New Delhi: Russia’s Sputnik Light vaccine against Covid-19 on Wednesday received permission for phase 3 trials in India, news agency ANI reported.
Developed by the Russian Direct Investment Fund (RDIF), the single-dose Sputnik Light vaccine was also registered in Belarus in April 2021. The vaccine consists of the first component of Sputnik V based on human adenovirus serotype 26.
The Drug Controller General of India has given its approval to Sputnik Light to conduct trials on the Indian population to check whether the vaccine gives a similar immune response in trials similar to what it has shown on the Russian population.
A Subject Expert Committee (SEC) meeting held on August 5 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. “Interim analysis can be conducted on day 42 as this data was generated during the Sputnik V trials in India after the first dose, which was stated to be available up to day 21,” reads the minutes of the SEC meeting.
Earlier in the month of April, the two-dose version of the vaccine, Sputnik V, was approved for ’emergency use’ by the Drugs Controller General of India (DCGI).
The RDIF announced the real-world data of the Ministry of Health of the Republic of Belarus on the Russian Sputnik V coronavirus vaccine confirming its high efficacy during the vaccination campaign in the country.
The Russian vaccine has demonstrated 97.2 per cent efficacy against coronavirus in Belarus. The efficacy of Sputnik V was measured based on data from more than 860,000 people vaccinated between January and July 2021.
According to Dr V K Paul, Member (Health), NITI Aayog, till now 8-9 lakh doses of Sputnik V has been administered in India.