Russia said Thursday that its coronavirus vaccine, which is the first to be registered worldwide, will be tested on more than 40,000 people as it looks to ramp up production.
The vaccine, dubbed “Sputnik V,” has received skepticism from international observers over its potential efficacy, particularly given the rapid speed of its approval, but Moscow maintains that it is safe after granting it domestic regulatory approval earlier this month.
“Next week, a previously planned post-registration, randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity and safety of the Sputnik V vaccine will begin in Russia, simultaneously with the vaccination of volunteers from risk groups. More than 40,000 people will take part in the study in more than 45 medical centers,” the Russian Direct Investment Fund, which is working on the vaccine with the Gamaleya National Research Institute of Epidemiology and Microbiology, said in a statement.
More than 22.4 million people have contracted COVID-19 worldwide, including nearly 940,000 people in Russia.
However, concerns have risen over the reliability of the Sputnik V vaccine given its rapid phase one and phase two clinical trials, which were conducted on relatively small groups of people. The phase three tests are set to begin soon, but Moscow has already said it plans on producing the vaccine as early as September.
"Having a vaccine and proving that a vaccine is safe and effective are two different things," Anthony FauciAnthony FauciOvernight Health Care — Presented by Indivior — CDC panel approves boosters for some, but not based on jobs Fauci: 'Worst time' for a government shutdown is in middle of pandemic The Hill's Morning Report - Presented by Alibaba - Government shutdown fears increase as leaders dig in MORE, the U.S.’s leading infectious disease expert, said earlier this month.
"I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they've done that."
Still, both the World Health Organization and the United Nations are in discussions with Russia over the production of the vaccine, officials told CNBC.