“This approval is based on the availability of additional stability data, which was submitted to CDSCO,” the company said. 

Bharat Biotech had earlier this year written to India’s drug regulator seeking an extension of the shelf-life of its vaccine to 24 months. The Hyderabad-based firm said that it submitted necessary real-time stability data of Covaxin to the drug regulator to substantiate its application.

Currently, Covaxin has an approved shelf-life of six months subject to its storage at two to eight degrees celsius.

Covaxin WHO approval

This comes even as the Technical Advisory Group (TAG) of the World Health Organisation (WHO) is likely to decide on Covaxin’s Emergency Use Listing (EUL) on Wednesday. 

“The TAG met on 26 October and decided to seek additional clarifications from the Covaxin manufacturers that are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” a WHO official was quoted as saying by news agency ANI.

“The TAG expects to receive these clarifications from the manufacturer by the end of this week and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” the official added. 

Covaxin has demonstrated 77.8% effectiveness against symptomatic Covid-19 and 65.2% protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are the two widely used vaccines in India.