Bharat Biotech International on Monday said that its BBV154 intranasal Covid vaccine has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.

BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized 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. It is also easier to administer on a mass scale.

BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.

The Government of India partly funded product development and clinical trials through the Department of Biotechnology's, COVID Suraksha program.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule; and a heterologous booster dose for subjects who have previously received 2 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.

“If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy-to-administer formulation and delivery device," said Suchitra K. Ella, Joint Managing Director, Bharat Biotech.