Merck’s COVID Pill Has Been Called a ‘Game Changer’ — Is It?

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You get sick with COVID-19. Instead of quarantining and hoping you don’t get worse, or heading into the hospital, you can simply call your doctor, get a prescription, and take it at home. Seems too good to be true. But is it the future of COVID-19 treatment?

Merck is hoping their new antiviral will do just that. The company officially submitted an application Monday to the FDA for emergency use authorization, for what would be the first pill to treat COVID-19. This pill, molnupiravir, has been called everything from a “game changer” to “blockbuster.” The approval could come in a matter of weeks. But is it all it’s been talked up to be?

On this week’s episode, William Schaffner, MD, a professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, helps explain what the new pill means in the fight against COVID-19, and what to watch for as it moves toward emergency use.

The following is an abridged transcript of Schaffner’s interview with “Track the Vax” host, Serena Marshall:

Marshall: Dr. Schaffner, it’s always a pleasure. We had you at the end of our last season. The start of the first one. So much has changed in just a couple of months. One being this pill. Explain for us how it works and how it’s different from what we currently are using for treatments.

Schaffner: What we’re using for treatment is something called a monoclonal antibody, and we have to get people early identified who’ve had COVID, bring them into a clinic location, where, through an IV or multiple injections, we can give them this treatment. The treatment is designed to prevent the development of severe disease.

That’s very good — to keep you out of the hospital, but it’s cumbersome. You have to have an appointment, it’s expensive. You have to go to the treatment. Now, Merck has brought in this new pill form. It’s an antiviral drug, molnupiravir, and the notion would be, as soon as you’re diagnosed, you can contact your healthcare provider and if you qualify, you could go to your pharmacy and get some pills, which you would have to take twice a day for 5 days, but they are designed, likewise, to prevent this illness from becoming more severe. It’s designed to keep you out of the hospital. And it looks to be, at least in the early trials, about 50% effective. That’s not bad.

Marshall: That seems really great. I mean, it really sounds like just any other antibiotic that your doctor could call in for you.

Schaffner: It’s kind of similar to Tamiflu, which we give for influenza infection. And so we hope that this will get approved and can be used more widely.

Marshall: So talk us through, doctor, how the actual medicine works. How it would be attacking COVID differently than the monoclonal antibody, or is it really the same and just the delivery method is different?

Schaffner: It’s the same and different. The first thing is the virus is in your body already because you are infected. In order to make you very sick, it has to keep multiplying. And what this drug will do is interfere with the virus’s capacity to multiply. So you cut it off at the pass.

The monoclonal antibodies are really antibodies which are then given artificially to you. We call that passive vaccination. You haven’t got enough antibodies developed in your own system to stop the virus. We’ll give you those. There are two different ways to prevent the virus from further multiplying in your body.

Marshall: Now is this, you mentioned Tamiflu, that it’s kind of similar, but is this new research? I read that they started developing this type of pill for COVID-type symptoms 10 years ago, but we didn’t have COVID then. So explain to us how this research came about.

Schaffner: Well, it came about through the work of one of my colleagues right here at Vanderbilt, who was an expert in this whole field of coronaviruses, and COVID is a member of that virus family. And he was really concerned that someday we might have a rogue coronavirus, such as COVID, cause a pandemic.

And so he was looking in his laboratory for drugs that would interfere with the multiplication of the virus. And he found that it did. That led to further experiments in animals. And now when we have this pandemic in front of us, clinical trials were undertaken in people, volunteers. Now we have the documentation that this drug will actually work.

And so that data have now been submitted to the Food and Drug Administration, and they’ll examine it very carefully and see whether they approve it for general use.

Marshall: So, let’s talk about some of that data and the phase III clinical trial. One, is that 50% number really high enough? I mean, what is the comparison for something like Tamiflu?

Schaffner: Well, what Tamiflu will do to influenza is if you give it quickly — for optimal work, it has to be given within 48 hours of your first getting symptoms, and there’s a problem because you have to realize that you might be infected and go to the doctor very quickly or call the doctor — but what Tamiflu will do is reduce the duration of the illness and make it less severe.

That’s similar to what molnupiravir is anticipated to do for COVID. What it will do is make the illness less severe.

Marshall: So is this really a game changer?

Schaffner: Game-changer is enthusiastic. It certainly is another tool we have in our toolbox. And it would be wonderful to have. Because if it could be distributed through pharmacies, we can reach many populations that are harder to reach. Almost everybody knows where a pharmacy is located and if we could do it through pharmacies, then we could extend this benefit to a wider group of patients than we can with the monoclonal antibodies — where the patient has to get an appointment and come to a clinic, etc. It’s much more involved.

Marshall: And lessen the stress on our hospital system?

Schaffner: For sure, that too, and this is likely to be cheaper. I didn’t say cheap, but cheaper. Less expensive.

Marshall: Yeah, we’re going to talk about the cost here in just a second, but before we get there, I’m just so curious on why it’s taken so long to get this treatment. Why maybe we weren’t pushing for this treatment faster versus vaccination. We got those vaccines out in just about a year, right? Operation Warp Speed. If this could have stopped the virus from getting worse and lessen the strain on our hospital system, why weren’t we putting more resources into this and why did it take longer to come about?

Schaffner: I think it’s just a matter of how quickly the science can develop. The information, the science, was very, very mature, just waiting for a problem and that enabled people to develop the vaccine so rapidly. I mean, that was a world’s record.

Here, the science was not quite as well developed. And so you had to do that before the FDA would allow those clinical trials in people to actually take place.

Marshall: So what do we know about those possible side effects?

Schaffner: Actually, the side effect profile has not been widely released yet. And I haven’t seen that. That’s going to be of great interest to the Food and Drug Administration and to its advisory committee. So we all are eager to see that and see exactly how well it works.

Tamiflu, which is another different kind of an antiviral, has very few, but it does have some notable side effects that we need to be aware of. So we’ll have to watch this very closely.

Marshall: The side effect report for this drug hasn’t been out, but for oral antiviral medications in general, don’t they sometimes integrate into the genetic makeup of the virus and cause a lot of mutations to help destroy it?

Schaffner: That’s been actually already out in the social media and a matter of concern. Believe me, the company was — the company scientists — were well aware of this. The Food and Drug Administration scientists were well aware of it. And as the various laboratory and animal studies went forward, they looked into this question very, very carefully. It seems not to be an issue. Otherwise, they would never have permitted trials in human beings to take place.

Marshall: So that issue was actually solved way before they even got to phase III?

Schaffner: That’s my understanding, and I’m sure we’ll discuss that some more going forward.

Marshall: Well, what about antiviral drug resistance?

Schaffner: We would have to see how well these viruses are able to develop resistance to the drug as they’re widely used. Now, it doesn’t always happen. You can use Tamiflu until the cows come home and that does not generate resistance in the influenza virus. Do we know exactly why that is? No. Are we happy that there’s no resistance? Yes.

I don’t think we can predict with assurance whether resistance to these drugs will develop in COVID virus. That’s something we’ll have to see as we start using it in the real world.

Marshall: What about with the different strains of COVID?

Schaffner: My understanding is that this drug will work on all the different variants of the COVID virus. And that makes sense because all these viruses multiply in exactly the same way.

Marshall: So, we wouldn’t have to worry about some becoming resistant and others still having it work?

Schaffner: I think not. That may be more of a concern actually with our vaccines than it is with these antivirals.

Marshall: And what about antivirals and vulnerable populations, children, pregnant women. Those aren’t being tested yet …

Schaffner: With any drug, any drug, you test in people who are not pregnant and in adults first, before you try it in children and people who are pregnant. So I think that information will come along a little bit later. For sure, we can use monoclonal antibodies in pregnant women. That we know, and studies are underway regarding monoclonal antibodies in children at the present.

Marshall: So now it’s up to the FDA. They’re going forward with this emergency use authorization. What’s the realistic timeline on when this can be provided at a pharmacy? When can you call your doctor and say, “Hey, I got COVID and can I go get my prescription?”

Schaffner: Well, two things about that. The FDA is committed to review everything related to COVID very rapidly. I’d hate to put a stopwatch on it, but I would think within 6 to 8 weeks their committee might be able to look at this and let us know. Now the company then, that’s the second part, they say they can manufacture and distribute it. It looks as though if we get approval, once again, you and I, and all your listeners, will have paid for it through our taxes and it will be distributed, I think, without cost. So we’ll see how that all works.

Marshall: You really brought that full circle for me, doctor. Bringing it back to the cost here. You said it’s cheaper than monoclonal antibodies, not cheap. And now you’re saying that we possibly could get it distributed without cost. So let’s talk about.

Schaffner: Well, I’ve heard various estimates about how much the drug itself would cost. And a course of therapy has been estimated to me between $400 and $700. So that’s not chicken feed. However, administration of the monoclonal antibody, including the IV setup and the clinical time and the professional time that’s necessary, that’s on the order of about $2,000. So we could bring that cost per unit down, I would hope.

Marshall: So per unit cost is down. Why would it be at no cost to you if you got COVID, and why is the government picking up that tab?

Schaffner: Well, the government is interested in doing everything it can, of course, to mitigate, to reduce the spread of this virus. And so, I think, at least in the early stages — and we’re still in the early stages of controlling this pandemic — the government would like to keep as many people out of the hospital as possible. If you do it just for the financial aspects, keeping someone out of the hospital saves a ton of money.

Marshall: So it’s free to you to pick up, but our tax dollars are really footing the bill, right?

Schaffner: Yes. I mean, there’s no free lunch. Someone’s going to have to pay for it, but you could conceivably as a single person, as an individual, I would say, go to the pharmacy, your prescription has been called in, you would pick up your medicines with instructions about how to take them, but you wouldn’t have to reach for your wallet.

Marshall: But I saw this report, doctor, and I’d love to have you weigh in on it, that according to experts at Harvard School of Public Health and King’s College Hospital in London, as you mentioned, the price tag for it is around $400 to $700 for a 5-day treatment, much less than monoclonal antibodies, but it only costs $17.74, according to this report, to produce. Why the huge markup?

Schaffner: Well …

Marshall: Is that the million dollar healthcare question moving out of COVID pill territory?

Schaffner: I’m always confused about drug pricing. I’m not one of those people who wears a green eye shade and knows all about the economics of drug pricing. I am sure the pharmaceutical companies will tell you: you’re paying, in part, for years of research that have gone into the development of this drug, not just how much it costs to produce an individual pill.

So you have to pay for all the background work that went into it. Please. I have no idea. I would think that the responsibility would be to the folks in our government to negotiate an appropriate price from the company.

Marshall: So, if it gets into the pharmacy, you know, cost aside, is this pill really gonna mean — if it’s approved — all these “if’s,” right, but does it really mean that we are moving out of the pandemic phase, that it’s more endemic at that point?

Schaffner: Well, we have to remember, this is treatment. It’s not prevention. So let’s remember the fundamental way to get out of this pandemic is for all of us to get vaccinated. The fact that we might have some treatments, monoclonal antibodies and now this new drug, that’s not a reason not to get vaccinated.

You know, Benjamin Franklin, all the way back to one of our founding fathers, reminded us an ounce of prevention is worth a pound of cure.

So, prevention is much better than requiring any sort of treatment. And there are “if’s” around this treatment. You really have to have your diagnosis made quickly. You have to get to your healthcare provider quickly to get the prescription. And even if you were to take the medicine exactly for the full 5 days, remember, some people who take the medicine are still going to get sick. Who wants to risk that?

Marshall: Dr. Schaffner, thank you so much for joining us. We’ll be continuing to watch as this moves through FDA approval, emergency use authorization. And I guess if they’re going to submit data for a peer-reviewed journal, perhaps?

Schaffner: There’s always something new with COVID, Serena. Glad to be with you.