Sputnik V, the Russian Covid-19 vaccine, has passed a crucial test. Its efficacy has been confirmed at 91.4 per cent bsed on data analysis of the final control point analysis of data obtained 21 days after administering the first dose.
The National Research Center for Epidemiology and Microbiology named after N F Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), have announced the efficacy of over 90 per cent of the Russian Sputnik V vaccine.
It was as demonstrated by the final control point data analysis of the largest double-blind, randomized, placebo-controlled Phase III post-registration clinical trials of the Sputnik V vaccine against novel coronavirus infection in Russia’s history.
It is to be noted that Sputnik V is the world’s first registered vaccine against coronavirus based on a well-studied human adenoviral vectors platform.
According to Mikhail Murashko, Minister of Health of the Russian Federation, “The new data on efficacy of the Gamaleya Center vaccine is extremely encouraging. Today it has become obvious to everyone that the end of the pandemic is possible only after the mass vaccination of the entire global population. In this regard, ensuring equal access to effective and safe vaccines, including the Sputnik V vaccine, for people in every country should be the goal of foreign regulatory bodies and international organizations.”
Efficacy evaluation
Evaluation of efficacy was carried out among volunteers (n = 22 714) 21 days after receiving the first dose of the vaccine or placebo upon reaching the third and final statistically significant representative control point of the trial in compliance with the Phase III clinical trial protocol of the Sputnik V vaccine.
The data analysis at the final control point of the trials demonstrated a 91.4% efficacy rate. According to the protocol the advance to the final control point allowed for the final proof of the efficacy of the vaccine of over 90%.
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The analysis of the Sputnik V vaccine efficacy at the final control point was carried out on the basis of 78 confirmed cases identified in the placebo group (62 cases) and in the vaccine group (16 cases). The ratio of the placebo group to the vaccinated group is 1 to 3.
(With inputs from The OnLook News Research Bureau)
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