Russia said Thursday that its coronavirus vaccine, the first to be registered worldwide, will be tested on more than 40,000 people if it appears to increase production.
The vaccine, called “Sputnik V”, has received skepticism from international observers about its potential effectiveness, in particular the rapid pace of its approval, but Moscow maintains that it is safe after approving domestic regulations earlier this month. .
Next week, a previously scheduled post-enrollment, randomized, double-blind, placebo-controlled multicenter clinical trial will begin on the efficacy, immunogenicity, and safety of the Sputnik V vaccine in Russia, along with the vaccination of at-risk volunteers. More than 40,000 people will participate in the study in more than 45 medical centers, ”said the Russian direct investment fund, which works on the vaccine with the Gamaleya National Research Institute of Epidemiology and Microbiology, in a statement.
More than 22.4 million people have contracted COVID-19 worldwide, including nearly 940,000 people in Russia.
However, concerns have been raised about 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. Phase three testing is set to begin soon, but Moscow has already said it plans to produce the vaccine as early as September.
“Having a vaccine and proving that a vaccine is safe and effective are two different things,” Anthony Fauci
Anthony FauciOvernight Health Care: VA Problems Increase Prescription Concerns During Postpay | Reopening of schools with COVID-19 provides example of chaotic autumn | Fauci undergoes surgery for pollen polyps Russia says coronavirus vaccine will test 40,000 people Fauci undergoes surgery for pollen polyps MORE, the leading expert of the US, said earlier this month.
“I hope the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt they did.”
Both the World Health Organization and the United Nations are still in talks with Russia over the production of the vaccine, officials told CNBC.
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