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Drug regulator seeks more data from Sputnik V | India News


NEW DELHI: It may be some time before the Russian Covid Sputnik V vaccine is available in India as the drug regulator’s committee of experts on vaccines has deferred its decision on the application for emergency use authorization for injections .
The expert committee asked Hyderabad-based Dr Reddy’s Laboratories, which is conducting bridge studies in India for the vaccine, for more stability-related data and a fact sheet. A variant of the vaccine must be stored at a temperature of minus 18 degrees Celsius and the company has been asked to come up with a clear logistical plan to support the required cold chain and storage.
Dr. Reddy’s Lab had applied for an emergency use license in February, but was asked to return after completing phase 2 and 3 bridge studies in India. Sputnik V, co-developed by RDIF and the Gamaleya Research Institute of Epidemiology and Microbiology, has a provisional high efficacy of 91.6%.

Times of India