Bharat Biotech gets CDSCO nod for shelf-life extension of Covaxin
Bengaluru: Bharat Biotech's COVID-19 vaccine has been granted an extension of shelf life for up to 12 months from the date of manufacture by India's drug regulator, Central Drugs Standard Control Organisation (CDSCO) the company said on Wednesday.
Covaxin initially had a shelf life of six months when it first received emergency use approval in the country, which was later extended to nine months, a company spokeswoman told Reuters.
The company said that the approval is based on the availability of additional stability data, which was submitted to the Central Drugs Standard Control Organisation.
The Indian drug regulator's extension approval comes shortly ahead of a much awaited decision from the World Health Organization (WHO) regarding Covaxin's addition for emergency use listing.
The pending WHO approval has left millions of Indians, who have received the homegrown shot, contemplating foreign trips as most countries rely on the WHO nod for allowing international travellers.
The WHO's advisory group was expected to make a decision on Covaxin last week, but asked for additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine's global use.
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