Why Take PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)

PAXLOVID is authorized for emergency use

PAXLOVID has not been approved, but has been authorized for emergency use by the FDA under an EUA, for adults and children [12 years of age and older weighing at least 88 pounds (40 kg)] with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death; and
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

What is mild-to-moderate COVID-19?

Mild-to-moderate COVID-19 has symptoms (such as fever, cough, sore throat, and more) that generally can be treated at home
These symptoms usually occur within the first few days of illness
Many people recover without needing special treatment, but in some people, COVID-19 becomes severe, often days into their symptoms. This is more likely if you have a high-risk factor

What can happen with severe COVID-19?

If COVID-19 becomes severe, it can result in:

Hospitalization and intensive care

Needing a ventilator to receive enough oxygen

Death

Don’t just “wait and see” if your COVID-19 will get worse

If you have a high-risk factor and mild-to-moderate symptoms or test positive,
talk to your healthcare professional about PAXLOVID

How does PAXLOVID work?

When you’re infected with the COVID-19 virus, it starts to multiply inside your nose and throat
PAXLOVID works to stop the virus from multiplying and reduces the amount of it in your body

When taken within the first 5 days of symptoms,
PAXLOVID can help keep COVID-19 from becoming severe.

Keep reading to see how it worked in a clinical trial

PAXLOVID
Clinical Trial Results

A total of 2246 people from around the world participated in the PAXLOVID clinical trial.

All people who participated:

Tested positive for COVID-19
Were unvaccinated^*
Had mild-to-moderate symptoms for 5 days or fewer
Had certain high-risk factors for progression to severe COVID-19^†
Were at least 18 years old^‡

The study looked at whether PAXLOVID helped prevent hospitalization or death when compared to placebo.

PAXLOVID reduced the risk of COVID-19–related hospitalization or death by

86%

In a clinical trial vs placebo, 9 out of 1039 people who started treatment with PAXLOVID within 5 days of their first COVID-19 symptoms were hospitalized and none died.

For those who took a placebo, 66 out of 1046 people were hospitalized and 12 died (from any cause).

Studied with real-world people in mind

The study group included:

People from different races and ethnicities
A near equal number of male and female participants
People as young as 18^‡ and as old as 88

Everyone studied had at least one risk factor for progression to severe COVID-19. The most common risk factors among study participants included^†:

A body mass index (BMI) of 25 or more
Current cigarette smoking
Hypertension (high blood pressure)

Additionally, 61% of people in the study had two or more high-risk factors.

^*The authorized use of PAXLOVID isn’t limited to unvaccinated people, but all people who participated in the clinical trial were unvaccinated.

^†Participants all had at least one of these high-risk factors: diabetes, overweight (BMI >25), chronic lung disease (including asthma), chronic kidney disease, current smoker, a disease or treatment that causes a weakened immune system, heart disease, high blood pressure, sickle cell disease, neurodevelopmental disorders, active cancer, medically related technological dependence, or were 60 years of age and older. Based on the latest guidance, some of this high-risk inclusion criteria may differ from the CDC’s list of high-risk factors (ie, the CDC defines high risk as 50+). PAXLOVID is authorized for emergency use in patients at high risk for severe COVID-19 as defined by the CDC.

^‡While the clinical trial did not include people under the age of 18, PAXLOVID is authorized for children ages 12-17 who weigh at least 88 pounds (40 kg).

Why Take PAXLOVID

PAXLOVID is authorized for emergency use

Don’t just “wait and see” if your COVID-19 will get worse

If you have a high-risk factor and mild-to-moderate symptoms or test positive, talk to your healthcare professional about PAXLOVID

PAXLOVID Clinical Trial Results

A total of 2246 people from around the world participated in the PAXLOVID clinical trial.

PAXLOVID reduced the risk of COVID-19–related hospitalization or death by

Studied with real-world people in mind

AUTHORIZED USE

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If you have a high-risk factor and mild-to-moderate symptoms or test positive,
talk to your healthcare professional about PAXLOVID

PAXLOVID
Clinical Trial Results