HQ Team
December 2, 2022: India’s drug regulator, the Central Drugs Standard Control Organisation, has given its nod for the restricted use of the world’s first intra-nasal vaccine for Covid-19.
The vaccine can be used only in emergencies and is meant for people above 18 for two primary doses and a booster, according to a government statement.
The vaccine can enable faster development of variant-specific vaccines and easy nasal delivery, promoting mass immunization to protect from emerging concern variants.
It can become an essential tool in mass vaccinations during pandemics and endemics, according to the government.
The product development and clinical trials were funded by the Department of Biotechnology (DBT), the Government of India and the Biotechnology Industry Research Assistance Council (BIRAC) under the Mission COVID Suraksha (Protection) Program.
Immunogenicity
About 3,100 participants in 14 trial sites across India were involved in the Phase-III trials for safety and immunogenicity.
Heterologous booster dose studies were conducted for safety and immunogenicity in about 875 subjects.
This booster, or the third dose, of the BBV154 intranasal vaccine, was administered to study participants previously vaccinated with licensed Covid-19 vaccines.
The clinical trials were conducted in nine trial sites across India.
The National Institute of Immunology (NII), an autonomous institute of DBT in New Delhi, utilized its platform to examine the vaccine-induced SARS-CoV-2-specific systemic and mucosal cellular immune responses of the trial participants.
Nasal drops
Interactive Research School for Health Affairs (IRSHA), Pune (supported by BIRAC) completed the quantifying the titer of neutralizing antibodies for the virus from three trial sites.
The vaccine is administered as nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
It is stable at 2-8°C for easy storage and distribution. Extensive manufacturing capabilities have been established by Bharat Biotech at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan-India.
