The Russian coronavirus vaccine Sputnik V is 95% effective, data has shown. It will likely cost less than $10 (Rs 740) globally.
One dose of Sputnik V, the Russian coronavirus vaccine, which has shown over 95% efficacy, will cost less than $10 (Rs 740) for international markets. Two doses of the Covid-19 vaccine is required for every person to be protected from SARS-CoV-2 coronavirus, the cost of the Russian jab will be less than $20 (Rs 1480) per individual.
The first international delivery of Sputnik V Covid-19 vaccine will be made in January. The Russian Covid-19 vaccine will be manufactured in India besides other countries, said the Russian Direct Investment Fund (RDIF), which is managing the global reach of the Russian vaccine candidate.
The RDIF is expanding the existing agreements with international manufacturing partners to produce the vaccine for more than 500 million people in 2021.
Vaccination with Sputnik V will be free of charge for Russian citizens.
At $10 (Rs 740) per dose, Sputnik V is expected by half or less as expensive as the mRNA vaccine candidates being developed by Pfizer and Moderna. All three Covid-19 vaccine candidates have shown similar efficacy levels. This is based on the announced mRNA vaccines pricing and interim Phase III results.
The RDIF and partners have launched the production of the lyophilized (dry) form of the vaccine (stored at 2-8°C). It enables the logistics of distribution of the vaccine in international markets, as well as use in remote locations including areas in the tropical climates having higher temperatures.
SPUTNIK V EFFICACY DATA
The second interim analysis of the clinical trial data showed a 91.4 per cent efficacy for the Sputnik V vaccine on Day-28 after the first dose — 7 days after the second dose.
Calculation was based on the analysis of data on volunteers (n = 18,794) who received both the first and second doses of the Sputnik V vaccine or placebo at the second control point (39 confirmed cases as of November 23, 2020) in accordance with the clinical trial protocol.
Preliminary data from volunteers obtained 42 days after the first dose — 21 days after the second dose — indicate an efficacy of the vaccine above 95 per cent.
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, Gamaleya Center will provide access to the full clinical trial report.
There were no unexpected adverse events during the trials. Monitoring of the participants continues. Preliminary data has already been given to the WHO, the RDIF said.
Currently, 40,000 volunteers are taking part in the Phase-III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia, of whom more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
SUPPLY OF SPUTNIK V TO BUYERS
The RDIF said it is working with the regulatory agencies with all the fifteen countries with whom agreement has been signed for the supply of Sputnik V. the Russian fund said the manufacturing of Sputnik V will take place in India, Brazil and China among other countries.
The RDIF is currently considering additional applications from a number of countries and companies to further increase production capacity. Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021, it said.
HOW IT WORKS
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has proven to be safe and effective with no long-term side effects in more than 250 clinical trials conducted over the past two decades. The RDIF said more than 100,000 people have received approved and registered drugs based on human adenoviral vectors.
The uniqueness of the Russian vaccine lies, it said, in the use of two different human adenoviral vectors. This results into a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.
RDIF CEO Kirill Dmitriev said, “The Gamaleya Center has developed one of the most efficient vaccines against coronavirus in the world with an efficacy rate of more than 90% and a price that is two times lower than that of other vaccines with similar efficacy rate. 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. We are ready to start deliveries of the Sputnik V vaccine to foreign markets thanks to partnerships with manufacturers in India, Brazil, South Korea, China and four other countries.”
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.