India’s drug regulator rejected a proposal from Dr Reddy’s Laboratories Ltd to conduct a large study in the country to evaluate Russia’s Sputnik-V COVID-19 vaccine and asked it to first test the vaccine in a smaller trial.
Recommendations from a panel of experts from the Central Standard Medicines Control Organization (CDSCO) noted that safety and immunogenicity data from early-stage studies conducted abroad are small and no information is available on the Indian participants.
India’s move marks a setback for Russia’s plan to launch the vaccine even before full trials show how well it works, while delaying its efforts to get the vaccine approved in the world-leading country. in average number of new infections.
India is expected to overtake the United States in the coming weeks as the country with the highest number of cases in the world.
The Russian Direct Investment Fund (RDIF), which markets Sputnik V, and Dr. Reddy’s Laboratories announced last month their partnership to conduct clinical trials and distribute the vaccine in India.
Russia was the first country to grant regulatory approval for a new coronavirus vaccine, and it did so before large-scale trials were completed, raising concerns among scientists and clinicians about the safety and efficacy of the vaccine.
RDIF and Dr. Reddy’s did not immediately respond to Reuters requests for comment outside of business hours.
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