Manas Dasgupta
NEW DELHI, Dec 20: Not only the shelf life, even an opened vial of “Covaxin,” India’s first indigenous Covid-19 vaccine, can be stored at 2-8 degrees Celsius for up to 28 days, Bharat Biotech, the manufacturer of the vaccine against Coronavirus disease, claimed on Monday.
Announcing this, the company said even the opened vials of “Covaxin” need not be discarded immediately in a day or at the end of the immunization session and could be stored for re-use for up to 28 days under the controlled temperature. It stated that the extension of Covaxin’s shelf life up to 12 months from the date of manufacturing was recently approved by the Central Drugs Standard Control Organisation (CDSCO).
The company’s announcement gives a big boost to the mass immunization programme in the country where the issue of vaccine wastage is a major concern for companies as well as the health authorities since the demand has been not able to keep up pace with the supply. The latest announcement could help resolve the vaccine wastage issue to some extent, especially the vaccines nearing expiry. The Hyderabad-based vaccine maker said “Covaxin” had been approved for use under the 28-day multi-dose vial policy from the Drugs Controller General of India (DCGI) and the WHO Emergency Use Listing.
“This approval of shelf life is based on the availability of additional stability data, which was submitted to CSCO,” Bharat Biotech said, adding that the hospitals can now utilise the stock which was nearing the expiry and avoid vaccine wastage.
The company said the multidose vial policy would save money for procurement agencies by reducing the cold chain logistics and management and subsequently reducing the carbon footprint and costs related to open vial wastage.
“Most importantly, we believe in being environmentally friendly by reducing the quantum of packing materials and single-use plastics that are utilized in vaccines manufacturing, storage, distribution, and disposal,” it added.
Earlier in the day, Bharat Biotech had said it had submitted an application to the DCGI to conduct a phase 3 clinical trial for a booster dose of its intranasal Covid-19 vaccine. “We have submitted phase 3 clinical trial application to DCGI,” a Bharat Biotech spokesperson said.