Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, has announced that iNCOVACC (BBV154), will be rolled out in the fourth week of January.

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.

Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC. iNCOVACC is now available on CoWin, and priced at Rs. 800+GST for private markets and priced at Rs. 325+GST for supplies to Government of India and state Governments.

iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion-stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC 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.

Dr. Krishna Ella, Executive Chairman said, “We have achieved the goals we set for ourselves during this pandemic. We have developed COVAXIN and iNCOVACC, two COVID vaccines from two different platforms, with two different delivery systems. The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunization during public health emergencies and pandemics. We thank the Ministry of Health, CDSCO, Department of Biotechnology, Govt of India, Technology Development Board, and Washington University, St Louis, for their support and guidance.”

As a needleless vaccination, Bharat Biotech's iNCOVACC will be India's first such booster dose. India will now have more options when it comes to third doses or precautionary doses. iNCOVACC’s manufacturing platform 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.

Clinical trials 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 vaccines in India.

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. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials were conducted by Bharat Biotech. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.

Despite the lack of demand for COVID vaccines, Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases. iNCOVACC has been designed for efficient distribution and easy pain free administration. Bharat Biotech has also initiated development of variant-specific vaccines for COVID in an attempt to be future ready.

iNCOVACC is stable at 2-8 degree centigrade for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.