The Drugs Controller General of India (DCGI) has granted approval to the first intranasal COVID-19 vaccine iNCOVACC, the Department of Biotechnology said Tuesday.
Bharat Biotech International Limited (BBIL), the maker of iNCOVACC (BBV154), has received approval under Restricted Use in Emergency Situation for people aged 18 and above in India for heterologous booster doses.
The vaccine maker said in a statement: “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.”
According to Bharat Biotech, iNCOVACC was developed in partnership with Washington University in St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.