The Sputnik V vaccine, the world’s first registered vaccine against coronavirus created on the well-studied platform of human adenoviral vectors, in Russia has demonstrated high efficacy.
The vaccine was jointly created by The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund); it was registered on the 11th of August under the emergency use authorization mechanism.
In a statement signed by Press Secretary, Russian Direct Investment Fund Arseniy Palagin,said the confirmation was based on the first interim data gathered from the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia involving 40,000 volunteers.
It said the trials evaluated efficacy among over 16,000 volunteers who received the vaccine or placebo 21 days after the first injection.
“As a result of a statistical analysis of 20 confirmed cases of coronavirus, the case split between vaccinated individuals and those who received the placebo indicates that the Sputnik V vaccine had an efficacy rate of 92% after the second dose,” it said.
The statement said separately, in September the vaccine was first administered to a group of volunteers from the “red zones” of Russian hospitals and observed that 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.
It said data received would 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 III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report,” it said.
It said as of November 11, as part of the clinical trials in Russia’s 29 medical centers, more than 20,000 volunteers were vaccinated with the first dose and over 16,000 volunteers with the first and the second dose of the vaccine.
Additionally, it said 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.
It said during the clinical trials, the safety of the vaccine was constantly being monitored; information was analysed by the Independent Monitoring Committee comprising of leading Russian scientists.
It said 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).
“Observation of study participants will continue for six months after which the final report will be presented. Currently, Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, the UAE, Venezuela, and other countries, as well as Phase II-III in India. A separate detailed study of the vaccine’s safety and immunogenicity for elderly people is being conducted,” it said.
It said the research data would be provided by RDIF to the national regulators of countries interested in purchasing the Russian vaccine to streamline the registration process.
Mikhail Murashko, Minister of Health of the Russian Federation said the use of the vaccine and the results of clinical trials demonstrated that it was an efficient solution to stop the spread of coronavirus infection, a preventive healthcare tool, and was the most successful path to defeat the pandemic.
Alexander Gintsburg, Gamaleya Center Director said the publication of the interim results of the post-registration clinical trials that convincingly demonstrate the 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, the Sputnik V vaccine would soon be available for a wider population to reduce the infection rate in Russia and globally.