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Bharat Biotech International Ltd’s intranasal Covid-19 vaccine, BBV154, has proven to be "safe, well-tolerated, and immunogenic" in subjects in controlled clinical trials, it said in a statement. BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein.
Suchitra K Ella, Joint Managing Director, Bharat Biotech, said, “On this 75th Independence Day, we are proud to announce the successful completion of clinical trials for the BBV154 intranasal vaccine. If approved, this intranasal 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 targeted vaccines in response to emerging variants of concern, she added. Data from both phase III human clinical trials have been submitted for approval to National Regulatory Authorities. 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.
Cost-effective method
In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries. 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.
Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Hyderabad-based Bharat Biotech, which also manufactures intra-muscular Covid vaccine ‘Covaxin’. 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 (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.
Immunogenicity was evaluated through serum neutralising 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. The 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.
BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunisation protect from emerging concern variants. It promises to become an important tool in mass vaccinations during pandemics and endemics.
BBV154 is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India, the release added.
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