The Central Drugs Standard Control Organisation (CDSCO) has issued restricted emergency use approval to Bharat Biotech’s recombinant nasal vaccine for primary immunization against C-19 in those who are above 18 years of age.

The vaccine has the advantages of easy nasal delivery and is claimed to be more cost-effective.

Announcing the approval, Union minister of health and family welfare Dr Mansukh Mandaviya said that it is a big boost to India’s fight against C-19.

“Bharat Biotech’s ChAd36-SARS-CoV-S C-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_India_INF for primary immunization against C-19 in 18+ age group for restricted use in an emergency situation,” he said in his Twitter page.

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“This step will further strengthen our collective fight against the pandemic,” he said. India has harnessed its science, R&D, and Human Resources in the fight against C-19 under Prime Minister Narendra Modi’s leadership. “With the science-driven approach and Sabhka Prayas, we will defeat C-19,” he averred.

On August 15, this year, the company announced that the BBV154 intra-nasal vaccine has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.

The clinical trials were completed with about 4,000 volunteers participating, according to reports.

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

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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, said the company during the time.

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 Bharat Biotech.

The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, C-19 Suraksha program.

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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 C-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.

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 immunization protect from emerging concern variants, it added.

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