The Drugs Controller General of India (DCGI) has approved the first intranasal COVID-19 vaccine, iNCOVACC, the Department of Biotechnology said on Tuesday.
Bharat Biotech International Limited (BBIL), the maker of iNCOVACC (BBV154), has received approval under Restricted Use in Emergency Situations for heterologous booster doses for people aged 18 and above in India.
The vaccine maker said: “iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised 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 it in preclinical studies for efficacy.
