Approval of the Russian Sputnik V vaccine for emergency use authorization (EUA) in India amidst the alleged shortage has come as a shot in the arm.
Sputnik is expected to be rolled out as a third vaccine against Covid-19 after Covishield and Covaxin have brought cheers to the clinical trial team in Kolkata that was part of the phase III study of the vaccine.
“We began the phase III trial as part of a pan India study after getting the institutional ethics committee’s approval on December 18. It was randomized double blinded placebo control trial, in which 75% of the volunteers got the vaccine and the rest were administered the placebo. The vaccine receiving EUA is a great news in the face of the vaccine shortage and the second wave,” said Dr Subhrojyoti Bhowmick, clinical director, Research & Academics at Peerless Hospitals and principal investigator of the trial.
The hospital was the only centre in Eastern India that was part of the pan Indian phase III trial of the Russia-made vaccine on 1,500 volunteers from the Indian population.
Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Russia, Hyderabad-based Dr Reddy’s has partnered with Russian Direct Investment Fund (RDIF) for the phase III clinical trial in India.
“It is a proud moment for us that Sputnik V has been approved for EUA in India,” said Snehendu Koner, clinical trial facilitator attached with CliniMed LifeSciences that was the site management organization for the clinical study in Bengal.
Even as the immunogenicity data on Indian population is yet to be published, the vaccine’s efficacy is 91.6% based on the phase III trial conducted in various countries including Russia and published in the Lancet.
“At our site none faced any serious adverse issue till date, apart from the regular side effects like fever, nausea and mild malaise. None of the participants too have contracted Covid-19 infection while there has been a surge in Covid cases. We are still going through their follow-up visits as per schedule,” added Bhowmick.
Source: Times of India