India's indigenous developed COVID-19 vaccine - Covaxin - has been cleared by the Drug Controller General of India (DGCI) for the third phase of clinical trials. The vaccine which is being developed by Hyderabad-based Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR), had applied for Phase 3 trials permission on October 2.
In its application seeking permission for the third stage, the developers had stated that the trials would cover nearly 28,500 subjects aged 18 years and above and would also be conducted across 19 sites including Delhi, Mumbai, Patna and Lucknow.
Earlier in September, Bharat Biotech had informed that Covaxin had proved to be effective in inducing immunity against COVID-19 in animals. The firm had stated that two-dose vaccination regimen of inactivated SARS-CoV-2 vaccine candidates was administered in 20 rhesus macaques which were divided into four groups equally. The results showed protective efficacy, increasing SARS-CoV-2 specific IgG and neutralizing antibodies, reducing replication of the virus in the nasal cavity, throat, and lung tissues of monkey.
"To summarize, 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," the statement concluded.
Bharat Biotech got DCGA's approval in July to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19. Covaxin is the first of the indigenously developed vaccines against COVID-19 by India. Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) to develop the vaccine. Besides the Covaxin, India has two more vaccine candidates in the run. Ahmedabad-based Zydus Cadila's ZyCoV-D and another one is being developed by Serum Institute of India in collaboration with the Oxford University vaccine and UK's Pharmaceutical giant AstraZeneca.