Bharat Biotech Unveils World’s First Intranasal COVID-19 Vaccine

On the occasion of Republic Day, India achieved yet another milestone on the global stage as it launched the world’s first intranasal COVID-19 vaccine. Bharat Biotech’s iNCOVACC was unveiled by Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare  in the presence of Union Minister of State (IC) for Science and Technology, Dr Jitendra Singh, officials from the union government, co-founder and executive chairman, Bharat Biotech Dr Krishna Ella and co-founder and MD, Bharat Biotech Suchitra Ella.

World’s 1st intranasal
• iNCOVACC® is the world’s first Intranasal vaccine for COVID to receive approval for the primary 2-dose schedule, and as a heterologous booster dose, administered as nasal drops.
• iNCOVACC® is a cost effective COVID vaccine which does not require syringes, needles, alcohol wipes, bandage, etc, saving costs related to procurement, distribution, storage, and biomedical waste disposal, that is routinely required for injectable vaccines.
• iNCOVACC® utilizes a vector-based platform, which can be easily updated with emerging variants leading to large-scale production, within a few months. These rapid response timelines combined with the ability of cost-effective and easy intranasal delivery, makes it an ideal vaccine to address future infectious diseases.
• A rollout of iNCOVACC® is expected to begin in private hospitals that have placed advance orders. Initial manufacturing capacity of several million doses per annum has been established, this can be scaled up to a billion doses as required. iNCOVACC® is priced at INR 325/dose for large volume procurement by State Governments and Govt of India.
• Phase III trials (as a 2-dose regimen) were conducted for safety, immunogenicity in ~3100 subjects, in 14 trial sites across India.
• Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, with BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered COVID vaccines. The trials were conducted in 9 trial sites across India.
• iNCOVACC® recipients demonstrated significant levels of Mucosal IgA antibody levels (measured in the saliva). Mucosal IgA antibodies in the upper respiratory tract may provide benefits in reducing infections and transmission. New Delhi/Hyderabad, Jan 26, 2023: Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today dedicated iNCOVACC® (BBV154) to the nation, world’s 1st COVID intranasal vaccine for Primary series and Heterologous booster.

iNCOVACC® was launched by Dr. Mansukh Mandaviya, Hon’ble Minister for Health and Family Welfare, in the presence of Dr. Jitendra Singh, Hon’ble Minister for Science & Technology, on the occasion of Republic Day. Product development and clinical trials for iNCOVACC® were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.
Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for iNCOVACC® to be administered for primary series and as heterologous booster doses.

Amid growing COVID- 19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC® is now available on CoWIN, and priced at INR 800 for private markets and INR 325 for supplies to Govt of India and State Governments.

iNCOVACC® is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.

This vaccine has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries. As a needleless vaccination, Bharat Biotech’s iNCOVACC® will be the world’s first such booster dose. India will now have more options when it comes to third doses or precautionary doses.

Clinical trials and extensive humoral and cell mediated responses were conducted to evaluate iNCOVACC® as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID-19 vaccines in India. The intranasal vaccine is stable at 2- 8°C for easy storage and distribution and has been designed for efficient distribution and easy pain free administration.

iNCOVACC® was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.