17 December 2020
The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), announce the efficacy of over 90% of the Russian Sputnik V vaccine as demonstrated by the final control point data analysis of the largest double-blind, randomized, placebo-controlled Phase III post-registration clinical trials of the Sputnik V vaccine against novel coronavirus infection in Russia’s history. Sputnik V is the world’s first registered vaccine against coronavirus based on a well-studied human adenoviral vectors platform.
Evaluation of efficacy was carried out among volunteers (n = 22 714) 21 days after receiving the first dose of the vaccine or placebo upon reaching the third and final statistically significant representative control point of the trial in compliance with the Phase III clinical trial protocol of the Sputnik V vaccine. The data analysis at the final control point of the trials demonstrated a 91.4% efficacy rate. According to the protocol the advance to the final control point allowed for the final proof of the efficacy of the vaccine of over 90%.
The analysis of the Sputnik V vaccine efficacy at the final control point was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases). The ratio of the placebo group to the vaccinated group is 1 to 3.
The vaccine demonstrated 100% efficacy against severe coronavirus cases. There were 20 severe cases of coronavirus infection among confirmed cases in the placebo group and no severe cases in the vaccine group.
According to the protocol of Phase III clinical trials of the Sputnik V vaccine, its interim efficacy is calculated at three statistically significant representative control points – upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine. High efficacy rate of the vaccine above 90% was confirmed at each of the three control points of clinical trials – the calculated efficacy rate of the Sputnik V vaccine at the first control point (20 cases) was 92% and 91.4% at the second point (39 cases).
Based on the data obtained at the third control point the Gamaleya Center will create a report that will be used to submit for accelerated registration of the Sputnik V vaccine in various countries.
The research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals.
Kirill Dmitriev, CEO, Russian Direct Investment Fund, said:
“The data analysis at the third and final control point of the Sputnik V vaccine clinical trials confirmed the efficacy of the vaccine of over 90%. Clinical trials have proven this in the three consecutive statistically important points described in trials protocol. The data obtained will lay a basis for a report that will be used to submit applications for accelerated registration of the Russian vaccine in other countries. We also see high interest from international pharmaceutical companies in the Gamaleya Center vaccine, since the use of Sputnik V components in combination with other vaccines can significantly increase their efficacy.”Print
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