Bharat Biotech says Phase 3 trial over, intranasal vaccine safe

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 respiratory tract. These may provide the potential to reduce infection and transmission. Further studies are being planned,” the company noted on Monday.