Drug regulator declines proposal for large scale trials of Russian vaccine Sputnik V in India

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has declined a proposal by Dr Reddy's Laboratories to conduct large scale trials for the Russian coronavirus vaccine Sputnik V in India. The panel has suggested that the Russian COVID-19 vaccine be first tested for safety and efficacy in a smaller trial.

The CDSCO panel said that safety and immunogenicity data from early-stage trials that were conducted overseas had a small number of participants. Moreover, there's no data available on its effects on Indian participants, the panel noted.

This would come as a setback for Russia that plans to roll-out the vaccine even before full trials are completed. After CDSCO's recommendation, approval for the vaccine would take longer than earlier anticipated.

Dr Reddy's and Russian Direct Investment Fund (RDIF) have joined hands to carry out clinical trials and distribute 100 million doses of Sputnik V vaccine in India. A joint statement by the companies last month had stated that deliveries of the vaccine could begin in late 2020, depending on the completion of trials and registration of the vaccine by regulatory authorities.

"India is among 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 partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences," Kirill Dmitriev, CEO of the Russian Direct Investment Fund said.

Russia was the first country to grant regulatory approval for the novel coronavirus vaccine. The fact that it approved the vaccine before large-scale trials were completed raised concerns among scientists and doctors.

As cases continue to rise -- India is currently the second-most affected country in the world -- so are recoveries. The Union Health Ministry has said that COVID-19 recoveries have been on a steep rise, from 50,000 in May to over 57 lakh in October. The ministry said India is currently reporting more than 75,000 recoveries every day and that they are 6.3 times the number of active cases. India currently has 9,07,883 active cases, 57,44,693 recoveries and 1,04,555 deaths.

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