Nod sought over phase-3 trial of intranasal vax for 5-18 age group

NEW DELHI: 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 said.

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.