Bharat Biotech rolls out India’s first intra-nasal Covid vaccine iNCOVACC

Bharat Biotech on Thursday launched the country’s first intra-nasal Covid vaccine iNCOVACC for a primary as well as heterologous (mix-and-match) booster dose in India.

It is the world’s first nasal Covid-19 vaccine that has been approved both as a primary two-dose regimen, and as a heterologous booster after two doses of Covishield or Covaxin.

The vaccine’s roll-out is expected to begin in private hospitals that have placed advance orders.

iNCOVACC is priced at Rs 325 per dose for large volumes procured by states and the Centre. In the private market, the vaccine is priced at Rs 800 per dose.

The vaccine was launched by Union Health Minister Mansukh Mandaviya in the presence of Minister of Science and Technology Jitendra Singh. The Centre has not placed any orders for the nasal vaccine yet.

“India’s vaccine manufacturing and innovation capability is appreciated all over the world as it has made a mark in producing quality and affordable medicines,” Mandaviya said.

The vaccine’s manufacturer Bharat Biotech said, “Recipients of iNCOVACC demonstrated significant levels of antibody levels. Mucosal IgA antibodies in the upper respiratory tract may provide benefits in reducing infections and transmission.”

The company said iNCOVACC did not require syringes, needles, alcohol wipes or bandage, thereby saving costs related to procurement, distribution, storage and biomedical waste disposal. The vaccine can be stored at a temperature of 2-8 degree Celsius.

iNCOVACC utilises a vector-based platform, which can be easily updated with emerging variants, leading to large-scale production within a few months, the Hyderabad-based vaccine maker said.

Phase III trials (as a two-dose regimen) of the vaccine were conducted for safety, immunogenicity in around 3,100 subjects, in 14 trial sites across India. Heterologous booster dose studies were conducted for safety and immunogenicity in around 875 subjects, with BBV154 intra-nasal vaccine administered in those previously completing a regimen of the commonly administered Covid vaccines. The trials were conducted in nine trial sites across India.

Product development and clinical trials for iNCOVACC were funded in part by the Centre, Department of Biotechnology, and Covid Suraksha Program.

“With the roll-out, we have achieved our goal of establishing a novel vaccine delivery platform for intra-nasal delivery. It proves that India can innovate for itself and for the world,” Bharat Biotech Executive Chairman Krishna Ella said,

Michael S. Diamond of Washington University in St. Louis, who co-developed the nasal vaccine technology with his colleague Dr. David T. Curiel said, “The continued waves of Covid-19 necessitate new strategies to overcome transmission. By generating immunity in the upper respiratory tract (entry point of the virus), this vaccine has the potential to better limit spread of the virus than other approaches. Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.”

Meanwhile, moving a step closer to commercializing the vaccine in the US, Bharat Biotech’s partner Ocugen recently announced positive top-line data for Covaxin (BBV152) from the phase 2/3 immuno-bridging study.

If the studies are successful in meeting endpoints and the US drug regulator approves Covaxin, it would be the first ever India-developed vaccine to be approved in the US.