1 Revised: 03/2024
FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS
EMERGENCY USE AUTHORIZATION (EUA) OF PAXLOVID
FOR CORONAVIRUS DISEASE 2019 (COVID-19)
You are being given this Fact Sheet because your healthcare provider believes it is
necessary to provide you with PAXLOVID for the treatment of mild-to-moderate
coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus. This Fact Sheet
contains information to help you understand the risks and benefits of taking the
PAXLOVID you may receive. This Fact Sheet also contains information about how to
take PAXLOVID and how to report side effects or problems with the appearance or
packaging of PAXLOVID.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to make PAXLOVID available for the treatment of mild-to-moderate
COVID-19 in children 12 years of age and older weighing at least 88 pounds (40 kg)
who are at high risk for progression to severe COVID-19, including hospitalization or
death (for more details about an EUA please see “What is an Emergency Use
Authorization?” at the end of this document). Read this Fact Sheet for information
about PAXLOVID. Talk to your healthcare provider about your options or if you have
any questions. It is your choice to take PAXLOVID.
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus. You can get COVID-19 through
close contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild to severe, including illness resulting in
death. While information so far suggests that most COVID-19 illness is mild, serious
illness can happen and may cause some of your other medical conditions to become
worse. Older people and people of all ages with severe, long lasting (chronic) medical
conditions like heart disease, lung disease, and diabetes, for example seem to be at
higher risk of being hospitalized for COVID-19.
What is PAXLOVID?
PAXLOVID is a medicine that is available under EUA for the treatment of
mild-to-moderate COVID-19 in children 12 years of age and older weighing at least 88
pounds (40 kg) who are at high risk for progression to severe COVID-19, including
hospitalization or death.
PAXLOVID is FDA-approved for the treatment of COVID-19 in certain adults (see
section What other treatment choices are there?).
PAXLOVID is not FDA-approved or available under EUA for use in children younger
than 12 years of age or weighing less than 88 pounds (40 kg).
There is limited information about the safety and effectiveness of using PAXLOVID to
treat children younger than 12 years of age or weighing less than 88 pounds (40 kg)
with mild-to-moderate COVID-19.