Bharat Biotech International Limited (BBIL ) has received approval for its intranasal vaccine against Covid-19, iNCOVACC (BBV154), under Restricted Use in Emergency Situation for ages 18 and above. iNCOVACC is the ‘world’s first’ intranasal vaccine received approval in the country for Primary 2 dose schedule.
This approval comes a day after China approved ‘world’s first’ inhaled Covid-19 vaccine. In April, Russia registered the nasal version of Sputnik vaccine.
“... Despite the lack of demand for Covid-19 vaccines, we continued product development in intra nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases,” Krishna Ella, Chairman & Managing Director, Bharat Biotech, said in a release on Tuesday.
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. ``This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results. It has has been specifically formulated to allow intranasal delivery through nasal drops,’‘ the Hyderabad-based vaccine maker said.
It was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.
iNCOVACC has the “double benefit” of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunisation to protect from emerging variants of concern. “With the receipt of approval today, the product will be launched and available for use in due course of time,’‘ the company said.
iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana with operations pan India.
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.