{"id":40265,"date":"2021-03-12T07:26:20","date_gmt":"2021-03-12T07:26:20","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=40265"},"modified":"2021-03-12T16:14:21","modified_gmt":"2021-03-12T16:14:21","slug":"janssen-jj-vaccine-against-covid-19-is-approved-in-the-eu","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/40265","title":{"rendered":"Janssen\/J&J vaccine against COVID-19 is approved in the EU"},"content":{"rendered":"
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<\/span>Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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On 11 March 2021, the European Union authorised the COVID-19 vaccine developed by Janssen\/J&J. [1]<\/span><\/strong><\/p>\n<\/div>\n

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Approval is based on results that include an international phase 3 study (ENSEMBE 1).<\/p>\n<\/div>\n

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The was a double-blind that equally randomised 44,000 adults (age 18 years and older) in the United States, South Africa and Latin American countries\u00a0<\/span>to either a single dose of the Janssen vaccine or placebo.<\/p>\n<\/div>\n

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Results included a 67% reduced risk of symptomatic COVID-19 two weeks: 116 vs 348, in active vs placebo groups respectively.<\/p>\n<\/div>\n

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Side effects were usually mild or moderate and cleared within a couple of days after vaccination. The most common were pain at the injection site, headache, tiredness, muscle pain and nausea.<\/p>\n<\/div>\n

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comment<\/span><\/h3>\n<\/div>\n
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A date for approval in the UK is not yet available, but news on EU approval was also with notice that access in Europe was not expected until April. <\/span><\/strong><\/p>\n<\/div>\n

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The US FDA approved this vaccine a couple of weeks earlier, on 27 February 2021.<\/strong><\/p>\n<\/div>\n

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The ENSEMBLE 2 study using a double dose vaccine schedule that includes UK sites is still ongoing. [3]<\/span><\/strong><\/p>\n<\/div>\n

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References<\/span><\/p>\n<\/div>\n

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    \n
  1. EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU. (11 March 2021).
    \n<\/span>https:\/\/www.ema.europa.eu\/en\/news\/ema-recommends-covid-19-vaccine-janssen-authorisation-eu<\/a><\/li>\n
  2. FDA. Janssen COVID vaccine.
    \n    https:\/\/www.fda.gov\/emergency-preparedness-and-response\/coronavirus-disease-2019-covid-19\/janssen-covid-19-vaccine<\/a><\/li>\n
  3. ClinicalTrials.gov. A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2).
    \n    https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04614948<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 11 March 2021, the European Union authorised the COVID-19 vaccine developed by Janssen\/J&J. [1] Approval is based on results that include an international phase 3 study (ENSEMBE 1). The was a double-blind that equally randomised …<\/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-40265","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\/40265","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=40265"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/40265\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=40265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=40265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=40265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}