The Russian Federation said it has approved a covid vaccine, even though skeptics say it has not been tested for safety and effectiveness. Serum specialists say it is a potentially dangerous political stunt.
Russian President Vladimir Putin announced today that his country is the first to approve a vaccine for COVID-19. He named the vaccine Sputnik-V, a nod to the world’s first artificial satellite launched by the Soviet Union more than 60 years ago. The Russians say they will start using the vaccine in October, even though they have not run tests to see if it is safe and effective.
Are the Russians really ahead of the pack when it comes to deploying and developing a vaccine for COVID-19?
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Certainly not in front of the pack for developing one. There are more than 160 COVID vaccines that are under development. Of those, 28 are currently being tested in humans according to the World Health Organization. And six of those tests are phase 3, that is, studies to show whether a vaccine is, in fact, safe and effective. Those tests involve thousands or tens of thousands of people. The Russians say they have tested their vaccine on just a few dozen individuals. Putin says one of his own daughters was a volunteer as matter of fact. But, you know, they haven’t even published any results.
Dr. Paul Offit, who heads the Vaccine Education Center at Children’s Hospital of Philadelphia, criticizes the Russians for approving the vaccine without having done those large and crucial phase 3 trials.
The notion that they would actually roll this vaccine out into the arms of the Russian public without doing adequate safety and efficacy testing, I think, is shameful.
So what’s going on here, Richard?
Well, Offit’s take is this is simply that Russia wants to seize the international spotlight and burnish Russia’s image at a time when the world is looking to scientists to rescue us, of course, from the coronavirus epidemic. Offit says that if the Russian vaccine turns out not to work, or, even worse, if it turns out to be harmful, he hopes people won’t draw broader conclusions about scientifically valid vaccine development.
Hopefully everyone in the world will see this announcement for what it is, which is a purely political announcement made specifically to get attention to Russian scientists and to make people think that Russia is ahead of the game when they’re not.
Svetlana Zavidova said she and her colleagues are worried about what her government is doing. They’ve even asked the authorities to withdraw their approval. She says this is all about winning the international race, being first.
They want to be the first in the world, but it’s ridiculous, of course.
And also, didn’t a Chinese company make a similar announcement not too long ago?
That’s right. At the end of June, in fact, the company CanSino Biologics announced that the Chinese government had approved its vaccine for use, specifically in the military, even though the vaccine has not passed phase 3 testing either. And two weeks ago at a congressional hearing, Dr. Anthony Fauci from the National Institutes of Health fielded a question about all this, and here’s what he said.
I exceedingly hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone because claims of having a vaccine ready to allot before you do testing, I think, is problematic at best.
I mean, that raises the question of whether it could happen in this country given election year political pressures. Could there be pressure on the Food and Drug Administration to approve a vaccine before we know if it works?
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Yeah. That is a huge concern. And, of course, Ari, if people believe that the vaccine here is being rushed for political reasons, they might decide not to get the shot. And if too many people opt out, the pandemic will simply rage on. In fact, the Food and Drug Administration commissioner and other top officials are sort of doing a charm offensive, trying to promise the public that they won’t be pushed by politics, that their work will instead be driven by science. This is something Dr. Fauci has also returned to as a point time and time again, saying trust us; we’re not going to just rush this through. And in this country, at least, we can expect to see some of the scientific results that the FDA uses as a basis for approving a vaccine. But the bottom line here is being first shouldn’t really be the main concern. We need a vaccine that we can trust, one that is both safe and effective.