Bharat Biotech had said it plans to cover 28,500 subjects in its phase 3 trial.
New Delhi:
Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), has been approved for the third phase of clinical trials.
The Hyderabad-based vaccine maker had submitted an application to the Comptroller General of Medicines of India (DCGI) on October 2, requesting their permission to conduct Phase 3 trials for its COVID-19 vaccine candidate.
The firm in its application said the study would cover 28,500 subjects aged 18 and over and would be conducted at 19 sites, including Delhi, Mumbai, Patna and Lucknow, in 10 states.
Additionally, Bharat Biotech, a candidate vaccine indigenously developed by Zydus Cadila Ltd, is also in phase 2 of human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
In a report last month, Bharat Biotech said that an animal study has shown that its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus.
“To summarize, the candidate vaccine was found to elicit strong immune responses. Therefore, it prevents infection and disease in primates after large amounts of exposure to the live SARS-CoV-2 virus,” Bharat Biotech posted on its website .
Although Covaxin was initially planned to be launched on August 15, government officials later told a permanent parliamentary committee that such a drug would not be possible until at least next year.
Globally, more than 100 vaccines are being developed and tested to try to stop the COVID-19 pandemic, which has killed hundreds of thousands and devastated the global economy.
On Thursday, one of the volunteers who were part of the Oxford University clinical trials of the possible COVID-19 vaccine, which many consider to be the world’s leading candidate, died in Brazil, but authorities said the trial would continue.
Oxford confirmed the plan to continue testing, saying in a statement that after careful evaluation “there have been no concerns about the safety of the clinical trial.”
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