1 EMERGENCY USE AUTHORIZATION
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of PAXLOVID for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate coronavirus disease 2019 (COVID-19) and who are at high riskDetermining whether a patient is at high risk for progression to severe COVID-19, including hospitalization or death, is based on the providers assessment of the individual patient being considered for treatment of COVID-19 and that patients medical history. For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. for progression to severe COVID-19, including hospitalization or death.
LIMITATIONS OF AUTHORIZED USE
PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19 [see Dosage and Administration (2.1)].Patients requiring hospitalization due to severe or critical COVID-19 after starting treatment with PAXLOVID may complete the full 5-day treatment course per the healthcare provider's discretion.
PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19 [see Clinical Studies (14.3)].
PAXLOVID is not authorized for use for longer than 5 consecutive days.
PAXLOVID may be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.
PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and
Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and non-prescribed) that the patient is taking to assess for potential drug interaction.
The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
Sufficient information is not available to assess renal and hepatic function.
Sufficient information is not available to assess for a potential drug interaction.
Modification of other medications is needed due to a potential drug interaction.
PAXLOVID is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under section 564(b)(1) of the Act, 21 U.S.C.
360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Justification for Emergency Use of Drugs During the COVID-19 Pandemic
There is currently an outbreak of COVID-19 caused by SARS-CoV-2, a novel coronavirus. The Secretary of Health and Human Services (HHS) has:
Determined that there is a public health emergency, or significant potential for a public health emergency.
See U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
360bbb-3. February 4, 2020; https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency. See also U.S. Department of Health and Human Services, Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
360bbb-3(b). March 15, 2023 (Amended Determination); https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-authorization-declaration.
Declared that circumstances exist justifying the authorization of emergency use of drugs and biological products for the prevention or treatment of COVID-19.
See U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
360bbb-3, 85 FR 18250 (April 1, 2020); https://www.federalregister.gov/documents/2020/04/01/2020-06905/emergency-use-authorization-declaration. See also Amended Determination (The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act.).
An EUA is a U.S. Food and Drug Administration authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include:
The biological agent(s) can cause a serious or life-threatening disease or condition;
Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that
othe product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and
othe known and potential benefits of the productwhen used to diagnose, prevent, or treat such disease or conditionoutweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s);
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition.
Information Regarding Approved Alternatives for the EUA Authorized Use This section only describes the uses for which an FDA-approved drug is considered to be an alternative to PAXLOVID. For additional information, including the full indications for the FDA-approved drugs referenced within this section, please refer to the relevant Prescribing Information at: Drugs@FDA: FDA-Approved Drugs. As stated in the Letter of Authorization, the emergency use of PAXLOVID must be consistent with the terms and conditions of its authorization.
PAXLOVID is FDA-approved for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Although different presentations of PAXLOVID are now FDA-approved for the treatment of mild-to-moderate COVID-19 in certain adults, there are not currently sufficient supplies of the approved PAXLOVID available for distribution to this patient population in its entirety; therefore, this EUA continues to authorize the emergency use of PAXLOVID See the Letter of Authorization and section 16 (HOW SUPPLIED/STORAGE AND HANDLING) in this Fact Sheet for the specific presentations of PAXLOVID authorized under this EUA.
for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death, at this time. Apart from this paragraph, all references to the term PAXLOVID in this Fact Sheet refer to product that is labelled in accordance with this EUA.
Veklury (remdesivir) is an FDA-approved alternative to PAXLOVID when used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days. Although Veklury is an FDA-approved alternative to PAXLOVID as described above, FDA does not consider Veklury to be an adequate alternative to PAXLOVID for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires an intravenous infusion daily for 3 days).
Other therapeutics are currently authorized for the same use as PAXLOVID. For additional information on all products authorized for treatment or prevention of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
For information on clinical studies that are testing the use of PAXLOVID in COVID-19, please see www.clinicaltrials.gov.