Bharat Biotech’s COVID-19 vaccine Covaxin gets shelf life extension to 12 months
Bharat Biotech in a statement on Wednesday said that this approval is based on the availability of additional stability data, which was submitted to CDSCO.
FollowIn a massive announcement, the Central Drugs Standard Control Organisation (CDSCO) has approved the shelf life extension of Bharat Biotech manufactured Covid-19 vaccine Covaxin to 12 months from the date of manufacture.
Bharat Biotech in a statement on Wednesday said that this approval is based on the availability of additional stability data, which was submitted to CDSCO.
Bharat Biotech in a tweet 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. The shelf life extension has been communicated to "our stakeholders."
This came just hours before the World Health Organisation (WHO) recommended the Emergency Use Listing status for Bharat Biotech’s Covaxin on Wednesday.
Earlier this year, Bharat Biotech had written to India's drug regulator seeking an extension of the shelf life of its vaccine up to 24 months. The Hyderabad-based firm had said that it submitted necessary real-time stability data of Covaxin to the drug regulator to substantiate its application.
Now, we are herewith applying for the extension of shelf-life from six months to 24 months when stored at 2-8 degrees Celsius," the firm had said in its application to the Drugs Controller General of India.
Currently, Covaxin subject to its storage at two to eight degrees Celsius has an approved shelf-life of six months.
Covaxin, and also Covishield manufactured by Serum Institute of India, are the two vaccines being used in India’s current Covid-19 vaccination drive so far. Russian vaccine Sputnik-V has also been approved for emergency use in India.
