DRL gets nod to conduct COVID-19 vaccine clinical trails | A look at coronavirus vaccines in India and their status
New Delhi | Jagran News Desk: With the country reporting a decline in active coronavirus cases, the Drug Control General of India (DCGI) on Saturday gave its nod to Dr. Reddys Laboratories Ltd. and Russian Direct Investment Fund to conduct the phase 2/3 human clinical trial for Sputnik V vaccine in India.
In a press release, Dr. Reddys Laboratories Ltd. said that this will be a multi-center and randomised controlled study, which will include safety and immunogenicity study.
"This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic," said GV Prasad, Co-chairman and Managing Director, Dr. Reddy.
As the Centre gives nod for phase 2/3 human clinical trial for Sputnik V vaccine in India, here's a look at coronavirus vaccines in the country and their status:
Covaxin is India's homegrown COVID-19 vaccine candidate. It has been jointly developed by Bharat BioTech, Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It is in its second phase of testing and as per reports, it will be made available to the public by early 2021.
"Phase 1 trial has been successfully completed. Phase 2 trial is most likely to get completed sometime in October. After this, the Phase 3 trial will begin. Covaxin may be launched in early 2021 (after completion of all trial stages)," Sanjay Rai, Professor, Community Medicine, and Principal Investigator for Covid-19 vaccine trial at AIIMS, was quoted as saying by The Times of India.
The phase-3 trial results of Covishield, which is jointly being developed by Pune-based Serum Institute of India (SII) and Oxford-AstraZeneca, will also be out by November.
"Serum is conducting Phase-3 trials as part of international trials in India, and the progress is on track. Results are expected by November or early December," said Dr VK Paul.
ZycovD is another COVID-19 vaccine which is being developed in India by Zydus Cadila. Reports suggest that the phase-2 clinical trial results of ZycovD will be by early November this year.
"By early November, we should get to know the Phase-2 trial results for both the vaccine candidates -- ZycovD and Covaxin," Dr VK Paul, chairman of the Covid-19 empowered group looking after vaccines, was quoted as saying by Hindustan Times.
The government has given its nod to Dr. Reddys Laboratories Ltd. and Russian Direct Investment Fund to conduct the phase 2/3 human clinical trial for Sputnik V in India. The Sputnik V vaccine has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in India. It is currently undergoing Phase 3 clinical trials in Russia and the proposed number of subjects is 40,000.
"We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India," PTI quoted Kirill Dmitriev, CEO of the Russian Direct Investment Fund, as saying.
Posted By: Aalok Sensharma