Bharat Biotech, a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that iNCOVACC, has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses.
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein.
Candidate who was given this vaccine was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC 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.
The vaccine was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “iNCOVACC, is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. This is a great achievement for us and the global scientific community. Despite the lack of demand for Covid vaccines, we have continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases.”
Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.
iNCOVACC was evaluated to determine its impact on safety. Product development data will be submitted shortly to peer reviewed journals and will be made available in the public domain. It is stable at 2-8°C for easy storage and distribution and has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunisation.
ABOUT BHARAT BIOTECH
Bharat Biotech International Limited (BBIL) has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 19 vaccines, four bio-therapeutics, registrations in more than 125 countries, and the World Health Organization (WHO) Prequalification.
It has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations across pan India.