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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. (Axelrod, 8/20)

Roughly 10 days after becoming the first nation to approve a COVID-19 vaccine, an announcement greeted with skepticism by many in the international community, Russia now said it intends to expand key drug trials by tens of thousands of subjects. Tests originally said to include just 1,600 to 2,000 persons now will use 40,000, including a control group, which is much more in line with the 30,000 individuals being examined in comparable Phase III trials by the drugmakers Moderna, Pfizer/Biontech and AstraZeneca/Oxford. (Reevell and Salzman, 8/20)

The World Health Organization’s Europe office said it has begun discussions with Russia to try to obtain more information about the experimental COVID-19 vaccine the country recently approved. Last week, Russia became the first country in the world to license a coronavirus vaccine when President Vladimir Putin announced its approval. But the vaccine has not yet passed the advanced trials normally required to prove it works before being licensed, a major breach of scientific protocol. Russian officials claimed the vaccine would provide lasting immunity to COVID-19 but offered no proof. (Cheng, 8/20)

Svetlana Zavidova, the executive director of the Association of Clinical Trials Organizations (ACTO) in Russia, warned against the untested vaccine in an interview with Bloomberg. "The rules for conducting clinical trials are written in blood. They can’t be violated,” Zavidova said. “This is a Pandora’s Box, and we don’t know what will happen to people injected with an unproven vaccine." (Maheshwari, 8/20)

A top U.S. health regulator who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective, Reuters has learned. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, made the statement in response to concerns raised on a conference call late last week of government officials, pharmaceutical executives and academics who serve on a vaccine working group organized by the National Institutes of Health, according to three sources familiar with the matter. (Levine and Taylor, 8/20)