May 12, 2021

covaxin: Bharat Biotech seeks DCGI’s nod to increase shelf lifetime of Covaxin

Bharat Biotech has written to the India’s drug regulator searching for extension of the shelf-life of its indigenously developed COVID-19 vaccine Covaxin from six to 24 months, sources mentioned on Sunday. Covaxin, together with Covishield manufactured by Serum Institute of India, are the 2 vaccines up to now being utilized in India’s present COVID-19 vaccination drive. Russian vaccine Sputnik-V has additionally been authorised for emergency use in India.

The Hyderabad-based Bharat Biotech was given permission on the market and distribution of Covaxin with shelf lifetime of six months when saved at two to eight levels Celsius.

“Now, we’re herewith making use of for the extension of shelf life from six months to 24 months when saved at 2-Eight degreesCelsius,” the agency mentioned in its software to the Medicine Controller Basic of India.

In help of their proposal, Bharat Biotech has submitted up to date accelerated and real-time stability knowledge of Coaxin together with the justification for the extension of shelf-life.

The DCGI had prolonged the shelf-life of Covishield from six to 9 months from its manufacturing date in February.