Russia’s Sputnik V COVID-19 Vaccine Shows 91.4% Efficacy in New Trial

Russia’s Sputnik V COVID-19 vaccine has demonstrated an efficacy of over 90% in the final control point data analysis of the largest double-blind, randomized, placebo-controlled Phase 3 post-registration clinical trials of the vaccine in Russia’s history.

The Sputnik V COVID-19 vaccine was developed by the Gamaleya Institute of Epidemiology and Microbiology (Moscow, Russia) and is the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. Evaluation of efficacy was carried out among volunteers 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 3 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 3 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. A 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 new data on efficacy of the Gamaleya Center vaccine is extremely encouraging,” said Mikhail Murashko, Minister of Health of the Russian Federation. “Today it has become obvious to everyone that the end of the pandemic is possible only after the mass vaccination of the entire global population. In this regard, ensuring equal access to effective and safe vaccines, including the Sputnik V vaccine, for people in every country should be the goal of foreign regulatory bodies and international organizations.”

“Results the Sputnik V vaccine has demonstrated during the Phase 3 clinical trials support our confidence in its high efficacy and complete safety for health,” said Alexander Gintsburg, Gamaleya Center Director. “This is especially important when it comes to the beginning of large-scale vaccination of the population. I believe we will be able to vaccinate most of the population in Russia in 2021 thereby significantly reducing the scale of pandemic and creating a strong long-term immunity to coronavirus infection in a significant part of Russia's population.”

Related Links:
Gamaleya Institute of Epidemiology and Microbiology