January 29, 2024 

Pfizer, Inc. 

Attention: Karen Baker 

Director, Global Regulatory Affairs 

235 East 42nd Street 

New York, NY 10017-5755 

RE: Emergency Use Authorization 105 

Dear Ms. Baker: 

This letter is in response to Pfizer, Inc.’s (Pfizer) request that the Food and Drug Administration 

(FDA or Agency) issue an Emergency Use Authorization (EUA) for the emergency use of 

PAXLOVID (nirmatrelvir co-packaged with ritonavir) for the treatment of mild-to-moderate 

coronavirus disease 2019 (COVID-19) in certain adults and pediatric patients pursuant to Section 

564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). 

On February 4, 2020, as amended on March 15, 2023, pursuant to Section 564(b)(1)(C) of the 

Act, the Secretary of the Department of Health and Human Services (HHS) determined that there 

is a public health emergency, or a significant potential for a public health emergency, that has a 

significant potential to affect national security or the health and security of United States citizens 

living abroad, and that involves the virus that causes coronavirus disease 2019 (COVID-19).1

 On 

the basis of such determination, the Secretary of HHS on March 27, 2020, declared that 

circumstances exist justifying the authorization of emergency use of drugs and biological 

products during the COVID-19 pandemic, pursuant to Section 564 of the Act (21 U.S.C. 360bbb3), subject to terms of any authorization issued under that section.2 

On December 22, 2021, the FDA issued an EUA for emergency use of PAXLOVID for the 

treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and 

1

 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; 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. 88 FR 

16644 (March 20, 2023) (“Amended Determination”). 

2

 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). See 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.”). 
 

 

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older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who 

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

time, PAXLOVID was not FDA-approved for any indication. 

PAXLOVID is comprised of nirmatrelvir, a SARS-CoV-2 main protease inhibitor (Mpro: also 

referred to as 3CLpro or nsp5 protease), co-packaged with ritonavir, an HIV-1 protease inhibitor 

and CYP3A inhibitor. Ritonavir, which has no activity against SARS-CoV-2 on its own, is 

included to inhibit the CYP3A-mediated metabolism of nirmatrelvir and consequently increase 

nirmatrelvir plasma concentrations to levels anticipated to inhibit SARS-CoV-2 replication. 

FDA subsequently reissued the Letter of Authorization (LOA) on March 17, 20223

, April 14, 

20224, July 6, 20225, August 5, 20226, October 27, 20227, February 1, 20238, May 25, 20239, and 

November 1, 202310. 

3 In its March 17, 2022 revision, FDA revised the LOA to add a new condition of authorization regarding 

registration and listing. Condition H in the LOA was also revised to require Pfizer to recall distributed product, upon 

request by FDA, in the event a significant quality problem is identified that impacts already distributed PAXLOVID. 4

 In its April 14, 2022 revision, FDA revised the LOA to authorize an additional dose pack presentation of 

PAXLOVID with appropriate dosing for patients within the scope of this authorization with moderate renal 

impairment. Corresponding revisions were also incorporated into the “How Supplied” section of the Fact Sheet for 

Healthcare Providers. 

5

 In its July 6, 2022 revision, FDA authorized state-licensed pharmacists to prescribe PAXLOVID subject to certain 

conditions detailed in Section II (Scope of Authorization) of this LOA. Corresponding revisions were also 

incorporated into the Fact Sheet for Healthcare Providers. Updates were also incorporated to certain postauthorization requirements detailed in Condition O of this letter. 

6

 In its August 5, 2022 revision, FDA revised the LOA to add new post-authorization requirements in Condition O 

of this letter for Pfizer to conduct a clinical trial in patients with “COVID-19 rebound” and a clinical trial evaluating 

different durations of treatment in immunocompromised patients with mild-to-moderate COVID-19. The Fact Sheet 

for Patients, Parents, and Caregivers was also revised to include additional clarifying information on how to take 

PAXLOVID, which included pictures of packaging and tablets for both dosing presentations. 7

 In its October 27, 2022 revision, FDA incorporated clarifying revisions to Condition X of this letter. Condition W 

was also revised to require that all printed matter, advertising and promotional materials relating to the use of 

PAXLOVID under this authorization be submitted to FDA for consideration at least 14 calendar days prior to initial 

dissemination or first use. 

8

 In its February 1, 2023 revision, FDA revised the scope of authorization to no longer require positive results of 

direct SARS-CoV-2 viral testing. As revised, the scope of authorization required, in addition to other requirements, 

that adults and pediatric patients (12 years of age and older weighing at least 40 kg) have a current diagnosis of 

mild-to-moderate COVID-19. Corresponding changes were also made to the authorized Fact Sheets. Condition O in 

this letter was also revised based on the completion of a post-authorization requirement. The Fact Sheet for 

Healthcare Providers was also revised to reflect the current indication for Veklury, an approved alternative to 

Paxlovid, and to include new information on drug-drug interactions. 9 In its May 25, 2023 revision, FDA revised condition L on the monitoring and analysis of SARS-CoV-2 variants, 

and to remove certain post-authorization requirements from this LOA that are adequately addressed as post-market 

requirements or post-market commitments associated with the approval of NDA 217188. Corresponding revisions, 

when appropriate, were incorporated into the authorized Fact Sheets. The authorized Fact Sheet for Healthcare 

Providers was also revised to include a boxed warning on the identification of and assessment for drug-drug 

interactions with PAXLOVID. Relevant information on drug-drug interactions was also incorporated in the Fact 

Sheet for Patients, Parents and Caregivers.

10 In its November 1, 2023 revision, FDA revised the scope of authorization to no longer require the distribution of 

PAXLOVID under this EUA to be directed by the United States Government. The scope of authorization was also 

revised to authorize the emergency use of PAXLOVID labeled and packaged in accordance with NDA 217188 for 

the treatment of mild-to-moderate COVID-19 in certain pediatric patients. Corresponding revisions were also 
 

 

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On May 25, 2023, FDA approved NDA 217188 for PAXLOVID, which is indicated 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. 

On January 29, 2024, having concluded that revising this EUA is appropriate to protect the 

public health or safety under Section 564(g)(2) of the Act, FDA is reissuing the November 1, 

2023 letter in its entirety, to include information in the Product Description section of this letter 

on the timing for when PAXLOVID described in “Category A” will no longer be authorized for 

emergency use. 

Based on the totality of scientific evidence available to FDA, including data from the clinical 

trial EPIC-HR (NCT04960202), a Phase 2/3 randomized, double blind, placebo-controlled 

clinical trial, it is reasonable to believe that PAXLOVID may be effective for the treatment of 

mild-to-moderate COVID-19, as described in the Scope of Authorization (Section II), and when 

used under the conditions described in this authorization, the known and potential benefits of 

PAXLOVID outweigh the known and potential risks of such product. 

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the 

Act are met, I am authorizing the emergency use of PAXLOVID for the treatment of mild-tomoderate COVID-19, as described in the Scope of Authorization section of this letter (Section II) 

and subject to the terms of this authorization. 

I. Criteria for Issuance of Authorization 

I have concluded that the emergency use of PAXLOVID for the treatment of COVID-19, when 

administered as described in the Scope of Authorization (Section II), meets the criteria for 

issuance of an authorization under Section 564(c) of the Act, because: 

1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including 

severe respiratory illness, to humans infected by this virus; 

2. Based on the totality of scientific evidence available to FDA, it is reasonable to 

believe that PAXLOVID may be effective for the treatment of mild-to-moderate 

COVID-19, as described in the Scope of Authorization (Section II), and that, when 

used under the conditions described in this authorization, the known and potential 

benefits of PAXLOVID outweigh the known and potential risks of such product; and 

3. There is no adequate, approved, and available alternative to the emergency use of 

PAXLOVID for the treatment of mild-to-moderate COVID-19.11,12 

incorporated to the Fact Sheet for Health Care Providers and Fact Sheet for Patients, Parents and Caregivers. Postauthorization requirements, formerly condition L in this LOA, were also removed since they were redundant with 

post-market requirements associated with the approved NDA for Paxlovid. Clarifying edits were also incorporated 

to conditions H and I of this LOA. 

11 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. 12 Veklury (remdesivir) is an FDA-approved alternative to PAXLOVID when used for the treatment of mild-tomoderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at 
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II. Scope of Authorization 

I have concluded, pursuant to Section 564 of the Act, that the scope of this authorization is 

limited as follows: 

x PAXLOVID, as described in Category A13 of the Product Description section of this 

letter, is authorized for emergency use by healthcare providers 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 COVID19, including hospitalization or death; 

x PAXLOVID, as described in Category B14 of the Product Description section of this 

letter, is authorized for emergency use by healthcare providers 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; 

Limitations on Authorized Use 

x PAXLOVID is not authorized for use as pre-exposure or as post-exposure 

prophylaxis for prevention of COVID-19. 

x PAXLOVID may be prescribed for the emergency uses authorized for a product in 

Category A and Category B, as described above, by physicians, advanced practice 

registered nurses, and physician assistants licensed or authorized under state15 law to 

prescribe drugs. In addition, PAXLOVID may 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, as applicable, and subject to the following conditions: 

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). Additionally, although different presentations of PAXLOVID are now FDA-approved for 

the treatment of mild-to-moderate COVID-19 in certain adults, there are not sufficient quantities of the approved 

PAXLOVID available for distribution to the authorized adult population in its entirety at the time of reissuance of 

the EUA, and PAXLOVID is not FDA-approved for individuals younger than 18 years of age. 13 The presentations of PAXLOVID described in Category A of the Product Description section of this letter are 

those that are labeled and packaged in accordance with EUA 105.

14 The presentations of PAXLOVID described in Category B of the Product Description section of this letter are 

those that are labeled and packaged in accordance with NDA 217188.

15 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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x 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 

x 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 nonprescribed) that the patient is taking to assess for potential drug interaction. 

x The use of PAXLOVID covered by this authorization must be in accordance with the 

authorized Fact Sheets. 

Product Description 

PAXLOVID consists of 150 mg tablets of nirmatrelvir that are co-packaged with 100 mg tablet 

ritonavir. 

PAXLOVID is authorized to be distributed in the following presentations: 

Category A16,17 

x 300 mg nirmatrelvir;100 mg ritonavir: Each carton contains 30 tablets divided in 5 

daily-dose blister cards. Each blister card contains 4 nirmatrelvir tablets (150 mg 

each) and 2 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets 

are supplied in separate blister cavities within the same child-resistant blister card. 

Each carton and individual blister card include the following statement: “For use 

under Emergency Use Authorization.” NDC: 0069-1085-30, 0069-1085-06, 0069-

0345-30, 0069-0345-06. 

x 150 mg nirmatrelvir; 100 mg ritonavir18: Each carton contains 20 tablets divided in 5 

daily-dose blister cards. Each blister card contains 2 nirmatrelvir tablets (150 mg 

each) and 2 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets 

are supplied in separate blister cavities within the same child-resistant blister card. 

Each carton and individual blister card include the following statement: “For use 

under Emergency Use Authorization.” NDC: 0069-1101-20, 0069-1101-04. 

16 Supra at Note 13. 

17 PAXLOVID in Category A that has been distributed prior to the reissuance of this letter on January 29, 2024, is 

authorized for emergency use, consistent with the terms and conditions of this authorization, through the currently 

labeled or extended expiry, as applicable, or through March 8, 2024, whichever is earlier. Individuals who are 

dispensed Paxlovid in Category A on or prior to March 8, 2024, in accordance with the terms and conditions of this 

authorization, and who have initiated treatment on or prior to that date, may complete their course of treatment even 

if completion of treatment were to occur after March 8, 2024. Such EUA-labeled product remains authorized for 

patient use in these circumstances. 

18 The 150 mg nirmatrelvir;100 mg ritonavir presentation is designed to provide appropriate dosing for patients 

within the scope of this authorization with moderate renal impairment. See section 2.2 of the Fact Sheet for 

Healthcare Providers for more information. 
 

 

 

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Category B19 

x 300 mg nirmatrelvir;100 mg ritonavir: Each carton contains 30 tablets divided in 10 

daily-dose blister cards. Each blister card contains 2 nirmatrelvir tablets (150 mg 

each) and 1 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets 

are supplied in separate blister cavities within the same child-resistant blister card. 

NDC: 0069-5321-30, 0069-5001-30, 0069-5045-30, 0069-5001-06, 0069-5045-06, 

0069-5321-03.

x 150 mg nirmatrelvir; 100 mg ritonavir20: Each carton contains 20 tablets divided in 

10 daily-dose blister cards. Each blister card contains 1 nirmatrelvir tablets (150 mg 

each) and 1 ritonavir tablets (100 mg each). Nirmatrelvir tablets and ritonavir tablets 

are supplied in separate blister cavities within the same child-resistant blister card. 

NDC: 0069-5017-20, 0069-5317-20, 0069-5017-04, 0069-5317-02 

The authorized storage and handling information for PAXLOVID is included in the authorized 

Fact Sheet for Healthcare Providers. 

PAXLOVID is authorized for emergency use with the following product-specific information 

required to be made available to healthcare providers and to patients, parents, and caregivers, 

respectively, through Pfizer’s website www.COVID19oralRX.com (referred to as the 

“authorized labeling”): 

x Fact Sheet for Healthcare Providers: Emergency Use Authorization (EUA) for 

PAXLOVID 

x Fact Sheet for Patients, Parents and Caregivers: Emergency Use Authorization (EUA) 

of PAXLOVID for Coronavirus Disease 2019 (COVID-19) 

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that 

the known and potential benefits of PAXLOVID, when used for the treatment of mild-tomoderate COVID-19 in accordance with this Scope of Authorization (Section II), outweigh the 

known and potential risks. 

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific 

evidence available to FDA, that it is reasonable to believe that PAXLOVID may be effective for 

the treatment of mild-to-moderate COVID-19 in accordance with this Scope of Authorization 

(Section II), pursuant to Section 564(c)(2)(A) of the Act. 

Having reviewed the scientific information available to FDA, including the information 

supporting the conclusions described in Section I above, I have concluded that PAXLOVID (as 

described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) 

of the Act concerning safety and potential effectiveness. 

The emergency use of PAXLOVID under this EUA must be consistent with, and may not exceed, 

the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions 

19 Supra at Note 14.

20 Supra at Note 18. 
 

 

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of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set 

forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the 

Secretary of HHS’s corresponding declaration under Section 564(b)(1), PAXLOVID is authorized 

for the treatment of mild-to-moderate COVID-19, as described in the Scope of Authorization 

(Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise 

required by applicable federal law. 

III. Conditions of Authorization 

Pursuant to Section 564 of the Act, I am establishing the following conditions with respect to the 

emergency use of PAXLOVID as described in the Scope of Authorization (Section II)21: 

Pfizer and Authorized Distributors22 

A. Pfizer and authorized distributor(s) will ensure that PAXLOVID is distributed and the 

authorized labeling (i.e., Fact Sheets) will be made available to healthcare facilities and/or 

healthcare providers as described in Section II of this Letter of Authorization. 

B. Pfizer and authorized distributor(s) will ensure that appropriate storage is maintained until 

the product is delivered to healthcare facilities and/or healthcare providers. 

C. Pfizer and authorized distributor(s) will ensure that the terms of this EUA are made available 

to all relevant stakeholders (e.g., U.S. government agencies, state and local government 

authorities, authorized distributors, healthcare facilities, healthcare providers) involved in 

distributing or receiving PAXLOVID. Pfizer will provide to all relevant stakeholders a copy 

of this Letter of Authorization and communicate any subsequent amendments that might be 

made to this Letter of Authorization and its authorized accompanying materials (i.e., Fact 

Sheets). 

D. Pfizer may request changes to this authorization, including to the authorized Fact Sheets for 

PAXLOVID. Any request for changes to this EUA must be submitted to the Office of 

Infectious Diseases/Office of New Drugs/Center for Drug Evaluation and Research. Such 

changes require appropriate authorization prior to implementation.23 

21 This EUA does not restrict the distribution or administration of PAXLOVID, as described in Category B of the 

Product Description section, when it is distributed or administered for its approved use. 22 “Authorized Distributor(s)” are identified by Pfizer as an entity or entities allowed to distribute authorized 

PAXLOVID. 

23 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized 

labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new 

fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing 

processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to 

require data collection or study; (8) new strengths of the authorized product, new product sources (e.g., of active 

pharmaceutical ingredient) or of product components. For changes to the authorization, including the authorized 

labeling, of the type listed in (3), (6), (7), or (8), review and concurrence is required from the Counter-Terrorism and 

Emergency Coordination Staff/Office of the Center Director/CDER and the Office of Counterterrorism and 

Emerging Threats/Office of the Chief Scientist. 
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E. Pfizer may develop and disseminate instructional and educational materials (e.g., materials 

providing information on product administration and/or patient monitoring) that are 

consistent with the authorized emergency use of PAXLOVID as described in this Letter of 

Authorization and authorized labeling, without FDA’s review and concurrence, when 

necessary to meet public health needs. Any instructional and educational materials that are 

inconsistent with the authorized labeling for PAXLOVID are prohibited. If the Agency 

notifies Pfizer that any instructional and educational materials are inconsistent with the 

authorized labeling, Pfizer must cease distribution of such instructional and educational 

materials. Furthermore, as part of its notification, the Agency may also require Pfizer to 

issue corrective communication(s). 

F. Pfizer will report to FDA all serious adverse events and medication errors potentially related 

to PAXLOVID use that are reported to Pfizer using either of the following options. 

Option 1: Submit reports through the Safety Reporting Portal (SRP) as described on the FDA 

SRP web page. 

Option 2: Submit reports directly through the Electronic Submissions Gateway (ESG) as 

described on the FAERS electronic submissions web page. 

Submitted reports under both options must state: “PAXLOVID use for COVID-19 under 

Emergency Use Authorization (EUA).” For reports submitted under Option 1, include this 

language at the beginning of the question “Describe Event” for further analysis. For reports 

submitted under Option 2, include this language at the beginning of the “Case Narrative” field. 

G. All manufacturing, packaging, and testing sites for both drug substance and drug product 

will comply with current good manufacturing practice requirements of Section 501(a)(2)(B) 

of the Act. 

H. Pfizer will submit information to the Agency within three working days of receipt of any 

information concerning significant quality problems with distributed drug product of 

PAXLOVID that includes the following: 

x Information concerning any incident that causes the drug product or its labeling 

to be mistaken for, or applied to, another article; or 

x Information concerning any microbiological contamination, or any significant 

chemical, physical, or other change or deterioration in the distributed drug 

product, or any failure of one or more distributed batches of the product to meet 

the established specifications. 

If a significant quality problem affects unreleased product and may also impact product(s) 

previously released and distributed, then information must be submitted for all potentially 

impacted lots. 

Pfizer will include in its notification to the Agency whether the batch, or batches, in question 

will be recalled. If FDA requests that batches of PAXLOVID, as described in Category A of 
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the Product Description section of this letter, at any time, be recalled, Pfizer must recall 

them. 

If not included in its initial notification, Pfizer must submit information confirming that 

Pfizer has identified the root cause of the significant quality problems, taken corrective 

action, and provide a justification confirming that the corrective action is appropriate and 

effective. Pfizer must submit this information as soon as possible but no later than 45 

calendar days from the initial notification. 

I. Pfizer will manufacture PAXLOVID, as described in Category A of the Product Description 

section of this letter, to meet all quality standards and per the manufacturing process and 

control strategy as detailed in Pfizer’s EUA request. Pfizer will not implement any changes 

to the description of the product, manufacturing process, facilities and equipment, and 

elements of the associated control strategy that assure process performance and quality of the 

authorized product, without notification to and concurrence by the Agency as described 

under Condition D. 

J. Pfizer will list each presentation of PAXLOVID with a unique product NDC under the 

marketing category of Emergency Use Authorization. Further, the listing will include each 

establishment where manufacturing is performed for the drug and the type of operation 

performed at each such establishment. 

K. Through a process of inventory control, Pfizer and authorized distributor(s) will maintain 

records regarding distribution of PAXLOVID (i.e., lot numbers, quantity, receiving site, 

receipt date). 

L. Pfizer shall provide samples as requested of the authorized nirmatrelvir to HHS for 

evaluation of activity against emerging global viral variants of SARS-CoV-2, including 

specific amino acid substitution(s) of interest (e.g., variants that are highly prevalent or that 

harbor substitutions in the target protein(s) or target cleavage sites) within 5 business days of 

any request made by HHS. Analyses performed with the supplied quantity of authorized 

nirmatrelvir may include, but are not limited to, cell culture potency assays, biochemical 

assays, and in vivo efficacy assays. 

M. Pfizer and authorized distributor(s) will make available to FDA upon request any records 

maintained in connection with this EUA. 

Healthcare Facilities to Whom PAXLOVID Is Distributed and Healthcare Providers 

Administering PAXLOVID 

N. Healthcare facilities and healthcare providers will ensure that they are aware of the Letter of 

Authorization, and the terms herein, and that the authorized Fact Sheets are made available 

to healthcare providers and to patients, parents, and caregivers, respectively, through 

appropriate means, prior to administration of PAXLOVID. 
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O. Healthcare facilities and healthcare providers receiving PAXLOVID will track all serious 

adverse events and medication errors that are considered to be potentially related to 

PAXLOVID use and must report these to FDA in accordance with the Fact Sheet for 

Healthcare Providers. Complete and submit a MedWatch form 

(www.fda.gov/medwatch/report.htm), or complete and submit FDA Form 3500 (health 

professional) by fax (1-800-FDA-0178) (these forms can be found via link above). Call 1-

800-FDA-1088 for questions. Submitted reports must state, “PAXLOVID use for COVID19 under Emergency Use Authorization” at the beginning of the question “Describe Event” 

for further analysis. A copy of the completed FDA Form 3500 must also be provided to 

Pfizer per the instructions in the authorized labeling. 

P. Healthcare facilities and healthcare providers will ensure that appropriate storage is 

maintained until the product is administered consistent with the terms of this letter and the 

authorized labeling. 

Q. Through a process of inventory control, healthcare facilities will maintain records regarding 

the dispensing and administration of PAXLOVID for the use authorized in this letter (i.e., lot 

numbers, quantity, receiving site, receipt date), product storage, and maintain patient 

information (e.g., patient name, age, disease manifestation, number of doses administered 

per patient, other drugs administered). 

R. Healthcare facilities will ensure that any records associated with this EUA are maintained 

until notified by Pfizer and/or FDA. Such records will be made available to Pfizer, HHS, and 

FDA for inspection upon request. 

S. Healthcare facilities and providers will report therapeutics information and utilization data as 

directed by HHS. 

Conditions Related to Printed Matter, Advertising, and Promotion 

T. All descriptive printed matter, advertising, and promotional materials relating to the use of 

PAXLOVID under this authorization shall be consistent with the authorized labeling, as well 

as the terms set forth in this EUA, and meet the requirements set forth in Section 502(a) and 

(n) of the Act, as applicable, and FDA implementing regulations. References to “approved 

labeling”, “permitted labeling”, or similar terms in these requirements shall be understood to 

refer to the authorized labeling for the use of PAXLOVID under this authorization. In 

addition, such materials shall: 

x Be tailored to the intended audience. 

x Not take the form of reminder advertisements or reminder labeling, as those 

terms are described in 21 CFR 202.1(e)(2)(i) and 21 CFR 201.100(f), 

respectively, except that reminder advertisements and reminder labeling 

intended only to provide price information to consumers, as described in 21 

CFR 200.200, are permissible so long as such materials meet all conditions 

described in 21 CFR 200.200(a)(1)-(a)(4). 
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x Present the same risk information relating to the major side effects and 

contraindications concurrently in the audio and visual parts of the presentation 

for advertising and promotional materials in audio-visual format. 

x Be accompanied by the authorized labeling, if the promotional materials are not 

subject to Section 502(n) of the Act. 

x Be submitted to FDA accompanied by Form FDA-2253 for consideration at 

least 14 calendar days prior to initial dissemination or first use. 

U. Pfizer may disseminate descriptive printed matter, advertising, and promotional materials 

relating to the emergency use of PAXLOVID that provide accurate descriptions of safety 

results and efficacy results on a clinical endpoint(s) from the clinical trial(s) summarized 

in the authorized labeling. Such materials must include any limitations of the clinical 

trial data as described in the authorized labeling. Pfizer may not imply that PAXLOVID 

is FDA-approved for its authorized use in the pediatric patient population as detailed in 

the Scope of Authorization (Section II) by making statements such as “PAXLOVID is 

safe and effective for the treatment of COVID-19 in pediatric patients.” 

V. All descriptive printed matter, advertising, and promotional material, relating to the use of 

PAXLOVID under this authorization clearly and conspicuously shall state that: 

x PAXLOVID has not been approved, but has been authorized for emergency use 

by FDA under an EUA, 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; and 

x 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. 

If the Agency notifies Pfizer that any descriptive printed matter, advertising, or promotional 

materials do not meet the terms set forth in Conditions T through V of this EUA, Pfizer must cease 

distribution of such descriptive printed matter, advertising, or promotional materials in accordance 

with the Agency’s notification. Furthermore, as part of its notification, the Agency may also require 

Pfizer to issue corrective communication(s). 
____________________________ 

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IV. Duration of Authorization 

This EUA will be effective until the declaration that circumstances exist justifying the 

authorization of the emergency use of drugs and biological products during the COVID-19 

pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 

564(g) of the Act. 

Sincerely, 

Digitally signed by Patrizia A. Patrizia A. Cavazzoni -S 

Date: 2024.01.29 Cavazzoni -S 09:12:09 -05'00' 

Patrizia Cavazzoni, M.D. 

Director 

Center for Drug Evaluation and Research 

U.S. Food and Drug Administration