NEW DELHI / 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 endorsement .
India surpassed Brazil to become the country with the second highest number of infections in the world after the United States, as it fights a second wave, having given about 105 million doses between a population of 1.4 billion.
The RDIF, which is in charge of marketing the vaccine abroad, said the Comptroller General of Medicines of India (DCGI) had approved the use of Sputnik V.
“India, the second most populous nation in the world, became the 60th country to register #SputnikV after the positive results of the local Phase 3 clinical trial. Sputnik V is now authorized in 60 countries with a population of more than 3 billion people, “said a post on Sputnik V’s official Twitter account.
Earlier Monday, two people familiar with the matter said the Central Drug Control Organization (CDSCO) group had recommended the permit.
RDIF has signed agreements to produce more than 750 million doses of Sputnik V in India with six domestic companies.
So far India has used two vaccines, one developed by AstraZeneca and Oxford University, and the other by the national 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 more than 50 countries.
The Indian drug regulator did not respond to a request for comment on the approval of the Russian vaccine expert group.
The Indian pharmaceutical company Dr. Reddy, who markets the vaccine in India, said he was waiting for formal news from authorities.
“Dr. Reddy and RDIF are working diligently with the Indian regulatory authorities to get the approval of Sputnik V. We are fully committed to doing our part in India’s fight against COVID, ”the company said.
Dr. Reddy’s shares ended 5% after the Economic Times reported for the first time the news.
The firm has helped conduct a small national trial 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