The expert committee said Bharat Biotech should generate safety and immunogenicity data in Phase-I clinical trial, with 75 subjects, in the proposed doses as per the protocol.
The clinical trial of Bharat Biotech’s intranasal vaccine for COVID-19 is likely to take some time to get off ground with a subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) directing the vaccine maker to submit a revised trial protocol.
On an application from Bharat Biotech, seeking permission for phase I/II clinical trial of the Chimpanzee Adenovirus Vectored COVID-19 intranasal vaccine (BBV154), the committee said the firm should generate safety and immunogenicity data in Phase-I clinical trial, with 75 subjects, in the proposed doses as per the protocol.
Thereafter, the firm should submit the data for consideration of the committee to proceed to Phase II clinical trial. “Accordingly, [the] firm should submit revised clinical trial protocol for consideration,” the committee recommended when it met last week.
Bharat Biotech, whose Covaxin is one of the two intra-musuclar vaccines used under the largest inoculation programme India launched on January 16, had submitted before the expert panel animal toxicity and immunogenicity, CMC data along with the protocol to conduct Phase I/II clinical trial.
While Covaxin, the indigenous vaccine approved for use in clinical trial mode by the regulator is being developed in association with ICMR-National Institute of Virology, for the nasal vaccine candidate Bharat Biotech and Washington University School of Medicine in St. Louis had in September announced a licensing agreement.
Bharat Biotech has got rights to distribute the vaccine in all markets except the U.S., Japan and Europe. Founder and Chairman and Managing Director Krishna Ella had been highlighting how the single dose nasal vaccine will be easy to administer as well as bring down the use of medical consumables such as syringes and needles and thereby the cost of vaccination. The company plans to manufacture the nasal vaccine at its facility in Genome Valley here.