New Delhi: The Gamaleya National Research Centre and the Russian Direct Investment Fund (RDIF) said Tuesday that interim results of the Phase III clinical trials of COVID-19 vaccine ‘Sputnik V’ showed 91.6 per cent efficacy against the pandemic. Medical journal ‘The Lancet’ has published interim results of a Phase III clinical trial of Sputnik V, confirming the vaccine’s high efficacy and safety, they said in a joint statement.
“In the interim efficacy analysis of the randomised, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo) the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6 per cent against COVID-19,” the statement said.
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). Sputnik V generated a robust humoral and cell mediated immune response.
“The Russian vaccine’s safety and high efficacy are shown by the hard scientific data presented and I congratulate the entire team of Gamaleya National Research Centre for this monumental achievement,” Gamaleya Research Institute of Epidemiology and Microbiology Director Alexander Gintsburg said in the statement.
“Several vaccines have already been created based on human adenoviruses and this tool is one of the most promising for development of new vaccines in the future. Sputnik V is one of only three vaccines in the world with efficacy of over 90 per cent but outperforms them in terms of safety, ease of transportation due to storage requirements of +2 to +8 degrees and a more affordable price,: Russian Direct Investment Fund CEO Kirill Dmitriev said.
“The vaccine fully protects against severe COVID-19 according to data which has been independently compiled and reviewed by peers and then published in ‘The Lancet’,” he added.
According to the peer-reviewed study results, the vaccine provides full protection against severe cases of the novel coronavirus infection, the statement said.
“The interim results of the phase 3 clinical trial of Sputnik V COVID adenovirus vector vaccine are fairly impressive. This vaccine appears to be highly efficacious and immunogenic across age groups,” National Institute of Health and Medical research, France, Research Director Cecil Czerkinsky said.
In the first week of February, vaccination with Sputnik V will start in 12 countries, including Bolivia, Kazakhstan, Turkmenistan, Palestine, UAE, Paraguay, Hungary, Armenia, Algeria, Bosnian Serb Republic, Venezuela and Iran, the statement said.