Government panel seeks additional data from SII on Covovax
The Hindu
In August 2020, U.S.-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
An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of COVID-19 vaccine , 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 Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trials conducted in the country as well as interim clinical trial data of safety and efficacy from phase 3 clinical trials conducted in the U.K. and the U.S. along with its application, official sources said.
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