World
India says its safety study of Sputnik V vaccine comparable to Russian trial
India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.Reuters
India’s health ministry said on Tuesday its drug regulator had found that safety and immunogenicity data from a local trial of Russia’s Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.
The vaccine has now been “recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions”, the ministry said, commenting on the approval earlier confirmed by the drug’s marketing agencies.
The vaccine can now be imported, it said.
India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a second wave, having given about 105 million doses among a population of 1.4 billion.
The Russian Direct Investment Fund (RDIF), which is responsible for marketing the vaccine abroad, confirming earlier reports of its imminent endorsement had said on Monday that India had approved the use of Russian Sputnik V Covid-19 vaccine.
“India, the world’s 2nd most populous nation, became the 60th country to register #SputnikV after positive results of local Phase 3 clinical study. Sputnik V is now authorized in 60 countries with population of over 3 bln people,” a post on the Sputnik V official Twitter account said.
Earlier on Monday, two people familiar with the matter said the panel of the Central Drugs Standard Control Organisation (CDSCO) had recommended the authorisation.
The RDIF has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.
India has so far used 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.