Completes clinical trials for Intranasal Covid vaccine, submits data to regulatory authority for final nod
IndiGlobal Bureau
It is a matter of a push and a shove now. Bharat Biotech International Limited (BBIL) has made an important announcement on the eve of 75th Independence Day of India in the country’s fight against Covid-19. The company stated that BBV154 (its intra nasal vaccine) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials. The company has data submitted to National Regulatory Authorities for final approval.
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.
The intranasal vaccine 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. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, was conducted by Bharat Biotech. 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.
Suchitra K. Ella, Joint Managing Director, Bharat Biotech, said, “On this 75th Independence Day, we are proud to announce successful completion of clinical trials for BBV154 intranasal vaccine. We stay committed and focused on innovation and product development; this is yet another achievement for the multidisciplinary teams at Bharat Biotech. If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy to administer formulation and delivery device.”
The intranasal vaccine has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunization protect from emerging concern variants. It promises to become an important tool in mass vaccinations during pandemics and endemics. The intra nasal vaccine is stable at 2-8°C for easy storage and distribution.