Bharat Biotech seeks DCGI's approval to conduct trials of nasal COVID-19 vaccine

The Bharat Biotech International Limited has sent a proposal to the Drugs Controller General of India (DCGI) for conducting the phase 1 trials of a nasal vaccine against COVID-19, informed a government official on Friday.

"Bharat Biotech sent an application to DCGI for conducting the phase 1 trials of a nasal vaccine against COVID-19. The matter is yet to be taken up," the official said.

A nasal vaccine could save on medical equipment, such as syringes, and save time taken for vaccination.

COVID-19 vaccines of Serum Institute of India's 'Covishield' and Bharat Biotech's 'Covaxin' were granted permission for restricted use in an emergency situation by the DCGI on January 3.

This comes a day after Bharat Biotech announced the successful completion of volunteer enrolment for phase-3 clinical trials of 'Covaxin.'

The indigenous vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

COVAXIN has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer-reviewed scientific journals, the company had said in a statement.

COVAXIN is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, it had added.

Union Health Minister Dr Harsh Vardhan had asserted that the COVID-19 vaccines 'Covishield' and 'Covaxin' are on the verge of being available in the country.