{"id":40038,"date":"2021-02-24T07:26:50","date_gmt":"2021-02-24T07:26:50","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40038"},"modified":"2021-02-27T18:47:45","modified_gmt":"2021-02-27T18:47:45","slug":"janssen-vaccine-reports-efficacy-after-single-injection-fda-decision-imminent","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40038","title":{"rendered":"Janssen vaccine reports efficacy after single injection: FDA decision imminent"},"content":{"rendered":"

<\/span><\/strong>Simon\u00a0Collins,\u00a0HIV\u00a0i-Base<\/b><\/p>\n

On 29 January 2021, Johnson & Johnson reported 66% efficacy against moderate to severe COVID-19 after a single dose of the Ad26.COV2.S\u00a0 <\/span>adenovirus-based vaccine developed by Janssen.<\/strong> The vaccine reduced the risk of severe COVID-19 by 85% and results included efficacy against the B.1.351 variant in South Africa.\u00a0 <\/span>[1]<\/strong><\/p>\n

On 25 February, the results were published in an FDA briefing report with a planned FDA review the next day, which recommended authorisation in the US. [2, 3]<\/p>\n

The phase 3 ENSEMBLE 1 study randomised almost 44,000 participants in eight countries and included 34% aged over 60 years old. Approximately 44% of participants were in the US, 41% in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% in South Africa.\u00a0Approximately 40% had at least one comorbidities associated with an increased risk for severe COVID-19. This included obesity (28%), type 2 diabetes (7%), hypertension (10%) and HIV (3%).<\/p>\n

Efficacy results were based on COVID-19 symptoms 28 days after the injection and were similar in different regions: 72% in the US, 66% in Latin America and 57% in South Africa. Efficacy increased over time with no cases of severe COVID-19 reported seven weeks after infection.<\/p>\n

Overall tolerability was good, with grade 3 fever reported in 0.2% of participants and no cases of anaphylactic reactions.<\/p>\n

A second study, ENSEMBLE 2, that includes sites in the UK, is also looking at a two-dose schedule with this vaccine.<\/p>\n

comment<\/h3>\n

On 26 February 2021, (just after the HTB mailing) the US FDA vaccine advisory panel recommended unanimously that the vaccine should be approved for emergency use authorisation (EUA). [3]<\/strong><\/p>\n

Although recommendations are non-binding, an EUA is expected shortly.<\/strong><\/p>\n

Reference<\/p>\n

    \n
  1. Johnson & Johnson announces single-shot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of its phase 3 ENSEMBLE trial. (29 January 2021).
    \nhttps:\/\/www.jnj.com\/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial<\/a><\/li>\n
  2. FDA Briefing Document. Janssen Ad26.COV2.S vaccine for the prevention of COVID-19. (28 February 2021).
    \n    https:\/\/www.fda.gov\/media\/146217\/download<\/a><\/li>\n
  3. J&J press statement. Johnson & Johnson single-shot COVID-19 vaccine candidate unanimously recommended for emergency use authorization by U.S. FDA advisory committee. (26 February 2021).
    \n    https:\/\/www.jnj.com\/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee<\/a><\/li>\n<\/ol>\n

    This report was updated on 27 February 2021 to include the FDA approval.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Simon\u00a0Collins,\u00a0HIV\u00a0i-Base On 29 January 2021, Johnson & Johnson reported 66% efficacy against moderate to severe COVID-19 after a single dose of the Ad26.COV2.S\u00a0 adenovirus-based vaccine developed by Janssen. The vaccine reduced the risk of severe COVID-19 by 85% and results …<\/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-40038","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\/40038","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=40038"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40038\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40038"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40038"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40038"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}