The Drugs Controller General of India (DCGI) has approved the Phase III bridging trials of Sputnik Light on the Indian population. Sputnik Light is a single-dose COVID-19 vaccine derived from the Russian vaccine Sputnik.
The approval follows a recent study published in the medical journal The Lancet that found Sputnik Light to have 78.6 to 83.7 percent efficacy against COVID-19, which is significantly higher than most two-shot vaccines.
The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee refused to grant Sputnik-Light emergency-use authorization in July, ruling out the need for the Russian vaccine’s phase III trial in the country.
The committee noted that Sputnik Light was the same as Sputnik V component-1, and that data on its safety and immunogenicity in the Indian population had already been generated in a trial.
The study included at least 40,000 elderly people from Argentina. According to the study, Sputnik Light also reduced hospitalizations among the target population by 82.1-87.6 percent.
Last year, the Russian Direct Investment Fund (RDIF) collaborated with Dr. Reddy’s Laboratories to conduct phase III trials of the Sputnik V vaccine in India. Sputnik V was granted an emergency use permit in India in April. On May 14, Reddys administered the first dose of the vaccine in Hyderabad as part of a limited pilot program.