Sputnik V shows 91.4% efficacy 28 days after 1st dose; over 95% 42 days after 1st dose
Phase III trials ongoing in Belarus, UAE, Venezuela and other countries, as well as Phase II-III in India; vaccine suppliers to include RDIF’s international partners in India, Brazil, China, South Korea and other countries
Russia’s Sputnik V vaccine could have an efficacy rate of over 95 per cent, based on a second interim analysis Phase III trial data, released by the National Research Center for Epidemiology and Microbiology (Gamaleya Center) and the Russian Direct Investment Fund (RDIF).
Evaluation of efficacy was carried out among volunteers (n = 18,794) 28 days after receiving the first dose (seven days after the second dose) of the vaccine or placebo upon reaching the second control point of the trial in compliance with the clinical trial protocol. As per a release, the analysis demonstrated a 91.4 per cent efficacy ratesecond interim analysis Phase III
According to the protocol of Phase III clinical trials of the Sputnik V vaccine, its interim efficacy is calculated at three statistically significant representative control points – upon reaching 20, 39 and 78 cases of novel coronavirus infection among volunteers both in the placebo group and in the group that received the vaccine.
The second interim analysis of the Sputnik V vaccine efficacy was carried out on the basis of 39 confirmed cases identified in the placebo group (31 cases) and in the vaccine group (eight cases). The ratio of the placebo group to the vaccinated group is 1 to 3.
As per the release, preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they are expected to have formed a stable immune response, indicates the efficacy rate of the vaccine is above 95 per cent.
The next interim data analysis will be conducted upon reaching the third control point of 78 confirmed coronavirus cases among the study participants. Final data analysis will be available by the end of Phase III clinical trials.
The interim research data is to be published by the Gamaleya Center team in a leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, the Gamaleya Center will provide access to the full clinical trial report.
As of November 24 more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and the second dose of the vaccine at 29 medical centers in Russia as part of the ongoing clinical trials. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.
As of November 24, 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 point and flu-like symptoms including fever, weakness, fatigue, and headache, as per the statement.
Alexander Gintsburg, Gamaleya Center Director expects “the efficacy rate to be even higher based on the data three weeks after the second immunisation when the body’s strongest and most stable response is achieved. We plan to conduct the third interim data analysis after 78 confirmed coronavirus cases among volunteers and we have every reason to believe that the results will exceed our initial expectations.”
According to Kirill Dmitriev, CEO, Russian Direct Investment Fund, the uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.
On September 4, The Lancet published a research paper on the results of Phase I and Phase II clinical trials of the vaccine that showed no serious adverse events and an effective immune response of those vaccinated.
Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries as per the release, and vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries.