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Add FDA approval of J&J (Janssen) and Pipeline and Statnews discussio…
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…ns of it

I have added no actual data, I should add some later when I actually read the document
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ljl-covid committed Feb 24, 2021
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* [Pfizer-BioNTech COVID-19 vaccine and related biological product advisory committee briefing document](https://www.fda.gov/media/144246/download) announces that this vaccine meets the FDA success criteria, with vaccine efficacy after the booster dose at 95.0%, counting 8 COVID-19 cases in the vaccine group compared to 162 COVID-19 cases in the placebo group, with a 95% credible interval of 90.3% to 97.6%
* [Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study](https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against) in a press release where they state that their BNT162b2 vaccine has more than 90% efficacy, based on 94 participant who got COVID-19 during the trial, without any serious safety concerns; the article [Vaccine Efficacy Data!](https://blogs.sciencemag.org/pipeline/archives/2020/11/09/vaccine-efficacy-data) by Derek Lowe provides an early opinion on these results
* [Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine](https://www.nejm.org/doi/pdf/10.1056/NEJMoa2034577) is the phase III study paper
* [Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 briefing document](https://www.fda.gov/media/146217/download) was released by the FDA endorses the Johnson&Johnson vaccine; [Dered Lowe](https://blogs.sciencemag.org/pipeline/archives/2021/02/24/the-jj-vaccine-at-the-fda) and [StatNews](https://www.statnews.com/2021/02/24/new-data-shed-light-on-efficacy-of-jjs-single-dose-vaccine-against-covid-19/) discuss the data


#### Oxford-AstraZeneca (AZD 1222 or ChAdOx1)
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* [Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial](https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3), as announced in a press release by the company about their NVX-CoV2373 protein-based vaccine, based on a trial that included 27% over the age of 65, and on an interim analysis after 62 cases developed, of which 56 were in the placebo group; at the same time, in the South Africa Phase 2b clinical trial, 60% efficacy was attained, possibly due to 90% prevalence of the South African escape variant, which the company says has initiated development of boosters for
* [Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial](https://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), with an overall efficacy of 66% using a single-shot scheme, although the efficacy was 72% in the US and 57% in South Africa, possibly owing to the variant there (95% of cases), and 85% effectiveness in preventing severe disease, and the vaccine was well tolerated
* [Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext) presents the first phase 3 results for the Sputnik V vaccine, with an estimated efficacy of 91.6%, and no serious adverse effects associated with vaccination
*


### Diagnostics
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