Will Improved Testing And New Antivirals Change The Pandemic’s Path?
This story is a part of Science Friday’s coverage on the novel coronavirus, the agent of the disease COVID-19. Listen to experts discuss the spread, outbreak response, and treatment.
Late last week, the pharmaceutical company Merck released data on a new antiviral medication called molnupiravir—a drug taken as a course of pills over five days that the company said was dramatically effective at keeping people with COVID-19 out of the hospital. In a press release, the company said that trial participants on the medication had a 50% lower risk of hospitalization or death compared to people getting the placebo. And while eight people in the placebo group died during the trial, none of the people getting the new drug did.
However, the full data from the trial has yet to be released—and the medication must still go through the FDA approval process before it can be used. Matthew Herper, senior writer at STAT covering medicine, joins Ira to talk about the drug and what questions remain.
Then, infectious disease specialist and epidemiologist Dr. Céline Gounder discusses other recent coronavirus news—from a government plan to spend a billion dollars on at-home testing to recent data on the Delta variant, including projections of what might happen next.
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Matthew Herper is a senior writer at STAT in Boston, Massachusetts.
Céline Gounder is an infectious disease specialist and epidemiologist at NYU and Bellevue Hospital. She’s also host of the Epidemic and American Diagnosis podcasts, and a member of the Biden-Haris Transition COVID-19 Advisory Board. She’s based in New York, New York.
IRA FLATOW: This is Science Friday. I’m Ira Flatow. Last week, the pharmaceutical company, Merck, released data on a new antiviral medication. This one, a pill. That it said was dramatically effective at keeping people with COVID out of the hospital. But just how good is it and will it change the equation for fighting the pandemic here in the US? Joining me now is Matthew Herper, a senior writer at STAT covering medicine. Welcome to Science Friday.
MATTHEW HERPER: Thank you for having me. It’s a thrill.
IRA FLATOW: You’re welcome. Tell us about this new medication. Why are people so excited by it?
MATTHEW HERPER: Well, there’s been a real hunger since the beginning of the pandemic to have a medicine that could keep people who get COVID out of the hospital and keep them from dying that’s a pill. The real success we’ve had here has been with the monoclonal antibodies, which are great drugs, but they mostly need to be given via IV. The Regeneron one can be given by injection but it’s a lot of injections. It’s inconvenient to give them and logistically difficult. And so, the idea is if you had a pill that you could give to people when they start to get sick that kept them from getting sicker, it would make this whole pandemic a lot less bad.
This is the first one to show efficacy. So although we don’t have full data and there are a lot of questions, we know that this drug did in fact keep people out of the hospital. And there was even a difference in deaths. There were eight deaths in the placebo group and none in the treatment group, which is an impressive result.
IRA FLATOW: You know, this pill reminds me of that other pill, that other antiviral– Tamiflu– which people took. So that’s the same idea. It’s not a vaccine, it’s a pill to fight the virus.
MATTHEW HERPER: Exactly. Now Tamiflu has been a controversial drug because what it mostly seems to do is shorten illness. And so there are big believers and skeptics. The result here in COVID really does seem to be a reduction in hospitalization and in deaths. So that’s important.
IRA FLATOW: And how do you take it? What’s the course of treatment here?
MATTHEW HERPER: It’s several pills a day twice a day for five days every 12 hours.
IRA FLATOW: What do we know about how safe the drug is and the cost of this drug, if and when it does reach the market?
MATTHEW HERPER: Well, those are two very big questions and it hasn’t even gone through the FDA yet so usually you don’t know. But what we do know is that on the kind of side effects that showed up in this drug study, there were actually more people who withdrew from the drug from what were thought to be adverse events due to the drug in the placebo group– who were actually probably we assume having effects from COVID– than in the drug group.
But this is also a drug that some experts have had questions about because of the way it works, because it does work by affecting the virus’s genetic material. And what if it has long term effects? And we really haven’t seen, with any granularity, what the safety data aside being told in a press release that the number of adverse events was the same between drug and placebo groups. So that’s very much something I’d expect to hear a lot more of as we go through the normal FDA process, which could involve a public advisory committee where a lot of that data gets aired.
You asked about cost and that’s a very good question. Right now, the US government has bought a lot of this drug. 1.2 million courses at $700 per course. We don’t know whether that price– which is a pretty expensive price if you’re going to stockpile lots of it, especially if you’re going to use it all over the world. We don’t know if that’s going to hold up. There isn’t really any comment from Merck.
You mentioned Tamiflu. Flu drugs like that cost a lot less, I think around at $150. So how this drug is going to be bought, who is going to be able to get it is a big question. Another thing that’s important about this trial is that this trial only tested the drug in unvaccinated people. So one big question for regulators is you’d like to be able to give a drug to people who are at high risk who have breakthrough infections, people on the vaccine who develop an infection.
But your risk of being hospitalized or dying is already much lower if you’re having a breakthrough infection. So how does one think about balancing the risks and benefits there for vaccinated people. Should they have a breakthrough infection? That’s going to be one of the important questions for this and other antiviral drugs.
IRA FLATOW: Can you give us an idea on what the likely timeline here on this Merck medication is? When might the FDA Act on this data?
MATTHEW HERPER: Well, Merck has to finish filing. Then– the FDA’s been acting very quickly on some of these things. So normally, this would take six months. But I would think a month to two months time frame would be realistic here.
IRA FLATOW: And are there other drugs like this on the horizon?
MATTHEW HERPER: So to me, that’s really one of the exciting things here. This is the first [? oral ?] we’ve seen be effective. And on Wall Street, there’s a debate of how much that first mover advantage matters. But the fact that one of them worked also raises the odds that the next ones will work. And there are. There is one from the drug giant, Roche, and a small company called [? Etea. ?] There is one from Pfizer that works differently. The big news to me is that it looks much more likely that we’re going to get an oral and maybe this is it. Maybe this is the drug. We need to see a lot more data before we know that for sure.
IRA FLATOW: Do these drugs target just the COVID or could they be effective against other viral diseases?
MATTHEW HERPER: That’s a good question. One of the things that was exciting about this drug initially was that it was expected to be more panviral. I mean, it’s a tight rope that researchers walk in developing these drugs because the more specific it is, the less likely you are to affect the host, which is us, but it would be great to have something that if there’s a new coronavirus, this is the drug to use. And that also means you’re less likely to get resistance because if it’s killing all of them, then you’re less likely to have resistant strains emerge.
IRA FLATOW: OK. So what’s going to be taking up your attention? What will you be looking for in the coming week?
MATTHEW HERPER: What I’m really looking for on this drug, I really do want to see more safety data. One big question about this study is that if you look at the monoclonal antibody studies or you look at studies that were done, there was a positive study of remdesivir, which is another IV treatment, in mild to moderate COVID. The rates of hospitalization and death in those studies in the placebo groups are much lower than they were in this one. So we really are going to want to know why that is, why these patients were so at risk. It may have to do with the geography of where those patients were but we need to see more clinical trial data to know that. I think that’s one big question.
The safety is certainly something that people are going to want to pick apart. I mean, if this is going to become a drug that is going to be given to lots of people as soon as they get COVID, it’s a 1,500 patient study. We also haven’t really even seen the full efficacy readout because this study was stopped early because the efficacy was so good. But they’d actually enrolled the whole study. So we’ve seen data from about 750 patients. We will probably be getting 4,300 in total, so that should be a lot more information on efficacy. So I’m watching for all of those to read out. These data have not been published, they have not been peer reviewed, they have not undergone review by the FDA, or a public review by its experts. So the details matter and I’m waiting to see the details.
IRA FLATOW: Well, Matthew, we will follow that along with you and talk about it later. Thank you for taking time to be with us.
MATTHEW HERPER: Thank you for having me.
IRA FLATOW: Matthew Herper is a senior writer at STAT covering medicine. You’ll find links to his reporting on this medication on our website at sciencefriday.com. Continuing our COVID conversation, It’s been a busy week with data coming out about the success of some of the vaccine mandates. And new news from the FDA regarding at-home testing.
Joining me now to talk about that and other topics in the pandemic is Dr. Celine Gounder, an infectious disease specialist and epidemiologist at NYU and Bellevue Hospital. She’s also the host of the EPIDEMIC and AMERICAN DIAGNOSIS podcasts. And a member of the Biden-Harris transition COVID-19 advisory board. Welcome back to Science Friday, Dr. Gounder.
CELINE GOUNDER: It’s great to be here, Ira.
IRA FLATOW: Nice to have you. OK, we’ve been talking about the antiviral medication announced by Merck last week. What is your take on that?
CELINE GOUNDER: I think people need to think about this new drug as well as other treatments for COVID as backup plans, not your first line option. It’s a bit like you don’t want to get in a car accident but if you do, you have your seatbelts, your airbags to protect you. I think similarly here, you don’t want to get COVID, but if you do get COVID it’s great to have some new treatments available to us.
IRA FLATOW: And in other news this week, the FDA approved a new brand of at-home tests for COVID. And news came out this week that the administration is planning to spend a billion dollars on the purchase of rapid, at-home tests. How important is having access to this kind of testing?
CELINE GOUNDER: I think it’s really important and I’m really glad to see that they made this announcement before the winter holidays. The vaccines are wonderful but they’re not perfect. And as long as there’s a significant amount of transmission in the community, even if you are vaccinated, you’re still at risk for a breakthrough infection. And so one of the most important things we can do other than getting vaccinated over the holidays is to test ourselves at-home every morning, every other morning. And that’s the best way to keep ourselves, and our families, and friends safe and to prevent transmission of COVID when we’re gathering together over the holidays.
IRA FLATOW: The fact that the administration is sinking a billion bucks into the purchase of the at-home tests, does that mean they will be free to us or do we still have to buy them?
CELINE GOUNDER: Well, the administration is aiming to increase free testing through the pharmacy program that provides free testing. Whether at-home tests will be available for free, I’m not entirely sure yet. Other countries certainly have gone that route where in some countries, they’re mailed to people at home to use and they’re free. And so I think if we eventually got to that point, I think that would be a wonderful development.
IRA FLATOW: Are they reliable? Do we think home tests are as reliable as we would like them to be?
CELINE GOUNDER: They are pretty good. They’re not perfect either but they are quite good at detecting people who are infectious, who are at risk for transmitting the infection onward to others. It is important to remember that just because you test negative on one day, doesn’t mean you’ll test negative the following day. And so you do need to be testing pretty frequently to make best use of these.
IRA FLATOW: Yeah. There’s been a lot of talk in recent weeks about vaccine mandates. And now it looks like as they are starting to go into effect that they’re working. They’re effective in pushing folks to take the shot.
CELINE GOUNDER: They’ve been remarkably effective. In New York City, where I live, we’ve seen the impact on nursing home staff, on health care staff, where we’ve seen vaccination rates jump up into the mid to high 90s. And we’ve seen this impact in other industries too. Tyson Foods, for example, which is a meat and food processor, we’ve seen vaccination rates jump.
And so I think– for a couple of reasons, this works. I think people in the United States are more receptive to something coming down from their employer, from the private sector than from the government, necessarily. And it also provides a kind of cover. I’m getting vaccinated because I have to keep my job, as opposed to I’m getting vaccinated because that’s what public health officials have told me to do and I think it gives people sort of that cover socially to do this.
IRA FLATOW: I would imagine with the success of this, we would see the mandate showing up in more than just the workplace.
CELINE GOUNDER: We may. We may see other mandates. And in New York, again, where I live, we are seeing mandates to go to restaurants indoors, to go to gyms indoors, and the like. And so you may see more and more places adopting those kinds of mandates.
IRA FLATOW: This is Science Friday from WNYC Studios. Moving on to the data, some of the data seems to suggest that the latest surge from the Delta variant may be on the decline. What should we make of those numbers?
CELINE GOUNDER: Well, we’ve seen an interesting pattern over the course of the pandemic and we still don’t entirely understand this. But the virus does seem to occur with these two-month cycles of waves of infection and we seem to be at the tail end of that now. I do think things are improving dramatically across the country, although some parts of the country are still very hard hit. Parts of Alaska, Appalachia, parts of the Northwest, for example. But I do think big picture, things do seem to be improving. I don’t know that this is going to be our last wave. I think that’s highly unlikely. And I think there’s a very good chance that we’ll see a resurgence– not as bad as last year– but a resurgence over Thanksgiving, Christmas, and New Year’s when people travel, when they let down their guard, when they hang out with family and friends.
IRA FLATOW: This week, New Zealand, which had been famously trying a policy of reducing cases to zero, basically changed tactics. What happened there?
CELINE GOUNDER: Well, I think there’s been the realization that with the Delta variant– which is significantly more infectious than the early strains of the virus– that a elimination strategy or COVID zero strategy is just near impossible. And so understanding that, how do you reallocate your resources while minimizing impact on society and the economy. And I think that’s what they’re recalibrating right now.
IRA FLATOW: Whatever happened to that mu variant people were worried about just a few weeks ago?
CELINE GOUNDER: Well, it really hasn’t turned out to be a problem so far. I think you have to think of these variants as being in competition with one another. And the Delta variant is so good, it is so infectious. You can think of it as being that much faster in a race that it has really outrun all the other variants so far and so continues to be the dominant variant.
IRA FLATOW: Do we have any idea when the Moderna booster may be coming out? Because I know I’m certainly waiting for it, I know a lot of other people are. What is holding that up?
CELINE GOUNDER: So Moderna, as you’ll remember, was rolled out after the Pfizer vaccine. And so they’re just a little bit farther behind and also gathering data on questions like boosters. The FDA and the CDC are going to be reviewing that data. I will say that the Moderna vaccine does seem to be holding up better than the Pfizer vaccine. So I would not be surprised if recommendations from Moderna recipients to be boosted are a bit narrower than what they were for Pfizer.
IRA FLATOW: And there are people who are going to say, I don’t want to wait for that Moderna. I’m going to go get the Pfizer and mix and match them. Anything wrong with that?
CELINE GOUNDER: Well, that may not be the best mix and match option. What we’ve seen with other mix and matching, in particular the AstraZeneca vaccine, which is an adenovirus vector vaccine, not unlike the J&J vaccine, what we’ve seen is that when you mix and match that vaccine with mRNA vaccines like the Pfizer and Moderna vaccine.
So, really, crossing different technologies. That’s when you get the best combination. The NIH is currently studying every possible combination of Pfizer, Moderna, and J&J, which one did you get first and which do you get as booster to see what combo is the best. And we should have data on all of those mix and match regimens by mid to late October. So at least personally, I’d rather wait and see what that data shows. And if I do need a booster, I would go based on that.
IRA FLATOW: OK, doc. You’re the doctor. I’ll take your advice. Dr. Celine Gounder. Thank you for taking time to be with us.
CELINE GOUNDER: My pleasure.
IRA FLATOW: Dr. Gounder is an infectious disease specialist and epidemiologist at NYU and Bellevue Hospital. Also the host of the EPIDEMIC and AMERICAN DIAGNOSIS podcasts. And a member of the Biden-Harris transition COVID-19 advisory board.