Hyderabad: City-based Bharat Biotech on Monday announced that its Covid-19 intranasal vaccine iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) for 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 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, the chairman and managing director of Bharat Biotech, said, "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."
He said that iNCOVACC has been designed for efficient distribution and easy and pain-free administration. "We have also initiated development of variant-specific vaccines for Covid for future preparedness," he added.
Development and trails
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 programme.
Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid vaccines in India.
"We are excited by the expansion of the EUA for iNCOVACC as a booster which enables this intranasal vaccine to be used by many more people, and hopefully curtail transmission," said Michael S. Diamond of Washington University who co-developed the nasal vaccine technology with Washington University colleague David Curiel. "This approval will increase the options for people to get vaccinated and protected against the SARS-CoV-2 virus during the ongoing pandemic," he added.
Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.
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. With the receipt of this approval, launch dates, pricing and availability will be announced in due course of time.