The efficacy of Sputnik V vaccine is 91.4 percent, based on the final control point analysis of data obtained 21 days after administering the first dose, according to a statement issued by Russian Direct Investment Fund (RDIF) and Gamelya Institute on Monday.
The vaccine efficacy against severe cases of coronavirus was 100 percent. Among the confirmed cases of coronavirus infection, 20 severe cases were recorded in the placebo group, while no severe cases were recorded in the vaccine group, the statement said.
BREAKING: The #SputnikV vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials. https://t.co/E9j1wk2YZT #covidvaccine #coronavirus #COVID19
— Sputnik V (@sputnikvaccine) December 14, 2020
The analysis of the efficacy at the final control point was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases). The ratio of the placebo group to the vaccinated group is 1 to 3.
As per official figure, by now more than 26,000 volunteers have been vaccinated as part of double-blind, randomised, placebo-controlled Phase III post-registration clinical trials of Sputnik V in Russia.
“The advance to the third and final statistically significant representative control point allowed for the final proof of the efficacy of the vaccine of over 90 percent,” said the statement.
RDIF said the phase III clinical trials of the vaccine is conducted in compliance with the best international standards and practices.
It stated that during the clinical trials, the safety of the vaccine is constantly being monitored; information is analysed by the Independent Monitoring Committee comprising leading scientists.
Calculation was based on the analysis of data of volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point of 78 confirmed cases in accordance with the Phase III clinical trials protocol, it said.
First Published: IST