An expert panel of India’s drugs regulator has recommended emergency use approval for Russia’s Sputnik V coronavirus vaccine, two sources said on Monday (April 12), which could make it the nation’s third to be approved as infections surge again.
India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a massive second wave, having given about 105 million doses among a population of 1.4 billion.
The panel of the Central Drugs Standard Control Organisation (CDSCO) recommended the authorisation, said two people familiar with the matter, who sought anonymity as they were not authorised to speak to media.
Most panel recommendations are generally accepted by the regulator’s chief.
Neither Dr. Reddy’s Laboratories, which markets the vaccine in India, nor the drugs regulator, responded immediately to Reuters’ requests for comment.
India is now using two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.
Shares of Dr Reddy’s ended up 5 per cent after the Economic Times newspaper reported the news.
The firm has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response.
Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6 per cent effective against Covid-19 and has been approved for use in more than 50 countries.
The Russian Direct Investment Fund has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.