The efficacy of the Sputnik V vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose (7 days after the second dose).
Calculation was based on the analysis of data on volunteers (n = 18,794) who received both the first and second doses of the Sputnik V vaccine or placebo at the second control point (39 confirmed cases as of November 23, 2020) in accordance with the clinical trial protocol.
Preliminary data from volunteers obtained 42 days after the first dose (corresponds with 21 days after the second dose) indicates an efficacy of the vaccine above 95%.
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, 40,000 volunteers are taking part in the Phase III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia, of whom more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has 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 the use of human adenoviruses in vaccine development began in 1953. More than 100,000 people have received approved and registered drugs based on human adenoviral vectors.
The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.
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