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Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment 

of COVID-19

Click to jump to each section 

1) Questions related to Paxlovid’s approval or EUA

2) Efficacy and Safety Considerations

3) Provider Considerations when Prescribing Paxlovid

4) Questions for Pharmacist Prescribers

5) General EUA-related questions

 
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Questions related to Paxlovid’s approval or EUA 

 

Q. Now that Paxlovid is FDA-approved, what does the EUA for Paxlovid authorize?

A. On May 25, 2023, FDA approved a New Drug Application (NDA) for Paxlovid for the treatment of mildto-moderate coronavirus disease (COVID-19) in adults who are at high risk for progression to severe 

COVID-19, including hospitalization or death. FDA has determined that Paxlovid is safe and effective 

when used in accordance with the FDA-approved labeling.

On October 30, 2023, Pfizer announced that Paxlovid labeled and packaged in accordance with the 

approved New Drug Application 217188 (NDA-labeled Paxlovid) will be available beginning November 1, 

2023. The Administration for Strategic Preparedness and Response in the U.S. Department of Health and 

Human Services has also announced its transition from and winding down of the U.S. government’s 

distribution of Paxlovid that is labeled and packaged in accordance with the Emergency Use 

Authorization (EUA-labeled Paxlovid). For more information, please refer to the COVID-19 treatments 

transition operational guide. 

To facilitate this transition, on November 1, 2023, FDA revised the EUA for Paxlovid to authorize NDAlabeled Paxlovid for the treatment of mild-to-moderate COVID-19 in 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. 

To ensure continued patient access to Paxlovid during this transition, the EUA for Paxlovid continues to 

authorize EUA-labeled Paxlovid for the treatment of 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. 

Thus, during the period of transition, either NDA-labeled Paxlovid or EUA-labeled Paxlovid can be used 

for the treatment of both adults and adolescents consistent with the approved and authorized labeling 

as appropriate. 

Q. Does the EUA-labeled Paxlovid provide the same clinical benefit as the NDA-labeled Paxlovid?

A. Yes. EUA-labeled Paxlovid contains the same medication (nirmatrelvir tablets and ritonavir tablets) as 

the NDA-labeled Paxlovid. Since Paxlovid was initially authorized for emergency use, Pfizer has been 

required, as a condition under the EUA, to comply with the same good manufacturing practices that 

apply to approved products. 

Based on these considerations, it is FDA’s expectation that patients being treated for COVID-19 with 

either EUA-labeled Paxlovid or NDA-labeled Paxlovid, will receive the same clinical benefit as long as the 

product is used in accordance with the labeling. 

Q. What are the differences between EUA-labeled Paxlovid and NDA-approved Paxlovid? 

A. There are certain differences in the design of the carton packaging and the blister cards containing 

the nirmatrelvir and ritonavir tablets. It is important that patients recognize which presentation they 

have received. For more information, please see the HCP and Patient Dosing Cards.
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Q. Can adolescents still receive Paxlovid?

A. The EUA authorizes the use of Paxlovid for the treatment of mild-to-moderate COVID-19 in 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. 

Under the EUA, either EUA-labeled Paxlovid or NDA-labeled Paxlovid may be dispensed for this use. This 

is to ensure continued patient access to Paxlovid as the U.S. government transitions from and winds 

down the distribution of EUA-labeled Paxlovid. For more information on this transition, please refer to 

the COVID-19 treatments transition operational guide. 

Q. Why does the EUA still authorize Paxlovid for the treatment of certain adults with COVID-19? 

A. The EUA authorizes the use of EUA-labeled Paxlovid 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. 

Either EUA-labeled Paxlovid or NDA- labeled Paxlovid may be dispensed for this use. This is to ensure

continued patient access to Paxlovid as the U.S. government transitions from and winds down the 

distribution of EUA-labeled Paxlovid For more information on this transition, please refer to the COVID19 treatments transition operational guide. 

Q. What is the contact information if I have questions about “compassionate use” or expanded access 

for Paxlovid? 

A. Health care providers seeking to obtain Paxlovid under expanded access should first contact Pfizer 

through its website. 

Once Pfizer has provided the requisite authorization, health care providers should submit an emergency 

IND (EIND) request to FDA which can be done multiple ways. An electronic application that can be 

completed on a phone or computer allows for submission of an EIND to FDA at any time. This eRequest 

application can be found on the Reagan-Udall Foundation for the FDA website. EIND requests may also 

be submitted to FDA using the information detailed below:

• During normal business hours (8:00 a.m. – 4:30 p.m. ET, weekdays): 

o By phone – (301) 796-3400 or (855) 543-3784 

o By email – DDI.EIND@fda.hhs.gov 

• Outside of normal business hours (After 4:30 p.m. ET weekdays and all day on 

weekends/federal holidays) 

o By phone – (301) 796-9900 

o By email – CDER-EIND@fda.hhs.gov 

General information on expanded access for providers and patients, respectively, can be found on FDA’s 

website. 

Q. Paxlovid is approved and authorized only for certain patients at “high risk”. What does “high risk”

mean?

A. Determining whether a patient is at high risk for progression to severe COVID-19, including 

hospitalization or death, is based on the provider’s assessment of the individual patient being 

considered for treatment with COVID-19 and that patient’s medical history. 
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Resources providing information on conditions that place a patient with mild-to-moderate COVID-19 at 

high risk for disease progression, including hospitalization or death, can be found at the Centers for 

Disease Control and Prevention site: Underlying Medical Conditions Associated with Higher Risk for 

Severe COVID-19: Information for Healthcare Professionals and at NIH’s COVID-19 Treatment 

Guidelines: Clinical Spectrum of SARS-CoV-2 Infection. 

Q. Why is pediatric use not approved for Paxlovid and only authorized under the EUA? 

A. The clinical development of Paxlovid for pediatric use is ongoing.

Q. How can Paxlovid be obtained?

A. For questions on how to obtain EUA-labeled Paxlovid, please contact COVID19therapeutics@hhs.gov.

For questions on how to obtain NDA-labeled Paxlovid, please visit the Pfizer website.

Efficacy and Safety Considerations 

 

Q. Are there data showing the benefit of Paxlovid for treatment of mild-to-moderate COVID-19 for 

certain patients?

A. Yes. The primary data supporting the approval as well as the EUA for Paxlovid are from EPIC-HR, a 

randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of nonhospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection. Patients 

were adults 18 years of age and older with a prespecified risk factor for progression to severe disease or 

were 60 years and older regardless of prespecified chronic medical conditions. All patients had not

received a COVID-19 vaccine and had not been previously infected with COVID-19. The main outcome 

measured in the trial was the proportion of people who were hospitalized due to COVID-19 or died due 

to any cause during 28 days of follow-up. Paxlovid significantly reduced the proportion of people with 

COVID-19 related hospitalization or death from any cause through 28 days of follow-up by 86% 

compared to placebo among patients treated within five days of symptom onset and who did not 

receive COVID-19 therapeutic monoclonal antibody treatment. 

In this analysis, 977 patients received Paxlovid, and 989 patients received placebo, and among these 

patients, 0.9% who received Paxlovid were hospitalized due to COVID-19 or died from any cause during 

28 days of follow-up compared to 6.5% of the patients who received placebo. Of the people who 

received Paxlovid, no patients died through 24 weeks after receipt compared to 15 people who received 

placebo. 

Details on the clinical trial results can be found in Section 14 of the authorized Fact Sheet for Health Care 

Providers and approved Prescribing Information. 

Q. Are there data supporting the benefit of Paxlovid for high-risk patients with mild-moderate COVID19 regardless of prior/acquired immunity? 

A. Benefit of Paxlovid was observed in patients with prior immunity to the virus that causes COVID-19. 

Among patients in EPIC-HR who were antibody positive at trial enrollment, the risk of COVID-19-related 

hospitalization or death from any cause during 28 days of follow-up was 0.2% among those treated with 

Paxlovid compared with 1.7% of those receiving placebo. EPIC-SR was another clinical trial that enrolled 

vaccinated patients with at least one risk factor for progression to severe COVID-19. Among these 

vaccinated patients, there was a reduction in the risk of COVID-19 related hospitalization or death from 

any cause with use of PAXLOVID versus placebo, although not statistically significant.
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Q. Does Paxlovid retain activity against currently circulating Omicron variants?

A. Yes. Based on virology data, Paxlovid retains activity against currently circulating Omicron variants. 

Q. Does Paxlovid cause COVID-19 rebound?

A. EPIC-HR, described above, and EPIC-SR, another trial that enrolled vaccinated patients with at least 

one risk factor for progression to severe COVID-19 or unvaccinated patients with no risk factors for 

progression to severe COVID-19, were both randomized placebo-controlled trials. These trials provide 

useful data to assess COVID-19 rebound. Data from these two trials showed that rebound in SARS-CoV-2 

(RNA or virus) shedding or self-reported COVID-19 symptoms occurred in a subset of patients and 

happened at similar rates in both the patients receiving Paxlovid and placebo. Based on the data 

currently available to FDA, there is not a clear association between Paxlovid treatment and COVID-19 

rebound.

Q. Are there potential side effects of Paxlovid? 

A. Yes. Paxlovid consists of nirmatrelvir and ritonavir, and ritonavir interacts with many other medicines, 

which may lead to serious or life-threatening adverse reactions. Patients should tell their health care 

providers all of the medicines they are taking, including over-the-counter medications and herbal 

supplements, when deciding whether to take Paxlovid.

Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the 

approved Prescribing Information and authorized Fact Sheet for Health Care Providers for the Paxlovid 

EUA include a boxed warning with instructions for providers to review all medications taken by the 

patient to assess for potential drug-drug interactions and determine if other medicines that a patient 

may be taking require a dose adjustment, interruption and/or additional monitoring.

The most common side effects of taking Paxlovid include impaired sense of taste (for example, a 

metallic taste in the mouth) and diarrhea.

Liver problems have occurred in patients receiving ritonavir. Therefore, caution should be exercised 

when administering Paxlovid to patients with pre-existing liver diseases, liver enzyme abnormalities, or 

hepatitis. Patients should talk with their health care provider if they have a history of liver problems. 

Paxlovid is not recommended for patients with severe kidney problems, and a different dose is needed 

for patients with moderate kidney problems. Patients should talk with their health care provider if they 

have a history of kidney problems. 

See Warnings and Precautions in the FDA-approved Prescribing Information and the Fact Sheet for 

Health Care Providers for additional information on risks associated with Paxlovid. 

Q. Why was a boxed warning included in the Paxlovid prescribing information?

A. Paxlovid includes ritonavir, a strong CYP3A inhibitor, which may lead to greater exposure of certain 

other medications the patient may be taking, resulting in potentially severe, life-threatening, or fatal 

events due to drug-drug interactions. Such interactions can be avoided by appropriate handling of the 

patient’s other medications when starting treatment with Paxlovid or, in some situations when 

adjustments of the patient’s other medication may not be feasible, choosing an alternative COVID-19 

treatment for the individual patient. Since the authorization of Paxlovid under EUA, FDA has reviewed 

new data related to the risk of drug-drug interactions. These data were discussed by FDA during the 

recent Antimicrobial Drugs Advisory Committee on March 16, 2023.
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• FDA identified more than 250 cases of serious adverse events assessed as possibly or probably 

related to Paxlovid drug-drug interactions. Many of these cases reported hospitalization, and a 

fatal outcome was reported in a few cases. 

• From an updated analysis cumulatively through October 4, 2023, FDA identified more 

than 400 cases of serious adverse events assessed as possibly or probably related to 

Paxlovid drug-drug interactions.

• FDA determined that greater than 50% of Paxlovid-eligible Medicare and VA patients were taking 

medications that were identified as having a drug-drug interaction with Paxlovid. FDA noted that 

most of these potential drug-drug interactions could be prevented or managed with dose 

modification, interruption, and/or additional monitoring. 

• FDA determined that most Paxlovid prescriptions were written by a broad range of health care 

providers, who may not be familiar with managing potential drug-drug interactions associated 

with ritonavir, which is more commonly prescribed by infectious disease physicians and other 

specialists who may have more experience managing ritonavir drug-drug interactions. 

Drug-drug interactions are not unique to Paxlovid and are almost always manageable risks. Prior to 

prescribing Paxlovid, health care providers must: 1) review all medications taken by the patient to assess 

potential drug-drug interactions with a strong CYP3A inhibitor like Paxlovid and 2) determine if 

medications require a dose adjustment, interruption, and/or additional monitoring if taken at the same 

time as Paxlovid. 

There are resources for health care providers to identify and manage potential drug-drug interactions 

with Paxlovid. These include: the approved prescribing information, the Fact Sheet for Health Care 

Providers and the Prescriber Patient Eligibility Screening Checklist available on the FDA EUA webpage. 

Other resources include: the NIH COVID-19 Treatment Guidelines, the IDSA COVID-19 Treatment 

Guidelines and the University of Liverpool COVID-19 Drug Interactions online checker. 

 

Provider Considerations When Prescribing Paxlovid 

Q. When should Paxlovid be administered to a patient?

A. Patients should talk to their health care provider to determine whether, based on their individual 

circumstances, they are eligible to receive Paxlovid. Paxlovid treatment should be initiated as soon as 

possible after diagnosis of COVID-19, even if symptoms are mild, and within five days after symptoms 

start. 

More information about administration is available in the in the FDA-approved Prescribing Information

and the Fact Sheet for Health Care Providers. 

Q. Is a positive result from a direct SARS-CoV-2 viral test required prior to prescribing Paxlovid to a 

patient who is at high risk for severe COVID-19? 

A. No. FDA recognizes that, in rare instances, individuals with a recent known exposure (e.g., a 

household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by 

their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test 

result. In such instances, their health care provider may determine that treatment with Paxlovid for 

COVID-19 is appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at highrisk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions 
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of the authorization are met, as detailed in the Letter of Authorization for Paxlovid and the authorized

Fact Sheet for Healthcare Providers. 

The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose 

COVID-19. 

 

Q. What if I have questions about the expiration date on the Paxlovid carton or container? 

A. FDA has authorized an extension to the expiration date (shelf-life) for certain lots of Paxlovid. To find 

the extended expiration date, enter the lot number found on the side of the carton or bottom of the

blister pack at this website or talk with the pharmacist or provider.

Information on the authorized shelf-life extensions for Paxlovid may also be found on FDA’s website. 

 

Questions for pharmacist prescribers 

Q. Are pharmacists permitted to prescribe Paxlovid?

A. In addition to any health care provider licensed or authorized under state1 law to prescribe drugs, 

PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist 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, in accordance with the FDA-approved Prescribing Information or authorized 

labeling subject to 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

The EUA does not place any limitation on the presentation of Paxlovid to be dispensed (EUA-labeled 

Paxlovid or NDA-labeled Paxlovid) when pharmacist prescribing is consistent with the conditions above. 

1

 The term “State” includes any State or Territory of the United States, the District of Columbia, and the 

Commonwealth of Puerto Rico. See Section 201(a)(1) of the Act. 
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Q. What do state-licensed pharmacist prescribers need to do to determine whether a patient may be 

eligible to receive Paxlovid? 

A. State-licensed pharmacist prescribers have the same requirements as all other prescribers to assess 

an adult or pediatric patient (12 years of age and older weighing at least 40 kg), who is being considered 

for treatment with Paxlovid, to determine that they have a diagnosis of mild-to-moderate COVID-19 and 

are at high risk for progression to severe COVID-19, including hospitalization or death. 

A review of reported symptoms should be completed to determine that patients have signs and 

symptoms consistent with mild-to-moderate COVID-19, and not severe COVID-19. Patients reporting 

shortness of breath or difficulty breathing should be immediately referred for further medical 

assessment to determine whether their illness has progressed to the severe stage, which may require 

hospitalization. Paxlovid is not authorized or approved for the treatment of severe COVID-19. 

Definitions for mild and moderate illness are provided in NIH’s COVID-19 Treatment Guidelines: Clinical 

Spectrum of SARS-CoV-2 Infection.

State-licensed pharmacist prescribers may determine whether an individual patient is at high risk for 

severe COVID-19 by obtaining a medical history from the patient or by accessing the patient’s medical 

records. Resources about conditions that place a patient with mild-to-moderate COVID-19 at increased 

risk for disease progression or death can be found at the Centers for Disease Control and Prevention 

site: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for 

Healthcare Professionals and at NIH’s COVID-19 Treatment Guidelines: Clinical Spectrum of SARS-CoV-2 

Infection.

Q. How do state-licensed pharmacist prescribers assess for potential drug interactions?

A. All prescribers are expected to utilize available health records or patient history to obtain a complete 

list of all medications (prescribed and non-prescribed) that the patient is taking. State-licensed 

pharmacists may also consult with a health care provider in an established provider-patient relationship 

with the individual patient to obtain a comprehensive list of medications the patient is taking. Resources 

to identify potential drug interactions include the approved Prescribing Information, the Fact Sheet for 

Health Care Providers and the Prescriber Patient Eligibility Screening Checklist available on the FDA EUA 

webpage. Other resources include: the NIH COVID-19 Treatment Guidelines, the IDSA COVID-19 

Treatment Guidelines and the University of Liverpool COVID-19 Drug Interactions. 

Should an adjustment to another medication be needed due to a potential drug interaction, the statelicensed pharmacist should refer the individual patient for clinical evaluation with a physician, advanced 

practice registered nurse, or physician assistant licensed or authorized under state law to prescribe 

drugs.

Q. How do state-licensed pharmacist prescribers assess renal and hepatic function? 

A. State-licensed pharmacist prescribers must have access to sufficient information from health records 

to assess renal and hepatic function. Health records include access to an electronic health record system 

containing this information in progress notes or laboratory records, reviewing a printed health record 

such as a laboratory report provided by the patient, or reviewing information in electronic health 

records the patient may have access to through a phone app or other means. Health records within the 

past 12 months are generally acceptable, provided there is no patient self-report or other information 
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suggestive of kidney or liver disease. State-licensed pharmacists may also consult with a health care 

provider in an established provider-patient relationship with the individual patient to obtain this 

information. If sufficient information is not available to assess renal and hepatic function, the statelicensed pharmacist should refer the individual patient to a physician, advanced practice registered 

nurse, or physician assistant licensed or authorized under state law to prescribe drugs. 

Physicians, advanced practice registered nurses, and physician assistants may rely on patient history and 

access to the patient’s health records to make an assessment regarding the likelihood of renal 

impairment. These providers may consider ordering a serum creatinine or calculating the estimated 

glomerular filtration rate (eGFR) for certain patients after assessment on a case-by-case basis.

Q. Will state-licensed pharmacists be able to prescribe both the standard and renal doses of 

Paxlovid? 

A. Yes, the EUA authorizes state-licensed pharmacists to prescribe both the standard and renal doses of 

Paxlovid, subject to the terms and conditions on pharmacist prescribing as detailed in the EUA, provided 

the pharmacist has adequate information to assess renal function and the patient is otherwise eligible to 

receive Paxlovid.

General EUA-related questions 

Q. What is an emergency use authorization (EUA)?

A. Under section 564 of the Federal Food, Drug & Cosmetic Act, after a declaration by the HHS Secretary 

based on one of four types of determinations, FDA may authorize an unapproved product or 

unapproved uses of an approved product for emergency use. In issuing an EUA, FDA must determine, 

among other things, that based on the totality of scientific evidence available to the agency, including 

data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the 

product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or 

condition caused by a chemical, biological, radiological, or nuclear agent; that the known and potential 

benefits of the product, when used to treat, diagnose or prevent such disease or condition, outweigh 

the known and potential risks of the product; and that there are no adequate, approved, and available 

alternatives. Emergency use authorization is NOT the same as FDA approval or licensure.

Q. Are there reporting requirements for health care facilities and providers as part of the EUA (when 

Paxlovid is for emergency use as described in the Letter of Authorization)? 

A. Yes. As a condition on the emergency use of Paxlovid (see section II “Scope of Authorization” in the 

LOA for Paxlovid) , FDA requires health care providers who prescribe Paxlovid to report all medication 

errors and serious adverse events considered to be potentially related to Paxlovid through FDA’s 

MedWatch Adverse Event Reporting program. Providers can complete and submit the report online; or 

download and complete the form, then submit it via fax at 1-800-FDA-0178. This requirement is outlined 

in the EUA’s Fact Sheet for Health Care Providers. FDA MedWatch forms should also be provided to 

Pfizer. 

Health care facilities and providers must report therapeutics information and utilization data as directed 

by the U.S. Department of Health and Human Services. 

Q. Do patient outcomes need to be reported under the EUA? 

A. No, reporting of patient outcomes is not required under the EUA. However, reporting of all 
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medication errors and serious adverse events considered to be potentially related to Paxlovid occurring 

during treatment is required. 

Q. FDA has issued a number of EUAs including for therapeutics. If state laws impose different or 

additional requirements on the medical product covered by an EUA, are those state laws preempted?

A. As stated in FDA’s Emergency Use Authorization of Medical Products and Related Authorities 

Guidance, “FDA believes that the terms and conditions of an EUA issued under section 564 preempt 

state or local law, both legislative requirements and common-law duties, that impose different or 

additional requirements on the medical product for which the EUA was issued in the context of the 

emergency declared under section 564.” The guidance explains the basis for FDA’s views on this subject. 

Q. Can health care providers share the patient/caregiver Fact Sheet electronically?

A. Under the authorization, Pfizer must make available the authorized Fact Sheets on its website at: 

www.COVID19oralRX.com. Health care facilities and health care providers must ensure that fact sheets 

are made available to patients, parents, and caregivers through “appropriate means” and electronic 

delivery of the Fact Sheet is an appropriate means.