NEW DELHI / MOSCOW (Reuters) – India has approved the use of Russia’s Sputnik V COVID-19 vaccine, the Russian Direct Investment Fund (RDIF) said Monday, confirming previous reports of the impending approval.
India overtook 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, with about 105 million doses in a population of 1.4 billion.
The RDIF, which is responsible for marketing the vaccine abroad, said the Drug Controller General of India (DCGI) had approved the use of Sputnik V.
“India, the second most populous country in the world, became the 60th country to register #SputnikV after positive results from a 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 on Monday, two people familiar with the matter said the Central Drugs Standard Control Organization (CDSCO) panel recommended the authorization.
The RDIF has entered into agreements with six domestic companies to produce more than 750 million doses of Sputnik V in India.
India has used two vaccines so far, one developed by AstraZeneca and Oxford University, and the other by the domestic company Bharat Biotech.
Sputnik V, developed by the Gamaleya Institute in Moscow, has been shown to be 91.6% effective against COVID-19 and is 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 by the expert panel.
The Indian pharmaceutical company Dr. Reddy’s, which markets the vaccine in India, said it is awaiting formal word from the authorities.
“Dr. Reddy’s and RDIF are working closely with Indian regulatory authorities to obtain approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.
The shares of Dr. Reddy’s were up 5% after the Economic Times newspaper first reported the news.
The company helped conduct a small domestic trial to test the vaccine’s safety and its ability to generate an immune response.
Additional reporting 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