{"id":8980,"date":"2021-05-17T16:28:00","date_gmt":"2021-05-17T16:28:00","guid":{"rendered":"https:\/\/www.asuntos-regulatorios.com\/asesoria-regulatoria-farmacovigilancia\/?p=8980"},"modified":"2021-05-21T16:29:19","modified_gmt":"2021-05-21T16:29:19","slug":"more-flexible-storage-conditions-for-biontech-pfizers-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/www.asuntos-regulatorios.com\/asesoria-regulatoria-farmacovigilancia\/more-flexible-storage-conditions-for-biontech-pfizers-covid-19-vaccine\/","title":{"rendered":"More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EMA\u2019s human medicines committee (<a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/chmp\" target=\"_blank\" rel=\"noreferrer noopener\">CHMP<\/a>) has recommended a change to the approved storage conditions of&nbsp;<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/comirnaty\">Comirnaty<\/a>, the COVID-19 vaccine developed by BioNTech and Pfizer, that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This change extends the approved storage period of the unopened thawed vial at 2-8\u00b0C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to <strong>one month<\/strong> (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/marketing-authorisation-holder\" target=\"_blank\" rel=\"noreferrer noopener\">marketing authorisation holder<\/a>. Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of vaccine roll-out in EU Member States.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The changes described will be included in the publicly available information on&nbsp;<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/comirnaty\">Comirnaty<\/a>&nbsp;and will be implemented by the <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/marketing-authorisation-holder\" target=\"_blank\" rel=\"noreferrer noopener\">marketing authorisation holder<\/a> in updated product <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/labelling\" target=\"_blank\" rel=\"noreferrer noopener\">labelling<\/a>. Users are reminded to always refer to the label and <a href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/package-leaflet\" target=\"_blank\" rel=\"noreferrer noopener\">package leaflet<\/a> of the supplied product for the correct storage information.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EMA is in continuous dialogue with the <a rel=\"noreferrer noopener\" href=\"https:\/\/www.ema.europa.eu\/en\/glossary\/marketing-authorisation-holder\" target=\"_blank\">marketing authorisation holders<\/a> of COVID-19 vaccines as they seek to make manufacturing improvements to enhance vaccine distribution in the EU.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/more-flexible-storage-conditions-biontechpfizers-covid-19-vaccine\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.ema.europa.eu\/en\/news\/more-flexible-storage-conditions-biontechpfizers-covid-19-vaccine<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine. EMA\u2019s human medicines committee (CHMP) has recommended a change to the approved storage conditions of&nbsp;Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU). This change extends the approved storage period of&#8230;<\/p>\n","protected":false},"author":1,"featured_media":8902,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[172],"tags":[],"class_list":["post-8980","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-asuntos-regulatorios"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v16.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine - RA ASUNTOS REGULATORIOS S.A.S<\/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.asuntos-regulatorios.com\/asesoria-regulatoria-farmacovigilancia\/more-flexible-storage-conditions-for-biontech-pfizers-covid-19-vaccine\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine - RA ASUNTOS REGULATORIOS S.A.S\" \/>\n<meta property=\"og:description\" content=\"More flexible storage conditions for BioNTech\/Pfizer\u2019s COVID-19 vaccine. 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