The Lancet has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine demonstrated efficacy of 91.6%. Sputnik V, which is based on a well-studied human adenoviral vectors platform, is the world’s first registered vaccine against coronavirus.
In the interim efficacy analysis of the randomized, 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% against COVID-19. The calculation is based on the analysis of 78 confirmed cases of COVID-19 identified in the placebo group (62 cases) and in the vaccine group (16 cases). Sputnik V generated a robust humoral and cell mediated immune response.
Alexander Gintsburg, Director of the 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. The Russian vaccine’s safety and high efficacy are shown by the hard scientific data presented and I congratulate the entire team of Gamaleya National Research Center for this monumental achievement. Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for development of new vaccines in the future.”
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented: “This is a great day in the fight against the COVID-19 pandemic. 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. It fully protects against severe COVID-19 according to data which has been independently compiled and reviewed by peers and then published in The Lancet. Sputnik V is one of only three vaccines in the world with efficacy of over 90% but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees and a more affordable price. Sputnik V is a vaccine for all mankind.”