Bharat Bio’s intranasal vaccine Phase 1 trials from this | Sidnaz Blog

HYDERABAD: Vaccine maker Bharat Biotech is all set to kick off Phase I clinical trials of its intranasal Covid-19 vaccine, codenamed BBV154, this week. “We are going to start Phase I trials of intranasal vaccine from Wednesday,” Bharat Biotech chairman & managing director Dr Krishna Ella told TOI here on the sidelines of the Bio-Asia 2021 inaugural on Monday.
Later in the day, during a panel discussion, Ella said the company was also keen on partnering with the World Health Organisation (WHO) for the intranasal vaccine so that things can move faster. The single-dose, chimpanzee adenovirus vectored vaccine candidate is being developed by Bharat Biotech in collaboration with the University of Washington School of Medicine at St Louis.
Bharat Biotech will be conducting the phase I trial of BBV154 on 75 volunteers to ascertain its safety and immunogenicity, as per the recommendation of the Subject Expert Committee (SEC) that advises the Indian drug regulator. The company had sought Drugs Controller General of India (DCGI) approval for Phase I/II trials but was told to conduct Phase I trials first, submit the data and then seek permission for Phase II trials.
Bharat Biotech had presented the animal toxicity and immunogenicity as well as CMC (chemistry, manufacturing and control) data to SEC last month. Bharat Biotech plans to produce 1 billion doses of the non-invasive, vaccine, which is being touted as a gamechanger as it will not only be quicker but also easier to administer.

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