Hyderabad-headquartered drugmaker Dr Reddy’s Laboratories (DRL) has entered into an agreement to help conduct final-stage human trials of Russia’s Sputnik V Covid-19 vaccine in India.
Once regulatory clearances are obtained, the firm will also begin to distribute up to 100 million doses for “mass vaccination” in the country.
This is the first concrete development on the Sputnik V front since India confirmed it was in discussions to take forward the testing and manufacture of the vaccine candidate that Russia cleared for public use last month.
“The Sputnik V vaccine, which is based on a well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, which will be supplying the vaccine to DRL for distribution, said.
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“The Phase 1 and 2 results have shown promise, and we will be conducting Phase-3 trials in India to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against Covid-19 in India,” DRL Co-Chairman and Managing Director GV Prasad said.
The firm will approach the Central Drugs Standard Control Organisation (CDSCO) for permission to conduct the phase 3 trials in India “shortly”, said an RDIF spokesperson.
“India is among the most severely impacted countries from Covid-19, and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against Covid-19,” RDIF CEO Kirill Dmitriev said.
Russia continues to be in talks with Indian vaccine firms to potentially manufacture the vaccine in the country, according to RDIF. “We confirm that we are in talks with Indian manufacturers,” said an RDIF spokesperson.
This includes firms like Hyderabad-based Indian Immunologicals. The Indian Express reported on September 15 that the firm has been in talks to ascertain whether it can successfully incorporate the Russian vaccine’s technology and scale up production here.
Indian Immunologicals has so far earmarked a capacity for around 20 million single-dose vaccines for Covid-19, which could go up to 200 million if the vaccine is multi-dose, according to the firm’s Managing Director, Dr K Anand Kumar.
At a press briefing on September 8, Niti Aayog Member (Health) Dr VK Paul had said that the Indian government had been exploring the possibility of manufacturing Sputnik V in the country, and that a scale-up would be required. The government has also been looking at conducting large scale phase 3 human trials of the vaccine in the country.
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