The efficacy of the Sputnik V vaccine is calculated based on 20 confirmed Covid-19 cases, who received either vaccine or the placebo
The National Research Centre for Epidemiology and Microbiology (Gamaleya Centre) and the Russian Direct Investment Fund (RDIF) announced that their Sputnik V vaccine has shown 92% efficacy in preventing Covid-19.
Sputnik V was developed by the Gamaleya Centre, using a technological platform of human adenoviral vectors.
The vaccine was registered by Russia’s Health Ministry on 11 August 2020, to become the world’s first registered Covid-19 vaccine.
The vaccine’s efficacy is based on the first interim data analysed from the large-scale double-blind, randomised, placebo-controlled Phase 3 clinical trials, conducted in 40,000 volunteers in Russia.
The Phase 3 trials evaluated the efficacy of the vaccine in more than 16,000 volunteers who received either the vaccine or placebo, 21 days after the first injection.
The statistical analysis of 20 confirmed Covid-19 cases indicated that the Sputnik V vaccine showed an efficacy rate of 92% after the second dose.
Gamaleya Centre director Alexander Gintsburg said: “The publication of the interim results of the post-registration clinical trials that convincingly demonstrate Sputnik V vaccine’s efficacy gives way to mass vaccination in Russia against Covid-19 in the coming weeks.
“Thanks to the production scale-up at new manufacturing sites, Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in Covid-19 infection rates, first in Russia, then globally.”
As part of the clinical trials, 29 medical centres in Russia vaccinated more than 20,000 volunteers with the first dose and more than 16,000 volunteers with the first and the second dose of the Sputnik V vaccine.
The collection, quality control and data processing are in line with ICH GCP standards, and Moscow’s Health Department and Crocus Medical, a contract research organisation (CRO) supported the clinical trials, said RDIF.
The vaccine did not result in any unexpected adverse events, except few short-term minor adverse events including pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache observed in the vaccinated individuals.
Phase 3 trials of Sputnik V being held in Belarus, UAE and Venezuela
Currently, Phase 3 Sputnik V trials are approved and are underway in Belarus, the UAE, Venezuela and other countries, along with Phase 2/3 trials in India.
RDIF said that the research data will be provided to the national regulators of countries willing to buy the Russian vaccine, to simplify the registration process.
RDIF CEO Kirill Dmitriev said: “Sputnik V is the first registered vaccine against Covid-19 in the world, the vaccine is based on safe and effective platform of human adenoviral vectors.
“More and more countries are recognizing the human adenoviral vector platform and plan to include these vaccines, as the most studied and known, in their respective national vaccine portfolio.
“I would also like to stress the importance of international cooperation and close partnership among vaccine-developing states. Vaccines should be above politics. The world needs a diversified portfolio of high-quality vaccines with Sputnik V, based on the well-tested human adenoviral vector platform, being an important element of it.”