Hyderabad-based Gland Pharma announced on Tuesday that it entered a partnership with Russian Direct Investment Fund (RDIF) to manufacture and supply up to 252 million doses of Russia's Sputnik V coronavirus vaccine. The production will begin in the third quarter of 2021.
"Gland Pharma will be leveraging its manufacturing capabilities for the production of Sputnik V COVID-19 vaccine. The agreement will see Gland Pharma utilising its Drug Substance and Drug Product facilities at its sites in Hyderabad. The production is expected to commence from third quarter of 2021 for estimated delivery starting from fourth quarter of 2021," said the pharma company in a statement.
The company said, "Under the terms of the agreement, Gland Pharma will first undertake technology transfer of the drug substance to its manufacturing facilities. After successful technology transfer, Gland Pharma will then undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions." It said that its expertise in manufacturing sterile injectable at significant scale will support the stable supply of the vaccine.
The COVID-19 vaccine Sputnik V has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. It became the world's first registered COVID-19 vaccine based on the human adenoviral vector platform.
Meanwhile, Dr Reddy's Laboratories is also working with RDIF to hold domestic clinical trials of the Sputnik V vaccine. The company also sought emergency use authorisation approval last month. The drug regulator, however, asked the company to provide immunogenicity data. India's Hetero has also entered into a deal with RDIF to manufacture 100 million doses of the vaccine.
The medical journal Lancet said about Sputnik V: "The trial results show a consistent strong protective effect across all participant age groups." It said that the vaccine candidate was over 90 per cent effective.
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