India grants approval to Bharat Biotech to test nasal Covid-19 vaccine as booster

India's drug regulator on Wednesday granted approval to Bharat Biotech for conducting late-stage trials of its nasal Covid-19 vaccine to be used as a booster shot, according to a Mint report, which cited ANI.

The vaccine maker submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December, adding that an intranasal vaccine as a booster dose will be easier to administer in mass vaccination campaigns.

The company had in August received the Drug Controller General of India's (DCGI's) nod for conducting phase 2 clinical trials of the nasal vaccine.

"DCGI's Subject Expert Committee has granted 'in principle' approval to Bharat Biotech for the conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine and has asked it to submit protocols for approval," according to the report on Wednesday.

Bharat Biotech and DCGI did not immediately respond to Reuters requests for comment.

As a precautionary measure in light of rising Omicron coronavirus variant cases across the country, India approved the administration of Covid-19 booster shots on Christmas, with healthcare and frontline workers set to receive them from January 10.

The country is yet to approve the use of Bharat Biotech's intranasal vaccine, BBV154. In August, BBV154 received regulatory approval for mid- to late-stage trials. Local media had reported the mid-stage trial has completed.

India's inoculation drive so far has been dominated by a domestically produced version of the AstraZeneca Covid-19 shot by Serum Institute of India and Bharat Biotech's inactivated vaccine Covaxin, both administered through injections.

The company reports that the doses of the vaccine administered to healthy volunteers in the phase-1 clinical trial have been well tolerated. No serious adverse events were reported, the DBT had said.