COVID-19 Vaccine Update: Covaxin By Bharat Biotech Cleared For Phase 3 Trials By The Drugs Controller General Of India (DCGI)

Covaxin, the COVID-19 vaccine has been cleared for the third phase of clinical trials. Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct Phase 3 trials. The application stated that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites, including Delhi, Mumbai, Patna & Lucknow, across 10 states. Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials. Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine, is also conducting Phase 2 & 3 human clinical trials of the candidate in India. Though it was initially planned that Covaxin would be launched in the market by August 15, government officials later told a parliamentary standing committee that such a drug would not be possible till at least next year. Globally, more than 100 vaccines are being developed and tested to try to stop the COVID-19 pandemic.