Dr Reddy's plans to complete phase 3 trial of Sputnik V COVID vaccine by March end

3 | FM Nirmala Sitharaman announces Rs 900 crore grant for COVID-19 vaccine research: Finance Minister Nirmala Sitharman on Thursday announced a Rs 900 crore grant to the Department of Biotechnology for COVID-19 vaccine research. "We are providing Rs 900 crore for research and development of COVID-19 vaccine. This is being provided for covid suraksha mission, purely for R&D but this money goes to Department of Biotechnology for research purposes," she said. Sitharaman said the grant does not cover the actual cost of vaccine and distribution expenses, which will be made separately as and when the vaccine is available.

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Dr Reddy’s Laboratories on October 28 said it plans to complete phase III clinical trials of its Sputnik V COVID-19 vaccine as early as March and will seek approval from the Drug Controller General of India (DCGI).

CEO Erez Israeli said the company would begin phase II trials in the next few days.

Dr Reddy's recently received permission from DCGI to conduct phase II and III trials of the Russian vaccine. In phase II, it will be enrolling 100 participants. If it receives an approval to continue, it will recruit 1,400 subjects for phase III, Israeli said. Phase III will follow after the completion of phase II trials.

“I hope we will finish phase II by December, which means not just the enrolment and the trial but also compilations of results," Israeli said.

If everything goes smoothly, the trial is expected to be completed by March-end, but if there any delays in compilation and submission, it could take up to mid-May, he explained. "Data from India will be complemented by the global clinical trial data of the vaccine."

In September, Dr Reddy’s and Russia’s sovereign wealth -- the Russian Direct Investment Fund (RDIF) -- entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of deal, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.

Israeli said the vaccine will be produced in India, at a third party site in Baddi, but declined to offer details on the vaccine pricing.

Sputnik V, the COVID-19 vaccine developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the sovereign Russian Direct Investment Fund, became the first vaccine to be cleared for public use. The results of Sputnik V of phase I/II clinical trials on 76 people were published in medical journal The Lancet in early September, showing that the vaccine candidate triggered a strong immune response. Russia is enrolling 40,000 volunteers as part of phase III trails, starting September, and will take six months to complete.