HYDERABAD: After the Indian drug regulator turned down Dr. Reddy’s Laboratories Ltd’s proposal earlier this month to conduct direct Phase-3 human trials in India for the Russian Covid-19 vaccine
Sputnik V, the company and
Russia’s sovereign wealth fund Russian Direct Investment Fund (RDIF) have now received the Drug Control General of India (DCGI) nod to conduct an adaptive Phase 2/3 human clinical trial for the Russian vaccine in India.
The Phase 2/3 trial will be a multi-center and randomized controlled study, which will include safety and immunogenicity study, Dr Reddy’s and RDIF said.
It is learnt that while the Phase-2 trials of the Russian vaccine in India will be conducted on 100 subjects, the Phase-3 trials will be conducted on 1,500 subjects.
The approval for the trials was given by the subject expert committee (SEC), that advises the drug regulator on clinical trials as well as drug and vaccine approvals, at its meeting held on Friday.
Dr Reddy’s co-chairman and managing director G V Prasad termed it as a significant development that will allow the company to commence the clinical trials for Sputnik V in India. “We are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” he said.
RDIF CEO Kirill Dmitrev said that in addition to Indian clinical trials data, RDIF will provide safety and immunogenicity study from the Russian Phase-3 clinical trials as well. “This data will further strengthen the clinical development of Sputnik V vaccine in India,” he said.
At its meeting on October 5, 2020, the SEC had turned down the protocol submitted by Dr Reddy’s to straightaway conduct Phase-3 trials of the Russian vaccine in India stating that the safety and immunogenicity data in overseas Phase 1/2 trials of Sputnik V was too small and that no data was available on Indian subjects.
“After detailed deliberation, the committee recommended that the company should follow the regulatory requirements and conduct Phase 2/3 clinical trials in the country with proper monitoring for humoral & cell mediated immune response,” the committee had said while asking Dr Reddy’s to submit a revised proposal with the protocol for conducting Phase-2 and Phase-3 studies.
RDIF had entered into an agreement with the Hyderabad-based pharma giant in September this year to carry out Phase-3 clinical trials of Sputnik V in India and distribute 100 million doses of the vaccine in the Indian market after regulatory approvals.
While Sputnik V is currently undergoing Phase-3 clinical trials involving 40,000 volunteers in Russia, a Phase-3 clinical trial of the vaccine has also commenced in the UAE last week.
While scientists had raised doubts about Sputnik V’s safety and efficacy as Russian President Vladimir Putin had announced its development to the world without conducting large-scale trials or publishing data, later medical journal Lancet had said that two trials of the vaccine in June and July 2020, involving 76 participants, showed all the participants developed antibodies to the novel
coronavirus without any serious side-effects.
Sputnik V, which has been developed by Gamaleya National Research Institute of Epidemiology and Microbiology and RDIF, became the first Covid-19 vaccine to be registered in the world based on the human adenoviral vectors platform on August 11, 2020. The vaccine uses two adenovirus vectors (rAd26 and rAd5) against SARS-CoV-2 virus.