02 February 2021 | News
Lancet has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety
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The Gamaleya National Research Center of Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund (RDIF) announce that the Lancet has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety.
In the interim efficacy analysis of the randomised, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo), the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6 per cent against COVID-19.
Alexander Gintsburg, Director, Gamaleya Research Institute of Epidemiology and Microbiology, said: “The publication of internationally peer reviewed data on Sputnik V’s clinical trial results is a great success in the global battle against the COVID-19 pandemic.”
Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “The data published by The Lancet proves that not only Sputnik V is the world’s first registered vaccine, but also one of the best.”
Cecil Czerkinsky, Research Director, National Institute of Health and Medical research (Inserm), France, said, “The interim results of the phase 3 clinical trial of Sputnik V COVID adenovirus vector vaccine are fairly impressive. This vaccine appears to be highly efficacious and immunogenic across age groups.”
Len Seymour, Professor, Gene Therapies, Department of Oncology, University of Oxford, UK, commented, “The data indicate that the Sputnik V vaccine shows encouraging activity, including in a cohort of participants aged 60 and above.”
Importantly, the study included 2,144 volunteers over 60 years old with the maximum ages of 87 years (vaccine group) and 84 years (placebo group), showing great safety results for the elder age strata.