According to the recommendations of the Subject Expert Committee (SEC) meeting held on July 30, which have been approved by the Drugs Controller General of India (DCGI), Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial.
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.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
The government is hopeful of a speedy launch of single-dose COVID-19 vaccine Sputnik Light in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been directed to fast-track the application and regulatory approval procedures for the jab to boost the country's vaccination drive, sources said.
Russia's Sputnik V vaccine and its one-shot version Sputnik Light booster demonstrates high virus-neutralising activity (VNA) against the highly-contagious Omicron variant of COVID-19, providing a strong defence against severe disease and hospitalisation, according to a study.
Due to the unavailability of enough number of vaccine doses, the COVID-19 vaccination drive in Mumbai will be suspended on Thursday at the centres run by the city civic body and the Maharashtra government, the Brihanmumbai Municipal Corporation (BMC) said.
India is expecting 156 million doses of the vaccine from August to September, reports Ruchika Chitravanshi.
Dr Reddy's Laboratories on Friday soft-launched imported COVID-19 vaccine Sputnik V, with Deepak Sapra, a senior executive of the drug-maker, taking the first shot in Hyderabad.
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