Russia announced on Tuesday the results of the second interim analysis of data from the Sputnik V Covid-19 vaccine clinical trial, which showed greater than 95% efficacy 42 days after the first dose.
Kirill Dmitriev, head of Russia’s RDIF sovereign wealth fund, said that new clinical trial data based on 39 confirmed cases and 18,794 patients who received both injections had shown that Sputnik V was 91.4% effective on day 28 and more than 95% on day 42.
The Sputnik V Covid-19 vaccine is the world’s first clinically approved vaccine against the new coronavirus. It has been manufactured by the Gamaleya Research Institute in collaboration with the Russian Ministry of Health. Experts from the Gamaleya Center confirmed the high efficacy of the Sputnik V vaccine after phase 3, double-blind, randomized, placebo-controlled clinical trials.
“The data demonstrating the high efficacy of the Sputnik V vaccine gives us hope that we will soon obtain the most important tool in the fight against the novel coronavirus infection pandemic,” said Mikhail Murashko, Russian minister of health at a release.
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The provisional efficacy has been calculated in three representative control points: reaching 20, 39 and 78 cases of infection by the new coronavirus among the volunteers, both in the placebo group and in the group that received the vaccine. The analysis was performed on the basis of 39 confirmed cases identified in the placebo group (31 cases) and in the vaccine group (8 cases).
Alexander Gintsburg, Director of the Gamaleya Center, stated that the provisional efficacy analysis of Sputnik V has confirmed the findings of the first stage. Gintsburg stated that they expect the efficacy rate to be even higher based on the data three weeks after the second immunization, when the body’s strongest and most stable response is achieved.
“The final evaluation of the drug’s efficacy will be available after the conclusion of phase III clinical trials,” he added.
The United States has been skeptical of the Russian vaccine and in August, US Health Secretary Alex Azar told a press conference that having a safe and effective Covid-19 vaccine is more essential than competing in the race. Murashko had dismissed the concerns, saying his foreign colleagues are perceiving the specific competitive advantages of the Russian drug and are trying to express “unfounded” doubts.
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