MOSCOW, November 11. /TASS/. Effectiveness of the Sputnik V vaccine against the coronavirus according to the results of the first interim analysis of Phase Three clinical trials in Russia is at 92%, the report of the Russian Direct Investment Fund (RDIF) published on the vaccine’s official Twitter page on Wednesday said.
"The Sputnik V vaccine efficacy amounted to 92% (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo). Currently 40,000 volunteers are taking part in double-blind, randomized, placebo-controlled Phase III of clinical trials, out of which over 20,000 have been vaccinated with the 1st dose of the vaccine and more than 16,000 - with both the 1st and 2nd doses of the vaccine. Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection," the statement said.
It is also noted that the observation of 10,000 additional inoculated volunteers outside of clinical trials which include medical workers and other risk groups confirmed the vaccine’s effectiveness at a level over 90%.
The statement points out that the data obtained will be published by a team of the Gamaleya National Research Center for Epidemiology and Microbiology in one of the leading international peer-reviewed medical journals after an independent evaluation by leading international epidemiological experts.
As of November 11, during clinical trials in Russia on the basis of 29 medical centers over 20,000 volunteers were inoculated with the first dose of the vaccine and over 16,000 volunteers with the first and the second dose. No unexpected adverse effects were detected during the study. Some of the inoculated experienced short-term adverse effects such as pain at injection site, flu-like syndrome including elevated body temperature, weakness, fatigue, headache.
Observation of the study participants will continue during six months after which the final report will be prepared. Currently Phase Three trials have been approved and are conducted in the Republic of Belarus, the United Arab Emirates, Venezuela, and a number of other countries, while Phases Two and Three are conducted in India. Russia is currently conducting a separate clinical study of the vaccine’s safety and immunogenicity with the participation of elderly volunteers.
To date, requests to obtain over 1.2 bln doses of the Sputnik V vaccine have been received from over 50 countries. The vaccine for foreign markets will be produced by international partners of the RDIF in India, Brazil, China, Korea and other countries. The existing agreements between the RDIF and the international partners allow to produce abroad 500 mln doses of the Sputnik V vaccine annually. Currently the RDIF is considering additional requests from a number of countries and companies to further increase the production capacities outside of Russia.
On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Center obtained the registration certificate of the Russian Healthcare Ministry, becoming the first registered vaccine against the coronavirus worldwide.