Hyderabad Bharat Biotech on Tuesday said that its intranasal Covid-19 vaccine iNCOVACC will be priced at Rs 800 per dose for the private markets and Rs 325 per dose for central and state governments. However, if one adds a GST of 5% and administration charges of Rs 150 per dose for private hospitals, the total pricing to the user could add up to Rs 1,000 per dose in the private market.
The company also said iNCOVACC, which has already made its debut on CoWin, will be rolled out in the fourth week of January 2023 as a booster dose for those aged 18 years and above that have received two doses of other vaccines like Covaxin and Covishield, the company announced on Tuesday.
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. 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.
Pointing out that iNCOVACC will be the first needle-less booster for Covid-19 in the country, Bharat Biotech said 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.
Commenting on the development, Dr Krishna Ella, executive chairman, Bharat Biotech 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,” Ella added.
iNCOVACC became the world’s first intranasal Covid-19 vaccine to receive approval for the primary 2-dose schedule as well as a heterologous booster dose.
Bharat Biotech said iNCOVACC recipients demonstrated significant levels of mucosal IgA antibody levels that were measured in the saliva. Mucosal IgA antibodies in the upper respiratory tract may provide benefit in reducing infections and transmission, it said.
The Phase III trials of the vaccine as a 2-dose regimen were conducted for safety, immunogenicity in around 3,100 subjects, at 14 trial sites across India.
The heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects at 9 trial sites across India, with the vaccine administered in those who had previously completed a regimen of the commonly administered Covid vaccines.
Bharat Biotech said iNCOVACC is stable at 2-8°C for easy storage and distribution and that the company has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
The vaccine was developed by Bharat Biotech in partnership with Washington University at St. Louis, which designed and developed the recombinant adenoviral vectored construct and evaluated in preclinical studies for efficacy.
The 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.
The product development and clinical trials were funded in part by the Indian government through the Department of Biotechnology’s Covid Suraksha Programme.
