The world’s first intranasal vaccine for COVID developed by India has received approval from the Central Drug Control Organization (CDSCO) for limited emergency use in the 18 and above age group. This was stated here today by the Union Minister for Science and Technology (Independent Charge); Minister of State (Independent Representative) for Earth Sciences; MoS PMO, Personnel, Public Grievances, Pensions, Atomic Energy and Space, Dr Jitendra Singh while presiding over the meeting of autonomous institute societies of Department of Biotechnology, where he also informed about the historic decision to merge 14 biotechnology institute societies into a single society for convenient functioning, economy and integrated work .
Product development and clinical trials
The Minister appreciated the role of the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance (BIRAC) for supporting the development of the world’s first intranasal vaccine for COVID by Bharat Biotech International Limited (BBIL). Dr Jitendra Singh informed that the product development and clinical trials were funded by the Ministry of Biotechnology, Government of India and BIRAC under the Mission COVID Suraksha programme. This vaccine has been approved for limited emergency use for ages 18 years and older for the primary two-dose schedule, homologous booster doses.
Dr Jitendra Singh said India’s efforts through the COVID Suraksha Mission under the dynamic leadership of Prime Minister Narendra Modi have not only strengthened AtmaNirbhar Bharat but also enhanced India’s status as a global hub for vaccine development and manufacturing, showcasing the power of science and technology. It is a matter of great pride for the country, added the minister. Phase III trials were conducted for safety and immunogenicity in ~3100 subjects at 14 trial sites across India (with support from BIRAC). Heterologous booster studies were conducted for safety and immunogenicity in ~875 subjects, where study participants previously vaccinated with licensed COVID vaccines were given a booster dose (3rd dose) of BBV154 intranasal vaccine.
Clinical studies were conducted at 9 test sites across India. The National Institute of Immunology (NII), an autonomous institute of DBT in New Delhi, used its “Human Immune Monitoring and T-cell Immunoassay Platform” to investigate vaccine-induced systemic and mucosal cellular immune responses specific to SARS-CoV-2. participants. Interactive Research School for Health Affairs (IRSHA), Pune (supported by BIRAC) completed a “Plaque Reduction Neutralization Assay” (PRNT) to quantify the titer of neutralizing antibodies to the virus from three test sites.
This vaccine has the dual advantage of allowing for more rapid development of variant-specific vaccines and ease of nasal administration that allows for mass immunization to protect against emerging variants of concern. It promises to become an important tool for mass vaccination during pandemics and endemics.
The vaccine is a recombinant replication-deficient adenovirus vector vaccine with a pre-fusion stabilized spike protein. This vaccine candidate has been evaluated in Phase I, II and III clinical trials with successful results. It has been specially formulated to allow intranasal administration via nasal drops. The nasal delivery system was designed and developed to be cost-effective in low- and middle-income countries. This vaccine is stable at 2-8°C for easy storage and distribution. Bharat Biotech has set up large manufacturing capacity at several locations across India, including Gujarat, Karnataka, Maharashtra and Telangana, with pan-India operations.
In another historic and groundbreaking decision today, Dr. Jitendra Singh approved the amalgamation of 14 autonomous DBT institutions to form one Apex autonomous body – the Biotechnology Research and Innovation Council (BRIC) to achieve centralized and unified governance to maximize the impact of biotechnology research. Dr. Jitendra Singh, the move is a tribute to Prime Minister Modi’s vision of “minimum government, maximum governance” as well as his call for greater integration of ideas and institutions for cost reduction and efficient output.
Dr Jitendra Singh explained that the restructuring of DBT institutes is being done with a larger objective to improve the scientific character and scientific output in the institutes by building research synergies, new educational programs in line with the national education policy, improving human resource structures across cadres. and effective management and monetization of assets derived from research conducted. The Minister hoped that BRIC would build on the foundations developed in the DBT institutions to promote synergies while maintaining their distinct research mandates. With an emphasis on interdisciplinary interactions that cross institutional boundaries, the BRIC institutes will conduct cutting-edge research focused on national priorities, the minister added.
