{"id":39535,"date":"2020-12-09T07:33:38","date_gmt":"2020-12-09T07:33:38","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39535"},"modified":"2020-12-10T17:24:25","modified_gmt":"2020-12-10T17:24:25","slug":"interim-results-report-94-efficacy-with-moderna-nih-mrna-vaccine-fda-hearing-on-17-december","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39535","title":{"rendered":"Interim results report 94% efficacy with Moderna\/NIH mRNA vaccine: FDA hearing on 17 December"},"content":{"rendered":"<div><\/div>\n<div>\n<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<\/div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">On 16 November 2020, a press statement from the UK NIH (a partner with Moderna for the mRNA-1273 vaccine) announced 94% efficacy in an interim analysis from the ongoing phase 3 COVE study. [1]<\/span><\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The results, released from the trial\u2019s Data and Safety Monitoring Board (DSMB) reported 95 cases of symptomatic infection: 90 vs 5 cases in the placebo vs vaccine groups, respectively.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Additionally, all 11\/95 cases of severe COVID-19 were in placebo recipients.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The study was launched on 27 July 2020 and has enrolled 30,000 participants at 100 sites in the US. [2]<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The FDA advisory committee hearing for this vaccine is due on 17 December 2020. Meeting amterials are posted online and the hearing is webcast. [3]<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBreferences\"><span lang=\"EN-US\">References<\/span><\/p>\n<\/div>\n<div>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">NIH press statement. Promising interim results from clinical trial of NIH-Moderna COVID-19 Vaccine\/ (16 November 2020).<br \/>\n<\/span><a href=\"https:\/\/www.nih.gov\/news-events\/news-releases\/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine\">https:\/\/www.nih.gov\/news-events\/news-releases\/promising-interim-results-clinical-trial-nih-moderna-covid-19-vaccine<\/a><\/li>\n<li class=\"HTBreferences\">clinicaltrials.gov. A study to evaluate efficacy, safety, and immunogenicity of mRNA-1273 vaccine in adults aged 18 years and older to prevent COVID-19.<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04470427\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04470427<\/a><\/li>\n<li class=\"HTBreferences\">Vaccines and related biological products advisory committee: December 17, 2020 meeting announcement.<br \/>\n<a href=\"https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement#event-information\">https:\/\/www.fda.gov\/advisory-committees\/advisory-committee-calendar\/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement#event-information<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 16 November 2020, a press statement from the UK NIH (a partner with Moderna for the mRNA-1273 vaccine) announced 94% efficacy in an interim analysis from the ongoing phase 3 COVE study. [1] The results, &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-39535","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\/39535","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=39535"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39535\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39535"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39535"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39535"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}