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What to Know about First COVID Pill Heading for FDA Review

Health officials say antiviral treatments are promising, but vaccination remains first-line choice to prevent COVID-19 infections, hospitalizations

October 12, 2021

This week, the drug manufacturer Merck applied for emergency approval for its antiviral pill to treat mild-to-moderate COVID-19 in adults at risk of severe cases or hospitalization.

If approved through an emergency use authorization (EUA), molnupiravir would be the first available pill to treat COVID-19—with other manufacturers working closely behind on other oral therapies. Current COVID-19 treatments available under EUA require injection or infusion.

Public health officials said the antiviral pill and others in development could offer another “tool in the toolbox” to prevent severe COVID-19, while stressing that the available COVID-19 vaccines are the first-line option to protect against infection, hospitalization, and death from the virus.

Here’s more about the drug and where it stands in the review process:

About the name:  The antiviral pill is named after Thor's hammer, Mjölnir

How it works: The therapy prevents the virus during its attempts to replicate inside the body

Study results:  Merck said interim analysis of trial data indicated the drug reduced the risk of hospitalization or death by approximately 50 percent for at-risk, non-hospitalized, adult patients with mild-to-moderate COVID-19

Regimen:  The regimen is 40 total pills—four capsules taken twice a day for five days. In the study, patients had to begin therapy within five days of the onset of symptoms

Availability:   Even after potential approval, the rollout and supply is unclear. The U.S. government has placed an advance order for about 1.7 million courses of treatment, and the drug maker has said it could scale up to more than 10 million courses by the end of 2021

Quotable:  “This is a potential additional tool in our toolbox to protect people from the worst outcomes of COVID,” said Jeff Zients, the White House’s COVID-⁠19 response coordinator. “But I think it’s really important to remember that vaccination … remains far and away our best tool against COVID-19. It can prevent you from getting COVID in the first place, and we want to prevent infections, not just wait to treat them once they happen.”

The company’s application now heads to the U.S. Food and Drug Administration (FDA) for review, where a panel of public health experts will determine if the drug meets its criteria for approval. This includes presentations and an independent evaluation of the therapy’s side effects, safety profile, and efficacy.

HAP will continue to monitor the latest COVID-19 public health developments and provide updates to members. HAP strongly encourages everyone who is eligible to receive the COVID-19 vaccine. The vaccines are safe, free, and effective to help protect you and your community from COVID-19.

For more information, contact Robert Shipp III, PhD, BSN, RN, NEA-BC, HAP’s vice president, population health and clinical affairs.