Bharat Biotech gets conditional approval for Phase III trial of Coronavirus vaccine
The Expert Panel of Drugs Controller General of India (DCGI) has recommended Bharat Biotech's Corona vaccine covaxin for approval for the Phase III clinical trial. The panel said the recommendation was made after assessing the first and second stage data as well as studies on animals.
The panel also stated that this is a conditional approval recommendation to allow the conduct of a third stage clinical trial. The primary efficacy for symptomatic cases in Phase III trials can be modified understudy results. According to the report, more than 25,000 people are expected to enroll for the trial and will be given two doses of the experimental vaccine within 28 days. Preliminary results of covaxin tests have shown promising results.
Under the conditions, PI will evaluate clinical information to classify it as the asymptomatic case when a suspected case is confirmed. The second rule is that the participant must be asymptomatic with criterion A or B and positive confirmation of RT-PCR.
Bharat Biotech is currently conducting Phase II human trials of covaxin after receiving approval from DCGI. Earlier, the expert panel of the Central Drugs Standard Control Organization (CDSCO) asked Bharat Biotech to present the second stage data of the indigenous covid19 vaccine.