India's drug regulator has refused to allow a large scale clinical trial of Russia's Sputnik V Covid-19 vaccine. The decision comes as a setback for the Vladimir Putin-led nation, which had given the shot a fast-tracked approval in August to provide its own as well as other nations' citizens a way to fight the ongoing pandemic.
A few weeks back, India's Dr Reddy's Laboratories and the Russian Direct Investment Fund (RDIF) struck a trial-and-supply deal to take the Sputnik V Covid-19 vaccine to the Indian population. However, when the lab applied to conduct a large scale clinical human study with the shot, the Central Drugs Standard Control Organization (CDSCO) refused to accept the proposal. The expert panel of CDSCO told Dr. Reddy's Laboratories that it cannot give the permission to conduct trials on a large scale, as the early-stage safety and immunogenicity data on Sputnik V is available from smaller studies conducted on foreign population.
It advised the lab to first consider a smaller clinical trial instead of jumping directly to the large Phase-3 study. "After detailed deliberation, the committee recommended that the firm should follow the regulatory requirements and conduct phase-2/3 trial in the country with proper monitoring for humoral and cell-mediated immune response," the committee said.
Previously, the lab had said it would conduct the Phase-3 trial to demonstrate the safety and efficacy of Sputnik V on the Indian population and make about 100 million doses available to the local public starting the end of this year. Now, with segmented trials, it could take more time.
Developed by Gamaleya Research Institute of Epidemiology and Microbiology and backed by RDIF, Sputnik V was registered on August 11, with Putin claiming that the shot forms stable immunity and one of his daughters had already been inoculated. However, as the approval was given after just two-month-long trials and no public data, many claimed that Russia may have cut necessary corners, risking people's safety.
Despite the questions, Russia has been moving ahead with the internal production and distribution of Sputnik V. The company started production in August and has already released the first batch of the shot in civil circulation, following necessary quality tests in the laboratories of Roszdravnadzor [Russia's medical device regulator]. The country had also expressed willingness to partner with India for scaling up its production.
