Sputnik V Light Single Dose Vaccine Trial Data to DGCI Soon

Hyderabad: Dr. Reddy's Laboratories, the Hyderabad-based pharmaceutical company, said on Friday that it expects to submit phase 3 trial data for Sputnik V Light, a single-dose vaccination, to the Drugs Controller General of India (DCGI) next month.

The company will be starting the trials of children, ranging in age from 2 to 12 years and from 12 to 18 years.

Deepak Sapra, Dr. Reddy's CEO of API and Services, said the company is in talks with the FDA to perform trials on adding Sputnik V as a booster dose. The company is done with the finalization of the protocol and plans to utilize the booster dose for patients who have been completely inoculated. There will have to be a gap of six months in between. 

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Russian Direct Investment Fund (RDIF) is currently conducting trials for Sputnik as booster dose and also the children dose of vaccine. The trials in India are said to begin sometime in November. The company is also in talks with other partners in order to launch the vaccine in Latin America, Africa, and other places.

As part of its arrangement with the RDIF, the business has sole distribution rights in India for the first 250 million doses of the Sputnik V and Sputnik Light vaccines. The doses being administered in India are completely made in the country.