The Drugs Controller General of India (DCGI) has approved Bharat Biotech’s intranasal heterologous ‘Five Arms’ booster dose for restricted use for COVID-19, according to a report in news agency ANI. According to the news agency, members of the Subject Expert Committee (SEC) of DCGI met on November 15 to discuss the intranasal ‘five arms’ booster dose – INCOVACC (BBV154).
Bharat Biotech applied for market authorization of the intranasal heterologous booster in September.
Five arm 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.
DCGI had already granted Emergency Use Authorization (EUA) to Bharat Biotech for the intranasal vaccine. The company had said 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 Phase 1, 2 and 3 clinical trials with successful results. iNCOVACC was formulated to allow intranasal delivery via nasal drops.
Bharat Biotech Chairman and Managing Director Dr Krishna Ella said in a statement at the time of approval of INCOVACC that even though there is a lack of demand for COVID-19 vaccines, Bharat Biotech continues to develop intranasal vaccines to ensure that So that they are well prepared with platform technologies for future infectious diseases.
The company said clinical trials were conducted to evaluate iNCOVACC as a primary dosing schedule as a heterologous booster dose for subjects receiving two doses of commonly administered COVID-19 vaccines.
iNCOVACC is stable at 2-8 °C, and can be easily stored and distributed.
