Hetero Labs to manufacture 100 mn doses of Sputnik V vaccine for India

Hyderabad-based Hetero Labs would be working with the Russian Direct Investment Fund (RDIF) to produce 100 mn doses per year of the Sputnik V vaccine.

The parties intend to start the production of Sputnik V in the beginning of 2021, the statement said. Earlier this week Kirill Dimitriev, CEO of RDIF, Russia's sovereign wealth fund, said that the fund was planning to supply 1 bn doses of Sputnik V across the globe in 2021 and had forged partnerships in India, China, Brazil, Korea, Hungary and some other locations.

Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries, RDIF claimed.

Another Hyderabad-based player Dr Reddy's Laboratories (DRL) is RDIF's partner in India for conducting clinical trials and distribution of the vaccine. It had indicated this month that the process of technology transfer had begun at its partner site (for manufacturing) in India. The first batch of Sputnik V vaccines have also arrived for clinical trial purposes.

“We are delighted to announce the agreement between RDIF and Hetero that will pave the way for production of the safe and highly effective Sputnik V vaccine on Indian soil. The vaccine’s interim clinical trial results show 95% efficacy on the 42nd day after the first dose. I am confident that Sputnik V should become an integral part of the national vaccine portfolio of every country willing to protect its population from the coronavirus. Thanks to our co-operation with Hetero, we will be able to significantly increase production capacity and provide people of India with an efficient solution in this challenging period of the pandemic," Dimitriev said.
B Murali Krishna Reddy, director – International Marketing, Hetero Labs, said that manufacturing the product locally is crucial to enable swift access to patients.

The Sputnik V vaccine has been priced at $10 per dose. It is a two-dose course.

Further, to make the logistics easy, a variant is being developed that would remain stable at 2-8 degree Celsius. This will be a lyophilised version. Lyophilisation or freeze drying as it is commonly known is a process of low temperature dehydration that involves freezing the product, lowering pressure and then removing ice by sublimation. So having Sputnik V in the dry form would reduce logistical hurdles significantly and improve its accessibility. It now requires a temperature of -18 degree Celsius to remain stable.

Meanwhile, a second interim analysis of clinical trial data showed a 91.4 percent efficacy for the Sputnik V vaccine on day 28 after the first dose. The vaccine efficacy is over 95 per cent 42 days after the first dose.

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 ofpPhase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report, it said. Currently, 40,000 volunteers are taking part in the phase III double-blind, randomised, 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.

Currently, phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as phase II-III trials in India.