Bharat Biotech’s Covaxin get approval for 3rd phase of trails
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking permission to conduct Phase 3 trials.
Bharat Biotech, the Indian pharmaceutical company that is working on the coronavirus vaccine has been given approval for the third phase of clinical trials. Bharat Biotech is developing Covaxin 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 permission to conduct Phase 3 trials.
The official at the Central Drugs Standards Control Organisation (CDSCO) confirmed that the reports of the first two phases of trials for Covaxin have been satisfactory. The reports have further been sent to the Drugs Controller General of India (DCGI) for final approval.
Bharat Biotech has informed that it will conduct the third phase of the trial on around 28,500 subjects aged 18 years and above across 19 cities in 10 different states including Delhi, Maharashtra, Bihar, and Uttar Pradesh.
Along with Bharat Biotech, another pharmaceutical company Zydus Cadila is also developing the vaccine and is currently conducting the second phase of the 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.
