NEW DELHI, Nov 28: The Central Drugs Standard Control Organisation (CDSCO) has given approval to the Bharat Biotech’s Intra-Nasal Covid Vaccine iNCOVACC ( BBV154) under restricted use in emergency situation for ages 18 and above for heterologous booster doses.
It is the first intra-nasal vaccine to receive both primary series and heterologous booster approval, the vaccine maker said on Monday. Heterologous booster dose studies were conducted for safety and immunogenicity in about 875 subjects, with BBV154 intranasal vaccine administered post two doses of the two commonly administered COVID-19 vaccines. The trials were conducted at nine sites across the country.
The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, the company said in a release. The intra-nasal vaccine was developed in partnership with Washington University, St. Louis, which designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy. Product development pertaining to preclinical safety evaluation, large-scale manufacturing scale up, formulation and delivery device development, including human clinical trials were conducted by Bharat Biotech.
Product development and clinical trials were funded in part by the Centre through the Department of Biotechnology’s COVID Suraksha Programme. “This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases,” Bharat Biotech Chairman and Managing Director Krishna Ella said.