Bharat Biotech International Limited (BBIL) on Monday announced that its intra-nasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
According to the company, 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,” the company said in a statement on Monday.
Moreover, two separate and simultaneous clinical trials were conducted to evaluate the intranasal vaccine as a primary dose schedule and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID-19 vaccines in India.
“Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG’s through ELISA’s. To assess vaccine response through the intranasal route, secretory IgA’s were evaluated by ELISA in serum and saliva. Evaluation was also carried out for the ability of BBV154 to elicit long term memory T and B cell responses against the ancestral and omicron variants,” the company stated.
Earlier this month, the company had stated that it is hopeful of getting regulatory licenses soon. The company’s Chairman and Managing Director, Krishna Ella had also said that the firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no instance of side effect or adverse reaction reported so far.
The Drug Controller General of India (DCGI) had granted permission to the firm to conduct phase-3 clinical trial to compare the immunogenecity and safety of the intranasal vaccine with Covaxin. The regulatory body had also given its nod to conduct clinical trials for BBIL’s intranasal vaccine as booster dose.
“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. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principle investigators, and clinical trial personnel for all their efforts,” Suchitra K. Ella, Joint Managing Director, Bharat Biotech, said in a statement.
The vaccine maker claims that BBV154 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. BBV154 is stable at 2-8°C for easy storage and distribution, the company stated.