Bharat Biotech is said to have received the drug regulatory authority’s approval for the final stage of testing of its coronavirus vaccine in India and is likely to start the trial next month, according to Economic Times.
Bangladesh and India earlier agreed to start this final-stage trial in Dhaka also simultaneously.
The Indian 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, people familiar with the matter told Economic Times.
Over 25,000 people are expected to enrol for trial in India and 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 October 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 the definition of asymptomatic, etc. However, the study should be initiated with an appropriate dose identified from the phase-2 safety & immunogenicity data. Accordingly, the firm should submit safety & immunogenicity data from the phase-2 trial for consideration,” it was noted in the minutes of the committee’s meeting.
