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Intranasal covid-19 vaccine safe, immunogenic: Bharat Biotech

Bharat Biotech’s BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. (File Photo: Hindustan Times)Premium
Bharat Biotech’s BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. (File Photo: Hindustan Times)

If approved, the intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy-to administer formulation and delivery device. Vectored vaccines enable faster development of targeted vaccines in response to emerging variants of concern

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NEW DELHI: Bharat Biotech International Ltd. on Monday said its intra-nasal covid-19 vaccine, BBV154, is safe, well-tolerated, and immunogenic in subjects studied during phase 3 clinical trials for primary dose and a heterologous booster dose. The company said data from phase 3 trials have been submitted for approval to national regulatory authorities.

BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. The 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.

The company said 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 two commonly administered covid vaccines in India.

While primary dose schedule phase III trials were conducted for safety, and immunogenicity in about 3,100 subjects at 14 trial sites across India and compared with COVAXINÒ, the heterologous booster dose studies were conducted for safety and immunogenicity in about 875 subjects at nine trial sites across India where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated.

Immunogenicity was evaluated through serum neutraliding 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," as per the company statement.

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. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principal investigators, and clinical trial personnel for all their efforts."

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. It promises to become an important tool in mass vaccinations during pandemics and endemics, stated the company.

The vaccine candidate stays stable at 2-8°C, and is thus for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana.

The company said that the product 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 Bharat Biotech. The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program," it said.

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