Sputnik Light, Russia's single-dose COVID-19 vaccine, gets DCGI nod for Phase-III trials in India
New Delhi | Jagran News Desk: Russia's COVID-19 vaccine Sputnik Light has got permission for phase three trials in India as reported by news agency ANI. This comes after the Drugs Controller General of India (DCGI) granted permission for conducting the phase three trials of Sputnik Light on the Indian population. Sputnik Light is a single-dose COVID-19 vaccine developed by Russia's Gamaleya Institute and backed by the Russian Direct Investment Fund (RDIF).
The Drug Controller General of India has given its approval to the single-dose COVID-19 vaccine version of the Sputnik V vaccine 'Sputnik Light' 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).
According to Dr. V K Paul, Member (Health), NITI Aayog, till now 8- 9 lakh doses of Sputnik V has been administered in India.
Sputnik Light, which is the first dose of the original two-dose composition, has shown the efficacy of 79 per cent. Its price is yet to be determined for the Indian population. RDIF entered into a partnership with Dr. Reddy's Laboratories to market the Russian vaccine in India and also to conduct trials for the grant of required regulatory approvals. Currently, India is administering Covishield, Covaxin, and Sputnik V in the country.
(With inputs from ANI)
Posted By: Sugandha Jha