Experts defer decision on Sputnik V vaccine
1 min read 01 Apr 2021, 08:42 PM ISTThe SEC has asked the Hyderabad-based drugmaker to submit the fact sheet for the vaccine along with details on stability of Sputnik V as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius
PremiumThe subject expert committee (SEC) of India’s drug regulator has deferred its decision on whether to recommend the Russian Sputnik V vaccine for emergency use, and instead asked applicant Dr Reddy’s Laboratories for more data, two people aware of the development said.
The SEC asked the Hyderabad-based drugmaker to submit the fact sheet for the vaccine along with details on stability, as a variant of the vaccine needs to be stored at a temperature of -18 degree Celsius, one of the persons cited above said.
While the liquid form requires a storage temperature of -18 degree Celsius, the freeze-dried form can be stored at 2-8 degree Celsius.
Dr Reddy’s is in a pact with Russian Direct Investment Fund (RDIF), the co-developer of the vaccine. The Indian firm will conduct clinical trials and also distribute the vaccine in the country depending on its securing an authorization.
Dr Reddy’s had applied for the emergency use licence in February but was asked to return after completing the phase 2 and 3 bridging study.
Sputnik V, co-developed by RDIF and Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology, has a high interim efficacy of 91.6%.
Apart from Dr Reddy’s, RDIF has also signed manufacturing pacts with four other Indian companies for a total of 750 million doses.
