New Delhi: India’s top regulatory body, the expert committee of the Central Drugs Standard Control Organisation (CDSCO) has denied Dr. Reddy’s Laboratories permission to conduct the Phase-3 trials for the Russian-made Sputnik Light coronavirus disease (COVID-19) vaccine in India, Hindustan Times reported quoting news agency ANI.
The Hyderabad-based pharmaceutical company was told there was no “scientific rationale” behind the trial.
Dr. Reddy’s Laboratories had partnered with the Russian Direct Investment Fund (RDIF) last year in September to conduct the Phase-3 trials of the Russian-made Sputnik V COVID-19 vaccine in India, and distribute up to 100 million doses of it in India. The vaccine was approved for emergency use in the country in April this year.
About Sputnik Light
Sputnik Light is a single-dose COVID-19 vaccine. It is a slimmed-down, one-shot version of Sputnik V.
Dr. Reddy’s Laboratories had filed an application seeking regulatory approval for it in June. If approved, it would have been the first and only single-dose vaccine in the country.
Sputnik Light demonstrated 79.4% efficacy, according to an analysis of data gathered 28 days after the shot was administered as part of Russia’s mass vaccination programme between December 2020 and April 2021, the vaccine’s developers said in a statement, the report added.
Gamaleya Center also demonstrated during laboratory tests that Sputnik Light had proven effective against all new strains of the coronavirus, the statement said.
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