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Tuesday, November 24, 2020

91.4% efficiency for Sputnik V vaccine on Day 28 after 1st dose, over 95% 42 days after

 

  • 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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