Covaxin, Bharat Biotech's Coronavirus Vaccine, Cleared For Phase 3 Trials

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) on October 2, 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.

Besides, 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.

In a report last month, Bharat Biotech had said that an animal study has shown its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus.

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