Bharat Biotech, the Hyderabad-based vaccine maker has sought approval from Indian drug regulators to conduct the phase 3 human clinical trials for the indigenous Covid-19 vaccine known as Covaxin, the Economic Times reported.
As the race to develop a vaccine heats up at a global level, Bharat Biotech has approached the Drug Controller General of India’s (DCGI) office and presented its phase 3 clinical trial protocol along with all the interim data of phase 1 and 2 clinical trials.
The DCGI’s Subject Expert Committee (SEC) has asked the firm to resubmit the protocol after extensive deliberation.
“After detailed deliberation, the committee opined that the design of the phase III study is in principle satisfactory except for clarification on the definition of asymptomatic, etc,” said the minutes of the meeting, reports ET.
“However, the study should be initiated with an appropriate dose identified from the phase II safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from the phase II trial for consideration,” it added.
Bharat Biotech had already approached some of the states, Delhi, Uttar Pradesh, Bihar, Maharashtra, Punjab and has sought permission for initiating the phase 3 trials this month.