NEW DELHI / MOSCOW (Reuters) – India has approved the use of the Russian Sputnik V COVID-19 vaccine, the Russian Direct Investment Fund (RDIF) said on Monday, confirming earlier reports of its impending approval.
India has overtaken Brazil to become the country with the second highest number of infections worldwide after the United States, as it fights a second wave, with about 105 million doses among a population of 1.4 billion.
The RDIF, which is responsible for marketing the vaccine abroad, says the Drug Control General 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 positive results from the local clinical phase 3 study. Sputnik V is now authorized in 60 countries with a population of more than 3 billion people, ‘reads a report on Sputnik V’s official Twitter account.
Earlier Monday, two people familiar with the matter said the panel of the Central Drugs Standard Control Organization (CDSCO) had recommended the authorization.
The RDIF has signed agreements to manufacture more than 750 million doses of Sputnik V in India with six local businesses.
India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by local firm Bharat Biotech.
Sputnik V, developed by the Gamaleya Institute in Moscow, is 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 expert panel of the Russian vaccine.
The Indian pharmaceutical firm Dr. Reddy, who markets the vaccine in India, said it was awaiting formal words from the authorities.
“Dr. Reddy’s and RDIF are working closely with the Indian regulatory authorities to obtain the approval of Sputnik V. We are committed to playing our part in India’s fight against COVID,” the company said.
Shares of Dr Reddy eventually reached 5% after the newspaper Economic Times reported the news.
The firm helped conduct a small household trial to test the vaccine’s safety and 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