NEW DELHI: India’s first nasal Covid vaccine iNCOVACC has received approval from the Central Drugs Standard Control Organisation (CDSCO) under restricted use in an emergency for ages 18 and above, in India, for heterologous booster doses; Bharat Biotech announced on Monday.
The Hyderabad-based pharma company said that the intranasal vaccine, BBV154 or 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 company claimed. iNCOVACC has explicitly been 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 intranasal vaccine was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vector construct and evaluated it in preclinical studies for efficacy.
The 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.
The Indian government partly funded product development and clinical trials through the Department of Biotechnology (DBT)’s Covid Suraksha Program. Dr Rajesh S. Gokhale, Secretary, DBT, and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said the DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC to be used as a heterologous booster dose against currently available Covid-19 vaccines is a moment of great pride for our country.
‘Replication-deficient adenovirus vectored’
The Hyderabad-based pharma company Bharat Biotech said that the intranasal vaccine, BBV154 or iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein