In a setback to Russia’s plan to roll-out Covid-19 vaccine Sputnik-V even before full trials show how well it works, India’s drug regulator has turned down a proposal from Dr Reddy’s Laboratories Ltd to carry out a large study in the country to evaluate Russia’s Sputnik-V and has asked it to first test the vaccine in a smaller trial.
The recommendations by an expert panel of the Central Drugs Standard Control Organisation (CDSCO) noted that safety and immunogenicity data from early-stage studies being conducted overseas is small, with no inputs available on Indian participants.
India is expected to go past the United States over the next several weeks as the country with the world’s largest number of cases.
The Russian Direct Investment Fund (RDIF), which is marketing the Sputnik V, and Dr Reddy’s Laboratories last month declare their partnership to run clinical trials and distribute the vaccine in India.
Russia was the first country to grant regulatory approval for a novel coronavirus vaccine, and did so before large-scale trials were complete, stirring concerns among scientists and doctors about the safety and efficacy of the shot.
