Russia's Sputnik V vaccine demonstrated efficacy of 91.6 percent against COVID-19, according to interim results of Phase 3 trials published in the journal The Lancet.
Data on 19,866 volunteers were included in the efficacy analysis. 14,964 of whom received the vaccine and 4,902 the placebo.
The calculation is based on the analysis of 78 confirmed cases of COVID-19, identified in the placebo group (62 cases) and in the vaccine group (16 cases).
Efficacy in the elderly group of 2,144 volunteers over 60 years old was 91.8 percent and did not differ statistically from the 18-60 group, said the study, adding that Sputnik V provided full protection against severe cases of COVID-19.
Registered by Russia on August 11, 2020, Sputnik V became the world's first coronavirus vaccine.
The vaccine was developed by the Gamaleya National Research Center of Epidemiology and Microbiology.
"The publication of internationally peer-reviewed data on Sputnik V's clinical trial results is a great success in the global battle against the COVID-19 pandemic," Alexander Gintsburg, Director of the Gamaleya Research Institute of Epidemiology and Microbiology, said in a statement.
The vaccine is based on a platform of human adenoviral vectors.
“Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for the development of new vaccines in the future,” Gintsburg said.
The data in the new study showed 70 episodes of serious adverse events not related to COVID-19 in 68 study participants — in 45 volunteers from the vaccine group and 23 volunteers from the placebo group.
None of these events were associated with the vaccination, as stated by an independent data monitoring committee.
Sputnik V is already registered in several countries including Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Venezuela, Paraguay, Turkmenistan, Hungary, the UAE, Iran, Republic of Guinea, Tunisia, and Armenia said the makers of the vaccine
In the first week of February, vaccination with Sputnik V is starting in several countries including Bolivia, Kazakhstan, Armenia, Algeria, Venezuela, and Iran.
The two-dose regimen of Sputnik V is administered 21 days apart.
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