Hyderabad-based Hetero will work with the Russian Direct Investment Fund (RDIF) to produce 100 million doses of Covid-19 vaccine Sputnik V per year for India. The parties plan to start the production of Sputnik V in the beginning of 2021, a statement said.
Earlier this week, RDIF Chief Executive Officer Kirill Dimitriev had announced the Russia sovereign wealth fund’s plan to supply 1 billion doses of Sputnik V across the globe in 2021. RDIF claimed more than 50 countries had requested for over 1.2 billion doses of Sputnik V vaccine. It has forged partnerships in India, China, Brazil, Korea, Hungary, and some other locations.
“We are delighted to announce the agreement between RDIF and Hetero that will pave the way to the production of the safe and highly effective Sputnik V vaccine on Indian soil. The vaccine’s interim clinical trial results show 95 per cent 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,” Dimitriev said.
“Thanks to our cooperation 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,” the RDIF CEO said.
B. Murali Krishna Reddy, director (International Marketing) of Hetero Labs, said local manufacturing was crucial to enable swift access to patients.
Another Hyderabad-based player, Dr Reddy’s Laboratories, 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 started at its partner site (for manufacturing) in India. The first batch of Sputnik V vaccines, too, has arrived for clinical trial purposes.
The Sputnik V is priced at $10 per dose. It is a two-dose course.
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 the Sputnik V in the dry form would reduce logistical hurdles significantly and improve its accessibility. It now requires a -18 degree Celsius temperature to remain stable.
Meanwhile, a 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. 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 of phase III 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 phase III double-blind, randomised, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia. Of them, more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
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.