Russia's Sputnik V vaccine against covid-19 would be more than 95% effective 42 days after the first of two mandatory inoculations has been administered, the Gamaleya National Center and the Russian sovereign wealth fund that supports it financially announced on Tuesday. The data, which have not yet been reviewed by any group of independent specialists, suggest that on a double-blind clinical trial (placebo and prototype) done on 18,794 people, 39 confirmed cases of coronavirus have been recorded. Within 28 days of the first inoculation, the efficacy was 91.4%, and over 95% two weeks later. Twenty-one days must elapse between the first and second doses.
BREAKING: I feel ond interim analysis of clinical trial data showed a 91.4% efficacy for the #SputnikV vaccine where day 28 after the first dose; vaccine efficacy is over 95%- Sputnik V (@sputnikvaccine) November 24, 2020
42 days afterthe first dose.
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The information takes place twenty-four hours after AstraZeneca and the University of Oxford have made public the results of the efficacy of their prototype, 70% on average, and 90% if first only half a dose is administered and later a full dose. In the last ten days both Pfizer-BioNTech (USA and Germany) and Moderna (USA) have also announced similar and equally encouraging results.
The 39 control cases detected according to the Russian vaccine study protocol, from which efficacy ratios are derived, are significantly less than those of Pfizer (170), Oxford (131) and Moderna (95).
The data from the provisional research will be published by the team from the National Gamaleya Centre in one of the most important international medical journals, according to the heads of the laboratories, who have also indicated that after the completion of the Phase III clinical trials they will provide access to the full report of the clinical trials.
Currently, more than 40,000 volunteers are participating in the double-blind, randomised, placebo-controlled clinical study of the Sputnik V vaccine in Russia, of which more than 22,000 were vaccinated with the first dose and more than 19,000 with the first and second doses.
The Sputnik V vaccine - named after the first satellite that circled the Earth's orbit - is based on a human adenoviral vector platform that "has been shown to be safe and effective without long-term side effects in more than 250 clinical trials worldwide over the past two decades," the researchers say. 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 compared to vaccines using the same vector per dose.
The Russian sovereign wealth fund RDIF, which has paid for the research, also assures that the cost of the vaccine will be much lower than that of its competitors - for international markets it will be less than 8.5 euros. RDIF and its collaborating partners have launched production in the freeze-dried form of the vaccine, which is stored at a conventional refrigerator temperature, between 2 and 8 degrees. As in the case of the Oxford vaccine, this would make it easier to handle.
Current agreements between RDIF and major foreign pharmaceutical companies suggest that the Sputnik V vaccine will be produced outside Russia for 500 million people a year, starting in 2021. The first international deliveries will be made to customers in January 2021. Brazil, South Korea and Hungary are among the countries with which Moscow has established collaborative agreements to produce or receive the vaccine.
In early September, The Lancet magazine validated the first safety results of the prototype. Almost a month before, Russian health authorities gave Sputnik V an emergency licence. The publication, however, asked for more information to complete the analysis.