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What You Need to Know About a Potential “COVID Pill” as Merck asks for emergency use authorization for its twice-daily pills

  • Merck has requested emergency use authorization for a pill designed to treat COVID-19.
  • The first-of-its-kind treatment would be for people who have mild to moderate COVID and who are at risk for progressing to severe illness.
  • Pfizer is currently conducting clinical trials for another COVID-19 treatment pill.

It’s been a year and a half since the COVID-19 pandemic began, and treatment options are still limited for people who don’t have a more severe form of the virus. While monoclonal antibody treatments are gaining in popularity, they’re technically only recommended for those who are considered high risk for serious complications of the virus.

But that may change relatively soon. Pharmaceutical company Merck revealed on Monday that it has applied for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its so-called COVID pill. The medication, known as molnupiravir, is an oral anti-viral designed to treat mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19. If authorized, it would be a first of its kind treatment.

Preliminary data shared by Merck in a press release found that molnupiravir reduced the risk of hospitalization or death from COVID-19 by about 50%. Of the patients who took the medication, 7.3% of patients were either hospitalized or died through Day 29, compared with 14.1% of placebo-treated patients. If granted an EUA, Merck says it will be able to produce 10 million treatments by the end of 2021, with more expected in 2022.

Molnupiravir was so successful in its clinical trial that an external advisory committee, in consultation with the FDA, recommended that it halt the trial early so that more people might benefit from the medication.

Merck isn’t the only company working on a COVID pill. Pfizer shared in late September that it has moved into phase 2/3 clinical trials for its COVID pill, known as PF-07321332/ritonavir. If these medications work out, there could eventually be a drug available that you could take when you have COVID-19 that could work like Tamiflu does on the flu, says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine.

But what’s the timeline for this pill? And will it be accessible? Here’s everything you need to know about the “COVID pill.”

What is the COVID pill, exactly?

Each medication is slightly different. Merck’s molnupiravir, is an “investigational oral antiviral therapeutic” that’s designed to keep people from developing severe COVID-19. Molnupiravir is meant to be taken at home—four capsules twice a day for five days.

Molnupiravir “inhibits viral replication,” explains Jamie Alan, Pharm.D., Ph.D., associate professor of pharmacology and toxicology at Michigan State University. Meaning, it keeps SARS-CoV-2, the virus that causes COVID-19, from reproducing in your body and making you sick.

Pfizer’s PF-07321332 is being given alongside a low dose of ritonavir, a drug that’s expected to help slow the breakdown of PF-07321332 so that it can remain in the body for longer periods of time at higher concentrations.

“Ritonavir is a protease inhibitor—it inhibits an enzyme needed for certain viruses to work properly,” explains Jamie Alan, Pharm.D., Ph.D., associate professor of pharmacology and toxicology at Michigan State University.

Ideally, a drug like this will help your body fight COVID. “The hope is that the Pfizer drug and ritonivir together will sufficiently inhibit the SARS-CoV-2 protease to slow down the virus enough that [the] host’s immune defenses will overcome and eliminate it,” explains Martin J. Blaser, M.D., director of the Center for Advanced Biotechnology and Medicine at Rutgers University.

Pfizer’s randomized, double-blind trial will enroll about 1,140 participants who will get the PF-07321332/ritonavir combination or a placebo every 12 hours for five days, the company says.

Why having a COVID pill is so important

There isn’t currently an easy-to-use medication to treat COVID-19 infections, especially in people who aren’t at risk for severe complications from COVID-19. “The aim is to make an oral antiviral for COVID that would be akin to Tamiflu and reduce symptoms, reduce complications, and reduce contagiousness,” says infectious disease expert Amesh A. Adalja, M.D., a senior scholar at the Johns Hopkins Center for Health Security. He calls the idea of a COVID pill “game changing.”

Dr. Schaffner also says that, “lots of people—myself included—are excited about this.”

Having medications like this to treat COVID-19 “might work to shorten the course and severity of disease,” Alan says.

A treatment like this is definitely needed, Dr. Schaffner says. “At the moment, we’re using monoclonal antibodies, but they’re much more complicated and expensive than giving someone a pill. Monoclonal antibodies have to be given intravenously or through a series of inoculations under your skin,” he says. “If we had an oral drug that we could give somebody, that would be so much easier.”

It’s unclear when, exactly molnupiravir may be available to the general public, but it’s likely to be in a matter of weeks if it’s authorized by the FDA, Dr. Schaffner says.

Originally published in Prevention,

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