Bharat Biotech International Limited (BBIL) announced that iNCOVACC (BBV154), has received approval from the Drugs Controller General of India (DCGI) under Restricted Use in Emergency Situations for ages 18 and above, in India, for heterologous booster doses.
iNCOVACC is the world’s first Intranasal vaccine for COVID to receive approval for the primary 2-dose schedule and the heterologous booster dose. 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.
World’s first Intranasal vaccine iNCOVACC gets Approved by DCGI- Key Points
- 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.
- iNCOVACC was developed in partnership with Washington University, St. Louis, which had earlier designed and developed the recombinant adenoviral vector construct and evaluated it in preclinical studies for efficacy.
- Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID vaccines in India.
- Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.
- iNCOVACC 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.