Bharat Biotech seeks drug regulator’s nod for Incovacc’s phase-III study in five-18 age group

Bharat Biotech has sought permission from the drug regulator to conduct phase-III study of its intranasal COVID-19 vaccine in the five-to-18 age group.

On 6th September, 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-III, multicentre study to evaluate the safety, reactogenicity and immunogenicity of Incovacc (BBV154) in those aged 18 to 5 years,” an official source told PTI.

Incovacc is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results, a release from the vaccine-maker said.

BBV154 has been specifically formulated to allow intra-nasal delivery.

“Being an intra-nasal 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-III clinical trial to compare the immunogenicity and safety of BBV154 (intranasal) with Covaxin.

This trial has been permitted to be conducted at nine sites.

Edits by EP News Bureau