SPUTNIK-LIGHT GETS PHASE-3 TRIAL APRROVAL

The Drug Controller General of India (DGCI) has given the nod to Dr. Reddy’s Laboratories Sputnik Light, the single-dose version of the Russian vaccine Sputnik-V for phase-3 trials in India. The approval comes shortly after the medical journal The Lancet reported that the single-dose vaccine shows the efficacy of 78.6-83.7 percent against coronavirus that is significantly higher than many double and triple-dose vaccines.

Last year, Dr. Reddy’s had partnered with the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund, to conduct phase three trials of the vaccine in India.

In April, the standard Sputnik-V had received emergency use permission from the DGCI however in July, the subject expert committee of Central Drugs Standard Control Organisation (CDSCO) had refused emergency usage permission to Sputnik light.

“The committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies which gives a measure of the persistence of antibodies in the participants,” the CDSCO statement said. The committee has now provided permission to Dr. Reddy’s Laboratories to conduct the trials on the Indian population.

The Light version costs around Rs.730 per dosage compared to Rs.995 for the Sputnik-V. The latter was developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology and was the world’s first vaccine against COVID-19.

The Sputnik Light has been already passed by the Russians for use for the population above the age of 60 years. If the vaccine gets approval, it will become India’s 1st single-dose vaccine to be available for use.

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