Vaccine maker Bharat Biotech's intranasal vaccine for Covid-19, the first in the world, is scheduled to be introduced in the country as a booster dose shortly.
The vaccine, iNCOVACC (BBV154), is now available on CoWin, and priced at Rs 800 for private markets and Rs 325 for supplies to the Centre and state governments, the Hyderabad-based company said.
Last last month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC.
It 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 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, it added.
"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," said Bharat Biotech Executive Chairman Dr. Krishna Ella.
He thanked 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 needle-less vaccination, Bharat Biotech's iNCOVACC 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 vaccine maker said.
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.
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.