Russia announced on Tuesday the results of the second interim analysis of clinical trial data of Sputnik V Covid-19 vaccine which showed over 95 per cent 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 got both shots had shown that Sputnik V was 91.4% effective on day 28 and over 95% effective on day 42.
Sputnik V Covid-19 vaccine is the world’s first clinically approved vaccine against the novel coronavirus. It has been manufactured by the Gamaleya Research Institute in collaboration with the Russian Health Ministry. Gamaleya Center experts confirmed the high efficacy of the Sputnik V vaccine after double-blind, randomised, placebo-controlled Phase 3 clinical trials.
“The data demonstrating high efficacy of the Sputnik V vaccine give us hope that we will soon obtain the most important tool in the fight against the pandemic of the novel coronavirus infection,” Mikhail Murashko, Russian health minister said in a statement.
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The interim efficacy has been calculated at three representative checkpoints – upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers, both in the placebo group and in the group that received the vaccine. The analysis was carried out on the basis of 39 confirmed cases identified in the placebo group (31 cases) and in the vaccine group (8 cases).
Alexander Gintsburg, Gamaleya Center Director, asserted that the interim efficacy analysis of Sputnik V has confirmed the findings from the first stage. Gintsburg stated that they expect the efficacy rate to be even higher based on the data three weeks after the second immunisation when the body’s strongest and most stable response is achieved.
“The drug’s final efficacy assessment will be made available after Phase III clinical trials are concluded,” he added.
The United States has been sceptical over the Russian vaccine and in August, US Health Secretary Alex Azar told a news conference that it is more essential to have a safe and effective Covid-19 vaccine than acing the race. Murashko had dismissed the concerns, saying foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express “groundless” doubts.