An expert panel of India’s drugs regulator has recommended emergency use approval of Russia’s Sputnik V coronavirus vaccine, two sources said on Monday, 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.
The Russian Direct Investment Fund, which is responsible for marketing the vaccine abroad, said it was expecting to hear from the Indian drugs authority soon.
“RDIF confirms it is awaiting imminently the recommendation by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) of India to approve the use of the Russian Sputnik V vaccine against coronavirus in India,” it said.
The Fund has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.
India is now using two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.
Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.
Indian pharmaceutical firm Dr. Reddy’s, which is marketing the vaccine in India, said it was awaiting formal word from the authorities.
“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.
Shares of Dr Reddy’s ended up 5% after the Economic Times newspaper first 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.