The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation has recommended the conduct of Phase III clinical trials of Russia's single dose COVID-19 vaccine Sputnik Light.
According to the recommendations of the SEC meeting held last month, Dr Reddy's, which has tied up with Russian Direct Investment Fund to market the jab in India, presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct the clinical trial in India.
"After detailed deliberation, the committee recommended for grant of permission for conduct of Phase III immune-bridging clinical trial in Indian population subject to the condition...", the SEC recommendation said.
The Committee noted that the firm has now presented the safety and immunogenicity along with the longevity of the antibodies, which gives a measure of persistence of antibodies in the participants.
The primary endpoint of the trials should be assessed at day 42, 90 and 180 and interim analysis can be conducted at the 42nd as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only, the SEC said.
The single dose Sputnik Light vaccine demonstrated 79.4 per cent efficacy according to analyzed data taken from 28 days after the injection was administered as part of Russia's mass vaccination program between December 5, 2020 and April 15, 2021.
An efficacy level of almost 80 per cent is higher than that of many two-dose vaccines.
Sputnik Light has proven effective against all new strains of coronavirus, as demonstrated by the Gamaleya Center during laboratory tests, a press release from RDIF had said on May 6.
