Russia’s sovereign wealth fund RDIF (Russian Direct Investment Fund) on Monday said it had entered into an agreement with Virchow Biotech of Hyderabad to produce up to 200 million doses per year of COVID-19 vaccine Sputnik V in the country.
The technology transfer is expected to be completed in the second quarter of 2021, followed by a full-scale commercial production, a statement from RDIF said.
Virchow Biotech’s capacities will help facilitate global supply of Sputnik V to international partners of RDIF, it said.
It is the the fourth such agreement RDIF has entered into for producing Sputnik V in India, beginning with the Hetero Group to make 100 million doses.
The other two are with Gland Pharma (252 million doses) and Stelis Biopharma (200 million doses).
With Dr. Reddy’s Laboratories, RDIF had formed a partnership in September 2020 for the clinical trials as well as distribution of the vaccines in the country. The Hyderabad-based pharma major recently completed dosing volunteers of the Phase III trials and also submitted additional data sought by an expert committee of the Central Drugs Standard Control Organisation (CDSCO) for grant of emergency use authorisation.
Sources in Dr. Reddy’s said the company has not yet been intimated of the next meeting of the committee. The analysis of the clinical trial data was expected to be ready in early April. Sputnik V is likely to be imported initially, once it received the emergency use nod.
Production in India would follow since the process involved technology transfer as well as approval from the from Drugs Controller General of India.
The efficacy of Sputnik V was reported at 91.6%and the vaccine has been approved in 55 countries. The first COVID-19 vaccine to be registered globally, it has been developed by the Gamaleya Center and supported by RDIF.
CEO of RDIF Kirill Dmitriev said there is a growing interest in Sputnik V. “The agreement with Virchow Biotech is an important step to facilitate the full-scale local production of the vaccine in India and to supply our international partners globally,” he said.
MD of Virchow Biotech Tummuru Murali said “Virchow’s proven capabilities in large scale drug substance manufacturing should help meet the global demand for this vaccine.”
