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Reddy’s Laboratories Ltd could start late-stage Indian clinical trials of Russia’s potential coronavirus vaccine within the next few months, an executive in the Indian drugmaker said on Tuesday.
Indian trials of this Sputnik-V vaccine candidate, being developed by Russia’s sovereign wealth fund, will enroll 1,000-2,000 participants and also be conducted at multiple private and government hospitals throughout the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy’s, told Reuters.
“We want to get to the first step – which is the commencement of the clinical trials by getting the necessary approvals from the Indian authorities – within the next few weeks,” Sapra said.
The 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.
The RDIF has also reached agreements with Indian producers to produce 300 million doses of the shot in India.
Sputnik-V doses provided 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 stated vaccine deliveries to India could begin in late 2020, but Sapra suggested it could take more. “I think it’s going to be several months before we accomplish all the steps in the procedure,” he added.
India, which has a population of over 1.3 billion, is the world’s second worst affected country by COVID-19 behind the United States. For weeks, it has reported the world’s highest daily jump in infections, which reached a total of 5.6 million on Tuesday.
