Bharat Biotech seeks DCGI nod for the phase-3 study of intra-nasal Covid vaccine as a booster dose

The application has been filed and the company is awaiting approval from the drug regulator. The intranasal vaccine will be administered to those who have already taken their two-dose vaccine.

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New Delhi: Bharat Biotech has asked the Drug Controller General of India (DGCI’s) approval to conduct phase-3 trials of its COVID-19 intranasal vaccine (BBV154) as a booster dose.
As per media reports, the application has been filed and the company is awaiting approval from the drug regulator. The intranasal vaccine will be administered to those who have already taken their two-dose vaccine.
The vaccine has already passed phase 2 trials, in which BBV154 (Bharat Biotech’s nasal vaccine) was combined with COVAXIN. Nasal Cavity was used to input the drug.

The Company has also asked for the nod to increase the shelf life of the COVAXIN. The official at the company said, “This approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO. With the shelf-life extension, hospitals can now utilize the stock which was nearing expiry and avoid vaccine wastage.”

The Intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has an aim to lower or prevent transmission heavy transmission of the virus.

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