New Delhi, November 28
Makers of the world’s first intranasal Covid 19 shot, Hyderabad-based Bharat Biotech, on Monday announced that the 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.
The vaccine was earlier approved as a primary dose schedule in September.
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.
“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. It 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,” the company said in a statement.
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.
Krishna Ella, Chairman 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.”
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.
Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG’s through ELISA’s.
To evaluate the vaccine, taken through the intranasal route, IgA’s were evaluated by ELISA in serum and saliva.
Evaluation was also carried out for ability iNCOVACC to elicit responses against the ancestral and omicron variants.
Rajesh Gokhale, union biotechnology secretary said, “The DCGI’s approval of Bharat Biotech’s intranasal vaccine iNCOVACC® (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country.”
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.
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