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India’s first intra-nasal Covid vaccine, the iNCOVACC, is released by Bharat Biotech

The first intra-nasal Covid vaccination for a primary and heterologous (mix-and-match) booster dose was introduced by Bharat Biotech on Thursday in India.

The nasal Covid-19 vaccine is the first in the world to have received approval for both a primary two-dose regimen and a heterologous booster shot following two doses of Covishield or Covaxin.

The roll-out of the vaccination is anticipated to start in private hospitals where prior orders have been secured.

For significant quantities purchased by the Center and the States, iNCOVACC is priced at Rs 325 per dose. The cost of the vaccination is Rs 800 per dosage on the private market.

Mansukh Mandaviya, the Union Health Minister, introduced the vaccine in the presence of Jitendra Singh, the Minister of Science and Technology. Orders for the nasal vaccination have not yet been placed by the Center.

According to Mandaviya, “India’s vaccine manufacturing and innovation capability is acknowledged throughout the world as it has earned a name for itself in generating high-quality, reasonably priced medications.

“Recipients of iNCOVACC revealed significant levels of antibody levels,” the vaccine’s maker Bharat Biotech claimed. The upper respiratory tract’s mucosal IgA antibodies may help prevent infections and their spread.

Syringes, needles, alcohol wipes, and bandages were not necessary for iNCOVACC, according to the manufacturer, which reduced costs associated with biomedical waste disposal and procurement, distribution, and storage. The vaccination can be kept between 2 and 8 degrees Celsius.

According to the Hyderabad-based vaccine manufacturer, iNCOVACC uses a vector-based platform that can quickly adapt to new varieties and enable large-scale production within a few months.

Around 3,100 participants were tested for safety and immunogenicity during the vaccine’s phase III trials (as a two-dose regimen) at 14 study sites across India. Around 875 patients participated in heterologous booster dose tests for safety and immunogenicity, with BBV154 intra-nasal vaccination given to those who had already finished a course of the frequently administered Covid vaccines. Nine people participated in the trials.

The Centre, Department of Biotechnology, and Covid Suraksha Program all contributed money toward the creation of the iNCOVACC product and its clinical trials.

“With the roll-out, we have successfully established a revolutionary intra-nasal vaccination delivery platform. According to Krishna Ella, executive chairman of Bharat Biotech, “It shows that India can innovate for both the country and the rest of the world.

The nasal vaccination technology was co-developed by Dr. David T. Curiel and Michael S. Diamond of Washington University in St. Louis. According to Dr. Curiel, “The ongoing Covid-19 waves need novel strategies to overcome transmission. This vaccine has the potential to better control the transmission of the virus than previous methods because it develops protection in the upper respiratory tract, the virus’ entry location. Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.”

In the meantime, Bharat Biotech’s partner Ocugen recently declared positive top-line data for Covaxin (BBV152) from the phase 2/3 immuno-bridging research, bringing the vaccine’s US commercialization one step closer.

It would be the first vaccine created in India to receive US approval if the studies’ goals are met and Covaxin is authorised by the US pharma agency.