The Drugs Controller General of India (DCGI) has approved Bharat Biotech’s intranasal heterologous ‘Five Arms’ booster dose for restricted use for COVID-19, as per a report by news agency ANI. This approval comes after the Subject Expert Committee (SEC) members of the DCGI met on November 15 to hold a discussion on intranasal ‘Five Arms’ booster dose – iNCOVACC (BBV154), as per the news agency.
Bharat Biotech had applied for the market authorisation of the intranasal heterologous booster in September.
The five arms heterologous intranasal booster dose means Arm 1: 2 Covaxin – booster Covaxin, Arm 2: 2 Covaxin – booster I/N vaccine, Arm 3: 2 Covishield- booster Covishield, Arm 4: 2 Covishield- booster I/N vaccine, Arm 5: 2 intranasal- booster intranasal.
The vaccine candidate was evaluated in phases 1, 2 and 3 clinical trials with successful results. iNCOVACC was formulated to allow intranasal delivery through nasal drops.
iNCOVACC is stable at 2-8 degree Celsius, and can be easily stored and distributed.