India clears world's 1st nasal Covid vaccine

New Delhi, September 6

The world’s first intranasal Covid vaccine, developed by Bharat Biotech, received regulatory approvals for restricted emergency use in Indian adults on Tuesday, boosting the national response to SARS-CoV-2 virus.

The vaccine is the world’s first intranasal shot to receive approvals for a primary two-dose inoculation schedule. Union Health Minister Mansukh Mandaviya said the approval to the Chimpanzee adenovirus vectored shot would further strengthen the collective fight against the pandemic.

After the approval by the Drug Controller General of India, Hyderabad-based Bharat Biotech unveiled iNCOVACC, a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. The vaccine candidate was evaluated in phase I, II and III clinical trials with successful results and 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.

“iNCOVACC was developed in partnership with Washington University in St Louis. 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 and funded in part by the Department of Biotechnology’s ‘Covid Suraksha’ programme,” Biotech said.

The trials were conducted in over 3,100 persons at 14 sites to evaluate iNCOVACC as a primary dose schedule and in over 875 subjects at nine sites to test the vaccine as a heterologous booster dose for subjects who have previously received two doses of the Covid vaccines in India.

Bharat Biotech Chairman Krishna Ella said the approval would be a global game-changer in intranasal vax technology.” — TNS

Bharat Biotech’s twin-dose vaccine

• iNCOVACC will be available for use soon
• Easy nasal delivery makes it a major tool in mass vaccinations
• Phase III trials conducted in over 3,100 persons across 14 sites
• Heterologous booster dose studies done in 875 subjects at 9 sites
• Stable at 2-8°C for easy storage and distribution