CDSCO panel seeks additional data on Covovax from Serum Institute
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New Delhi: An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of Covid-19 vaccine Covovax, has sought additional data from the firm, while noting the jab has not yet been approved in the country of origin, official sources said.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on the DCGI's approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses, they said.
In August 2020, US-based vaccine maker Novavax, Inc had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries and India.
Read also: SII seeks DCGI nod to manufacture Covovax
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