Russia’s Sputnik V vaccine shows 95% efficacy after 42 days, one dose to be priced under $10

New Delhi/Moscow: During the interim trial results, Russia’s COVID-19 vaccine, Sputnik V has shown 95% efficacy. As per its developers, the cost of vaccines for international markets will be less than $10 per dose starting from February 2021, which is less than $20 for the two doses necessary to vaccinate one person.

Sputnik V vaccine is the world’s first registered vaccine against coronavirus based on a well-studied platform of human adenoviral vectors. The National Research Center for Epidemiology and Microbiology, Russia, and the Russian Direct Investment Fund announced positive results obtained during the second interim data analysis of the largest double-blind, randomized, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers.

Evaluation of efficacy was carried out among volunteers (n = 18,794) 28 days after receiving the first dose (7 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. The analysis demonstrated a 91.4% efficacy rate for the Sputnik V vaccine.

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 (8 cases). The ratio of the placebo group to the vaccinated group is 1 to 3.

The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and the same vector for two doses. So, preliminary data on volunteers on the 42nd day after the first dose (equivalent to 21 days after the second dose), when they have already formed a stable immune response, indicates the efficacy rate of the vaccine is above 95%.

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 will be published by the Gamaleya Center team in one of the 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 per the company, 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.

During the clinical trials, the safety of the vaccine is constantly being monitored; information is analyzed by the Independent Monitoring Committee comprising leading Russian scientists. Collection, quality control and data processing is conducted in line with ICH GCP standards and involves the active participation of Moscow’s Health Department and Crocus Medical, the contract research organization (CRO).

One dose of Sputnik V vaccine to be priced under $10 for international markets

As per RDIF, the cost of Sputnik V vaccine for international markets will be less than $10 per dose starting from February 2021, which is less than $20 for the two doses necessary to vaccinate one person. Thus, Sputnik V will be two or more times cheaper than foreign vaccines based on mRNA technology with similar efficacy rates. For Russian citizens, vaccination with Sputnik V will be free of charge.

The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as compared to vaccines using one and same vector for two doses.

Currently, RDIF and partners have launched production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius. Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates.

Current agreements between RDIF and leading foreign pharmaceutical companies allow production of the vaccine abroad for 500 million people per year starting from 2021. RDIF is currently considering additional applications from a number of countries and companies to further increase production capacity.

The first foreign deliveries of the Russian Sputnik V vaccine will be made to customers in January 2021 based on existing partnerships with foreign manufacturers. Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021.