World’s first intra-nasal vaccine for COVID gets CDSCO nod for restricted use in emergency situations

The Central Drugs Standard Control Organization (CDSCO) has given the first intra-nasal COVID vaccination in the world clearance for limited use in life-threatening conditions in people age 18 and older.

This was said on Thursday by Union Minister Dr. Jitendra Singh, who was presiding over a meeting of the Societies of Autonomous Institutions of the Department of Biotechnology. He also announced the historic choice to combine the 14 societies of Biotechnology Institutes into a single society for the sake of practical operation, financial efficiency, and integrated working.

The Minister praised the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC), for helping Bharat Biotech International Limited produce the first intranasal COVID vaccine ever (BBIL).

Dr. Jitendra Singh stated that the Department of Biotechnology, Government of India, and BIRAC supported the product development and clinical testing under the Mission COVID Suraksha Program. This vaccine was authorised for primary 2 dose schedule, homologous booster doses for ages 18 and older in emergency conditions.

Dr Jitendra Singh said, “India’s efforts through Mission COVID Suraksha under the dynamic leadership of Prime Minister Narendra Modi has not only strengthened AtmaNirbhar Bharat but also bolstered India’s status as a worldwide vaccine development and manufacturing centre showcasing the strength of Science and Technology. It is a matter of great pride for the country.”

On November 28, iNCOVACC – the intra-nasal vaccine received both Primary series and Heterologous booster approval, as per a press release by Bharat Biotech International Limited (BBIL).

This vaccine has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. It promises to become an important tool in mass vaccinations during pandemics and endemics.

The vaccine is a recombinant replication-deficient adenovirus vector vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in Phases 1, 2, and 3 clinical trials with successful results.

It has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries. This vaccine is stable at 2-8 degree celsius for easy storage and distribution.

Large manufacturing capabilities have been established by Bharat Biotech at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.

It has the potential to be a crucial tool for mass immunisation campaigns during pandemics and endemics. Launch dates, prices, and availability will be disclosed in due course following the receipt of this clearance.

Data on product development will be shared with the public and submitted to peer-reviewed journals.