(ATF) Amid reports that some countries, including the US, are holding tight to their supplies and the raw materials needed to make more vaccines, the Indian drug maker Gland Pharma said on Tuesday it had struck a deal with the Russian Direct Investment Fund (RDIF) to make up to 252 million doses of the Sputnik V Covid vaccine.
In the first of multiple partnerships being explored to leverage its manufacturing capacity, and capabilities to ramp up Covid vaccine availability, the deal will bring India’s total production of the shot to at least 352 million a year. That will not only boost the vaccine supply in India but it will also boost the global efforts of delivering millions of doses to poorer and middle-income nations, the company said.
Hyderabad-based Gland Pharma, a subsidiary of China’s Fosun Pharma, is the third drug maker to collaborate with RDIF to make vaccine developed by Moscow’s Gamaleya Institute, which has been approved in 22 countries, with the RDIF signing supply deals with over 13 countries.
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Indian drug-maker Dr.Reddy’s Laboratories Ltd has also been holding small clinical studies of Sputnik V domestically. It had sought emergency use approval for the vaccine last month but India’s drug regulator had asked for more data.
India’s Hetero already has a deal in place to produce over 100 million doses of the vaccine, which has proven to be 91.6% effective against the Covid virus.
Still, according to Gland Pharma, the drug maker is the first to receive the full transfer of technology to make Sputnik V at its manufacturing facilities.
After successful technology transfer, Gland Pharma will undertake manufacturing of drug substance and drug product filling into vials under aseptic conditions, the company said.
DEAL SIGNED
“That means Sputnik’s drug substance will be supplied by Gamaleya. All other ingredients would be procured by Gland, however, the nitty-gritty has not been worked out yet. We have just signed the deal and those details would be expected to be available in about a month,” a company source told Asia Times Financial, requesting anonymity since he is not authorised to speak.
The vaccine’s production is expected to commence from the third quarter of 2021 for estimated delivery starting from the fourth quarter of 2021, Gland said.
According to RDIF’s agreement, while Gland will produce the vaccine following regulatory authorisation in India, “the distribution will be handled solely by RFID,” the company source said
“The RFID will distribute wherever it wants and that means that Gland’s production is not just meant for India,” the source explained adding, Glan’s expertise in manufacturing sterile injectables at a significant scale will support a stable supply of Covid vaccine in the country and globally as well.
FOREIGN PARTNERS
RDIF claims it has successful joint implementation experience of more than 80 projects with foreign partners totalling more than $40 billion investments.
According to the company, the deal is also a step forward for Gland to help ease global supplies and aiding the country as a generous sponsor of the global vaccination efforts.
India, the world’s biggest vaccine maker, has so far given emergency use approval to AstraZeneca Plc’s shot and a homegrown vaccine made by Bharat Biotech. It has donated or sold vaccines to more than three dozen countries, while significantly ramping up its own inoculation program this month.
The country’s leading vaccine maker and supplier, the Serum Institute Ltd (SII) for instance, that makes the Covid vaccine, Covishield – developed by AstraZeneca Plc and Oxford University – plans to develop a capacity of 2.3 billion doses in 2021.
SUPPLY COMMITMENTS
SIL has several supply commitments for these vaccines – the Indian government, the World Health OrganiSation-led COVAX and other bilateral deals.
Besides, having produced 1.5 billion doses of the vaccine last financial year, SII has already supplied around 60 million doses of Covishield to the Indian government for the national immunisation programme. SII has also supplied 90 million doses to 51 countries – a record pace for the company, it said.
Serum Institute is working on many other Covid vaccine projects in technical collaboration with various makers like Novavax (US), Codagenix (US), for which it depends on import of critical raw materials, consumables and components from various foreign manufacturers, especially from the US, that has recently restricted export of key items.
These include bags and filters that will likely ease US vaccine makers’ procurement constraints but cause “serious bottlenecks” in vaccine production globally, say vaccine makers.
Meanwhile, European Union governments are considering launching talks with Sputnik V developers as the EU tries to get its vaccination program back on track.
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