India’s drug regulator, the Central Drugs Standards Control Organisation (CDSCO) has approved the extension of shelf life of indigenously-developed Covid-19 vaccine Covaxin from nine to 12 months.
The Hyderabad-based Bharat Biotech announced on Wednesday that the CDSCO approved the extension of shelf life of the vaccine 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 the CDSCO. The shelf life extension has been communicated to our stakeholders,” the vaccine maker said.
It was initially given permission for sale and distribution of Covaxin with a shelf life of six months when stored at two to eight degrees Celsius.
The CDSCO later gave its approval for extending the shelf life to nine months after Bharat Biotech submitted updated accelerated and real-time stability data of Covaxin.
Covaxin, along with Covishield manufactured by Serum Institute of India, are the two vaccines so far being used in India’s current Covid-19 vaccination drive, which was launched in January this year.
Russian vaccine Sputnik-V has also been approved for emergency use in India.