Hyderabad-based vaccine maker Bharat Biotech has sought Indian drug regulator's approval to conduct the phase 3 human clinical trials of its indigenous Covid-19 vaccine known as Covaxin, reports Economic Times.
The vaccine maker approached the Drug Controller General of India's (DCGI) office and presented its phase 3 clinical trial protocol along with interim data of phase 1 and 2 clinical trials.
The DCGI's Subject Expert Committee (SEC) deliberated upon Bharat Biotech's proposal on 5 October and asked the firm to resubmit the protocol.
“After detailed deliberation the committee opined that the design of the phase III study is in principle satisfactory except for clarification on definition of asymptomatic, etc,” said the minutes of the meeting, reports ET.
“However, the study should be initiated with appropriate dose identified from the phase II safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from phase II trial for consideration,” it added.
It should be noted that the firms had already approached the states including Delhi, Uttar Pradesh, Bihar, Maharashtra and Punjab seeking their permission for initiating the Phase 3 trials this month.
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