Bharat Bio gets CDSCO’s nod for intranasal Covid vax

Bharat Biotech International Ltd’s recombinant intranasal Covid-19 vaccine has been approved by the CDSCO for primary immunisation against Covid-19 in the 18 plus age group for restricted use in emergency situations.

This was tweeted by Union Minister for Health and Family welfare Mansukh Mandaviya on Tuesday.

Last month, the Hyderabad-based company said its intra nasal Covid-19 vaccine, BBV154, has proven to be “safe, well-tolerated, and immunogenic” in subjects in controlled clinical trials. BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein.

Specific formulation
Data from both Phase III human clinical trials has been submitted for approval to National Regulatory Authorities. BBV154 is specifically formulated to allow intranasal delivery.

The nasal delivery system is also designed and developed to be cost-effective in low and middle-income countries.

The nasal vaccine was developed in partnership with Washington University St Louis, which designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. The Hindu BusinessLine