Bharat Biotech is likely to start the phase-3 trial of its coronavirus vaccine in India next month after receiving approval from the drug regulatory authority.
The regulator’s subject expert committee met on Tuesday and approved the phase-3 trial of the company’s indigenously developed vaccine candidate Covaxin with “minor amendments” in the protocol, reports the Economic Times.
Over 25,000 people are expected to enroll for the trial in India. They will be given two doses of the experimental vaccine 28 days apart. Preliminary results from the Covaxin trials have shown promising results.
“We did face minor adverse reactions in some, but overall, the preliminary results show that it is safe,” said Savita Verma, the principal investigator who leads the trial at PGI Rohtak.
Covaxin is the first indigenous vaccine candidate and was developed in collaboration with the Indian Council of Medical Research.
At a meeting on Oct 5, the subject expert committee had asked the company to resubmit the protocol for the phase-3 trial.
“The committee opined that the design of the phase-3 study is, in principle, satisfactory except for clarification on definition of asymptomatic, etc. However, the study should be initiated with appropriate dose identified from the phase-2 safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from phase-2 trial for consideration,” it was noted in the minutes of the committee’s meeting.
Meanwhile, on Sept 29, Bangladesh and India “agreed in principle" to go for the clinical trials of Covid-19 vaccines in Bangladesh soon after India launched these trials there.
Indian External Affairs Minister Dr S Jaishankar on Tuesday conveyed to Bangladesh that they are ready to start phase-III clinical trials of Covid-19 vaccines in Bangladesh soon after they launch these trials in India.
Bangladesh "agreed in principle" on the proposal, a source at the Indian High Commission in Dhaka told UNB.
Coronavirus cases were first reported in China in December last year. The World Health Organization declared it a pandemic in March.
India has so far recorded 7,706,946 coronavirus cases, the second-highest in the world after the USA. Its death tally of 116,616 is the third-highest globally, according to Johns Hopkins University data.
Bangladesh, on the other hand, has so far reported 394,827 cases with 5,747 deaths.
There is currently no vaccine for the virus but a number of promising candidates are in the final stage of the trials.