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COVID pill update: Pfizer seeks emergency FDA approval as US buys 10M courses

Pfizer's oral antiviral drug may reduce the risk of hospitalization or death by 89%, according to early tests.


Pfizer has asked for emergency use authorization for its COVID-19 antiviral pill.

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Saying Pfizer's COVID-19 antiviral pill "could prove to be another critical tool in our arsenal that will accelerate our path out of the pandemic," President Joe Biden today said his administration has purchased 10 million courses of the Pfizer oral drug. The announcement comes two days after the drug-maker asked the Food and Drug Administration to authorize the pill for emergency use.

Pfizer said its oral drug could cut the risk of hospitalization or death from COVID by 89%, according to data from clinical trials. Called Paxlovid, Pfizer's pill would be taken orally to fight the severe symptoms. Currently, the only antiviral medication authorized in the US requires a health care professional to administer the medication intravenously, through a needle, over five to 10 days. An easy-to-take pill could become part of a growing toolkit that doctors could use to fight COVID, which already includes the three COVID vaccines authorized for use in the US. Merck also has an antiviral drug in the works it is seeking FDA approval for.

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 Pfizer's antiviral pill. We'll update this story as more details emerge. For more on COVID-19, here's the latest on vaccine mandates, keeping your vaccine card handy and this year's flu season.

What is Pfizer's COVID-19 antiviral drug?

In the US, the three approved COVID vaccines from Moderna, Pfizer and Johnson & Johnson can protect you from infection. But for those already infected, antiviral drugs could reduce the chance of serious illness and reduce the risk of hospitalization and death.

If approved, Pfizer's drug won't replace the need for vaccines. Health officials see the vaccines and antiviral drugs working in tandem to tame the pandemic: Vaccines can prevent infection and lessen the severity of illness if you get infected. Antiviral drugs can lessen the effects of the illness, including for those unvaccinated.

In clinical trials, Paxlovid -- taken in combination with ritonavir, a drug used to treat HIV -- reduced the risk of hospitalization or death by 89% when taken three days of symptoms for those who are at a higher risk of serious infection, Pfizer said. 

During its clinical trials, Pfizer said, reported side effects between those taking the antiviral drug and those taking the placebo were about the same.

How many courses of the COVID drug is the US government buying?

Pfizer said the Biden administration has purchased enough of the antiviral drug for 10 million treatment courses. A treatment course runs five days. See below for more.

Pfizer said it will begin delivering the first doses of the drug to the government later this year and continue through 2022. In a statement, Biden said his administration is working to make sure the treatments "will be easily accessible and free."

Will the FDA authorize Pfizer's drug?

Pfizer on Tuesday asked the FDA for emergency use authorization for its antiviral drug. The New York Times reported Pfizer is seeking authorization right now just for use with unvaccinated people.

How does it compare with molnupiravir, Merck's COVID pill?

Merck applied for an emergency use authorization of its antiviral pill with the FDA in mid-October. 

Merck has said its pill -- also intended to be taken orally at home -- can reduce the risk of hospitalization and death by 50% if taken within five days of the onset of symptoms for people who have tested positive and are at higher risk of serious illness. 

An FDA advisory committee plans to meet at the end of November to consider Merck's emergency use application for molnupiravir.

When could Pfizer's antiviral pill be available in the US?

The New York Times reported that Pfizer's pill could be available in a few weeks, if approved by the FDA.

What would be Pfizer's treatment course for its antiviral pill?

During Pfizer's tests on the drug, patients took the pill orally every 12 hours for five days.

Will Pfizer's drug be free?

Biden in a statement said the antiviral treatments will be "easily accessible and free" with his administration's purchase of 10 million treatment courses. Separately, the US government is purchasing 1.7 million courses of Merck's antiviral drug to provide if and when it is approved by the FDA.

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.