New Delhi, Feb 5: Drugs Controller General of India’s (DCGI) Subject Expert Committee (SEC) on Friday recommended granting restricted emergency use authorisation (EUA) to single-dose COVID-19 vaccine Sputnik Light, sources informed news agency ANI.
Hyderabad-based Dr Reddy’s Laboratories is the Indian partner of the Russian Direct Investment Fund (RDIF), which has sought approval from the Indian drug regulator for use of single-dose Russia’s Sputnik Light one shot.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application by Dr Reddy’s Laboratories, noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the ongoing phase-3 clinical trial interim data from Russia,” The Print website quotes a source as saying.
The Sputnik Light vaccine is approved in 29 countries, including Argentina and Russia, the company claimed and interim data of the efficacy trial from Russia stated that it has an efficacy of 65.4 per cent against COVID-19, 21 days after immunisation.
“With regard to the use of the Sputnik Light vaccine as a booster dose, the applicant may provide clinical data, including immunogenicity data in the Indian population, for further evaluation,” the source told The Print.
The one-shot Sputnik Light is also a highly effective vaccine used both on standalone basis and applied as a booster. Findings by the Gamaleya Center based on data from 28,000 subjects in Moscow have demonstrated Sputnik Light vaccine administered standalone has 70% efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination. The vaccine is 75% effective among subjects under the age of 60, a statement from the company said earlier.