Bharat Biotech International, a leader in vaccine innovation and developer of vaccines for infectious diseases declared on Tuesday that the intranasal vaccine, iNCOVACC (BBV154), is scheduled to be introduced in the country as a booster dose shortly, the pharmaceutical company said in a statement.
Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC. The booster dose is now available on CoWin, and priced at Rs 800 for private markets and priced at Rs 325 for supplies to Govt 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. The booster vaccine 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, Dept of Biotechnology, Govt of India, Technology Development Board, and Washington University, St Louis, for their support and guidance.”
As a needleless vaccination, the intranasal vaccine 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, the company's statement read.
The vaccine 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.
The company in the statement said it has also initiated development of variant-specific vaccines for COVID in an attempt to be future-ready.