Nod to nasal Covid vaccine's phase-3 clinical trial
New Delhi, January 28
The drug regulator today approved Bharat Biotech’s intranasal Covid vaccine candidate for phase-3 clinical trial, which will take place at nine sites, including Rohtak.
The company said it had received approval from the Drugs Controller General of India (DCGI) to conduct phase-3 trial of Sars-Cov2 vaccine BBV154. The trials will evaluate the nasal vaccine for the two-dose primary inoculation schedule (as was done for Covaxin) and the booster dose schedule. Intranasal vaccines are easier to administer in mass immunisation campaigns and help reduce and stop transmission.
The trial clearance has been given to nine sites, including AIIMS, New Delhi; AIIMS, Patna; and Pt BD Sharma Postgraduate Institute of Medical Sciences, Rohtak.
DCGI VG Somani, in the approval letter, said the phase-3 clinical trial should be conducted as per protocol “to compare immunogenicity and safety of BBV154 with Covaxin and to assess the consistency of BBV154 in healthy volunteers”. Only the batches certified by Central Drug Laboratory, Kasauli, shall be used in the trial.
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