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Gamaleya Sputnik V

Sputnik V Vaccine Updates

Interim Findings

  • November 24, 2020: The Gamaleya Center and the Russian Direct Investment Fund announced that their COVID-19 vaccine candidate is 91.4% effective in preventing COVID-19 starting 28 days after participants receive the first dose of the vaccine (7 days after the second dose). The data reported included a total of 18,794 study participants. Of these, 14,095 received the Sputnik V vaccine and 4,699 received a placebo vaccine. A total of 39 cases of laboratory-confirmed COVID-19 were identified, 8 among people who received the Sputnik V vaccine and 31 among people who received a placebo vaccine. In addition, the vaccine is over 95% effective when only counting cases beginning 42 days after the first dose (21 days after the second dose). These findings are consistent with immunity from COVID-19 increasing over time following the second vaccination. However, we still do not know how long immunity lasts. No serious safety concerns have been reported.
    • Several unanswered questions remain:
      1. We do not know how long immunity lasts.
      2. The investigators appear to be including all cases of laboratory-confirmed COVID-19, not just those that cause the patient to have symptoms. This is different than studies being conducted in the United States, where the primary focus is on symptomatic COVID-19. Thus, we do not know if the Sputnik V vaccine reduces the risk of developing symptomatic COVID-19.
      3. We do not know if the Sputnik V vaccine reduces the risk of developing severe COVID-19, being hospitalized, or dying.
      4. We do not believe that the developers of this vaccine have made their full study protocol available online. This is important because all analyses conducted should be planned from the beginning of the study. Publishing the protocol helps to ensure that the developers do not change their analyses in a way that biases their findings.
  • November 11, 2020: The Gamaleya Center and the Russian Direct Investment Fund announced results from the first interim analysis of their COVID-19 vaccine candidate, Sputnik V. They report that the vaccine is 92% effective in preventing COVID-19 starting 21 days after the first dose of the vaccine. The trial included data from over 16,000 study participants. Among these individuals, a total of 20 people developed laboratory-confirmed COVID-19. The announcement does not say how many of these 20 people had received the Sputnik V vaccine.
    • Several unanswered questions remain:
      1. We do not know how long immunity lasts.
      2. The investigators appear to be including all cases of laboratory-confirmed COVID-19, not just those that cause the patient to have symptoms. This is different than studies being conducted in the United States, where the primary focus is on symptomatic COVID-19. Thus, we do not know if the Sputnik V vaccine reduces the risk of developing symptomatic COVID-19.
      3. We do not know if the Sputnik V vaccine reduces the risk of developing severe COVID-19, being hospitalized, or dying.
      4. We do not believe that the developers of this vaccine have made their full study protocol available online. This is important because all analyses conducted should be planned from the beginning of the study. Publishing the protocol helps to ensure that the developers do not change their analyses in a way that biases their findings.

Manufacturing

  • November 27, 2020: The Russian Direct Investment Fund and Hetero (a major generic pharmaceutical company in India) have reached an agreement to make 100 million doses of the Sputnik V vaccine per year beginning in 2021.
  • November 13, 2020: The Russian Direct Investment Fund has reached an agreement with GL Rapha (a major bio-tech company in South Korea) to make 150 million doses of the Sputnik V vaccine per year, beginning in December 2020. The vaccine will be distributed globally.
  • September 30, 2020: The Russian Direct Investment Fund has reached an agreement with Pharco (a major pharmaceutical group in Egypt) to supply 25 million doses of the Sputnik V vaccine to Egypt. This will give 25% of the population of Egypt access to this vaccine.
  • September 29, 2020: The Russian Direct Investment Fund has reached an agreement with Trinity Pharmaceutical (a major pharmaceutical distributor in Nepal) to supply 25 million doses of the Sputnik-V vaccine to Nepal. This will give 90% of the population of Nepal access to this vaccine.
  • September 25, 2020: The Russian Direct Investment Fund has reached an agreement with LAXISAM (a major pharmaceutical company in the Republic of Uzbekistan) to supply up to 35 million doses of the Sputnik V vaccine to Uzbekistan in 2020-2021.
  • September 16, 2020: The Russian Direct Investment Fund (RDIF) has reached an agreement with Dr. Reddy’s Laboratories (a major pharmaceutical company in India) to cooperate on clinical trials and distribution of the Sputnik V vaccine in India. After the vaccine is approved for use in India, the RDIF will supply 100 million doses of the vaccine, potentially beginning in December 2020.
  • September 11, 2020: The Russian Direct Investment Fund has reached an agreement with the State of Bahia (Brazil) to supply up to 50 million doses of the Sputnik V vaccine, potentially beginning in November 2020. The agreement assumes that the vaccine is approved for use in Brazil by regulatory agencies.
  • September 9, 2020: The Russian Direct Investment Fund has reached an agreement with Landsteiner Scientific pharmaceutical company to supply up to 32 million doses of the Sputnik V vaccine to Mexico. This will give 25% of the people in Mexico access to the Sputnik V vaccine.
  • August 26, 2020: The Russian Direct Investment Fund has reached an agreement with SK-Pharmacy (a pharmaceutical company in Kazakhstan) to supply the Sputnik V vaccine to Kazakhstan. The press release does not say how many doses will be provided.