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Submit immunogenicity data, SEC asks Dr Reddy before nod for Sputnik V

Meanwhile, the committee has also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin before seeking its trial on children.

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Delivery of supplies of the Russian Sputnik V at the State hospital in Cailungo, San Marino. Pic/AFP

Delivery of supplies of the Russian Sputnik V at the State hospital in Cailungo, San Marino. Pic/AFP

The Central Drug Standard Control Organisation's (CDSCO)Subject Expert Committee has asked Dr Reddy's Laboratories to present additional data of immunogenicity while reviewing its application for Emergency Use Authorisation (EUA) of Russian Covid vaccine Sputnik V in India, sources said.

Dr Reddy's had applied for EUA before the CDSCO, and its application was reviewed by the SEC on Wednesday, a source told IANS. Meanwhile, the committee has also asked Hyderabad-based Bharat Biotech to submit efficacy data of Covaxin before seeking its trial on children. The firm had sought permission from the Drug Controller General of India to conduct vaccine's trial on the children.

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