New Delhi: Covaxin, the coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials. The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI), seeking its permission to conduct Phase 3 trials for its COVID-19 vaccine candidate. The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites – including Delhi, Mumbai, Patna, and Lucknow across 10 states. Bharat Biotech, an indigenously developed vaccine candidate 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 for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India. Bharat Biotech had said in the last month that an animal study has shown its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus. “To summarise, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus,” Bharat Biotech posted on its website. 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 ravaged the global economy.