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.
In September 2020, Dr Reddy’s 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.