Give J&J vaccine its separate section

ljl-covid · Jul 2, 2021 · e1ef65d · e1ef65d
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@@ -355,6 +355,13 @@ Note that the WHO will generally be unable to make statements that their more pr
 * [AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis](https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html) in an AstraZeneca press release announcing the US trial found overall 79% efficacy including in 65+ people (who constituted 20% of the trial subjects, and 60% of them had comorbidities), and 100% efficacy in preventing severe disease and hospitalization; AstraZeneca also points out that the specifically monitored for thrombosis in general and [cerebral venous sinus thrombosis](https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis) (due to the events in Europe) and found no signs of it; however, this press release was [criticized the following night, in an unusual move](https://www.nih.gov/news-events/news-releases/niaid-statement-astrazeneca-vaccine), by the [DSMB](https://en.wikipedia.org/wiki/Data_monitoring_committee), which was quickly picked up by the NIIAD and NIH as well as [Anthony Fauci commenting on it](https://www.statnews.com/2021/03/23/astrazeneca-may-have-used-outdated-information-in-announcing-covid19-vaccine-results/); the Washington Post, which has obtained a letter from the DSMB to AstraZeneca, states that [AstraZeneca used ‘outdated and potentially misleading data’ that overstated the effectiveness of its vaccine, independent panel says](https://www.washingtonpost.com/world/astrazeneca-oxford-vaccine-concerns/2021/03/23/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html), the criticism mainly being around the fact that the data appeared cherry-picked to claim a higher efficacy than the 69% to 75% inferred when all data are included, and the DSMB having discussed this with AstraZeneca prior to their press release
 * [Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2104840) is a study published on the NEJM on 28 patients in Germany and Austria, after the German Society for Thrombosis and Hemostasis Research (GTH) issued a [statement on vaccination with the AstraZeneca COVID-19 vaccine](https://gth-online.org/wp-content/uploads/2021/03/GTH-Statement-AstraZeneca_englisch_3-29-2021.pdf) which describes their findings that a [HIT](https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia)-like reaction has occurred in examined patients who suffered or died from sinus or cerebral vein thrombosis after being administered the AstraZeneca AZD11222 vaccine in Germany; [Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2104882) reports analogous findings in 5 patients in Norway, and [Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination](https://www.nejm.org/doi/full/10.1056/NEJMoa2105385) reports on 23 patients in the United Kingdom, with 30% older than 50 and 61% female, of which 7 died
 
+#### Johnson&Johnson-Janssen (aka Ad26.COV2.S, JNJ-78436735, Ad26COVS1, VAC31518)
+
+* [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
+* [FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine](https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine) after the document [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 endorsing the Johnson&Johnson vaccine; [Derek 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
+* [EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU](https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu) and subsequently the Janssen (Johnson & Johnson) Ad26.COV2.S vaccine is authorized across the EU, with a 67% reduction in the number of symptomatic COVID-19 cases (efficacy) found after 2 weeks from the jab; the EMA also released a [Q&A document in "lay language"](https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-covid-19-vaccine-janssen_en.pdf) and a [summary of product characteristics](https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-janssen-epar-product-information_en.pdf) for healthcare providers that includes an efficacy table by ages showing higher efficacy in older people
+* [COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets](https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood) after eight cases in the US, one of which fatal, were observed, which were "were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca" (cerebral venous sinus thrombosis, or splanchnic thrombosis, with thrombocytopenia) and occurred mainly in women below 60 years of age; the EMA maintains that the benefits outweigh the risks and as such it still recommends its use as a safe and effective vaccine against COVID, without any specific limitations
+
 
 #### Novavax (NVX-CoV2373)
 
@@ -372,13 +379,9 @@ Note that the WHO will generally be unable to make statements that their more pr
 * [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, [Preliminary Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant](https://www.medrxiv.org/content/10.1101/2021.02.25.21252477v1) in South Africa was 60% (among HIV-negative individuals), likely due to 90% prevalence of the South African escape variant, which the company says has initiated development of boosters for
 * [Novavax announcement of UK and South AfricaTrial Results](https://www.novavax.com/sites/default/files/2021-01/UK-SouthAfrica%20-Trial-Results.pdf) is fairly boasting ("breaking news", seriously?) but contains a lot of nice infographics and variant spread graphs
 * [Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial](https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-90-overall-efficacy-and) with 29,960 in the United States and Mexico, among which 63 cases of COVID were seen in the placebo group and 14 in the vaccine group, and the efficacy appears to remain high in patients with sequenced variants of concern
-* [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
-* [FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine](https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine) after the document [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 endorsing the Johnson&Johnson vaccine; [Derek 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
 * [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
 * [GSK and CureVac to develop next generation mRNA COVID-19 vaccines](https://www.gsk.com/en-gb/media/press-releases/gsk-and-curevac-to-develop-next-generation-mrna-covid-19-vaccines/) and [CureVac and UK Government to collaborate on development of vaccines against SARS-CoV-2 variants](https://www.curevac.com/en/2021/02/05/curevac-and-uk-government-to-collaborate-on-development-of-vaccines-against-sars-cov-2-variants/) open the road to multi-variant mRNA vaccines by these companies
 * [CureVac Provides Update on Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV](https://www.curevac.com/en/2021/06/16/curevac-provides-update-on-phase-2b-3-trial-of-first-generation-covid-19-vaccine-candidate-cvncov/) where the primary efficacy endpoint is not met, with only 47% efficacy although the majority of cases were caused by variants of concern
-* [EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU](https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu) and subsequently the Janssen (Johnson & Johnson) Ad26.COV2.S vaccine is authorized across the EU, with a 67% reduction in the number of symptomatic COVID-19 cases (efficacy) found after 2 weeks from the jab; the EMA also released a [Q&A document in "lay language"](https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-covid-19-vaccine-janssen_en.pdf) and a [summary of product characteristics](https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-janssen-epar-product-information_en.pdf) for healthcare providers that includes an efficacy table by ages showing higher efficacy in older people
-* [COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets](https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood) after eight cases in the US, one of which fatal, were observed, which were "were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca" (cerebral venous sinus thrombosis, or splanchnic thrombosis, with thrombocytopenia) and occurred mainly in women below 60 years of age; the EMA maintains that the benefits outweigh the risks and as such it still recommends its use as a safe and effective vaccine against COVID, without any specific limitations
 
 
 ### Diagnostics