New Delhi: The Drugs Controller General of India (DCGI) has given its approval to Russia’s single-dose COVID-19 vaccine Sputnik Light to conduct the bridging trials in India. Testing for Sputnik Light’s phase-3 trials will now begin in India soon as the first tranche has been sent for quality and safety validation.Also Read - How to Identify Fake Covishield, Covaxin, Sputnik V Vaccine From Real Ones? Centre Issues Guidelines
The batch — manufactured by Panacea Biotec — has been sent for the checks after which the doses can be safely administered to the trial participants, reported News18 citing sources. Also Read - Serum Institute to Start Production of Sputnik V in September: Russian Manufacturer
“While samples of Sputnik Light, manufactured by domestic pharma company Panacea Biotec, have already been sent for quality, safety checks at the Central Drugs Laboratory in Kasauli, the hospitals have also been reached for setting the trial sites,” a senior government official reportedly said. Also Read - India Will Accept Sputnik Light’s Safety Data From Russia, No Need For Phase 3 Trials: Dr Reddy’s
“The enrollment of participants for the trial is likely to start this week,” the official added.
The nod comes after a recent study published in the medical journal The Lancet said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the phase III trial of the Russian vaccine in the country.
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.
The study was conducted on at least 40,000 elderly people in Argentina. Sputnik Light also reduced hospitalizations among the target population at 82.1-87.6 per cent, the study said.
The Russian Direct Investment Fund (RDIF) last year partnered with Dr Reddy’s Laboratories to conduct the phase III trials of Sputnik V vaccine in India. In April, Sputnik V received an emergency use authorisation in India. Reddy’s administered the first dose of the vaccine in Hyderabad under a limited pilot on May 14.
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V the world’s first registered vaccine against coronavirus.