SECOND INTERIM ANALYSIS OF CLINICAL TRIAL DATA SHOWED A 91.4% EFFICACY FOR THE SPUTNIK V VACCINE ON DAY 28 AFTER THE FIRST DOSE; VACCINE EFFICACY IS OVER 95% 42 DAYS AFTER THE FIRST DOSE
- 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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The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades - while the history of use of human adenoviruses in vaccine development started in 1953. Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so called "spikes" forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body's stable immune response. On September 4, The Lancet, one of world?s leading medical journals, published a research paper on the results of Phase I and Phase II clinical trials of the vaccine that showed no serious adverse events and an effective immune response of those vaccinated. Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF?s international partners in India, Brazil, China, South Korea and other countries. On August 11, the Sputnik V vaccine developed by the Gamaleya Center was registered by Russia?s Health Ministry and became the world?s first registered vaccine against COVID-19. Detailed information on the Sputnik V vaccine, its human adenoviral vectors technological platform, and other details are available at?sputnikvaccine.com Be the first to learn about Sputnik V on social networks: Twitter Facebook Instagram Youtube***
Russian Direct Investment Fund (RDIF)?is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF?s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 trillion and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia?s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn. Further information can be found at?rdif.ru The Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation?is one of the oldest research centers in Russia, which celebrated its 100th anniversary in 1991. The main focus of the center's research is the fundamental problems in epidemiology, medical and molecular microbiology, and infectious immunology. More information can be found at?gamaleya.org For additional information contact: Arseniy Palagin Russian Direct Investment Fund Press Secretary Tel: +7 495 644 34 14, ext. 2395 Mobile: +7 916 110 31 41 E-mail:?arseniy.palagin@rdif.ru Andrew Leach / Maria Shiryaevskaya Hudson Sandler Tel: +44 (0) 20 7796 4133