Bharat Biotech that is developing its own coronavirus vaccine has received the drug regulatory authority’s approval for the initiation of the final phase of trials. Phase 3 of the trials is likely to start next month. The expert committee that met on Tuesday to approve Bharat Biotech’s third phase of trials gave the nod to the pharma company and suggested “minor amendments” in the protocol.
As many as 28,500 people are expected to enroll for the trials in India, as mentioned in a report in The Economic Times. The volunteers would be given two doses of the experimental vaccine in a gap of 28 days.
Savita Verma, principal investigator at PGI Rohtak told the daily that there were minor adverse reactions in some but overall the preliminary results showed that Covaxin is safe. The vaccine is the first of a long list of coronavirus vaccine candidates developed indigenously. Bharat Biotech developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR).
As per earlier reports, the homegrown company has already written to states including asking them for permission to initiate trials. The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites — including Delhi, Mumbai, Patna, and Lucknow — across 10 states. The expert committee on October 5 had asked the company to resubmit its clinical trial proposal. The committee asked the company to clarify the definition of asymptomatic.
It also asked Bharat Biotech to submit full data of the Phase 2 trials. “However, the study should be initiated with an appropriate dose identified from the phase-2 safety and immunogenicity data. Accordingly, the firm should submit safety and immunogenicity data from the phase-2 trial for consideration,” the panel said in its recommendations.
Meanwhile, Bharat Biotech and Serum Institute are soon expected to start trials of an intranasal coronavirus vaccine, as mentioned by Health Minister Dr Harsh Vardhan.