The Drugs Controller General of India (DCGI) has approved phase III bridging trials on the Indian population for Sputnik’s single-dose Covid-19 vaccine, Sputnik Light.
Sputnik Light’s phase III bridging experiments were endorsed by the DCGI’s Subject Expert Committee (SEC).
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) has already refused to grant Sputnik-Light emergency-use authorization, ruling out the need for the Russian vaccine’s phase III trial in the country.
Sputnik Light was the same as component-1 of Sputnik V, as well as its safety and immunogenicity data in the Indian population was already generated in a trial.
Last year, Dr Reddy’s Laboratories teamed up with the Russian Direct Investment Fund (RDIF) to begin phase III Sputnik V vaccination trials in India. The SEC requested that Dr Reddy’s submit safety, immunogenicity, and effectiveness data from the phase III clinical trial of Sputnik-Light in Russia for the single-shot vaccine’s market authorization in India.
Sputnik Light exhibited 78.6-83.7 percent efficiency against Covid-19 in a recent research published in The Lancet, which is much greater than conventional two-shot vaccines. In Argentina, the survey included at least 40,000 older persons.
According to the study, Sputnik Light reduced hospitalizations among the target population by 82.1-87.6%.
Sputnik Light has been developed by Russia’s Gamaleya Institute and backed by RDIF.