Bharat Biotech seeks DCGI’s nod for its intranasal COVID-19 booster dose clinical trials

As India is witnessing a surge in cases of Omicron variant, Hyderabad-based Bharat Biotech has submitted the phase 3 clinical trial application to the Drugs Controller General of India (DCGI) to get approval for the booster dose of their intranasal COVID-19 vaccine.

“We have submitted phase 3 clinical trial application to DCGI. An intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns. Intranasal vaccines have the potential to prevent against transmission,” news agency ANI cited sources as saying.

According to the report, the application was submitted by Bharat Biotech on December 15 for its booster dose of their intranasal COVID-19 vaccine that can be given to Covaxin and Covishield vaccinated people.

The company is hoping for early approval for the trails of the intranasal COVID-19 booster given the fast spread of the Omicron variant, denoted as B.1.1.529.-

India has reported 161 Omicron cases so far, informed Union Home Minister Mansukh Mandaviya on Monday.

Bharat Biotech is the second company to submit an application for phase 3 clinical trial for the third dose in India.