New Delhi | Jagran News Desk: The Central Drugs Standard Control Organization (CDSCO) has approved the extension of the shelf-life of Covaxin up to 12 months, from the date of manufacture, said Bharat Biotech in a statement on Wednesday (November 3). Currently, Covaxin has an approved shelf-life of six months subject to its storage at two to eight degrees Celsius.
"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 statement.
"The shelf life extension has been communicated to our stakeholders," it added.
It was in April 2021 that the Hyderabad-based biotechnology company had written to India’s drug regulator seeking an extension of the shelf-life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months. In its proposal, Bharat Biotech had submitted the updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf-life.
The approval comes at a time when the Technical Advisory Group (TAG) of the World Health Organization (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 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, along with Covishield manufactured by Serum Institute of India, are the two vaccines so far being used in India’s current COVID-19 inoculation drive. Russian vaccine Sputnik-V has also been approved for emergency use in India.
Posted By: Sugandha Jha