Intranasal COVID vaccine: Bharat Biotech seeks DCGI nod for phase 3 study of iNCOVACC in 5-18 age group

Written by Ruchika Sharma Published On 2022-09-12T11:28:46+05:30 | Updated On 12 Sept 2022 11:28 AM IST

Intranasal COVID vaccine: Bharat Biotech seeks DCGI nod for phase 3 study of iNCOVACC in 5-18 age group

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein.

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 told the media agency.

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. iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops.

The nasal delivery system has been designed and developed to be cost effective in low- and middle-income countries BBV154 has been specifically formulated to allow intranasal delivery.

Read also: COVID-19: Bharat Biotech intranasal vaccine found safe in booster trials

"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.

Read also: Bharat Biotech gets DCGI emergency use nod for Intranasal COVID vaccine

Bharat Biotech International Limited is an Indian multinational biotechnology company headquartered in Genome Valley, Turakapally, Hyderabad. The company was founded by Krishna Ella in 1996.

It is engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751