Bharat Biotech gets approval to test nasal COVID-19 vaccine as booster shot

Bharat Biotech gets approval to test nasal COVID-19 vaccine as booster shot

As India is witnessing a surge in cases of Omicron variant, Hyderabad-based Bharat Biotech, on Wednesday, was approved to conduct late-stage trials of its nasal COVID-19 vaccine to be used as a booster shot.

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.

“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.

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 been 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.

Meanwhile, on Wednesday, the country reported 58,097 new coronavirus cases, twice the number seen only four days ago, taking its total caseload to over 35 million.