NEW DELHI: Bharat Biotech’s first-of-its-kind needle-free intranasal vaccine for Covid-19 has received approval from the Central Drugs Standard Control Organisation (CDSCO) 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 heterologous booster dose, the company said. It is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II, and III clinical trials with successful results.
This 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. It was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy.
The chairman of Bharat Biotech called the approval a matter of pride for the organization and said that the intra-nasal vaccine would be a global game changer.
The Hyderabad-based vaccine manufacturer has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.