The Indian drug regulator has approved Bharat Biotech’s iNCOVACC, an intranasal Covid-19 vaccine, for use as a booster dose, and it is a mix-and-match dose following the primary dose. iNCOVACC has been approved for limited emergency use on patients over the age of 18 as a heterologous booster following two doses of either Covaxin or Covishield.
After Biological E’s Corbevax, which can be used as a mix-and-match booster shot, this nasal vaccine becomes the second Covid-19 vaccine that has been approved in India.
Bharat Biotech received approval for this vaccine from the Drugs Controller General of India (DCGI) in September 2022. This makes the vaccine the second intranasal COVID-19 vaccine in the world, following the CanSino Biologics vaccine that received approval from the Chinese regulator in September 2022. However, the DCGI had approved iNCOVACC as a primary Covid-19 vaccine.
As a result, Bharat Biotech was awaiting approval to give the vaccine as a booster shot following Covishield or Covaxin shots. Only a small percentage of the eligible people has not received the COVID-19 vaccine in India to this point. Hence, the company had no possible market for iNCOVACC as an essential routine of two-doses.
Krishna Ella, chairman and managing director of Bharat Biotech, has acknowledged that there was little demand for the vaccine. He said that, they continued the development of the intra-nasal vaccine to ensure that they are prepared with technologies for future infectious diseases despite the lack of demand for COVID-19 vaccines.
After Covishield and Covaxin, Bharat Biotech has conducted clinical trials for the vaccine’s use as a heterologous booster dose, and also provided the DCGI with the results. Bharat Biotech claimed that iNCOVACC is the first intranasal vaccine for COVID-19 to receive approval for the primary two-dose schedule and also for heterologous booster. The booster dose study was conducted for safety and immunogenicity on around 875 volunteers.
iNCOVACC is a chimpanzee adenovirus-based vectored recombinant nasal vaccine, which is designed to be administered intravenously through drops. According to Bharat Biotech, the nasal delivery system has been developed to be affordable in low and middle-income countries.