{"id":87517,"date":"2021-11-24T03:00:27","date_gmt":"2021-11-24T02:00:27","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=87517"},"modified":"2021-11-23T12:52:37","modified_gmt":"2021-11-23T11:52:37","slug":"ema-evaluating-data-on-booster-dose-of-covid-19-vaccine-janssen","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/ema-evaluating-data-on-booster-dose-of-covid-19-vaccine-janssen\/","title":{"rendered":"EMA evaluating data on booster dose of COVID-19 Vaccine Janssen"},"content":{"rendered":"<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2021\/11\/Captura-7.png\"><img decoding=\"async\" class=\"size-full wp-image-87535 aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2021\/11\/Captura-7.png\" alt=\"\" width=\"785\" height=\"246\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2021\/11\/Captura-7.png 785w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2021\/11\/Captura-7-300x94.png 300w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2021\/11\/Captura-7-768x241.png 768w\" sizes=\"(max-width: 785px) 100vw, 785px\" \/><\/a><\/p>\n<p>EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older.<\/p>\n<p>EMA\u2019s human medicines committee (<a id=\"glossary-term-43090\" class=\"ecl-link glossary-term\" title=\"Committee for Medicinal Products for Human Use - the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.\u00a0 More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noopener\">CHMP<\/a>) will carry out an\u00a0<a id=\"glossary-term-43121\" class=\"ecl-link glossary-term\" title=\"Rapid assessment of medicines in the centralised procedure that are of major interest for public health, especially ones that are therapeutic innovations. Accelerated assessment usually takes 150 evaluation days, rather than 210.\u00a0 More information can be found under 'Accelerated assessment'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/accelerated-assessment\" target=\"_blank\" rel=\"noopener\">accelerated assessment<\/a>\u00a0of data submitted by the company that markets the vaccine. These data include results from more than 14,000 adults who received a second dose of COVID-19 Vaccine Janssen or placebo (a dummy treatment) two months after the initial dose.<\/p>\n<p>The\u00a0<a id=\"glossary-term-43090\" class=\"ecl-link glossary-term\" title=\"Committee for Medicinal Products for Human Use - the committee that is responsible for preparing the Agency's opinions on questions concerning human medicines.\u00a0 More information can be found under 'Committee for Medicinal Products for Human Use (CHMP)'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noopener\">CHMP<\/a>\u00a0will recommend whether updates to the\u00a0<a id=\"glossary-term-43231\" class=\"ecl-link glossary-term\" title=\"Documents providing officially approved information for healthcare professionals and patients on a medicine. The product information includes the summary of product characteristics, package leaflet and labelling.\u00a0 More information can be found under\u00a0'Product-information requirements'.\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/product-information\" target=\"_blank\" rel=\"noopener\">product information<\/a>\u00a0are appropriate. The outcome of this evaluation is expected within weeks, unless supplementary information is needed, and will be communicated by EMA.<\/p>\n<p>COVID-19 Vaccine Janssen is a vaccine for preventing COVID-19. It is currently authorised for use in people aged 18 and older, with the primary vaccination consisting of a single dose. The vaccine is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Vaccine Janssen does not contain the virus itself and cannot cause COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.<\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/covid-19-vaccine-janssen\" target=\"_blank\" rel=\"noopener\">More information about the vaccine<\/a>\u00a0is available.<\/p>\n<p>The implementation of vaccination campaigns in the EU, including the use of booster doses, remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State. These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.<\/p>\n<h3>More information<\/h3>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/ema-evaluating-data-booster-dose-covid-19-vaccine-janssen\">European Medicines Agency<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older. EMA\u2019s human medicines committee (CHMP) will carry out an\u00a0accelerated assessment\u00a0of data submitted by the company that markets the vaccine. These [&hellip;]<\/p>\n","protected":false},"author":101011,"featured_media":87535,"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":[4093,346,4094,4092],"tags":[4628,4627,1352,700],"class_list":{"0":"post-87517","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-diseases","8":"category-eu-news","9":"category-farmac","10":"category-health","11":"tag-authorisation","12":"tag-booster-dose","13":"tag-covid-19","14":"tag-vaccine-en","15":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>EMA evaluating data on booster dose of COVID-19 Vaccine Janssen | 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\/ema-evaluating-data-on-booster-dose-of-covid-19-vaccine-janssen\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA evaluating data on booster dose of COVID-19 Vaccine Janssen | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older. 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