Drug regulator extends shelf life of Covaxin to 12 months

Covaxin-maker Bharat Biotech on Tuesday said that the Central Drugs Standard Control has approved the extension of the vaccine's shelf-life to up to 12 months from the date of manufacture.

The company said that the approval is based on additional stability data, which was submitted to Central Drugs Standard Control.

Earlier this year, the Hyderabad-based Bharat Biotech had written to India’s drug regulatory body seeking an extension on the shelf life of Covaxin from a period of six months to 24 months.

The extension came just hours before WHO gave Covaxin approval for emergency use.

Bharat Biotech was permitted the sale and distribution of its indigenously developed Covid-19 vaccine ”Covaxin” with a shelf life of six months when kept at 2°C-8°C.

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