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No Sputnik V approval yet, SEC asks Dr Reddy's for more data on vax


The Subject Expert Committee (SEC) of the Indian drug regulator, tasked with vetting Covid-19 vaccine proposals, sought additional data on Russian Covid-19 vaccine Sputnik V , while deciding on its emergency use authorisation, a senior government official said on Thursday.
In September 2020, Dr. Reddy s had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India. The company had conducted Phase 2 trials in India with 1,500 participants. Phase three trials are underway.
The Hyderabad-based pharma major had applied for its emergency licensure on February 19. The Committee looked into Dr. Reddy s application, on Thursday. Sputnik V has not received the emergency use authorisation yet, as the SEC has sought additional data, according to top sources. ....

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