Therapy Areas: Vaccines
India's late stage trials for Russia's 'Sputnik-V' COVID-19 vaccine could start in next few weeks
22 September 2020 -

Indian pharmaceutical company Dr Reddy's Laboratories Ltd has said it could begin late-stage Indian clinical trials of Russia's potential COVID-19 vaccine, Sputnik-V, in the next few weeks, Reuters news agency reported on Tuesday.

Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters that Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000 to 2,000 participants and be conducted at multiple government and private hospitals across the country.

"We want to get to the first step, which is the commencement of the clinical trials by getting the necessary approvals from the Indian regulators, within the next few weeks," Sapra said.

Reportedly, these trials are part of a deal between the Russian Direct Investment Fund (RDIF) and Dr Reddy's, in which the Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India. RDIF will supply 100 million doses to Dr Reddy's.

Also, the RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the vaccine in India.

Sapra said that Sputnik-V doses supplied in India will likely be a combination of Indian-made and Russian-made doses, adding that RDIF and Dr Reddy's would soon identify potential manufacturers in India.

Reportedly, the RDIF has said vaccine deliveries to India could begin in late 2020, but Sapra suggested it could take longer. "I think it's going to be several months before we accomplish all the steps in the process," Sapra added.

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