95+
The Sputnik V vaccine has shown efficacy above 95 percent
The second interim analysis of data from the clinical trial of the Sputnik V coronavirus vaccine showed an effectiveness of more than 95 percent on the 42nd day after the first injection.
At the same time, as reported in the Twitter account of the drug, on the 28th day after the first dose was administered, the effectiveness was 91.4 percent. The calculation was carried out after studying data on 18,794 volunteers who were vaccinated with Sputnik V or given a placebo.
According to the protocol of the third phase of studies, the intermediate efficacy of the drug is calculated at three statistically significant representative control points: upon reaching 20, 39 and 78 cases of coronavirus infection among subjects both in the control group and in the group that received the vaccine directly.
The new analysis was conducted on the basis of 39 confirmed cases in both groups (31 COVID-19 cases among placebo recipients plus eight among those vaccinated). The ratio of the control group to the vaccinated one is one to three.
"It is very important that the second interim analysis of the effectiveness of the Sputnik V vaccine confirmed the assessment that was given at the first stage, that is, we can talk about the effectiveness of the drug at 91-92 percent," Alexander Ginzburg, director of the N. F. Gamalei National Center that developed the drug, commented on the research results.
He added that the third interim data analysis is planned to be carried out after the confirmation of 78 cases of COVID-19 among volunteers. "And we have every reason to assume that the result will exceed our initial expectations. The final evaluation of the drug's effectiveness will be available at the end of phase III clinical trials," the scientist said.
For Russian citizens, vaccination with Sputnik V will be free of charge, the Russian Direct Investment Fund reported. In international markets, two doses will cost less than $20.
The world's first vaccine
At the beginning of August, the Ministry of Health registered the world's first vaccine for the prevention of COVID-19, developed on the basis of a well-studied human adenovirus vector platform by specialists of the Gamalei National Center with the support of the RDIF. It was named "Sputnik V".
In the summer, the drug successfully passed two stages of research on volunteers aged 18 to 60 years, who eventually formed an immune response and antibodies to SARS-CoV-2. The post-registration phase of testing started in September. In addition to Russia, research is carried out in the UAE, Venezuela, India and Belarus.
The third stage of the research involves 40 thousand volunteers, of whom more than 22 thousand people were vaccinated with the first injection, another 19 thousand subjects received the first and second injections.
Now Sputnik V is included in the list of ten vaccines being developed in the world that are closest to the end of the third phase of testing and the beginning of mass production. Moderna BioNTech (AstraZeneca) (mRNA-1273, efficiency – 94.5 percent), AstraZeneca (average efficiency – 70 percent) are also undergoing the final stage of research. In particular, drugs from the American Pfizer and the German BioNTech (BNT162b2, efficiency was estimated at 95 percent), Moderna (mRNA-1273, efficiency - 94.5 percent) are also undergoing the final stage of research.
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