{"id":41028,"date":"2021-08-01T06:20:43","date_gmt":"2021-08-01T06:20:43","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41028"},"modified":"2021-08-01T10:19:13","modified_gmt":"2021-08-01T10:19:13","slug":"results-from-novavax-phase-3-study-in-the-uk","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41028","title":{"rendered":"Results from Novavax phase 3 study in the UK"},"content":{"rendered":"<div>\n<p class=\"HTBsubhead2articletitle\"><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\" \/><\/span>Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">On 30 June 2021, result from the UK sites in the Novavax phase 3 study were published in the NEJM. [1]<\/span><\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This was a randomised, placebo controlled study in over 15,000 participants who received two doses (21 days apart) of <\/span><span lang=\"EN-US\">NVX-CoV2373 or placebo. The primary endpoint was confirmed COVID-19 occurring at least seven days after the second dose.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Baseline demographics included: 28% &gt;65 years and 45% had coexisting illnesses. <\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">There were 10 vs 96 infections in the active vs placebo groups respectively, showing efficacy of 89.7% (95% CI: 80.2 to 94.6). All 5 cases or severe infection were in the placebo group.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">A post hoc analysis reported 86.3% (95% CI: 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI: 73.8 to 99.5) against non-B.1.1.7 variants. <\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Serious adverse events were low and similar in the two groups.<\/span><\/p>\n<\/div>\n<div>\n<h3 class=\"HTBcommenttitle\"><span lang=\"EN-US\">comment<\/span><\/h3>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">It is always essential for phase 3 results to be published, though the interpretation of the results is complicated as the Alpha variant is no longer dominant in the UK.<\/span><\/strong><\/p>\n<p><strong>PHE have recently published two studies (one not yet peer reviewed) reporting modest reductions in efficacy of both Pfizer and Oxford vaccines against the Delta compared to Alpha variants. [2, 3]<\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBreferences\"><span lang=\"EN-US\">Reference<\/span><\/p>\n<\/div>\n<div>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">Heath PT et al. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. NEJM. <\/span>DOI: 10.1056\/NEJMoa2107659. (30 June 2021).<br \/>\n<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2107659\">https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2107659<\/a><\/li>\n<li class=\"HTBreferences\">Lopez Bernal J et al. Effectiveness of COVID-19 vaccines against the B.1.617.2 (Delta) variant. NEJM. DOI: 10.1056\/NEJMoa2108891. (21 July 2021).<br \/>\n<a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2108891\">https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2108891<\/a><\/li>\n<li class=\"HTBreferences\">Stowe J et al. Vaccines highly effective against hospitalisation from Delta variant. PHE, pre-review access. (14 June 2021).<br \/>\n<a href=\"https:\/\/www.gov.uk\/government\/news\/vaccines-highly-effective-against-hospitalisation-from-delta-variant\">https:\/\/www.gov.uk\/government\/news\/vaccines-highly-effective-against-hospitalisation-from-delta-variant<\/a><\/li>\n<\/ol>\n<p><em>This report was first published on 5 July 2021.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 30 June 2021, result from the UK sites in the Novavax phase 3 study were published in the NEJM. [1] This was a randomised, placebo controlled study in over 15,000 participants who received two doses &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-41028","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\/41028","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=41028"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41028\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41028"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41028"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41028"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}