\/uploads\\\/2020\\\/12\\\/injection-5722329_1920.jpg\",\"keywords\":[\"Covid\",\"EU\",\"vaccine\"],\"articleSection\":[\"Diseases\",\"EU News\",\"Health\",\"Market\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/\",\"url\":\"https:\\\/\\\/www.cde.ual.es\\\/en\\\/european-commission-authorises-first-safe-and-effective-vaccine-against-covid-19\\\/\",\"name\":\"European Commission authorises first safe and effective vaccine against COVID-19 | CDE Almer\u00eda - 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