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Bharat Biotech has sought the Drug Controller General of India’s approval to conduct phase-3 trials of its COVID-19 intranasal vaccine (BBV154) to use as booster dose, sources said on Monday.
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 sources told PTI.
An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has the potential to prevent transmission.
Already conducted phase-2 with Bharat Biotech’s Covaxin and with BBV154 (Bharat Biotech’s nasal vaccine). Using a combination of one intra-muscular and the other nasal is an innovative approach of heterologus, sources added.
Meanwhile, the Central Drugs Standard Control Organisation approved the extension of Bharat Biotech’s COVID-19 vaccine Covaxin’s shelf life up to 12 months from the date of manufacture, the vaccine-maker said in a press release.
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 utilise the stock which was nearing expiry and avoid vaccine wastage, it said.
Covaxin is approved for use under the 28-day multi-dose vial policy from Drugs Controller General of India and the WHO Emergency Use Listing (WHO EUL).
Covaxin Open Vial is stable at 2 to 8 degrees Celsius for 28 days and not required to be discarded immediately in a day or at the end of immunisation session.
Bharat Biotech said it believes in doing a bit to care for the environment. The multi-dose vial policy saves money for procurement agencies by reducing the cold chain logistics and management thereby reducing the carbon footprint, costs related to open vial wastage, cold chain distribution, cold chain storage and biomedical waste disposal among others.
Most importantly, we believe in being environmentally friendly by reducing the quantum of packing materials and single use plastics that are utilised in vaccines-manufacturing, storage, distribution and disposal, the company said.
