Hyderabad-based firm Bharat Biotech has sought permission from the drug regulator to conduct phase-3 study of its intranasal COVID-19 vaccine in the 5 to 18 age group. On September 6, the Drugs Controller General of India (DCGI) had approved its intranasal Covid vaccine iNCOVACC for restricted emergency use in those aged above 18 years.
“Now the Hyderabad based firm has submitted an application seeking permission to conduct phase-3, multicenter study to evaluate the safety, reactogenicity and immunogenicity of iNCOVACC (BBV154) in those aged 18 to 5 years," an official source told PTI.
Bharat Biotech has also applied for market authorisation for the intranasal heterologous booster from the DCGI, reported ANI news agency. The vaccine will be administered as a booster shot after Covishield and Covaxin.
According to the report, 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."
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase 1, 2 and 3 clinical trials with successful results, a release from the vaccine-maker said. BBV154 has been specifically formulated to allow intranasal delivery.
“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 firm had said. Separately, the DCGI also granted permission to the firm to conduct a phase-3 clinical trial to compare the immunogenicity and safety of BBV154 (intranasal) with Covaxin.
This trial has been permitted to be conducted at nine sites.