World's first intra-nasal vaccine for COVID gets CDSCO nod for restricted use

World's first intra-nasal vaccine for COVID developed by India has got approval from the Central Drugs Standard Control Organisation (CDSCO) for restricted use in emergency situations in the age group of 18 and above.

A press release from the vaccine maker said iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein, is the world's first intranasal vaccine to receive both primary series and heterologous booster approval.

The vaccine candidate was evaluated in Phases I, II and III clinical trials with successful results and has been specifically formulated to allow intranasal delivery through nasal drops, it said.

The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, Bharat Biotech said.

Union Minister Dr Jitendra Singh lauded the role of the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC) for supporting the development of the world's first Intranasal vaccine for COVID by Bharat Biotech International Limited (BBIL).

Dr Jitendra Singh informed that the Product development and Clinical trials were funded by the Department of Biotechnology, Government of India and BIRAC under the Mission COVID Suraksha Program. This vaccine received approval under restricted Use in emergency situations for ages 18 and above for primary 2 dose schedule, homologous booster doses.

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 promises to become an important tool in mass vaccinations during pandemics and endemics. With the receipt of this approval, launch dates, pricing and availability will be announced in due course of time.

Product development data will be submitted to peer-reviewed journals and will be made available in the public domain.

Krishna Ella, Chairman & Managing Director, Bharat Biotech, said: "Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases... We have also initiated development of variant-specific vaccines for COVID for future preparedness."

iNCOVACC was developed in partnership with Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy.

Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said, "The DCGI's approval of Bharat Biotech's intranasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage."

*With inputs from agencies