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. The vaccine has been specifically formulated to allow intranasal delivery through nasal drops.
Bharat Biotech International Limited (BBIL) announced that iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under restricted use in an emergency situation for ages 18 and above, in India, for heterologous booster doses. 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. The 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. The vaccine 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. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology
