Bharat Biotech Completes Trials for India’s First Intranasal Covid Vaccine, Calls It Safe and Immunogenic

According to the company, BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.

New Delhi: 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. “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.

According to the company, BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.

“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.

Bharat Biotech completes clinical development for phase III trials and booster doses for BBV154 intranasal covid vaccine.#BharatBiotech #covid19vaccine #bbv154 #intranasalvaccine #covid19 pic.twitter.com/oh76drnezz

— BharatBiotech (@BharatBiotech) August 15, 2022

The pharma company’s Chairman and MD Dr Krishna Ella had said earlier, “injectable vaccine only protects the lower level (of the body). That’s why people who were vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal jab gives protection to the whole body.”

“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.