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

New Delhi, Feb 24 : The Central Drug Standard Control Organisations (CDSCO)Subject Expert Committee has asked Dr Reddys 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 Reddys 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 vaccines trial on the children.

In September 2020, Dr Reddys partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India.The vaccine is currently undergoing the Phase 3 clinical trial in India.