UP: BRD Medical College to start Covaxin phase-3 trial in mid-October
Gorakhpur’s Baba Raghav Das Medical College is expected to start the phase three trials of Bharat Biotech’s Covid-19 vaccine Covaxin in mid-October. The government’s drug regulator approved Covaxin for human trials in June, making it India’s first domestic candidate to get the go-ahead.
Baba Raghav Das Medical College principal Dr Ganesh Kumar said they met the representatives of Bharat Biotech on Sunday to discuss the trials. Phase three of drug trials involve efficacy and monitoring of adverse reactions.
The college has constituted a three-member doctors’ team to prepare the standard operating procedure for the trials. A Bharat Biotech representative said the dates of the trials will be announced next week.
Officials said the work on data compilation and other procedures are continuing to prepare for the trials.
Kumar said they will follow the Centre’s safety and regulatory guidelines for conducting the trials and that experts from Gorakhpur’s Regional Medical Research Centre will be also be involved.
A state health department official said the earlier two phases of the trials were held at two private medical hospitals in Gorakhpur and Kanpur. The hospitals have sent their reports to Bharat Biotech and the Indian Council of Medical Research.
Amit Mohan Prasad, the additional chief secretary (health), last week announced Lucknow’s Sanjay Gandhi Post Graduate Institute of Medical Sciences and Baba Raghav Das Medical College have been selected for the Covaxin phase-3 efficacy and safety clinical trials.