{"id":38346,"date":"2020-07-22T07:13:49","date_gmt":"2020-07-22T07:13:49","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=38346"},"modified":"2020-07-23T18:11:25","modified_gmt":"2020-07-23T18:11:25","slug":"fda-guidance-on-covid-19-vaccine-includes-minimal-target-of-50-efficacy","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/38346","title":{"rendered":"FDA guidance on COVID-19 vaccine includes minimal target of 50% efficacy"},"content":{"rendered":"<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\"><img loading=\"lazy\" decoding=\"async\" class=\" alignright\" src=\"https:\/\/i-base.info\/wp-content\/uploads\/2020\/03\/COVID-19-graphic.png\" width=\"231\" height=\"142\" \/>Simon Collins, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">In June 2020 the US FDA published guidelines for manufactures working on producing a vaccine against COVID-19.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The 20-page document includes guidelines for investigating, testing and manufacturing, including appropriate populations for different stages of development. The document references the importance of racial diversity, use in children and during pregnancy.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Approval will need to be based on direct evidence of safety and efficacy in protection against SARS-CoV-2 and\/or clinical disease.<\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Phase 3 placebo-controlled studies need to show at least 50% effective for<\/span> the primary efficacy endpoint point of protection.<\/p>\n<p class=\"HTBBODYtext\">Safety data needs to be provided for at least 3000 participants but post-licensing pharmacovigilance data is also expected. Details on the duration of protection are not discussed.<\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Reference<\/span><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">US FDA. Development and Licensure of Vaccines to Prevent COVID-19. (June 2020).<br \/>\n<\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/development-and-licensure-vaccines-prevent-covid-19\" rel=\"noopener noreferrer\"><span lang=\"EN-US\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/development-and-licensure-vaccines-prevent-covid-19<\/span><\/a><\/p>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\"><a href=\"https:\/\/www.fda.gov\/media\/139638\/download\" rel=\"noopener noreferrer\">https:\/\/www.fda.gov\/media\/139638\/download<\/a> (direct PDF)<\/span><\/p>\n<p><em>This report was first published on 2 July 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base In June 2020 the US FDA published guidelines for manufactures working on producing a vaccine against COVID-19. The 20-page document includes guidelines for investigating, testing and manufacturing, including appropriate populations for different stages of development. The &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[292,278],"tags":[],"class_list":["post-38346","post","type-post","status-publish","format-standard","hentry","category-covid-19-vaccine","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38346","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=38346"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/38346\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=38346"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=38346"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=38346"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}