Written By: Longjam Dineshwori | Updated : December 2, 2022 1:11 PM IST
The Central Drugs Standard Control Organisation (CDSCO) has approved world's first intranasal vaccine for COVID-19 for restricted use in emergency situations in the age group of 18 and above in India. This vaccine is indicated for primary 2 dose schedule, and heterologous booster doses.
Called BBV154 intranasal vaccine, it has been developed by Bharat Biotech International Limited (BBIL). The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC) had funded the company for the product development and clinical trials under the Mission COVID Suraksha Program.
Dr Jitendra Singh, Union Minister of State (Independent Charge) Science & Technology, made the announcement on Thursday while chairing the meeting of the Societies of Autonomous Institutions of DBT at National Institute of Immunology in Delhi.
According to a statement released by the Ministry of Science & Technology, BBV154 intranasal vaccine is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. It has been specifically formulated to allow intranasal delivery through nasal drops. Phases I, II and III clinical trials have showed successful results.
The intranasal vaccine is expected to make mass COVID-19 immunization easier and cost-effective in low- and middle-income countries. The vaccine is stable at 2-8 C, which means easy storage and distribution.
Moreover, the nasal delivery system enables faster development of variant-specific vaccines to protect from emerging variants of concern. Nasal vaccines are anticipated to become an important tool in mass vaccinations during pandemics and endemics.
Bharat Biotech have established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.
To evaluate safety and immunogenicity of the intranasal COVID-19 vaccine, Bharat Biotech conducted Phase-III trials in about 3100 subjects, in 14 trial sites across India, with the support of BIRAC.
Additionally, heterologous booster dose studies were conducted including about 875 subjects who were previously vaccinated with licensed COVID-19 vaccines. A booster dose (3rd dose) of BBV154 intranasal vaccine was administered to them. The clinical trials were conducted in 9 trial sites across India.
National Institute of Immunology (NII), an autonomous institute of DBT in New Delhi utilized their "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.
