India Denies Permission For Sputnik Light Phase 3 Trials

• ByStartupStory     |    July 1, 2021

India’s drug regulator denied permission to pharmaceutical company Dr Reddy’s to conduct phase three trials for Sputnik Light in India on Wednesday. As per TOI, sources have claimed that the Central government Subject Expert Committee (SEC), which comes under the drug regulator, did not find any ‘scientific rationale’ to conduct the trials. Sputnik Light has been developed by the Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF). After launching Sputnik V, Russia had introduced Sputnik Light.  It is a single-dose vaccine with an efficacy of 79.4 percent, the launch of which was announced on 6 May, by the Russian Direct Investment Fund (RDIF). 

The Russian Direct Investment Fund had earlier said that according to real-world data collected by the Ministry of Health of the Buenos Aires province (Argentina) the Russian Sputnik Light Coronavirus Vaccine shows 78.6 percent to 83.7 percent efficacy among the elderly. According to the data from over 186,000 people aged 60-79, more than 40,000 of whom received a shot of Sputnik Light (first dose of Sputnik V) as part of the mass-scale civil vaccination program, the infection rate between 21st and 40th day from the date of receiving the first dose was only 0.446 per cent. 

On the other side, the infection rate among the unvaccinated adult population was 2.74 percent for a comparable period. The safety, efficacy, and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.

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