Dr. Reddy’s Laboratories has been denied permission by India’s top regulatory body to conduct the Phase-3 trials for the Russian-made Sputnik Light coronavirus disease (Covid-19) vaccine in India, reported news agency ANI on Thursday, citing people familiar with the development.
According to reports, the expert committee of the Central Drugs Standard Control Organisation (CDSCO) refused to allow the Hyderabad-based pharmaceutical company to conduct the third phase trials for the one-shot Sputnik Light vaccine because it did not find the “scientific rationale” behind the same.
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.
Sputnik Light is a single-dose Covid-19 vaccine. It is a slimmed-down, one-shot version of Sputnik V that the government was earlier looking at for a speedy launch in India, news agency PTI reported in late May. An application seeking regulatory approval for it was filed in June and Dr. Reddy’s Laboratories was expecting it to be approved by the drug regulatory body. 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. Gamaleya Center also demonstrated during laboratory tests that Sputnik Light had proven effective against all new strains of the coronavirus, the statement said.