Panel rules out separate trial for Sputnik Light

"The committee noted that Sputnik Light is same as component 1 of Sputnik V," according to the the minutes of the panel’s meeting.

The subject expert committee of the Central Drugs Standards Organisation (CDSCO) has refused to grant emergency-use authorisation to single-dose Russian Covid-19 vaccine, Sputnik Light, even as it ruled out the need to conduct a separate phase 3 clinical trial of the vaccine in the country.

A view shows vials with the one-dose Sputnik Light vaccine against the coronavirus disease (Covid-19) in a vaccination centre at a city market in Moscow, Russia. (REUTERS)

“The committee noted that Sputnik Light is same as component 1 of Sputnik V. Further, the firm has already generated safety and immunogenicity of component 1 in the country. The committee also noted that phase III efficacy trial is ongoing in Russia and the efficacy data is yet to be generated. After detailed deliberation the committee recommended that the firm should present the safety, immunogenicity efficacy data of phase III clinical trials of Sputnik Light that is being carried out in Russia for considering the proposal for grant of MA in the country,” said the minutes of the panel’s meeting.