Sputnik Light COVID-19 Vaccine receives permission for Phase-3 trials in India

DCGI) gave its approval to conduct Phase-3 trials of Sputnik Light COVID-19 vaccine on the Indian population. Know all details here.

Created On: Sep 15, 2021 17:11 ISTModified On: Sep 15, 2021 17:11 IST

Sputnik Light COVID-19 Vaccine: The Drug Controller General of India (DCGI) gave its approval to conduct Phase-3 trials of the Sputnik Light COVID-19 vaccine on the Indian population. Sputnik Light is the single-dose COVID-19 vaccine version of Sputnik V. The trials will assess if the vaccine gives a similar immune response as it did on the Russian population.

A Subject Expert Committee (SEC) in a meeting on August 5, 2021, had recommended the trial condition based on the efficacy of the vaccine also to be evaluated on the 42nd, 90th, and 180th day following the second dose. The SEC stated, “Interim analysis can be conducted on the 42nd day as this day was generated during the Sputnik V trials in India after the first dose, which was stated to be available up to day 21.”

Why did DCGI deny permission for Phase-3 trials of Sputnik Light vaccine in July 2021?

On July 1, 2021, the Subject Expert Committee (SEC) of the Central Government had denied permission to Dr. Reddy’s Laboratories to conduct the Phase-3 trials of the Sputnik Light vaccine in India on the account that it did not see the need for conducting the Phase-3 trials of the Russian vaccine. The SEC highlighted that the Sputnik Light was the first dose component of Sputnik V for which the safety and immunogenicity data on the Indian population has already been generated in a trial.

What is Sputnik Light COVID-19 vaccine?

Sputnik Light is the first dose component of the Sputnik V vaccine. The Gamaleya National Research Centre of Epidemiology and Microbiology in collaboration with the Russian Ministry of Health and the Russian Direct Investment Fund (RDIF) have developed Sputnik Light vaccine.

Russia had launched the single-dose Sputnik Light in May 2021. The vaccine was approved in Russia on June 2, 2021.

Sputnik Light Vaccine: Efficacy and Safety

The RDIF statement stated that the Sputnik Light vaccine showed 78.6 to 83.7 per cent efficacy in the elderly population. The data was collected by the Ministry of Health of the Buenos Aires province (Argentina). Approximately 40,000 elderly people were vaccinated during the study in Argentina.

The infection rate among the 40,000 vaccinated respondents was only 0.446 per cent between the 21st day and the 40th day. While the infection rate among non-vaccinated respondents was 2.74 per cent.

The vaccine also demonstrated efficacy of 79.4 per cent during the Phase-3 trials conducted in Russia, Ghana, and the UAE.

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