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.
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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.
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"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.
