Bharat Biotech’s COVID-19 vaccine Covaxin has been granted an extension of shelf life for up to 12 months from the date of manufacture, the company said in a statement. The approval of extension of shelf life by the Central Drugs Standard Control Organisation (CDSCO) was based on the “additional stability data”, it said.
Covaxin initially had a shelf life of six months when it first received emergency use approval in the country.
“This approval is based on the availability of additional stability data, which was submitted to CDSCO. The shelf life extension has been communicated to our stakeholders,” the company said.
Shelf life is the length of time for which an item remains fit for use.
The approval comes ahead of a much awaited decision from World Health Organization (WHO) regarding the vaccine’s addition for emergency use listing.
The pending approval has led to millions of Indians complaining of travel struggles as the vaccine has not been recognised for international travel by several countries.
Recently, Prime Minister Narendra Modi, nudging WHO for its approval to Covaxin, said India is ready to produce over 5 billion Covid vaccine doses next year to help the world in the fight against the pandemic.
Earlier this year, Bharat Biotech had written to the Drugs Controller General of India or DCGI seeking extension of the shelf life of the indigenously developed vaccine from six to 24 months.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.
The drug regulator extended the shelf life of Covishield from six to nine months from its manufacturing date.