The world’s first nasal Covid-19 vaccine will be rolled out by Bharat Biotech International in the fourth week of January 2023. The vaccine, iNCOVACC, has been priced at `800 for private market and `325 for government procurement. The vaccine is now available on CoWin and will be rolled out as a booster dose for those above 18 years.
iNCOVACC, which will be administered as nasal drops, has received approval for the primary two-dose schedule and as a heterologous booster dose. India will now have one more option for the third dose or precautionary Covid doses. Krishna Ella, executive chairman, Bharat Biotech, said the company has achieved the goals set during this pandemic and developed Covaxin and iNCOVACC, two Covid vaccines from different platforms, with different delivery systems.
“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,” Ella said. As a needle-less vaccination, Bharat Biotech’s iNCOVACC will be India’s first such booster dose. Despite the lack of demand for Covid vaccines, Bharat Biotech said it continued product development in intranasal vaccines to be well-prepared with platform technologies for future infectious diseases. Another benefit of the iNCOVACC ’s manufacturing platform was that it would enable faster development of variant-specific vaccines.
iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion-stabilised SARS-CoV-2 spike protein. 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 vaccines in India.
Bharat Biotech said the Phase III trials (as a 2-dose regimen) were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across the country. The heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects in nine trial sites across India. The intranasal vaccine was administered in those previously completing a regimen of the commonly administered Covid vaccines.
“iNCOVACC recipients demonstrated significant levels of mucosal IgA antibody levels (measured in the saliva). Mucosal IgA antibodies in the upper respiratory tract may provide benefit in reducing infections and transmission.” the company said.
iNCOVACC was developed by Bharat Biotech in partnership with Washington University, St Louis Product development and clinical trials were partly funded by the government of India through the Department of Biotechnology’s Covid Suraksha Programme.