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Bharat Biotech seeks DCGI nod to extend shelf life of Covaxin: Report

Bharat Biotech's Covaxin gets DCGI nod for phase 2,3 trial for 2-18 age group


Bharat Biotech seeks DCGI nod to extend shelf life of Covaxin: Report

Bharat Biotech has sought permission from India’s drug regulator DCGI to extend the shelf-life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months, sources said on Sunday. Covaxin, along with Covishield manufactured by Serum Institute of India, are the two vaccines so far being used in India’s current COVID-19 vaccination drive. Russian vaccine Sputnik-V has also been approved for emergency use in India. The Hyderabad-based Bharat Biotech was given permission for sale and distribution of Covaxin with shelf life of six months when stored at two to eight degrees Celsius.

“Now, we are herewith applying for the extension of shelf life from six months to 24 months when stored at 2-8 degreesCelsius,” the firm said in its application to the Drugs Controller General of India.

In support of their proposal, Bharat Biotech has submitted updated accelerated and real-time stability data of Coaxin along with the justification for the extension of shelf-life. The DCGI had extended the shelf-life of Covishield from six to nine months from its manufacturing date in February.

The vaccine maker on Saturday said it would provide its COVID-19 vaccine, Covaxin, to state governments at Rs 600 per dosage. The Hyderabad-based vaccine major also said that it would provide the vaccine to private hospitals at Rs 1,200 per dosage.

In a statement, Bharat Biotech Chairman and Managing Director Krishna M Ella said the company is supplying the vaccine to the central government at Rs 150 per dosage and the government on its part is distributing it free of cost.

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“We would like to state that more than 50 per cent of our capacities have been reserved for central government supplies,” Ella said. Recovering the cost is essential in the journey of innovation towards other vaccines such as intranasal Covid-19, Chikungunya, Zika, Cholera and others, he added.

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