The FDA Granted Emergency Use Authorization to the Pfizer COVID-19 Pill

The agency called the move "a major step forward in the fight against this global pandemic."

COVID-19 Pfizer pill , Directly above view of red pill on a blue colored background

Almost two years into a global pandemic, the world continues to contend with new highs and lows of the crisis. In the last month alone, the Omicron variant and a push for boosters have emerged. Now, the situation may take another turn (hopefully in the right direction) thanks to a new development. On Wednesday, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer's COVID-19 pill, Paxlovid.

This means that health care professionals will be able to prescribe the pill for the treatment of COVID-19 in specific circumstances. As a refresher "emergency use authorization" from the FDA isn't a full-fledged approval, but rather approval for use throughout an emergency (e.g. the COVID-19 pandemic) when there's no available alternative and under the condition that certain criteria are met. In the case of Paxlovid, the criteria includes that patients must be 12 or older, have positive test results for mild-to-moderate COVID-19 (i.e. are not severely or critically ill to the point they've already been hospitalized), and be at high risk for severe complications (meaning symptoms likely to require hospitalization or death).

Last month, Pfizer shared preliminary results on its experimental treatment for COVID-19. It noted that the drug cut the risk of hospitalization or death by 89 percent when given to high-risk adults within three days of their first symptoms or by 88 percent when taken within five days. On December 14, the company announced the final results from its analysis, noting that the aforementioned findings continued to hold.

The study of Paxlovid involved 2,246 unvaccinated volunteers at high risk of severe disease. Less than 1 percent (0.7 percent, to be exact) of patients who received Paxlovid were hospitalized within 28 days of entering the study and none died, according to the company. By comparison, 6.5 percent of patients who received a placebo were hospitalized or died.

In a separate, smaller analysis of 662 people with lower risk — some who were vaccinated with a risk factor for severe disease and others who were unvaccinated with no risk factors — Paxlovid reduced the odds of hospitalization and death by 70 percent, stated the company. (

The data supporting the drug's efficacy led the company to note in a December 14 news release that a Pfizer pill for COVID "could have a meaningful impact on the lives of many" if it is authorized or approved by the FDA. The drug is a combination of a new antiviral drug named nirmatrelvir and an existing medication called ritonavir. Nirmatrelvir inhibits an enzyme that allows COVID-19 to replicate itself, and ritonavir slows the body's metabolism of nirmatrelvir, allowing it to better take effect, according to the FDA.

As the pandemic continues to unfold, it's clear that treatments such as Paxlovid for COVID-19 could be helpful. "Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," stated Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in an update about Paxlovid's emergency use authorization. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19." (

As for how the Pfizer pills will work, it's packaged as a five-day course in which three pills are administered twice a day. Currently, Pfizer has produced enough of the medication for around 180,000 patients, but the company is aiming to produce 30 million pill packs by mid-2022, according to The Washington Post. The Biden Administration made advance purchases of 10 million treatment courses of Paxlovid, contingent upon the emergency use authorization that is now a reality. (

When it comes to its development of an antiviral for COVID-19, Pfizer isn't alone. Earlier this year, fellow pharmaceutical company, Merck, announced that its antiviral COVID-19 pill, also known as molnupiravir, reduced the risk of hospitalization or death by 50 percent with patients infected with the novel coronavirus, according to the results of a late-stage trial conducted with fellow pharmaceutical company Ridgeback Biotherapeutics. Today, the FDA announced that it's granted emergency use authorization to molnupiravir as well. (

While Paxlovid and molnupiravir have received a green light in the treatment of COVID-19, vaccines remain the ultimate form of prevention, so don't hesitate to get vaccinated — and boosted — whenever you're eligible.

The information in this story is accurate as of press time. As updates about coronavirus COVID-19 continue to evolve, it's possible that some information and recommendations in this story have changed since initial publication. We encourage you to check in regularly with resources such as the CDC, the WHO, and your local public health department for the most up-to-date data and recommendations.

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