New Delhi: Covaxin, the indigenous COVID-19 vaccine candidate has received nod for Phase-3 clinical trials in the country. The vaccine is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Drug Controller General of India (DCGI) has given the approval for the last phase of clinical trials with certain conditions.
The development comes even as several companies across the world are racing against time to develop an effective vaccine against Coronavirus which has claimed more than 10 lakh lives worldwide.
In the third and final phase of trials, scheduled to begin in first week of next month, the potential vaccine candidate will be tested on over 28,000 people aged 18 years and above. These tests will be conducted across 10 states and 19 sites including Delhi, Mumbai, Patna and Lucknow among others.
Besides, Bharat Biotech’s COVAXIN, Zydus Cadila Limited is another indigenously developed vaccine candidate which is in Phase -2 of human clinical trials.
Recently, drug maker–Bharat Biotech submitted safety and immunogenicity data from an ongoing phase II trial to DCGI for conducting phase III clinical trial for Covaxin. However, the expert committee asked the pharma company to submit safety and immunogenicity data from the phase II clinical trial for consideration.
In July, the Drug Controller General of India (DCGI) had granted permission to Bharat Biotech pharma giant to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
Bharat Biotech in collaboration with ICMR is making COVID-19 vaccine using the virus strain isolated by Pune-based National Institute of Virology (NIV).
