Hyderabad-based Bharat Biotech on Monday, 28 November, announced that its Covid-19 nasal vaccine iNCOVACC (BBV154) had 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.
It is said to have been specifically formulated to allow intranasal delivery through nasal drops.
According to Bharat Biotech, the nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
Dr Krishna Ella, Chairman & Managing Director of Bharat Biotech, said in a statement that despite the lack of demand for Covid-19 vaccines, the company continued product development in intranasal vaccines to ensure that they were well-prepared with platform technologies for future infectious diseases.
“iNCOVACC has been designed for efficient distribution and easy and pain-free administration. We have also initiated the development of variant-specific vaccines for Covid-19 for future preparedness,” said Ella.
The vaccine was reportedly developed in partnership with Washington University, St Louis, which designed and developed the recombinant adenoviral vectored construct and evaluated it 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 Central government 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-19 vaccines in India.
According to Bharat Biotech, iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunisation 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.
iNCOVACC is stable at 2-8° C for easy storage and distribution.
Bharat Biotech said it has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations across India.