DCGI gives permission to Bharat Biotech for intranasal booster dose trials

The dosage form of the vaccine is liquid for the intranasal route of administration and every single dose contains 0.5 ml

India's drug regulator has given permission to Bharat Biotech to conduct phase-3 clinical trial for its intranasal Covid vaccine as booster dose on participants who have been previously inoculated with SARS-CoV 2 vaccines.

India is yet to approve the use of intranasal COVID-19 vaccine BBV154 developed by the Hyderabad-based company.

Drugs Controller General of India (DCGI) on January 27 gave the nod to Bharat Biotech to conduct phase-3 randomised multi-centric clinical study to evaluate immunogenecity and safety of its intranasal vaccine as booster dose on participants who have been previously vaccinated with COVID-19 vaccines approved under new drugs under New Drugs & Clinical Trials Rules, 2019.

According to official sources, the trial would be conducted at five sites, including AIIMS Delhi.

In December, Bharat Biotech had sought permission from DCGI to conduct phase-3 study for its intranasal COVID-19 vaccine as a booster dose to participants previously vaccinated with SARS-CoV-2 vaccines.

Separately, the DCGI on Thursday also gave permission to the firm to conduct phase-3 clinical trial to compare the immunogenecity and safety of BBV-154 (intranasal) with Covaxin. This trial has been permitted to be conducted at 9 sites.

In August, the nasal vaccine had received the regulator's nod for conducting phase 2 clinical trials.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine.

"BBV154 (nasal covid vaccine) has received approval for phase-3 clinical trials. The trials will evaluate BBV154 nasal vaccine for both the two-dose primary schedule and booster dose schedule," a source in Bharat Biotech said.

An intra-nasal vaccine would not only be simple to administer but also reduce the use of needles and syringes, among others. It would also impact the overall cost of a vaccination drive, chairman of Bharat Biotech Krishna Ella had said.