Moscow: Russia on Wednesday said that its vaccine Sputnik V is 92 per cent effective at protecting people from COVID-19 according to the first interim analysis.
“The Sputnik V vaccine efficacy amounted to 92 per cent (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo),” the Russian Direct Investment Fund (RDIF) said in a statement read.
Currently, Sputnik V phase III clinical trials are approved and are undergoing in Belarus, the UAE, Venezuela and other countries. In India, phase II-III trials of the vaccine are underway.
Currently, 40,000 volunteers are taking part in double-blind, randomised, placebo-controlled Phase III of Sputnik V clinical trials, out of which over 20,000 have been vaccinated with the first dose of the vaccine and more than 16,000 with both the first and second doses of the vaccine.
“The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, a preventive healthcare tool, and this is the most successful path to defeat the pandemic.”Russian Health Minister Mikhail Murashko said
The efficacy was demonstrated based on a first interim analysis obtained 21 days after the first injection.
There were no unexpected adverse events during the trials and monitoring of the participants is ongoing.
The announcement by Russia comes days after drug giant American Pfizer announced that its coronavirus vaccine was more than 90 per cent effective at protecting people from infection as compared to placebo saline shot, as per the analysis.
Russia became the first country to register the world’s first COVID-19 vaccine on August 11. Sputnik V was developed by the Gamaleya National Research Centre for Epidemiology and Microbiology of the Russian Healthcare Ministry.
The company said that the Gamaleya Centre team will publish the interim research data in one of the leading international peer-reviewed medical journals.
Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Centre will provide access to the full clinical trial report.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that had 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 use of human adenoviruses in vaccine development started in 1953). More than 100,000 people have received approved and registered drugs based on the human adenoviral vectors.
Alexander Gintsburg, Gamaleya Centre Director said that the publication of the interim results of the post-registration clinical trials of Sputnik V vaccine would give way to mass vaccination in Russia against COVID-19 in the coming weeks
“Thanks to the production scale-up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in COVID-19 infection rates, first in Russia, then globally,” Gintsburg said.