Covaxin shelf-life extended to 12 months

New Delhi, Nov 03: The Central Drugs Standard Control Organisation (CDSCO) on Wednesday approved the extension of the shelf life of Covid-19 vaccine maker Bharat Biotech's Covaxin to up to 12 months from the date of manufacturing.

"The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO," Bharat Biotech said in a tweet.

The shelf life extension has been communicated to "our stakeholders," it added.

The Hyderabad-based firm had earlier this year written to India's drug regulator seeking an extension of the shelf-life of its vaccine to 24 months.

At present, Covaxin has an approved shelf-life of six months.

The approval comes at a time when the Technical Advisory Group (TAG) of the World Health Organisation (WHO) is likely to decide on Covaxin's Emergency Use Listing (EUL).

The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.

The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India. The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.