India emerges global manufacturing hub for Covid-19 vaccine Sputnik V

Hyderabad-headquartered Gland Pharma on Tuesday said it had inked a pact with Russian Direct Investment Fund (RDIF) to supply 252 million doses of the Covid-19 vaccine Sputnik V.

This is part of the Russian sovereign wealth fund’s efforts to increase manufacturing capacities in India to make for the country and to augment global supplies.

Sources said Bengaluru-based Strides Pharma Science, too, is in fray for contract manufacturing the Sputnik V. Another Hyderabad-based player, Hetero, will supply 100 million doses of the vaccine.

RDIF has lined up 250 million doses for India over the next 12 months, and the rest will be for global supplies.

Strides did not wish to comment on the matter.

Sputnik V has shown 91.6 per cent efficacy in trials, much higher than the efficacy of Covishield, the AstraZeneca-Oxford vaccine made by Serum Institute of India (SII), and Covaxin made by Bharat Biotech, which are currently being administered in India.

After Tuesday’s announcement, shares of Gland Pharma rose about 7 per cent on the BSE, while shares of Dr Reddy’s Laboratories (DRL), RDIF’s Indian partner, too, were up 2.4 per cent.

The Sputnik V is under review for emergency use authorisation in India. It will be marketed in India by DRL, which is also working with RDIF to conduct bridge clinical trials to establish safety and immunogenicity of the Sputnik V on Indians. The Indian expert panel on vaccines has asked DRL to provide more data on immunogenicity.

Covishield has an efficacy of around 53 per cent if the two doses are administered four weeks apart, while a longer gap of 12 weeks can raise efficacy to 79 per cent.

Oxford-AstraZeneca had said the vaccine has a 62 per cent efficacy overall. Covaxin, on the other hand, has 80.6 per cent efficacy, according to interim data from phase-3 clinical trial.

China’s Fosun-backed Gland Pharmaceuticals said production is expected to commence from the third quarter of 2021 for estimated deliveries starting from the fourth quarter. Gland Pharma will first undertake technology transfer of the drug substance to its manufacturing facilities. After that it will manufacture the drug substance and drug product filling into vials under aseptic conditions. Gland Pharma already makes sterile injectables at significant scale.

DRL had said earlier that RDIF has lined up 250 million doses of Sputnik V for Indian citizens from various manufacturing partners over the next 12 months.

The remaining doses would be exported to 51 countries, where the Sputnik V already has approval.

In November Kirill Dimitriev, RDIF CEO, had said that the plan was to supply 500,000 million courses or one billion doses globally thro­ugh manufacturing partnerships.

Without divulging details of capacities planned in each country, Dimitriev had said that the firm had forged partnerships in India, China, Brazil, South Korea, Hungary, and some other countries.

RDIF has indicated that 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, added Dimitriev. 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. This is in contrast to dehydration, which involves evaporation of water by using heat.

So, having the Sputnik V in the dry form would reduce logistical hurdles significantly. It now requires a temperature of -18 degree Celsius to remain stable.

Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, became the World’s first registered Covid-19 vaccine based on the human adenoviral vector platform.