India has approved the use of the Russian Sputnik V COVID-19 vaccine, the Russian Direct Investment Fund (RDIF) said on Monday, confirming previous reports of its impending approval.
India took Brazil to become the nation with the second highest number of infections worldwide after the United States, as it fights a second wave, after giving about 105 million doses among a population of 1.4 billion.
RDIF, which is responsible for marketing the vaccine abroad, says that the General Practitioner of India (DCGI) has approved the use of Sputnik V.
“India, the world’s 2nd most populous nation, 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 over 3 billion people,” a post on Sputnik V’s official Twitter account said.
Earlier on Monday, two people familiar with the matter said that the panel from the Central Drugs Standard Control Organization (CDSCO) had recommended the permit.
RDIF has signed an agreement to produce more than 750 million doses of Sputnik V in India with six domestic companies.
India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by the domestic company Bharat Biotech.
Sputnik V, developed by the Moscow Gamaleya Institute, has proven 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.
The Indian Medicines Agency did not respond to a request for comment on the expert panel’s approval of the Russian vaccine.
The Indian pharmaceutical company Dr. Reddy, who markets the vaccine in India, said it was waiting for a formal word from authorities.
“Dr. Reddy and RDIF are working closely with the Indian regulators to obtain approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.
Dr Reddy’s share dropped 5% after the Economic Times first reported the news.
The company has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response.