Bharat Biotech's ‘iNCOVACC' gets approval for heterologous booster use

29 Nov 2022 , 10:19 AM

The Indian drug regulator has approved Bharat Biotech’s intranasal Covid-19 vaccine iNCOVACC for use as a heterologous booster (a mix-and-match dose after the primary dose).

iNCOVACC has been approved for limited use in emergency situations on people over the age of 18 as a heterologous booster after two doses of either Covishield or Covaxin.

This nasal vaccine is the second Covid-19 vaccine to be approved in India, following Biological E’s Corbevax, which can be used as a mix-and-match booster shot.

The company received approval from the Drugs Controller General of India (DCGI) for this vaccine in September, making it the world’s second intranasal Covid-19 vaccine after CanSino Biologics, which received approval from the Chinese regulator the same month. However, the DCGI had approved iNCOVACC as a Covid-19 primary dose vaccine.

As a result, the company was waiting for approval to administer the vaccine as a booster shot after Covishield or Covaxin shots. At the moment, there aren’t many people in the eligible population who haven’t received a single dose of the Covid-19 vaccine. As a result, the company saw no market for iNCOVACC as a primary two-dose regimen.

The company conducted clinical trials for the vaccine’s use as a heterologous booster dose following Covishield and Covaxin, and the results were submitted to the DCGI. On approximately 875 subjects, a booster dose study was conducted for safety and immunogenicity.

According to Bharat Biotech, iNCOVACC is the world’s first intranasal vaccine for Covid to be approved for the primary two-dose schedule and as a heterologous booster.

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