pharmatimesNovember 12, 2020
Tag: COVID-19 vaccine , RDIF , Sputnik V
A COVID-19 vaccine developed by the Gamaleya Center in Russia is 92% effective, the Russian Direct Investment Fund (RDIF) said yesterday.
The results come from a phase III trial of Sputnik V, which evaluated the vaccine’s efficacy among over 16,000 volunteers who received the shot or placebo 21 days after the first dose.
Following statistical analysis of 20 confirmed cases of COVID-19 in the trial, the case split between vaccinated individuals and those who received placebo indicates that the Sputnik V vaccine had an efficacy rate of 92% after the second dose, said the RDIF.
As of 11 November, over 20,000 volunteers had been vaccinated with the first dose of the vaccine, and over 16,000 volunteers had received both the first and second dose.
The initial efficacy data is set to be published by researchers from the Gamaleya Center leading peer-reviewed medical academic journals. This will occur following an independent valuation of the data by epidemiology experts.
Researchers will continue to observe study participants for a further six months, after which the final report will be presented. An additional, separate study of Sputnik V’s safety and immunogenicity in elderly people is also being conducted.
“The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against COVID-19 in the coming weeks,” said Alexander Gintsburg, Gamaleya Center Director.
"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," he added.
Back in August, Sputnik V became the first COVID-19 vaccine in the world to become registered with a regulatory authority after it was approved for use by Russia’s Health Ministry.
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