Vaccine maker Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of COVID-19 vaccine Covaxin up to 12 months from the date of manufacture.
"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.
Last month, an expert panel of India's Central Drug Authority recommended granting emergency use authorisation to Bharat Biotech's Covaxin for children in the 2 to 18 years age group with certain conditions.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
"After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions," the SEC recommendations had stated.