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UK approves COVID antiviral pill: What we know about US approval, eligibility and cost

Britain has just approved Merck's antiviral drug. The drugmaker is applying for emergency use of its COVID pill in the US. What we know.

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Merck's COVID antiviral drug molnupiravir could cut serious illness and hospitalization.

Merck
For the most up-to-date news and information about the coronavirus pandemic, visit the WHO and CDC websites.

On Thursday, the UK approved for use molnupiravir from Merck and Ridgeback Biotherapeutics, the first antiviral pill authorized to fight the coronavirus.

Merck's pill now awaits US government approval. The drug giant says the pill can reduce the risk of hospitalization and death by 50%. And unlike another antiviral drug already approved by the Food and Drug Administration that requires careful monitoring and a needle, Merck says its COVID-19 medication can be taken orally at home to protect from severe illness and death. (Pfizer is seeking approval for its own antiviral pill.)

Vaccines can help manage the virus' spread and fend off its most dangerous strains. But if you do get COVID-19, you'll want ways to fight the infection, including the possibility of a pill you can take at home. That's the goal of Merck and Ridgeback Biotherapeutics in their development of the first antiviral pill to fight coronavirus.

In September, data from Johns Hopkins University showed that around 1 in 500 Americans have died from the coronavirus. While the available COVID-19 vaccines are highly effective, millions of Americans have not been vaccinated. According to a September report from the Centers for Disease Control and Prevention, unvaccinated people are over 10 times more likely to get hospitalized and die from the disease than fully vaccinated people.

Here's what we know about Merck's antiviral drug right now. We'll keep this story updated as more details emerge. For more on COVID-19, here's the latest on vaccine mandates, how to keep your vaccine card handy and what to do if you lose it.

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What is Merck's COVID-19 antiviral drug?

The approved COVID vaccines can protect you from infection. But if you are already infected, antiviral drugs can lessen the serious effects of the disease, reducing the risk of hospitalization and death.

Antiviral drugs won't replace the need for vaccines. Health officials see the two working side by side to keep infections in check: The vaccines prevent infection and lessen the severity of illness if you get infected. The antiviral can lessen the effects of the illness, regardless of vaccination status.

Merck isn't the only pharmaceutical company making an antiviral pill for COVID-19. But Merck's pill is farther along in the process and could become the first antiviral drug approved to be taken orally and taken at home with a prescription. (See below for more on other antiviral drugs.)

A study of molnupiravir slashed the risk of hospitalization or death by 50% when given to nonhospitalized adult patients who tested positive for COVID-19, according to Merck.

What is the UK authorization for the Merck antiviral pill?

On Thursday, the UK's Medicines and Healthcare products Regulatory Agency authorized Merck's antiviral pill for those with mild to moderate COVID-19 and at risk of developing severe illness. Risk factors include obesity, older age, diabetes mellitus or heart disease, the agency said.

The agency said that during the drug trials the oral drug was most effective when taken during the early stages of infection and recommends its use as soon as possible following a positive COVID-19 test, and within five days of symptoms.

When will the oral pill be available in the US?

The drug could be available by the end of 2021 if federal regulators don't turn up any problems, The New York Times reported

On Oct. 11, Merck applied for an emergency use authorization of its drug with the FDA. In anticipation of approval, Merck said it expects to produce 10 million courses by the end of 2021.

An FDA advisory committee is set to meet on Nov. 30 to consider the emergency use authorization.

Is it just one COVID antiviral pill or a bunch of them?

A course of the drug would require taking molnupiravir twice a day for five days.

Does swallowing a pill mean you don't need a COVID-19 vaccine?

Vaccines and antiviral drugs serve different purposes. A vaccine is intended to provide powerful protection to keep you from getting COVID-19. An antiviral drug helps your body fight a virus if you get infected.

"The vaccine is our first-line tool for preventing hospitalization," said Yale Medicine infectious diseases specialist Jaimie Meyer. "Some people might say, 'I'm not getting vaccinated because I'll have access to these medications,'" she said, "but you can't trade one for the other."

For example, chickenpox is a common virus that can be prevented in large part through vaccination. However, there are still cases of chickenpox that affect both vaccinated and unvaccinated people, and an antiviral medication may still be prescribed as a treatment. Taking that antiviral pill against the chickenpox won't stop you from erupting into blisters all over your body, running a high fever, itching like crazy or being contagious. It won't keep you from scarring, either. But it can help you recover a few days faster than you would have if you didn't take the medication. 

Will this antiviral treatment be free?

That is the plan. The US government has purchased 1.7 million courses of the drug to provide for free if and when it is approved, much as it does now with the three approved vaccines from Pfizer, Moderna and Johnson & Johnson. 

What do we know about eligibility for Merck's antiviral pill?

In its tests, Merck's molnupiravir pill was given to people who were unvaccinated and had tested positive with mild to moderate COVID-19 but were not hospitalized. 

According to The New York Times, the drug may be available at first to those who have tested positive and are at higher risk of serious illness. The FDA and CDC will have the final say about who will be eligible for the pill.

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Antiviral drugs will work side by side with vaccines.

Natalie Weinstein/CNET

What do we know about the COVID pill's side effects?

A Merck spokesperson said the incidence of drug-related side effects during the drug's trials was comparable between the group that received molnupiravir and the one that took the placebo -- 12% and 11%, respectively.

Which other antiviral COVID drugs are there?

According to a New York Times tracker, one other antiviral drug has so far been approved for COVID-19 treatment -- remdesivir from Gilead Sciences, which was approved in October 2020. The Times is tracking 32 other possible drugs in different stages of development and approval.

Unlike Merck's drug -- which you can get from a pharmacist and take orally at home -- remdesivir requires a health care professional to give you the medication intravenously, through a needle. One dose can take 30 to 120 minutes to administer, and the drug is given once a day for five to 10 days, depending on the number of doses required.

For more on COVID-19, here's the latest on COVID-19 vaccines for kids, what to know about mixing and matching vaccines and what is happening with booster shots.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.