Bharat Biotech gets DCGI nod to conduct phase-3 trials for Covid's intranasal booster dose
New Delhi: 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.
Read also: Bharat Biotech seeks DCGI nod for study of intra-nasal COVID vaccine as booster dose
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.
Read also: DCGI regular market nod to Covaxin, Covishield for adults
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