Russia’s sovereign wealth fund and the Hyderabad-based Hetero Biopharma, engaged in manufacturing generic medicines have inked a pact to produce more than 100 million doses per year in India of the Sputnik V vaccine.
The Russian Direct Investment Fund (RDIF), which has been backing the vaccine and marketing it globally, plans to start production at the beginning of 2021.
Sputnik V is based on a well-studied platform of human adenoviral vectors and has demonstrated a 91.4 percent efficacy rate, according to the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia involving 40,000 volunteers. The results were announced by Gamaleya Center and RDIF on November 24.
Phase 3 clinical trials of the vaccine are approved and ongoing in Belarus, the UAE, Venezuela and other countries, and Phase 2/3 have been approved in India. India, along with Brazil, China, South Korea and others, will provide the vaccine to at least 50 countries that have requested over 1.2 billion doses.
“An application has been submitted by RDIF to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of Sputnik V,” said Alexander Gintsburg, director general of The Gamaleya Research Institute, Moscow.
Evaluation of efficacy was carried out among volunteers 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.
The analysis demonstrated a 91.4 percent efficacy rate for the Sputnik V vaccine. 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 with vaccines using one and the same vector for two doses, according to a statement from the company.
Currently, the third and final phase of trials is underway, with some 40,000 volunteers involved in blind testing of the vaccine that uses two different human adenovirus vectors, said the statement.
Russia also announced the Sputnik V vaccine will be priced at USD10 per dose on international markets. Russia was the first country to announce the registration of a coronavirus vaccine in August – dubbed Sputnik V after the Soviet-era satellite – but did so ahead of large scale clinical trials.
