Home / News / World /  World's first nasal Covid vaccine by Bharat Biotech gets approval, but no efficacy data yet

iNCOVACC, the world's first intranasal vaccine by Bharat Biotech has received both primary series and Heterologous booster approval, the Hyderedab-based company said on Monday.

In a release regarding the same, Bharat Biotech said, iNCOVACC (BBV 154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses.

The intranasal vaccine had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for the primary 2-dose schedule. Phase III trials were conducted for safety, immunogenicity in~3100 subjects, at 14 trial sites across India.

Meanwhile, the heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, with BBV154 intranasal vaccine administered post 2 doses of the two commonly administered COVID-19 vaccines. The trials were conducted at 9 trial sites across India.

Speaking on the recent development, Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. 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 thank the Ministry of Health, CDSCO, Dept of Biotechnology, Govt of India, Technology Development Board, and Washington University, St. Louis, for their support and guidance, " he added. 

All that you need to know about iNCOVACC?

The iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.

This vaccine 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.

It was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated 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.

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