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Russian vaccine trials to begin once regulatory approvals in, says report

Third stage trials of the Russian Sputnik V vaccine for coronavirus can begin in India within the next few weeks once the regulatory clearances are in, said an official of the private company that has tied up with the Russian state firm that developed the vaccine.

The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories have gotten into a pact whereby the Indian firm will conduct Phase 3 studies in India, get local regulatory approvals and distribute the finished vaccine in India post the all-clear. Some 1,000 to 2,000 people will be enrolled in the Phase 3 trials at hospitals, both government and private.

Deepak Sapra, CEO for API and Pharmaceutical Services at Dr Reddy’s, told reporters he wanted to clear the first step by getting approvals from Indian regulators soon. Once approved, the Russian company is expected to supply 100 million doses of the coronavirus vaccine to India. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

Sputnik-V doses supplied in India will likely be a combination of Indian- and Russian-made doses, Sapra said, adding that RDIF and Dr Reddy’s would soon identify potential manufacturers in India. The RDIF has said vaccine deliveries to India could begin in late 2020, but Sapra suggested it could take longer.

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Russia was the first country to officially register a coronavirus vaccine in August. The vaccine has been named Sputnik V. It was developed by Russia’s Gamaleya Research Institute.

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