Government panel seeks additional data from SII on Covovax
The Hindu
Vaccine has not yet been approved in country of origin, it notes
An expert panel of India's Central Drug Authority, which recently reviewed Serum Institute's application seeking emergency authorisation of the 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 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 United Kingdom and the U.S. along with its application, official sources said.
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