World’s first intra-nasal vaccine for COVID developed by ‘Bharat Biotech’ has got approval from the Central Drugs Standard Control Organisation (CDSCO) for restricted use in emergency situations in the age group of 18 and above – The Union Minister of State (Independent Charge) Science & Technology, Dr Jitendra Singh announced in the meeting of the Societies of Autonomous Institutions of Department of Biotechnology.
The development of the world’s first Inta-nasal vaccine for COVID was funded and supported by the Department of Biotechnology, Government of India and Biotechnology Industry Research Assistance (BIRAC) under the Mission COVID Suraksha Program.
Phase-III trials were conducted for safety, and immunogenicity in ~3100 subjects, in 14 trial sites across India (supported by BIRAC). Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, where a booster dose (3rd dose) of BBV154 intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines.
The clinical trials were conducted in 9 trial sites across India. The National Institute of Immunology (NII) in New Delhi utilized its “Human Immune Monitoring and T-cell Immunoassay Platform” to examine the vaccine-induced SARS-CoV-2-specific systemic and mucosal cellular immune responses of the trial participants. Interactive Research School for Health Affairs (IRSHA), Pune (supported by BIRAC) completed the “Plaque Reduction Neutralization Assay” (PRNT) to quantify the titer of neutralizing antibody for the virus from three trial sites.
This vaccine has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern. It promises to become an important tool in mass vaccinations during pandemics and endemics.