The Central Drugs Standard Control Orgsation's (CDSCO) Subject Expert Committee (SEC) has recommended additional immunogenicity data from Dr Reddy's Laboratories which applied to the national drugs regulator seeking emergency use approval for Sputnik V, a Russian COVID-19 Vaccine.
"Today, SEC meeting helped discuss the application of Dr Reddy seeking emergency use approval for Sputnik V vaccine. However, the pharma company has been asked to submit additional immunogenicity data. Once the firm presents the additional data then the only further evaluation will be done," a government official said.
On 19 February, Dr Reddy's Laboratories announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorization (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.
In September last year, 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.
According to Dr Reddy's, Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine. Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old.
Sputnik V is being developed by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology to fight against COVID-19 based on the human adenoviral vector platform.
( With inputs from ANI )
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