NEW DELHI v MOSCOW (Reuters) – India has approved the use of the Russian vaccine Sputnik V COVID-19, the Russian Direct Investment Fund (RDIF) said on Monday, confirming previous reports of its imminent approval.
India has overtaken Brazil to become the second-largest country in the world after the United States, battling a second wave after delivering about 105 million doses to a population of 1.4 billion. .
RDIF, which is responsible for marketing the vaccine abroad, said the Comptroller General of Medicines of India (DCGI) has approved the use of Sputnik V.
“India, the second most populous country in the world, has become the 60th country to register #SputnikV after the positive results of the local Phase 3 clinical trial. Sputnik V is now licensed in 60 countries with a population of over 3 billion people, ”said a post on the official Twitter account of Sputnik V.
Earlier on Monday, two people familiar with the matter said the Central Organization for the Control of Drugs (CDSCO) group had recommended authorization.
RDIF has signed agreements to produce more than 750 million doses of Sputnik V in India with six national companies.
India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.
Sputnik V, developed by the Gamaleya Institute in Moscow, has been shown to be 91.6% effective against COVID-19 and has been approved for use in over 50 countries.
The Indian Drug Regulatory Authority did not respond to a request for comment on the approval by the Committee of Experts of the Russian vaccine.
Indian pharmaceutical company Dr. Reddy, which sells the vaccine in India, said it was waiting for an official word from the authorities.
“Dr. Reddy and RDIF are working diligently with Indian regulators to obtain Sputnik V approval. We are fully committed to playing our part in India’s fight against COVID, ”the company said.
Dr. Reddy’s shares reached 5% after the Economic Times first reported the news.
The company helped conduct a small internal study to test the safety of the vaccine and its ability to generate an immune response.
Additional reports by Rama Venkat and Shivani Singh in Bengaluru, Polina Ivanova and Vladimir Soldatkin in Moscow; Written by Sachin Ravikumar; Edited by William Maclean and Angus MacSwan