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Bharat Biotech’s intranasal Covid vaccine gets approval

iNCOVACC was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops.

iNCOVACC is the world’s first intranasal Covid vaccine to receive approval for the primary two-dose schedule and the heterologous booster dose.

Bharat Biotech International Limited (BBIL) on Monday announced that iNCOVACC (BBV154), an intranasal vaccine against coronavirus disease, has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for all adults in India, for heterologous booster doses.

According to a Bharat Biotech statement, iNCOVACC is the world’s first intranasal Covid vaccine to receive approval for the primary 2-dose schedule and heterologous booster dose. iNCOVACC is stable at 2-8°C for easy storage and distribution, it said.

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC 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, the statement said.


iNCOVACC was developed in partnership with Washington University, St Louis. 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. Product development and clinical trials were funded in part by the Government of India.

Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development. iNCOVACC was evaluated to determine its impact on safety. Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as heterologous booster dose for those who have previously received two doses of the two commonly administered COVID vaccines in India. The reactogenic events and adverse events that were documented during the trial were comparable to published data from other Covid-19 vaccines. Product development data will be submitted to peer reviewed journals and will be made available in the public domain.

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Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said: “iNCOVACC, is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. 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.”

First published on: 28-11-2022 at 20:03 IST
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