Today, Explained - Covid little pill

Episode Date: October 13, 2021

Vox’s Umair Irfan explains how a new pill that might soon be authorized by the FDA could fill major gaps in treating Covid-19. Today’s show was produced by Haleema Shah and Will Reid, edited by Matt Collette, engineered by Efim Shapiro, fact-checked by Laura Bullard and hosted by Sean Rameswaram. Transcript at vox.com/todayexplained Support Today, Explained by making a financial contribution to Vox! bit.ly/givepodcasts Learn more about your ad choices. Visit podcastchoices.com/adchoices

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What happened? On Monday, Merck, this $200 billion pharmaceutical giant, filed for an emergency use authorization from the Food and Drug Administration for its new anti-COVID antiviral drug. What does it look like? It's a little brown pill. A little brown pill? Yeah. If it's approved, it will likely be the first oral treatment for COVID-19.

The trial was designed to be given to people early in the course of infection. It's an orally administered drug that's really very important. It's prescribed as four pills taken twice a day for five days, though the dosing regimen may change as regulators review the data. Well, this is certainly an important advance. There's no doubt about that. Whenever you have an orally administered medical intervention that directly attacks the virus and has the kind of data that Merck announced with their announcement. According to Merck's internal studies and clinical trials, they found that it reduced the risk of hospitalization and death in at-risk patients

by 50%. Okay, how significant is that? That's pretty significant. You know, we have a number of different drugs that are available drawbacks for various reasons. But this one kind of stands out because it is very effective and it's also something that's fairly easy to administer. You just have to take it through the mouth. Okay, what's this little guy called? It's called Molnupiravir. Molnupiravir? The name is supposedly a reference to Thor's hammer from Nordic mythology, Mjolnir. Whosoever holds this hammer, if he be worthy, shall possess the power of Thor. Huh. Why is it a reference to Thor's hammer? Is this pill like a hammer? Yeah, it hammers the virus and knocks it out with a bolt of lightning.

No, not quite, but it's supposed to be, I mean, it has a pretty strong effect, and I think that name is meant to sort of reflect that. Did Thor's hammer only work 50% of the time? I don't know. I am not that well-versed in Nordic mythology. I now take from you your power. Now, I do take issue with your point that it only works half the time. It reduced hospitalization and death by 50%,

but it can also reduce other kinds of clinical outcomes that weren't specifically measured. So it can reduce the course of the illness by a certain amount as well. So it's not just that it works half the time, it's that that was one of the strongest effects, the reducing death and hospitalization. It could also work to a lesser degree

in other patients as well. How does Molnupiravir work? So Molnupiravir is an antiviral drug that interferes with how the virus makes copies of itself. So the other FDA-approved drug for COVID-19,19 remdesivir works in sort of a similar fashion. What it does is it imitates part of what's used to make up the genetic sequence of the virus. So in order to encode its instructions, the virus uses a molecule called RNA and it's assembled out of these building blocks that are represented by the letters AUGC. And so remdesivir is like a fake version of the molecule that's represented by the letter A, whereas molnupiravir imitates other letters. And what happens is when the virus takes those fake letters into its genetic sequence,

it causes a whole bunch of problems. With remdesivir, it causes the replication cycle to stop. But with molnupiravir, it causes mutations that are detrimental to the virus. So when you say it causes a bunch of problems, you're talking about like good problems because they're problems for the virus. Right. We want to sort of gum up the machinery that the virus uses to make copies of itself. And so you can do that through stalling its replication cycle or as Molnupiravir does, it induces mutations in the virus that make it just basically fall apart.

Sounds good. And what's additionally special about these drugs is that they fool the virus's replication machinery, but not human cells. So that causes only the virus to fail and normal healthy cells are left alone. And that gives it a targeted effect. Now with molnupiravir in particular, there were some concerns about its mechanism because it induces mutations. There were some concerns early on during testing about whether it could induce mutations in human cells or not. So during clinical trials, they limited participants to ensure that people who are pregnant were not participating. But so far the company Merck reports that there has been no evidence of this drug-inducing mutations in humans at all.

But this is something that regulators will also be paying very close attention to. Okay, you mentioned earlier that this 50% reduction in death or hospitalization in particularly vulnerable patients is something we know based on Merck's own studies. Does that mean there haven't been independent trials done on this? Well, there are ongoing clinical trials that are being monitored. The results were announced via a press release. So we're still waiting to see official published results in some sort of peer-reviewed article or even in a pre-print article. So we right now only have Merck's word to go on, but they did end their trial early because the effect was so strong and regulators had to approve that decision. So

it stands to reason that the overseers, the people who are monitoring the trial, did agree with their findings. So how does the way this thing's being tested affect its approval from the FDA? Do we know? Well, the FDA is going to review the data from the clinical trials, and it's going to evaluate how well it works as well as the safety profile.

We didn't really get a good sense of what the side effects are from this drug in the press releases. And so it's worth examining just what the potential risks are and then weigh them against the benefits. And that it's worth examining just what the potential risks are and then weigh them against the benefits. And that's what the FDA will do. One thing that the FDA does look at is, you know, who are the most ideal targets for using this drug? Like keep in mind that the 50%

reduction in hospitalization and death that was in at risk patients. So people who are older or had preexisting health conditions. So the authorization may be limited to them, or it may be expanded more broadly to the general population, depending on what the data actually looks like and what the reviewers actually consider. Okay. But we can expect this thing to get approved within the next month. Is that fair? Within a month, within days, it's really hard to say.

You know, the vaccines from the time that they filed for emergency use authorizations to approval, that took about a month. But some drugs have only taken about a few days to get approved from the FDA when they have filed for emergency use. So it really depends on how quickly they want to move on this and how much data they think they have right now. Okay. Well, if the drug is approved in the coming days or weeks or months, how much more treatable does COVID-19 become? Well, one thing that's hard to overstate about this drug is just how easy it is to administer. So basically, as soon as you're diagnosed with COVID-19 or you test positive, you can get in touch with your doctor and potentially ask them, you know, am I at a high risk group and should I start taking this pill as a precaution? And you can start getting, taking the medicine right away without having to risk going to a clinic, without having to spend the money or the resources to, you know, get transfusions, which can be pretty expensive

if you're paying out of pocket. So a lot easier to take, but still not a silver bullet. That's right. You know, no drug is going to be 100% effective against all the most severe cases of COVID-19, but on balance, they do tend to reduce the risks. And it's still not going to be anywhere near as effective as getting vaccinated to begin with. Do we think people will trust this new drug, this little brown pill that could treat COVID-19? Potentially. You know, there is a fair amount of vaccine hesitancy still around. There are still people who are adamantly against getting vaccinated, but may be more inclined to get a treatment. But it's really hard to say.

I mean, why? The reasons that people refuse vaccines may overlap with the same reasons that they would refuse therapy like this. Time will tell. We'll just have to see who takes this. But at this point, we know that the people that are facing some of the most severe consequences of the disease are those that are unvaccinated. So at least in the US, it may not move the needle that much. Where it can make a big difference is potentially in other countries where vaccination rates are really low because they just don't have the supply chain or just the resources to administer the vaccines at this point.

So places where you have still ongoing spread of COVID-19 but haven't been able to get vaccines to them, this might make a big difference there. So these are other countries, potentially some of the more remote regions of the world where this can make a big difference in reducing the overall impact of the COVID-19 pandemic. More with Umair in a minute.

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I've lost count, too. We're certainly on the downward slope of the wave that peaked in early September, but we don't know if this is going to be the last one. Yeah, I mean, we spoke back in June when Delta was really popping off about, you know, how things looked good, and then they didn't. Where are we now?

Well, things are starting to look good right now. You know, we do have a number of things that are positive, you know, some good developments that we didn't have last year. We have more than half of all Americans in this country vaccinated and certainly more than 80% of adults over the age of 65 that are vaccinated, you know, one of the highest risk groups. So that bodes well. The pace of vaccinations is certainly picking back up now that we are seeing vaccine mandates. If you want to work with the federal government and do business with us, get vaccinated. You know, now with the full approval

of the Pfizer-BioNTech vaccine, the federal government and a lot of private employers are starting to require their employees to get vaccinated. We're also seeing some of the first recipients of the vaccine get booster shots. 20 million Americans now qualify for a booster. I'm getting my booster shot. And soon kids may be able to receive a vaccine as well,

provided the FDA grants an emergency use authorization for children. And if this pace of vaccination continues, you know, we'll still have a larger and larger fraction of this population that's immune to COVID-19, which should put a big damper in the spread of the disease. Yeah, I mean, let's talk more about that. I think at this point, you know, October 2021, we're still at about 2,000 Americans dying from COVID-19 a day, which feels insane.

Do we have a sense of how much that number drops in a forthcoming best case scenario? There have been some models and estimates, but certainly, you know, if we continue on this trajectory, this downward slope, one modeling estimate found that we would get to about 90 deaths per day by the end of February 2022. And that would presume, you know, a continued decline through the winter that basically we maintain the gains that we have and we continue advancing in terms of vaccination, but also in terms of containing the overall spread of the disease. That's certainly a very optimistic picture, but, you know, it is one of the possibilities. Hmm. Well, let's talk about how we get there.

I mean, there's a lot of news about mandates right now, vaccine mandates, government mandates, business instituted mandates, school mandates. And then there's sort of this counter movement of people resisting those mandates. I think famously, Kyrie Irving of the Brooklyn Nets popped up in that department yesterday. How well are mandates working? Mandates seem to be working really well. You know, there are a few holdouts that are getting a lot of attention, but I think it's worth emphasizing that the vast majority of people who are facing a mandate do comply with it. That's workers in healthcare, that's workers in government, that's workers at airlines. We're seeing huge spikes in vaccination rates, and a lot of these mandates are helping close the gap. For instance, in New York, the vaccination rate among hospital and nursing home staff went from 75% to over 90%

after a mandate was implemented. So there's a lot of evidence that actually making this a requirement does work in terms of getting people to get vaccinated. Okay. What about boosters? I think we are now officially giving out boosters in the United States. Is that right? Yes. Pfizer received approval from the Food and Drug Administration on a limited basis to begin administering boosters to some of the earliest recipients of the vaccine. And right now, the FDA is also not taking a stance on boosters from Moderna, saying that there hasn't been enough evidence submitted that they're actually needed. Johnson & Johnson, the one-dose adenovirus vector vaccine, is also putting out data showing the effectiveness of their booster. So that might also receive approval in the coming

weeks and months. But yeah, there's a lot of moving parts here, and we may see more uses of vaccines being approved. Okay. And the kids? Well, kids right now are not even approved right now for vaccines. You know, the FDA is still weighing the evidence right now from clinical trials for children between the ages of five and 12. And as far as the kids are concerned, it's going to be safe in a couple of weeks for them to go out on Halloween and trick or treat. They may not be available by Halloween, but, you know, Dr. Fauci did say earlier this year that Halloween should be safe to enjoy. You're outdoors for the most part, at least when my children were out there doing trick or treating, and enjoy it. I mean, this is a time that children love. It's a very important part of the year for children. I know my children enjoyed it.

So, I mean, particularly... I imagine there would probably still be some precautions, you know, gathering in outdoor areas. There may still require some social distancing and masking. And Halloween's the perfect holiday for masking. Yeah, what are the anti-maskers going to do on Halloween? Do the whole inverse mask thing where they cover their eyes and leave their mouths open, you know, Batman style. Impossible. So it sounds like there's a lot of reasons to be hopeful, but we've all been hopeful before.

What are some of the reasons to be pessimistic? Well, there's always reasons to be pessimistic. And I think the track record of this pandemic did kind of validate a lot of the pessimistic folks here. One big thing that is really putting a damper on all this is that there are still people that are absolutely adamant that they will not get the vaccine. It's about 10 to 12% higher, depending on certain areas. And that's pretty closely associated with political leanings, people who tend to vote Republican or jurisdictions that voted in large numbers for Donald Trump tend to have a much lower vaccination rate.

And if those people remain unvaccinated, they still remain reservoirs for this virus. We are seeing that a large proportion, almost all of hospitalizations and deaths at this point are among unvaccinated people. And so as long as the virus continues to spread, it will continue causing harm, but it will also continue mutating and potentially those mutations could create another variant that would undermine progress against the disease. And the other factor to consider is also that human behavior is a key factor in controlling the spread of this disease. I mean, obviously, vaccines are super effective, but we've seen that, you know, without other precautions alongside vaccines, we don't make as much progress as we could. So that means

maintaining social distancing in some circumstances, wearing masks in high-risk settings may still be required. And if people are resistant to doing those things, then, you know, what little progress we're making could be eroded. And that's been the cycle thus far, right? It's bad, and then it's less bad, and then it's bad, and then it's less bad. Are we going to break that cycle at some point? Do we know when? I mean, again, it's really hard to say. It's not as though we're facing one uniform pandemic. We're seeing this pandemic play out in different ways in different places. In areas where we do have a high vaccination rate, but also good social distancing and masking, people are pretty close to normal. The transmission is low, the hospital beds are fairly empty, and people aren't as worried. But in other areas where transmission rates remain high, people aren't

vaccinated, and they aren't wearing masks, then we're still seeing hospitals getting filled up. And so we will continue to see this sort of mosaic of pandemics across this country, on a city-by-city, even on a county-by-county basis, where you have different approaches leading to different outcomes. And that's really a case for why we really need to take this pandemic seriously, even as cases decline. We do all want to get back to normal. I certainly do. But I also don't want to lose the fragile progress that has been made. And I certainly don't want to ratchet back some of the precautions that were in place during the darkest days. And so it will really require concerted effort on all fronts in all areas in order to actually get out of this thing for good. Can we make plans for the holidays

in there? You can if you want, but I would suggest booking flexible tickets with good cancellation policies. What are you going to do? Well, I'm actually going to Glasgow in November to attend the UN Climate Change Conference. Jealous. Don't be. Those conferences aren't that interesting. You spend a whole lot of time inside a conference hall talking to people who don't want to talk to you.

Word. All right, your turn, Sean. What are you planning to do? I think I'll get married. You think? Umair Irfan reports on science at Vox. Our show today was produced by Will Reed and Halima Shah. I'm Sean Romsferm.

It's Today Explained. Thank you.