12 April 2021 | News
DCGI to consider SEC's recommendation for Sputnik V
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Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has made the recommendation for the consideration and final decision of the Drugs Controller General of India (DCGI) to grant permission for restricted emergency use of Sputnik V vaccine.
As part of the review process, Dr Reddy’s presented the safety profile of the phase 2 study, and interim data of the phase 3 study to the government. The vaccine is currently undergoing the phase 3 clinical trial in India.
The first interim data analysis of the Sputnik V vaccine against COVID-19 phase III clinical trials in the Russian Federation has demonstrated 92% efficacy.
Sputnik V uses two different vectors - based on human adenovirus serotypes Ad5 and Ad26 - in two separate shots, allowing for a more effective defense against the coronavirus than vaccines using the same vector for both shots. By deploying two different vectors, Sputnik V avoids a possible neutralizing effect and generates a durable and longerlasting immune response.
The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) has also recently partnered with New Delhi based Panacea Biotec to produce 100 million doses per year of Sputnik V in India.