- The Sputnik V vaccine efficacy amounted to 92% (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo). Currently 40,000 volunteers are taking part in double-blind, randomized, placebo-controlled Phase III of Sputnik V clinical trials, out of which over 20,000 have been vaccinated with the first dose of the vaccine and more than 16,000 with both the first and second doses of the vaccine.
- Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection.
- There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
- The world’s first registration of COVID-19 vaccine, done in Russia on the 11th of August under the emergency use authorization mechanism, enables the Russian Federation to administer the vaccine outside of the clinical trials to volunteers such as medics and other high-risk groups. Trials conducted under the civil use of the vaccine in Russia (not being a part of clinical trials) based on the monitoring of additional 10,000 vaccinated confirmed vaccine efficacy at a rate of over 90%.
- The interim research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report.
- Currently Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, UAE, Venezuela and other countries, as well as Phase II-III – in India.
- The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that had proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953). More than 100,000 people have received approved and registered drugs based on the human adenoviral vectors.
- The uniqueness of the Russian vaccine is in using two different human adenoviral vectors that enable to provide strong and long-term immune response after the second injection.