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Bharat Biotech completes clinical development for phase-III trials and booster doses for BBV154 intra-nasal COVID vaccine

Data from both phase-III human clinical trials have been submitted for approval to National Regulatory Authorities

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Bharat Biotech recently announced that BBV154 (intra-nasal vaccine) has proven to be safe, well-tolerated and immunogenic in subjects in controlled clinical trials.

In a statement, the company said that 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 intra-nasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in Low and Middle-Income Countries (LMICs).

BBV154 was developed in partnership with Washington University 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.

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.

Immunogenicity was evaluated through serum-neutralising antibodies by PRNT assays and serum IgG’s through ELISAs. To assess vaccine response through the intra-nasal 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.

Speaking in this regard, Suchitra K Ella, Joint Managing Director, Bharat Biotech, said in the statement, “…………If approved, this intra-nasal 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 targetted vaccines in response to emerging variants of concern.”