The approval of extension of shelf life by the Central Drugs Standard Control Organisation was based on the ‘additional stability data’, Bharat Biotech tweeted
An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharath Biotech. Image: Bharath Biotech
Bharat Biotech’s 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”, Bharat Biotech said in a tweet.
The shelf life extension has been communicated to “our stakeholders,” it added.
The approval comes ahead of a much awaited decision from World Health Organization (WHO) regarding the Bharat Biotech’s COVID-19 vaccine’s addition for emergency use listing (EUL).
The pending approval has led to several Indians complaining of travel difficulties as Covaxin has not been recognised for international travel by several countries.
Recently at the G-20 Summit in Rome, Prime Minister Narendra Modi said India will be able to produce over 5 billion 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 (DCGI) seeking extension of the shelf life of the indigenously developed vaccine from six to 24 months.
Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2% protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
With inputs from PTI