Bharat Biotech had said it planned to cover 28,500 subjects in its Phase 3 trial.
New Delhi:
Covaxin, the coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker filed an application with the Comptroller General of Medicines of India (DCGI) on October 2, requesting permission to conduct phase 3 trials for its COVID-19 vaccine candidate.
The firm in its request 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 – across 10 states.
In addition, Bharat Biotech, a vaccine candidate developed locally by Zydus Cadila Ltd is also in phase 2 human clinical trials.
The Pune-based Indian Serum Institute, which has partnered with AstraZeneca to manufacture the Oxford COVID-19 vaccine candidate, is also conducting phase 2 and 3 human clinical trials on the candidate in India.
In a report last month, Bharat Biotech said that an animal study showed its vaccine candidate helped develop a strong immune response to the highly infectious coronavirus.
“To sum up, the vaccine candidate has been shown to generate robust immune responses. Thus, prevention of infection and disease in primates upon high exposure to live SARS-CoV-2 virus,” Bharat Biotech published on his website.
Although it was initially expected that Covaxin would hit the market on August 15, government officials later told a standing 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 in an attempt to stop the COVID-19 pandemic, which has killed hundreds of thousands of people and devastated the global economy.
On Thursday, one of the volunteers participating in the clinical trials of the potential COVID-19 vaccine at the University of Oxford, considered by many to be the world‘s leading candidate, died in Brazil, but authorities said the trial was underway. would continue.
Oxford confirmed its intention to continue testing, saying in a statement that after careful evaluation “there have been no concerns about the safety of the clinical trial.”
