The Sputnik V vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials
December 14, 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.
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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.***
As of December 14 more than 26,000 volunteers were vaccinated at 29 medical centers in Russia as part of the ongoing clinical trials. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.
As of December 14, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection point and flu-like symptoms including fever, weakness, fatigue, and headache.
During the clinical trials, the safety of the vaccine is constantly being monitored; information is analyzed by the Independent Monitoring Committee comprising leading Russian scientists. Collection, quality control and data processing is conducted in line with ICH GCP standards and involves the active participation of Moscow’s Health Department and Crocus Medical, the contract research organization (CRO).
Sputnik V has a unique set of parameters making it one of the most competitive vaccines globally.
The efficacy rate is over 90% and the vaccine is based on a safe and proven platform of human adenoviral vectors.
Cost of one dose is less than $10 for international markets while the production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius, enables easier distribution of the vaccine in international markets.
Mikhail Murashko, Minister of Health of the Russian Federation, said:
“The new data on efficacy of the Gamaleya Center vaccine is extremely encouraging. 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.”
Alexander Gintsburg, Gamaleya Center Director, said:
“Results the Sputnik V vaccine has demonstrated during the Phase III clinical trials support our confidence in its high efficacy and complete safety for health.
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.”
Denis Logunov, Gamaleya Center Deputy Director, commented:
“The Sputnik V vaccine has proven to be highly effective, as demonstrated by the data from the initial stages of the study that were announced earlier. It is important that at each stage the calculated vaccine efficiency rate exceeded 90%. We will definitely share the results achieved with the scientific community and will be happy to discuss them with all interested colleagues. Monitoring of participants’ condition will continue.”
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.”
https://rdif.ru/Eng_fullNews/6155/
