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Recommendation for emergency use authorisation granted to Russian COVID-19 vaccine Sputnik V
The SEC held a meeting on April 1 and recommended that the drug company must first present data related to all immunogenicity parameters
As a rise in the number of COVID-19 cases was observed in the country, emergency use authorisation (EUA) was granted to Russia's Sputnik V vaccine in India.
The development came to light on Monday, after the Subject Expert Committee (SEC), constituted by the Central government held a meeting and granted approval to the Russian vaccine. Three clinical trials were conducted on 1,600 persons in India before the authorisation was granted.
The storage temperature of liquid vaccination for Sputnik V is -18 degree Celsius. The expert panel of India's central drug authority sought additional data from Dr Reddy's Laboratories on April 1, after the company sought EUA for Sputnik V.
Last month, Dr Reddy’s Laboratories submitted the immunogenicity data. The SEC held a meeting on April 1 and recommended that the drug company must first present data related to all immunogenicity parameters, unblinded data of serious adverse events and RT-PCR positive cases, along with causality analysis reported to date, before a decision was taken.
A source told news agency PTI, "It has also asked the Hyderabad-based firm to submit a comparative analysis of the phase 3 immunogenicity data generated on the Indian and Russian studies at various time points. It has also asked the drug-maker to submit the factsheet. "
In September last year, Dr Reddy's and the Russian Direct Investment Fund (RDIF) entered into a partnership to conduct the clinical trials of Sputnik V and to work out the distribution rights in India.