Central Drugs Standard Control Organisation extends Covaxin shelf life to 12 months

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Hyderabad-based Bharat Biotech's Covid-19 vaccine Covaxin has received an extension of shelf life for up to 12 months from the date of manufacturing India's pharmaceuticals and medical regulatory body.

"The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of COVAXIN up to 12 months, from the date of manufacture," said Bharat Biotech in a statement posted by the biotechnology company on its official Twitter handle.

The company said, "Extension is based on the availability of additional stability data, which was submitted to CDSCO. The extension has been communicated to our
stakeholders." Meanwhile, the World Health Organisation (WHO) granted approval for Emergency Use Listing (EUL) for Covaxin.

It was approved on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides
recommendations to WHO on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure.

Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials. Bharat Biotech's Covaxin and AstraZeneca and Serum Institute's Covishield are the two
widely used vaccines in India. The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson - Janssen, Moderna, and Sinopharm for emergency use. Meanwhile, India's cumulative vaccination coverage crossed 107 crore.

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