The Drugs Control General of India (DCGI) on Saturday waved a green flag for Phase III clinical studies for Russian vaccine candidate Sputnik V Covid-19 in India at Hyderabad-based Dr. Reddy’s Laboratories.
The Russian Direct Investment Fund collaborated with Dr. Reddy’s Laboratories in September to perform clinical trials of the covid-19 vaccine and distribute its rights in India.
Sputnik V meets the primary safety criteria in India’s Phase 2 clinical trials, Dr. Reddy’s Laboratories Ltd stated on 11th January.
For further review and approval, in early January. The company submitted phase II safety data to the Indian drug regulator for review and approval to continue phase III trials.
On 16th January Dr. Reddy’s laboratory finally got approval from DCGI for the 3rd phase trials.
Phase 3 trials will be performed on 1,500 volunteers in India, according to Headquartered Hyderabad, as part of the randomized, double-blind, parallel community of placebo-competent research.
The Gamaleya National Institute of Epidemiology and Microbiology developed the Sputnik V corona vaccine.
Sputnik V became the first worldwide registered Covid-19 vaccine based on the proven human adenoviral vector platform.
The efficiency of the vaccine is verified in a 91.4% final control point analysis of clinical trials in Russia, Currently, clinical trials of the vaccine are ongoing in the UAE, Egypt, Venezuela, and Belarus.
It is also been Registered for inoculation in Argentina, Algeria, Bolivia, Belarus, and Serbia.
Dr. Reddy’s co-chairman, MD G.V. Prasad, declared in a statement this Friday that “We expect to commence the phase 3 study within this month and will continue to fast-track our efforts to bringing in a safe and efficacious vaccine for the Indian population”.
Dr. Reddy had announced recently that a phase-2 safety data analysis and recommendation for phase-3 recruitment was carried out by the Data and Safety Monitoring Board (DSMB). The DSMB concluded that no safety issues were found in its analysis and that the study met the primary safety endpoints, according to the statement.
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