DGCI gives a go-ahead for Phase III Sputnik Light trials
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DGCI gives a go-ahead for Phase III Sputnik Light trials

The Lancet study said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines

  • By IPP Bureau | September 16, 2021

The Drugs Controller General of India (DCGI), has given the go-ahead to conduct Phase III bridging trials of Sputnik Light in India. The vaccine is a single-dose Covid-19 vaccine of the Russian vaccine Sputnik


Two days ago, The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced the publication of a study in EClinicalMedicine (an open-access peer-reviewed clinical journal published by The Lancet, one of the world's most respected medical journals) on the efficacy of Russian Sputnik Light coronavirus vaccine

The Lancet study said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.

The committee had noted that Sputnik Light was the same as component-1 of Sputnik V and its safety and immunogenicity data in the Indian population was already generated in a trial.

Sputnik Light also reduced hospitalizations among the target population at 82.1-87.6 per cent, the study said.

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus. It has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests. Sputnik Light is compatible with standard vaccine storage and logistics requirements.

The Sputnik Light vaccine is based on a well-studied human adenoviral vector platform that has proven to be safe and effective, with no long-term side effects, as confirmed in over 250 clinical trials conducted globally over the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953).

 

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