Bharat Biotech says Phase 3 trial over, intranasal vaccine 'safe'

Seeks nod as both primary and precaution dose

Bharat Biotech has submitted data from Phase 3 clinical trials of BBV154, its intranasal Covid vaccine candidate, to the drug regulator. It has sought approval both as a primary two-dose vaccine, and a heterologous booster shot.

A heterologous booster implies that the third or subsequent dose of the vaccine is different from its primary dose. Typically, the primary dose comprises two shots. The Hyderabad-based company claimed that BBV154, which is stable at 2-8 degrees Celsius, is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials.

“Being an intranasal vaccine, BBV154 may produce local antibodies in the upper