Vaccine maker Bharat Biotech on Wednesday said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its COVID-19 vaccine Covaxin up to 12 months from the date of manufacture.
Bharat Biotech was initially given permission for the sale and distribution of Covaxin with a shelf life of six months, which was later extended to nine months, a company spokesperson said
“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 approval for the extension of shelf life of the vaccine comes ahead of crucial World Health Organisation (WHO) meeting for a final risk-benefit assessment for the emergency use listing (EUL) for the vaccine.
The WHO’s Technical Advisory Group for EUL last week had sought additional clarifications from Bharat Biotech for Covaxin.