The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 virus vaccine.
Bharat Biotech's iNCOVACC, the first intranasal COVID-19 vaccine approved for mix-and match booster inoculation, is priced at Rs 800 per dose for private market and at Rs 325 for large-volume government procurement.
The vaccine is available on the government's CoWIN Web site and it will be in the market by the fourth week of January, said the Hyderabad-based company.
Health ministry sources said no decision has been taken on whether to procure the nasal vaccine for the national COVID-19 vaccination drive.
iNCOVACC (BBV154) was approved by the Central Drugs Standard Control Organisation earlier this month for use as a heterologous booster dose. It is a recombinant adenovirus (flu virus) vaccine formulated to be administered through nasal drops.
India is on alert given the recent surge in Covid cases in China, Japan and some other countries.
The cases are likely to lead to a rise in demand for booster doses, and Bharat Biotech's nasal vaccine may find takers due to its ease of administration in a painless way.
The company is open to having global partners for manufacturing and distribution, a source said. This would help Bharat Biotech commercialise the vaccine faster in other geographies.
As the intranasal vaccine is easier to administer and does not require trained personnel, it can be popular in low- and medium-income countries that still have low vaccine coverage.
The vaccine would not have production scalability issues unlike Covaxin, Bharat Biotech's COVID-19 inactivated virus vaccine.
"We have achieved the goals we set for ourselves during this pandemic. We have developed Covaxin and iNCOVACC, two COVID-19 vaccines from two different platforms, with two different delivery systems," says Dr Krishna Ella, executive chairman, Bharat Biotech.
"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," Dr Ella adds.
iNCOVACC was developed with help from the department of biotechnology, Government of India, the Technology Development Board, and Washington University, St Louis.
Phase III trials (as a 2-dose regimen) were conducted for safety, immunogenicity in around 3100 subjects, in 14 trial sites across India.
Heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects, with BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered Covid19 vaccines: Covishield and Covaxin.
The trials were conducted in 9 trial sites across India.
'iNCOVACC recipients demonstrated significant levels of mucosal IgA antibody levels (measured in the saliva),' Bharat Biotech. 'Mucosal IgA antibodies in the upper respiratory tract may provide benefit in reducing infections and transmission.'
Feature Presentation: Ashish Narsale/Rediff.com
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