Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC.
iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. (Supplied)
Hyderabad-based Bharat Biotech on Tuesday, December 27, announced that its intranasal vaccine, iNCOVACC, is available on CoWIN, a central government-run portal for Covid-19 vaccine registration.
The intranasal vaccine has been priced at ₹800 for private supplies and ₹325 for government hospitals, excluding 5 percent GST.
iNCOVACC will soon be introduced in the country as a booster dose for those aged 18 and above. The company claimed it is the world’s first intranasal vaccine.
Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of heterologous booster doses of iNCOVACC.
iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a prefusion-stabilised SARS-CoV-2 spike protein, the vaccine-maker said in a statement.
It 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 of Bharat Biotech, said “the vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunisation during public health emergencies and pandemics.”
As a needleless vaccination, iNCOVACC will be India’s first such booster dose and it 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 immunisation to protect from emerging variants of concern, the pharma company said in a statement.
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.
iNCOVACC was developed in partnership with Washington University, St Louis, which had 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 scaleup, formulation and delivery device development, including human clinical trials, were conducted by Bharat Biotech.
The Government of India partially funded the product development and clinical trials, through the Department of Biotechnology’s, Covid Suraksha Programme.
iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including in Gujarat, Karnataka, Maharashtra and Telangana, with pan-India operations.
The vaccine has been designed for efficient distribution and easy, pain-free administration. Bharat Biotech has also initiated the development of variant-specific vaccines for Covid in an attempt to be future-ready.
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