Dr Reddy’s To Conduct Phase 3 Trials For Sputnik-V In India

Dr Reddy’s Laboratories, headquartered in Hyderabad, agreed to help conduct final-stage human trials of Sputnik-V COVID-19 vaccine in India.

After obtaining the regulatory clearances, the firm will distribute up to 100 million doses for mass vaccination in the country.

“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 Dr Reddy’s for distribution.”

“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,” said DRL Co-Chairman and Managing Director GV Prasad.

An RDIF spokesperson said that the firm will be approaching the CDSCO to have permission to conduct the phase 3 trials in India shortly.

“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.

According to RDIF, Russia continuously remains contacted with Indian vaccine firms to potentially manufacture the vaccine in India. “We confirm that we are in talks with Indian manufacturers,” said an RDIF spokesperson.

Indian vaccine firms which were in contact with Russia for the COVID-19 vaccine include firms like Indian Immunologicals which is Hyderabad based.

According to the managing director of Indian Immunologicals, Dr K Anand Kumar, the firm has till now acquired a capacity of around 20 million sin=ngle-dose vaccines for COVID-19 and this number can increase up to 200 million if the vaccine is multi-dose.

On September 8 in a press briefing, Niti Aayog Member (Health) Dr V K Paul said that for the manufacturing of Sputnik V, the Indian government had been searching the possibility. The government has also been looking at conducting large scale phase 3 human trials of the vaccine in the country.


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