Stop! Hammer time

How excited should you be about the Covid pill? 7 critical questions answered

The Merck drug could become the first antiviral pill for Covid-19.

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In May of this year, I was talking to Lisa Brousseau, an expert on respiratory protection and infectious diseases, about how easily Covid-19 is transmitted and vaccines.

Brosseau was concerned by the framing of vaccines by the media and public health officials. “There’s magical thinking that all these vaccines are going to completely solve the problem,” she said.

They’re not. With a high number of unvaccinated individuals throughout the country and the Delta variant being even more transmissible than the wild-type virus, it’s become clear the novel coronavirus is here to stay. That means we needed more effective and less expensive treatments yesterday. Possibly, treatments like the Merck Covid-19 pill.

Currently, the most effective antiviral treatment we have for Covid-19 patients is remdesivir, an antiviral medication initially developed to treat Hepatitis C. The drug is only approved for hospitalized patients, leaving the many people who get very sick from SARS-CoV-2, the virus that causes Covid-19, with virtually no options.

So when the pharmaceutical company, Merck, announced that they were seeking emergency approval for molnupiravir, a new antiviral treatment with very promising results in clinical trials, it was met with excitement. (The name is a reference to Thor’s hammer, Mjölnir.)

The Covid-19 antiviral, molnupiravir.

Copyright © 2009-2021 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A.

The results were so promising that an independent panel of experts felt confident about the safety and efficacy of the drug that they allowed the pharma giant to submit for emergency approval earlier than scheduled. Merck submitted its application to the FDA on Monday — if approved the drug will become the first antiviral pill to treat Covid-19.

With so much misinformation about COVID-19 treatments floating around, it’s worth exploring what we do and don’t know about the new treatment. These seven questions explore the purpose of the drug, how it works, how it could possibly change the pandemic, and more.

What is the Covid-19 pill?

Molnupiravir is a pill created by the pharma giant Merck.

Merck is seeking FDA approval for the pill’s emergency use. Emergency use is a way to fast-track approval of very promising drugs for public health emergencies. The vaccines were authorized under emergency use — that’s why they could be given to the public while they went through the much slower drug approval process.

How could this pill change this pandemic?

If the results Merk saw in its clinical trials meet the scrutiny of FDA regulators, it could be a serious game-changer. In its clinical trials, Merk found that the drug reduced hospitalizations and deaths among people with Covid-19 by half.

Many of the current Covid-19 treatments are limited to hospitalized patients. That would change if the “Covid-19 pill” is approved.

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As of October 11th, there were 58,706 people hospitalized with Covid-19. If the pill were approved and as effective as the trials suggest, that number would (theoretically) be 29,353.

That’s 50 percent fewer lost loved ones, 50 percent more hospital beds, 50 percent fewer hospital bills.

How does the Merk Covid-19 pill work?

If you’re a health science nerd like myself, learning how this works is extremely cool. Like remdesivir, molnupiravir is what’s called a nucleoside analog — the largest category of “small molecule” antivirals. Nucleoside analogs mimic some of the building blocks of RNA.

When the SARS-CoV-2 virus enters a cell, it immediately starts making copies of itself — duplicating its RNA genome. Because nucleoside analogs mimic the building blocks of RNA, it can interfere with that replication process.

Clinical trials suggest molnupiravir becomes incorporated into the virus’ RNA and thwarts the whole process. It’s a bit like a wedding crasher — it dresses up to look like it belongs, but then goes wild once inside. When the virus tries to duplicate itself, it’s now working with faulty RNA, and a mutation occurs. After enough mutations, the viral population collapses.

Because these mutations occur randomly, it’s unlikely that the virus can evolve to become resistant to the drug.

Again, all of these things need to be verified by the FDA — this information is based on Merck’s clinical trial focused on unvaccinated volunteers, and the results aren’t peer-reviewed or published in a journal. But an independent board of experts monitoring the trial was convinced by the results.

Who is the Covid-19 pill for?

This is also very exciting. The only other antiviral approved for Covid-19 is remdesivir: It’s given only to hospitalized patients and has to be delivered directly to the bloodstream. It’s also expensive. A typical cost course of treatment with remdesivir will cost a patient over $3100.

Molnupiravir is still expensive — a typical course of treatment will cost a patient $700, but that’s still cheaper and more easily administered than remdesivir.

Crucially, it’s also administered early in the course of treatment. And when you’re talking about a virus that replicates very efficiently inside your cells, the earlier you can treat it, the better.

When with the Covid-19 pill be available?

For now, we don’t know — but there’s reason to think it may be this winter.

Ultimately, it depends on how quickly the FDA takes to authorize it for emergency use (but you can be sure it’s their top priority). The Associated Press reports that the FDA’s outside experts are meeting on November 30, 2021 to discuss the drug. This suggests a decision won’t be issued until at least December 2021.

The name of Merck’s Covid-19 drug, molnupiravir, is a reference to Thor’s hammer, Mjölnir.

Once authorized, it should get to pharmacies fairly quickly. The U.S. government has already allocated $1.2 billion dollars for the drug (that’s about 1.7 million treatments).

And Merck is ready to mass-produce. It’s partnered with Ridgeback Biotherapeutics and expects to make enough pills to cover 10 million people by the end of 2021. After the results of the clinical trials, Austria, Malaysia, Singapore, and South Korea have all expressed interest in placing orders.

Are there similar treatments to the Covid-19 pill? What other drugs work?

Let’s start with what doesn’t work: there is no compelling evidence to suggest that either ivermectin or hydroxychloroquine are effective treatments for Covid-19.

As for other treatments, remdesivir — mentioned above — is the only approved antiviral for Covid-19. It’s only for people over the age of 12 who have been hospitalized with Covid-19; clinical trials suggest that it may moderately speed up recovery.

A vial of the drug remdesivir.

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A rheumatoid arthritis drug called Baricitinib is sometimes prescribed in conjunction with remdesivir. Research is mixed, but in some cases, the combination can improve a patient's outcome.

Dexamethasone is a commonly used steroid, both for Covid-19 and myriad other conditions. Many of the worst Covid-19 outcomes occur when the patient’s immune system goes into overdrive, creating a cytokine storm. When that happens, the immune system starts attacking the healthy things in your body, which can be fatal.

Steroids are anti-inflammatory and because inflammation is an immune response to harmful stimuli, steroids suppress the immune system. Dexamethasone had been proven to be fairly effective in quelling these storms.

A clinical trial found that of more than 6000 patients hospitalized with Covid-19, those who needed supplemental oxygen or ventilators and who received dexamethasone were less likely to die within 28 days than those who did not receive the steroid. If supplemental oxygen wasn’t required, however, the steroid did not improve the patient’s outcomes.

Tocilizumab is a monoclonal antibody — meaning it’s manufactured from antibodies naturally produced by the body’s immune system. Initially developed to treat rheumatoid arthritis, the drug targets a sign of inflammation called IL-6. IL-6 is particularly high in people with Covid-19, and tocilizumab helps calm that response. It is only approved for use in hospitalized patients.

Clearly, treatments that keep people out of the hospital are sorely needed. If molnupiravir is proven to be as effective as trials suggest, having a very effective, less expensive, easy to administer pill could change everything.

If that happens, it will have certainly earned its name; Thor’s hammer was a devastatingly effective weapon that protects humanity.

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