A subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) has given approval to Bharat Biotech to launch Phase I clinical trial of an intranasal vaccine candidate for COVID-19.
“After detailed deliberation, the committee recommended for conduct of proposed Phase I clinical trial,” read the minutes of the SEC meeting held earlier this month. The approval followed the Hyderabad-based vaccine maker presenting its proposal along with revised phase I clinical trial protocol of the Chimpanzee Adenovirus Vectored COVID-19 Vaccine (BBV154) (intranasal) as sought by the committee, at its meeting in January.
The committee had then advised the firm to generate safety and immunogenicity data in Phase-I clinical trial, with 75 subjects, in the proposed doses as per the protocol.
Bharat Biotech and Washington University School of Medicine in St. Louis had announced a licensing agreement in September for the nasal vaccine candidate, under which the firm bagged the distribution rights in all markets except the U.S., Japan and Europe.
Founder and CMD Krishna Ella had been highlighting that the single dose nasal vaccine would be easy to administer and reduce cost of vaccination since medical consumables such as syringes and needles would not be required. The company has plans to manufacture the nasal vaccine at its facility in Genome Valley here.
On Aurobindo Pharma’s proposal for conducting Phase II/III clinical trial of UB-612 vaccine for Covid-19, the SEC said the firm should submit revised clinical trial protocol for further deliberation. The company had presented the proposal for conduct of Phase II/III clinical trial along with protocol, animal studies and Phase I clinical trial report conducted in Taiwan.
The SEC said the Aurobindo Pharma should submit Phase II/III clinical trial protocol approved by the regulatory authority of Brazil. It said the proposed Phase II/III clinical trial protocol should be revised with respect to the sample size; specify Phase II and III parts in the trial; the trial sites should be geographically distributed; and the trial ought to be double blind. Also, the clinical parameters under study with respect to the immunogenicity cohort should be in line with the proposed clinical trial in Brazil.
In December, Aurobindo Pharma said it has entered into an agreement to develop, commercialise and manufacture U.S. firm COVAXX’s UB-612 for India and UNICEF. It is the first multitope, synthetic peptide-based vaccine candidate in clinical trials and does not require special cold storage facilities, the company had said.