DCGI approves Bharat Biotech’s intranasal heterologous ‘Five Arms’ COVID-19 booster dose

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 DCGI had already given the emergency use authorisation (EUA) to Bharat Biotech for the intranasal vaccine. The company had stated that the recombinant replication-deficient adenovirus vectored vaccine iNCOVACC was approved under restricted use in emergency situations for 18 years and above. 

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.

Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, had said in a statement at the time of the approval of iNCOVACC that even though there is a lack of demand for COVID-19 vaccines, Bharat Biotech continued to develop intranasal vaccines to ensure that they are well prepared with platform technologies for future infectious diseases. 

The company said that clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule as a heterologous booster dose for subjects who received two doses of the commonly administered COVID-19 vaccines.

iNCOVACC is stable at 2-8 degree Celsius, and can be easily stored and distributed. 

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