COVID-19: Sputnik Light vaccine gets DGCI nod for phase III bridging trials in India
The Subject Expert Committee (SEC) of the DCGI recommended the phase III bridging trials for Sputnik Light.
FollowThe Drugs Controller General of India (DCGI) has approved to conduct phase III bridging trials of Sputnik's single-dose Covid-19 vaccine, Sputnik Light.
Sputnik Light is the first component of Sputnik V based on human adenovirus serotype 26.
The approval comes after Dr Reddy’s submitted safety and immunogenicity along with the longevity of the antibodies which gives a measure of persistence antibodies in the participants to the Subject Expert Committee (SEC) that advises the drug regulator on new Covid-19 vaccines, drugs.
The Subject Expert Committee (SEC) of the DCGI recommended the phase III bridging trials for Sputnik Light.
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On July 1, the government's Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) had dismissed an application by Dr Reddy's, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country.
Reportedly they had not found any rationale behind conducting a fresh trial because the single dose jab is purportedly the same as a single dose of Sputnik V vaccine. At the time, an Economic Times report had quoted a source to say that the immunogenicity of a single dose of the vaccine had previously been tested and the results had been sub-par. "Hence the SEC did not find any rationale to conduct the trial again," the article quoted the source as saying.
Dr Reddy's Laboratories had partnered with the Russian Direct Investment Fund (RDIF)
A two-dose vaccine, Sputnik V is made from two components - recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5 The first dose (Ad26) is the main vaccine, and the second (Ad5) is a booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.
According to a recent study published in The Lancet, Sputnik Light demonstrated 78.6-83.7% efficacy against Covid-19, considerably higher than most two-shot jabs.
Sputnik Light also reduced hospitalisations among the target population at 82.1-87.6%, the study said.
Sputnik Light has been developed by Russia's Gamaleya Institute and backed by RDIF.
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