Russia’s potential Covid-19 vaccine candidate, Sputnik V, will be subjected to human clinical trials in India to test its efficacy against preventing the novel Covid-19 viral infection, in the mid of the following week, revealed the government officials.
An official revealed, “All necessary requirements are in place, especially the mandatory regulatory approvals, for human trials to start. It is likely to commence this week.”
A conformation regarding the update was given on last Tuesday by Dr. VK Paul, member in the health department of NITI Aayog. Paul said, “The phase II and III will be a combined trial. We have received permission from drug regulators and trials will start by next week.”
The vaccine candidate Sputnik V has been developed by Moscow-based Gamleya Institute. With its registration, a formalized agreement was made between India based Dr Reddy’s Pharmaceuticals headquartered in Hyderabad and the Russian Direct Investment Fund (RDIF) with respect to conducting the clinical trials for assessment and also for distribution of the approved vaccine in the country.
RDIF has planned to supply 100 million doses of Sputnik V to Dr. Reddy’s Laboratories.
Alongside, Russia has also presented Sputnik V to the World Health Organization (WHO) for its speed registration under Emergency use and for providing prequalification for the vaccine.
Meanwhile, the largest vaccine manufacturer in the world, Serum Institute of India based in Pune, has commenced the phase III trials for the vaccine candidate developed by Oxford-AstraZeneca jointly with the Indian Council of Medical Research. Also, the phase III trials have began for the vaccine candidate Covaxin developed by Bharat Biotech and ICMR.
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