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Russia rushes registration of unproven coronavirus vaccine

Russia rushes registration of unproven coronavirus vaccine


The drug, nicknamed ‘Sputnik V,’ has not completed critical clinical trials

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Russian President Vladimir Putin leads a government meeting on August 11th, where he announced that Russia would move forward with distributing its experimental coronavirus vaccine.
Photo by Alexey Nikolsky / Sputnik / AFP via Getty Images

Russian President Vladimir Putin announced on Tuesday that Russia had registered a coronavirus vaccine — but that vaccine is still widely considered unproven, as it has not completed critical clinical trials to prove that it is safe and effective.

Putin also claimed that one of his daughters had received the vaccine. “She has taken part in the experiment,” Putin said, according to The Associated Press. So far, the vaccine, made by the Gamaleya Institute, has only been tested in relatively small groups of people. It has not yet completed the third phase of clinical trials, which are designed to demonstrate that vaccines can work safely in the general population.

Instead, Russia plans to vaccinate volunteers, including medical workers and teachers, while those phase III trials are still underway, according to The Washington Post.

The rules for conducting clinical trials are written in blood

“Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” Svetlana Zavidova, executive director of Russian nonprofit Association of Clinical Trials Organizations, told Bloomberg News on Monday. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”

The Russian vaccine uses a live, weakened virus to inject genetic material from the coronavirus into human cells. This triggers an immune response that should help protect people against coronavirus infection in the future. It’s the same method being used by Oxford University and AstraZeneca in their vaccine. It’s also the same technique used in China’s CanSino vaccine, which was recently approved for use in China’s military, even after seeing mixed results in earlier trials.

Countries and research institutions all over the world are racing to be the first to create a vaccine to halt the current coronavirus pandemic. As of Tuesday morning, the virus has infected more than 20 million people worldwide and killed more than 730,000. But experts worry that rushing an untested vaccine to market could have serious consequences.

Rushing an untested vaccine to market could have serious consequences

“I do hope that the Chinese and the Russians are actually testing the vaccine before they’re administering the vaccine to anyone,” Anthony Fauci said at a congressional hearing last month.

There are three major worries with releasing an unproven vaccine to the public. If the vaccine is unsafe or has severe side effects, then it could harm people, upending their lives. If the vaccine doesn’t work, then people could move through the world with a false sense of security, potentially exacerbating the spread of disease. And if either of those things happens, there’s a very serious risk that people’s distrust of vaccines will skyrocket, making it harder for public health officials to halt future disease outbreaks — not just this one.

“Trust in the process of developing new drugs and new medicines is fragile,” Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University, told The Verge last week. “We can’t put it in jeopardy.”

Russia appears to be less concerned with trust in the drug development process and more focused on being first to approve a vaccine for public use. In an echo of the Cold War, the vaccine is nicknamed “Sputnik V,” after the first satellite. Some experts worry that the move will create pressure for other countries to cut corners in similar ways. The Russian approval “may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines,” Scott Gottlieb, former head of the US Food and Drug Administration, said on Twitter.

The approval comes after accusations last month that Russian hackers were targeting vaccine development in the UK, US, and Canada. Russia denied the claims, and shortly afterward, it announced that it would quickly move its vaccine into phase III trials, with plans to distribute the vaccine widely starting in October.

Putin claimed during the announcement that the vaccine worked “effectively enough.” But there’s still almost no data to support that claim, which just isn’t good enough for many experts.

“Science takes a while,” Karen Maschke, editor of the journal Ethics & Human Research, told The Verge last week. Maschke was concerned that Russia’s plans to move ahead with vaccine approval before completing phase III trials might pressure other countries, including the US, to do the same. “We decided in this country that we’re going to go through a process that takes longer. And that’s hard to do sometimes when you have pressure because you’re saying, ‘Billy’s mom let him stay up too late. Why can’t I,’” Maschke says. “I think in the political world, that’s going to be a problem.”

Russia is now gambling that its unproven vaccine will work, staking the lives and well-being of its president’s daughter, a handful of soldiers, and, soon, teachers and medical workers in the process. It remains to be seen how that bet will pay off.

Additional reporting by Nicole Wetsman.