Leading vaccine maker, Bharat Biotech International Limited (BBIL) on Monday announced that the world`s first intranasal vaccine for Covid-19, iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under restricted use in emergency situation for ages 18 and above, in India, for heterologous booster doses.
iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results, the Hyderabad company said.
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. Bharat Biotech said that launch dates, pricing and availability will be announced in due course of time.
iNCOVACC is stable at 2-8 degrees Celsius 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.
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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.
INCOVACC, is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.
INCOVACC has been designed for efficient distribution, easy and pain-free administration. We have also initiated development of variant-specific vaccines for COVID for future preparedness,” he added.
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.
Bharat Biotech said that iNCOVACC 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. It promises to become an important tool in mass vaccinations during pandemics and endemics.