2 min read.Updated: 14 Jul 2021, 12:54 PM ISTLivemint, Edited By Sneha
India's drug regulator had earlier this month refused to grant emergency-use authorisation to the Russian-made vaccine
The single-dose Sputnik Light Covid-19 vaccine is expected to launch soon in India, Russian envoy Nikolay Kudashev was quoted as saying by news agency ANI.
"Sputnik V being part of the Indian vaccination campaign is gradually increasing. The launch of the Sputnik light vaccine is also expected soon," said Kudashev while speaking about the outcomes of the Russian-Indian foreign ministers’ talks in Moscow.
India's drug regulator had earlier this month refused to grant emergency-use authorisation to the Russian-made vaccine while ruling out the need for the conduct of the phase-3 trial.
However, the vaccine's India partner Dr Reddy's Laboratories had then said that a government expert panel has allowed it to submit the Russian safety data for approval in India.
"In view of the fact that (1) Sputnik Light is the first dose component of Sputnik V, and Dr. Reddy's has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and; (2) a phase III efficacy trial is currently underway in Russian on Sputnik Light, the SEC recommended that Dr. Reddy's should submit safety, immunogenicity and efficacy data from the phase III clinical trial of Sputnik V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India," the company said in a statement.
"Further, the SEC also observed that in view of the safety and immunogenicity data already generated by Dr. Reddy's in India on the first dose component of Sputnik V (in other words, Sputnik Light), there was no need for a separate Phase III trial of Sputnik Light in India," it added.
Earlier, reports in June had said that Dr Reddy's in talks with the central government for a speedy launch of the Sputnik Light vaccine in India.
There were also claims that all stakeholders, including the Russian manufacturer and its Indian partners, being directed to fast-track the application and regulatory approval procedures for the jab.
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of the Sputnik V coronavirus vaccine.
The Russian Direct Investment Fund (RDIF) had earlier said that it demonstrates 78.6% to 83.7% efficacy among the elderly, as per real-world data collected by the Ministry of Health of the Buenos Aires province (Argentina).
The vaccine has been developed by the Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology and the RDIF.
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