First interim data from Phase 3 study of the Sputnik V vaccine demonstrates 92 percent efficacy, with no unexpected adverse events occurring during the clinical trial.
The Gamaleya National Center for Epidemiology and Microbiology and the Russian Direct Investment Fund announced in November 2020 that one of the world’s first registered vaccines against COVID-19, the Sputnik V vaccine displayed high efficacy results from the Phase 3 clinical trial interim data. This vaccine uses human adenoviral vectors as the vaccine platform. The first interim data were from a double-blind, randomized, placebo-controlled Phase 3 clinical trials conducted in Russia and involved 40,000 volunteers.
The study first evaluated efficacy after 21 days among more than 16,000 volunteers who had received either the vaccine or placebo. Statistical analysis found that of the 20 confirmed cases of COVID-19, the cases were split between vaccinated individuals and those who received the placebo.
Separately, in September 2020 the vaccine was first administered to a group of volunteers from the “red zones” of Russian hospitals. The observation of additional 10,000 vaccinated volunteers representing medics and other high-risk groups under the civil use of the vaccine out of clinical trials also confirmed the vaccine’s efficacy rate of over 90 percent.
The data received will be published by Gamaleya Center researchers in one of the world’s leading peer-reviewed medical academic journals following an independent valuation of the data by leading epidemiology experts. Following the completion of Phase 3 clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report.
As of November 11, as part of the clinical trials in Russia’s 29 medical centres, more than 20,000 volunteers were vaccinated with first dose and over 16,000 volunteers with the first and the second dose of the vaccine. In addition, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache.
Mikhail Murashko, Minister of Health of the Russian Federation said, “The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, a preventive healthcare tool, and this is the most successful path to defeat the pandemic.”
During the trial, safety of the vaccine was monitored closely with information analysed by an Independent Monitoring Committee comprising of lead Russian scientists. Collection, quality control and data processing were conducted in line with ICH GCP standards and involving active participation of Moscow’s Health Department and Crocus Medical, the contract research organization (CRO).
“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.” Said Alexander Gintsburg, Gamaleya Center Director.
Study volunteers will be observed for another six months after the final report is presented. At present, the Sputnik V Phase 3 clinical trials has been approved and being carried out in Belarus, the UAE, Venezuela and other countries, as well as Phase 2/3 trials in India. The vaccine’s safety and immunogenicity for elderly people is also currently being studied.
The research data will be provided by RDIF to the national regulators of countries interested in purchasing the Russian vaccine in order to streamline the registration process.
In a separate media release on the 24 November 2020, second interim analysis of the clinical trial data demonstrated 91.4 percent efficacy for the Sputnik V vaccine on day 28 after the first dose and over 95 percent efficacy 42 days are the first dose.
RDIF also mentioned in a press statement that it will continue to expand existing agreements with international manufacturing partners to produce the vaccine for more than 500 million people in 2021. The human adenoviral vector platform vaccine, Sputnik V was also mentioned to be less than $10 and will be provided free of charge to Russian citizens. [APBN]