Add CureVac press release, failing primary endpoint with 47% efficacy

ljl-covid · Jun 16, 2021 · f136d49 · f136d49
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 * [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