Bharat Biotech completes clinical trials for intranasal Covid vaccine

Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission, and further studies are being planned, an official statement said on Monday.

“On this 75th Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine,” Suchitra K Ella, joint managing director, Bharat Biotech, said. “If approved, this intranasal vaccine will make it easier to deploy in mass immunisation campaigns with an easy-to-administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern,” Ella added.

BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated earlier in Phase I and II clinical trials with successful results. BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, the company said in a statement.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (two-dose schedule) and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India.

Data from both Phase III human clinical trials have been submitted for approval to national regulatory authorities. Primary dose schedule Phase III trials were conducted for safety, and immunogenicity in around 3,100 subjects, and compared with Covaxin. The trials were conducted in 14 trial sites across India, the company said in a statement.

Heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects, where a booster dose (third dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed Covid vaccines. The trials were conducted in nine trial sites across India.

BBV154 was developed in partnership with Washington University in St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in pre-clinical studies for efficacy. Product development related to pre-clinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech. The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s Covid Suraksha programme.