Today, Explained - Plasmania

Episode Date: August 25, 2020

Covid’s hottest new treatment is plasma. Vox’s Umair Irfan explains why, and where the world stands on a vaccine. Transcript at vox.com/todayexplained. Learn more about your ad choices. Visit podcastchoices.com/adchoices

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BetMGM.com for terms and conditions. Must be 19 years of age or older to wager. Ontario only. Please play responsibly. If you have any questions or concerns about your gambling or someone close to you, please contact Connex Ontario at 1-866-531-2600 to speak to an advisor free of charge. BetMGM operates pursuant to an operating agreement with iGaming Ontario. President Trump is looking for a win on COVID-19. There's an election and a convention,

and we're creeping up on 6 million confirmed cases in the United States, something like 200,000 deaths around the corner. It is not a rosy picture. But a breakthrough, that'd be something to talk about. And now he's talking about plasma. Umair Irfan, you've been listening for Vox. What's up with plasma all of a sudden? On Sunday, the Food and Drug Administration held a press conference at the White House, and they announced that they were granting an emergency use authorization for convalescent plasma to treat COVID-19. The FDA has issued an emergency use authorization, and that's such a powerful term, emergency

use authorization for a treatment known as convalescent plasma. And what does that even mean? Well, convalescent is just a fancy word for saying somebody who got sick with the disease but got better. Plasma is the part of blood that's left behind when you centrifuge blood. It separates out the blood cells from the liquid. And plasma is the liquid that's left behind, but it also contains some of the clotting factors. And the idea is in that liquid, there might be something that can help people who are currently sick get better. And the logic is that people who have recovered have generated antibodies and other kinds of immune factors

that are in that plasma. And if you give that to somebody who's currently sick, that could help them get better faster. So this isn't like a vaccine. This is a way to help people who already have COVID, just to be clear. Yeah, it's definitely meant as a treatment. There have been some experiments with using it as a prophylactic for people who may be exposed, but it's definitely not a vaccine. It's what's called passive immunity.

You're taking somebody else's antibodies, borrowing them for a while, and that'll help you fight off the infection if it's there. By granting the emergency use authorization, what they're effectively saying is that they think there's enough evidence here to show that there's more good than harm from this kind of treatment. And by doing so, they give hospitals more flexibility to use this as a treatment for their own patients. Previously, it has been used, but it was mainly on sort of an emergency basis as sort of a last resort for patients who are in very dire need or on an experimental basis. And now, by offering this emergency use authorization, more hospitals can use it under more circumstances. Hmm. You know, I didn't catch that White House press conference. Who was there and who was speaking? Well, in addition to President Donald Trump, there was Department of Health and Human Services Secretary Alex Azar, and most notably the head of the Food and Drug Administration, Dr. Stephen Hahn.

And he was the one that was talking up the promise of using convalescent plasma as a treatment. Those scientists have concluded that COVID-19 convalescent plasma is safe and shows promising efficacy, thereby meeting the criteria for an emergency use authorization. Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it has proven to reduce mortality by 35 percent. It's a tremendous number. So Trump's saying that this plasma transfer could reduce mortality by 35 percent, which sounds significant and huge if true. Is it true, Mayor? It's a bit of a misleading statistic. What they're talking about here is a change in the relative risk. Basically, they're looking at a study, and the study wasn't actually all that robust either. It was comparing patients who received plasma within three days of being diagnosed to patients who received it after those three days. Basically, the main variable was when they received it. And this is different from a standard clinical trial because one, it wasn't completely randomized. This is a retrospective study. And two, they weren't comparing it to a placebo. They were just comparing two different groups that received the same treatment at different times. So that's not as robust. And the main finding was that it did reduce the fatality rate, but only by about

3%. So it was a little irresponsible to use that 35 number? Yeah, I talked to a doctor about that, and he was very chagrined about that statement, saying that both the president and Stephen Hahn should have known better, or at least have issued a correction to clarify what they're specifically talking about when they invoke that statistic. Have the president or the commissioner of the FDA, Stephen Hahn, said anything to clarify that statement since Sunday? The president hasn't. He's been pretty busy with the convention. But Stephen Hahn took to Twitter on Monday night and issued a note saying that the criticism was valid and that he should have been more careful about delineating the difference between relative risk and absolute risk.

What could have led the FDA commissioner, Stephen Hahn to over-promise or make a statement that was inaccurate? Could it have been pressure from the president? Well, he's made it pretty clear that he's tying the prospect of a vaccine and a treatment for COVID-19 to his electoral prospects. He has hinted and alleged without evidence that the FDA has been stalling progress on treatments and vaccines for COVID-19 to try to hurt him electorally. So this is something he clearly sees as something that's going to help him get votes in November. And of course, this was what,

on the eve of the RNC. Right. The Republican National Convention is this week, and certainly he wants to have something to brag about during a pandemic where 170,000 Americans have died. How about our national doctor, Anthony Fauci? How does he feel about it? Well, he was very conspicuously absent from the White House press conference on Sunday. And there are some reports that came out, I think, in the New York Times that showed that he was actually pretty hesitant about this emergency use authorization, saying that they tried to actually put a stop to it because they said the evidence wasn't robust enough to justify it. Hmm. When people hear that the FDA is okaying this plasma treatment and the president's sort of talking it up in a nationally broadcast press conference, are people going to be flocking to it? And how will that change its efficacy,

its use, its popularity? That's a great question. And yeah, some doctors and researchers are definitely concerned that one of the side effects of this emergency use authorization is that it will actually make research into using convalescent plasma harder. The gold standard for clinical trials is something called a randomized control trial, where you basically have a group of people and you randomly split them into two groups. One group gets a placebo and one group gets the actual treatment. But now that this has been approved as a treatment, if you're really sick with the virus, why would you take the risk of actually getting a placebo when you could get the actual treatment? And so it might be harder for physicians and for researchers to actually recruit more patients into clinical trials, which would actually provide more robust evidence of whether or not this is an effective treatment.

So we're kind of darned if we do and darned if we don't? Well, it means that when you are doing something like this, you have to make really careful consideration of the risks and benefits that, you know, this is something that could impair research. But if the benefit is that good, then maybe it's worthwhile. But a lot of people say right now that the benefits have not been demonstrated at the scale necessary to justify this, and that's really the source of the controversy with this announcement. Well, in the meantime, what does this mean for treating COVID? Are there other issues with plasma that people need to be nervous about? Well, plasma is something that is harvested from other people. So the main limiting factor in how much plasma there is, is how many people are willing to donate it. You know, during that press conference, Stephen Hahn implored Americans to...

If you've recovered from COVID-19, please donate. It could save a life. And Mr. President... The other thing is that this is a transfusion. This is a transfusion of a blood product, and there are risks involved in that. There are some inflammatory problems. There can be some pretty severe lung issues that can arise from this as well, and some allergies that can lead to anaphylactic shock. So the risk of doing this is not zero. There are some balancing issues that you have to do. You have to make a cost-benefit analysis of whether or not it's worthwhile to get this treatment. How does it compare to the other treatments we have thus far?

It turns out we don't really have a lot of good treatments. There were some that were proposed earlier. You may recall hydroxychloroquine, the anti-malaria drug. I think we talked to you about it. That's right. This also received an emergency use authorization back in March, but the FDA revoked it back in June when they realized that there really wasn't much of a benefit and there was more harm than good. There is a drug called remdesivir. This is an antiviral drug that has shown some degree of effectiveness, but that's still undergoing testing. It is being used as a treatment as well in some cases. And then there's another

drug called dexamethasone. This is an anti-inflammatory drug. It's a corticosteroid, and it actually kind of tamps down on the immune system. So it's only used in really severe cases of this infection where the immune system starts to overreact and cause collateral damage. These are different treatments that are used in different cases. You kind of have to make a judgment call here, and I think doctors really want to have more options to deal with more patients. I mean, there's a lot of different circumstances in which one drug or one treatment might be viable where another one might not be. So it helps to have more tools on the table to help solve this problem. Okay. But still, not a vaccine, not some panacea. That's right. This is not the blockbuster drug that's going to get people out of the hospital within a day. And this is not something that's going to prevent you from getting sick and let you get back to work right away either. So it's a baby step. And, you know, some scientists are still questioning whether the evidence is there for this, but, you know, it's better than

nothing. Okay. Why don't we take a little break here and then we'll talk about what might actually get us back to work after the break. What do you say? Sounds good. Okay. Support for today explained comes from ramp. Ramp is the corporate card and spend management software designed to help you save time and put money back in your pocket. Ramp says they give finance teams unprecedented control and insight into company spend. With Ramp, you're able to issue cards to every employee with limits and restrictions and automate expense reporting so you can stop wasting time at the end of every month. And now you can get $250 when you join Ramp. You can go to ramp.com slash explained,

ramp.com slash explained, R-A-M-P dot com slash explained. Cards issued by Sutton Bank, member FDIC, terms and conditions apply. All right, Umair, let's get some updates on how we might eventually get out of this situation we're in right now. How many vaccines are currently being bandied about? There are more than 200 vaccine candidates from different research groups all over the world.

200? Yeah. That's reassuring. Yeah, and I think they're kind of throwing everything at the wall and seeing what sticks. And this is definitely a full court press against this disease. It kind of shows how important it is and how serious it is that so many people around the world are devoting their resources to it.

Cool. Well, which ones should we talk about? Like, how many of these 200 are worth taking seriously? that so many people around the world are devoting their resources to it. Cool. Well, which ones should we talk about? Like, how many of these 200 are worth taking seriously? Well, we can look at some of the ones that are a little bit further ahead. Okay. The ones that are moving into human trials. You know, I think that's also another unprecedented thing worth noting, that this was a disease that we only discovered a few months ago, and now we're already testing vaccines against it in humans.

This is an unprecedented pace of technological development. What we're talking about here with these vaccines are more conventional clinical trials. And even that is remarkable because, again, clinical trials typically take a long time to run. And so one of the ways they sped up clinical trials for vaccines is that they started doing some overlapping of the first and second phase of the trial, basically where you're looking for the safety and efficacy, the earlier stages. And so right now we have about 26 vaccine candidates that are in human testing, and there are six that are in phase three clinical trials.

This is the final phase before regulatory approval, and this is where you have to test the vaccine in tens of thousands of people. Hmm. Where are those six vaccines currently being manufactured? Well, there are a couple research groups here in the United States. There's one in the United Kingdom that's pretty far ahead. This is the University of Oxford group that is developing a vaccine with AstraZeneca, and there are a few in China as well that are entering phase three trials.

And what do we know about them? Well, right now with phase three, not all that much. Based on their phase one and phase two data, they showed that these vaccines were safe, that they didn't cause a huge amount of adverse reactions or cause any severe complications. And in the patients they tested, they saw an immune response,

that basically patients who were tested generated antibodies. Now they have to test it in the real world and test it against the actual virus. And that's going to be a little bit more complicated. And because these trials are recruiting thousands of participants, it takes a long time just to fill out the roster. The AstraZeneca vaccine in the United Kingdom that's being done with Oxford University, I mean, they have a 10,000-person trial. And the group that's furthest ahead right now, Moderna, which started recruiting its volunteers earliest, I mean, they're still trying to fill up that roster, and they don't expect to fill it out until September. So it takes a few weeks just from the beginning of a phase three

trial before you even have all the patients that you would need. And then you have to start dosing the patients with this vaccine. And many of these vaccines are two-dose vaccines. That means that you have to give one shot to the patient, wait a couple weeks, up to four weeks, and then give them the second shot. And then you have to wait and watch what happens. What about that Russian vaccine? I noticed you didn't mention that in the list of some of these vaccines that are further along. Was their vaccine no bueno? Well, this is the Sputnik V vaccine that the Russian government has been talking about. Is that what they called it? Yeah. Cute. It's cleared phase one and phase two, but they didn't really put it through phase three trials. This

was only tested in about 76 people. The Russian government says that that's enough to justify manufacturing and distributing this, but a lot of other researchers are saying that, you know, you need a lot more testing to do that. And you certainly can't import it to the United States because the FDA requires that you test it in, you know, tens of thousands of people before it's approved for widespread use. But we were just talking about how the FDA is sort of being pressured to move things along by the Trump administration? Is it not being pressured that hard where they accept some under-tested Russian vaccine? They will likely not accept anything from Russia, especially with that weak data.

But there are concerns that the FDA might do an emergency use authorization for a vaccine similar to what they did with plasma before the election. The concern is that they will use the very limited clinical trial data that has been learned so far and use that as a justification for manufacturing and distributing a vaccine, or at least making the announcement so that President Trump can use that as a campaign issue. That's problematic for a number of reasons, but the big one is that right now in the U.S., we have a rising vaccine hesitancy movement. Not just denial, but there are a number of reasons, but the big one is that right now in the U.S., we have a rising vaccine

hesitancy movement. Not just denial, but there are a lot of people that are kind of hesitant about how quickly everything is going, and they're concerned that a vaccine, especially one being tested so quickly, may not have been put through all the paces. And now that there's concern that there's political pressure to rush a vaccine out, that could make people even more reluctant to take a vaccine. And getting lots of people vaccinated is critical toward ending this pandemic. So that hesitancy, that trepidation about getting this vaccine could really undermine the fight against this disease. And based on how this thing's gone so far, you couldn't really blame Americans for being skeptical that everything will go right once we have a vaccine. Right. The important thing to remember is that a vaccine is pretty

important and almost necessary to end the pandemic as we know it, but it's not enough on its own. There's not likely to be a one-size-fits-all solution to this pandemic. We'll likely need different vaccines for different people, some for older people who may have weaker immune systems, some for very young people, some who are immunocompromised or have other kinds of pre-existing conditions. Those people might need to wait longer for a vaccine even after one is approved for widespread use. Then you kind of have to manufacture and distribute this vaccine. This is something that has never been done on this scale. We're talking about vaccinating almost everybody in this country,

hundreds of millions of people. And that's something just that would take time. I mean, just think about how difficult it is to do the census, just finding out how many people we have in this country. It's not going very well. Apparently something like four out of every 10 houses haven't completed the census yet. Right. And that's just checking boxes. Now, imagine going door to door and convincing people to get a shot of this brand new substance that supposedly can protect them.

But some people might be more hesitant to take. So now imagine how long it would take just to vaccinate people, to convince them to have all the resources to deploy this. Like, I mean, people are already anticipating shortages of the vials used to store the vaccine and the syringes needed to administer it. So that in itself is a big logistical challenge. There's no guarantee that the United States will be the first country to develop a vaccine. Another country might beat us to it. What that means is that if we want to use that vaccine, we have to come up with an agreement where we would help them manufacture it, help them recover some of the costs. And conversely, if the U.S. is first, there is going to be an expectation that the U.S. will help other countries as well fight their own pandemics. And so there's a lot

of different moving parts here. And obviously, the vaccine is certainly a big part of it, but it's not the only part. And we're likely to have to do all this social distancing and some of the mask wearing well after a vaccine is available. That's going to have to do all this social distancing and some of the mask wearing well after a vaccine is available. That's going to have to continue for a pretty long time after that. I think vaccinations have become a part of everyday conversation in this country, or maybe, you know, everywhere in the world. But you pay attention to the vaccine beat in a way that most of us don't. What do you think the likelihood is here that it's coming soon and that, you know, especially in this country,

it'll be executed well when it arrives? Personally, I do think we are going to set a record here with how fast a coronavirus vaccine is developed. The fastest a vaccine has ever been developed before in history was the mumps vaccine, and that took four years. And I think we're definitely going to beat that record here given the amount of effort and the pace of progress so far. But I wouldn't commit to anything within 2020. I think we're likely to

be looking at 2021 for when a vaccine becomes approved. And of course, what matters for you and I is when we can actually get the vaccine. When do we get that shot? And that can be much longer after that. And we're laying the groundwork for that right now. The Department of Health and Human Services, for instance, is funding the manufacture of different vaccine candidates right now, building factories and helping we have fewer cases when a vaccine is available, that means that we need much fewer vaccinations to contain the disease. If the disease is very rampant, if COVID-19 is spreading like wildfire, then you need many more vaccinations before you start seeing a decline in the numbers and a slowdown in the spread. I guess that just means I won't hang out with you for a long time, Umair. Well, maybe we can do a socially distant game of tennis sometime. There you go. That's what I like to hear. There's still things we can do. That's right. Game on. Umair Irfan writes about science for Vox.

You can find his plasma and vaccine reporting at Vox.com. I'm Sean Ramos for him. This is Today Explained.