Sputnik V vaccine efficacy confirmed at '91.4 per cent' during Phase 3 trials
Dec 14, 2020
Moscow [Russia], December 14 : The efficacy of the Sputnik V COVID-19 vaccine has been confirmed to be 91.4 per cent, based on data analysis of the final control point of clinical trials, announced the Gamaleya National Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) on Monday.
According to a joint statement, the Gamaleya Center and RDIF announced the efficacy of over 90 per cent, as demonstrated by the final control point data analysis of the largest double-blind, randomised, placebo-controlled Phase 3 post-registration clinical trials of the Sputnik V vaccine against the novel coronavirus.
"The data analysis at the third and final control point of the Sputnik V vaccine clinical trials confirmed its efficacy of the of over 90 per cent. Clinical trials have proven this in the three consecutive statistically important points described in the trial protocol," remarked RDIF Chief Executive Officer Kirill Dmitriev.
The joint statement read that 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," said the joint statement.
As of Monday, over 26,000 volunteers were vaccinated at 29 medical centres in Russia, as part of the ongoing clinical trials. Currently, Phase 3 trials are ongoing in countries like Belarus, the United Arab Emirates (UAE), and Venezuela, while Phase 2/3 trials are being conducted in India.
The statement mentioned that no unexpected adverse events were identified as part of the research as of now, although some of those vaccinated had short-term minor adverse events such as pain at the injection point and flu-like symptoms, including fever, weakness, fatigue, and headache.
"The new data on the 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, for people in every country should be the goal of foreign regulatory bodies and international organizations," said Mikhail Murashko, Minister of Health of the Russian Federation.
Russia became the first country to register the world's first COVID-19 vaccine on August 11, Sputnik V, named after Russia's first satellite.
