Pfizer-BioNTech COVID-19 Vaccine EUI Healthcare Providers Fact Sheet, ver 10/6/2023; originally CDC-issued 11/17/2021; 

prior revisions in 2021 (12/9), 2022 (1/7, 2/11, 2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12) Page 1 of 5

Emergency Use Instructions for Healthcare Providers: 

Additional Doses of Updated COVID-19 Vaccine, 2023-2024 Formula, by Pfizer-BioNTech

The Centers for Disease Control and Prevention (CDC) is issuing Emergency Use Instructions (EUI) to provide 

information about the use of the updated COVID-19 vaccine, 2023-2024 Formula1(monovalent, XBB 

containing), by Pfizer-BioNTech (Comirnaty), which is approved (licensed) by the Food and Drug Administration 

(FDA) for the prevention of COVID-19 in individuals ages 12 years and older.

2 The CDC-issued EUI provide

information for the use of this vaccine that are beyond the FDA-approved labeling. The CDC-issued EUI provide 

information on the following uses of the updated COVID-19 vaccine by Pfizer-BioNTech for:

• Additional doses for people ages 12 years and older who are moderately or severely 

immunocompromised, which include the following: 

o A 3-dose initial series for people ages 12 years and older who are moderately or severely 

immunocompromised and previously unvaccinated or who need revaccination. People who 

need revaccination are those who are moderately or severely immunocompromised who 

received COVID-19 vaccine dose(s) during treatment with B-cell-depleting therapies over a 

limited period or who received COVID-19 vaccine dose(s) prior to or during treatment involving 

hematopoietic cell transplant or chimeric antigen receptor (CAR)-T-cell therapy. 

o People ages 12 years and older who are moderately or severely immunocompromised and 

have previously received 1 original monovalent3 or bivalent4 mRNA COVID-19 vaccine doses 

are recommended to receive 2 homologous (i.e., from the same manufacturer) updated mRNA 

vaccine doses to complete the 3-dose initial series. 

o People ages 12 years and older who are moderately or severely immunocompromised and 

have previously received original 2 monovalent or bivalent mRNA COVID-19 vaccine doses are 

recommended to receive 1 homologous updated mRNA vaccine dose, at least 4 weeks after 

their last COVID-19 vaccine dose.

o For persons initiating or completing the 3-dose initial series with the Pfizer-BioNTech COVID-19 

vaccine, Dose 1 and Dose 2 are recommended with a 3-week interval; Dose 2 and Dose 3 are 

recommended with at least a 4-week interval.

o People ages 12 years and older who are moderately or severely immunocompromised and are 

previously vaccinated may receive more than 1 dose of the updated COVID-19 vaccine by 

Moderna, Pfizer-BioNTech, or Novavax, informed by the clinical judgement of a healthcare 

provider and personal preference and circumstances. 

The EUI for the updated COVID-19 vaccine by Moderna also allow similar uses as an alternative updated mRNA 

COVID-19 vaccine to Pfizer-BioNTech, and the same or similar recommendations in the EUI also apply to the 

use of the updated COVID-19 vaccine by Moderna under EUI (see the Moderna COVID-19 EUI Fact Sheet for 

Healthcare Providers). The updated COVID-19 vaccine by Novavax, which is authorized under Emergency Use 

Authorization (EUA; see the Novavax EUA Fact Sheet) is also available and similar recommendations to the 

updated Pfizer-BioNTech COVID-19 vaccine are available in the Interim Clinical Considerations. 

Refer to CDC’s Interim Clinical Considerations for specific recommendations on use of the updated COVID-19 

vaccine by Pfizer-BioNTech allowed under the EUI. For additional information about the COVID-19 vaccine by 

Pfizer-BioNTech COVID-19, refer to the Comirnaty package insert.

1 The updated Pfizer-BioNTech COVID-19 vaccine, 2023-2024 Formula, by Pfizer-BioNTech encodes the spike protein of SARS-CoV-2 Omicron variant 

lineage XBB.1.5 (Omicron XBB.1.5).

2 Comirnaty is the proprietary name for the product licensed under the Biologics License Application (BLA). Because Comirnaty is commonly referred to 

as the “Pfizer vaccine” or the “Pfizer-BioNTech COVID-19 Vaccine,” these EUI refer to this vaccine as the COVID-19 vaccine by Pfizer-BioNTech.

3 The Original monovalent Pfizer-BioNTech COVID-19 Vaccine encodes the spike protein of only the Original SARS-CoV-2, no longer authorized for use in 

the U.S.

4 The Pfizer-BioNTech COVID-19 Vaccine, Bivalent encodes the spike protein of the Original SARS-CoV-2 and the Omicron BA.4/BA.5 SARS-CoV-2, no 

longer authorized for use in the U.S.
Pfizer-BioNTech COVID-19 Vaccine EUI Healthcare Providers Fact Sheet, ver 10/6/2023; originally CDC-issued 11/17/2021; 

prior revisions in 2021 (12/9), 2022 (1/7, 2/11, 2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12) Page 2 of 5

What are EUI and why is CDC issuing EUI for the updated COVID-19 vaccine by Pfizer-BioNTech?

In 2013, the Pandemic and All-Hazards Preparedness Reauthorization Act included a new provision that 

allowed for the issuance of EUI to permit CDC to inform healthcare providers and recipients about certain uses 

of FDA-approved or cleared medical products. Specifically, EUI inform healthcare providers and recipients 

about such products’ approved, licensed, or cleared conditions of use. The CDC Director has statutory (legal) 

authority to create, issue, and disseminate EUI before or during an emergency.

The updated COVID-19 vaccine by Pfizer-BioNTech is approved by the FDA as a single dose for active 

immunization to prevent COVID-19 in persons ages 12 years and older to be administered at least 2 months 

after the last dose of COVID-19 vaccine. CDC is issuing these EUI to provide information about use of the 

updated COVID-19 vaccine by Pfizer-BioNTech for additional doses for people ages 12 years and older who are 

moderately or severely immunocompromised that extend beyond its FDA-approved labeling as described 

further under “Who can receive additional doses of the updated COVID-19 vaccine by Pfizer-BioNTech” and 

“What are the doses and intervals of the updated COVID-19 vaccine by Pfizer-BioNTech for people ages 12 

years and older who are moderately or severely immunocompromised”. 

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, 

that emerged in late 2019. It is predominantly a respiratory illness that can affect other organs. People with 

SARS-CoV-2 infection have reported a wide range of symptoms, ranging from no symptoms to severe illness. 

Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include fever or chills, cough,

shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat,

congestion or runny nose, nausea or vomiting, and diarrhea.

Who can receive additional doses of the updated COVID-19 vaccine by Pfizer-BioNTech?

The below describes who can receive the updated COVID-19 vaccine by Pfizer-BioNTech under EUI. The COVID19 vaccine by Moderna can also be used under EUI for similar uses as an alternative updated mRNA COVID-19 

vaccine (see the Moderna EUI Fact Sheet for Healthcare Providers). In addition, the updated COVID-19 vaccine 

by Novavax is available for persons ages 12 years and older (see the Interim Clinical Considerations or Novavax 

EUA Fact Sheet).

• People ages 12 years and older who are moderately or severely immunocompromised

What are the doses and intervals of the updated COVID-19 vaccine by Pfizer-BioNTech for people ages 12 

years and older who are moderately or severely immunocompromised?

• Additional doses for people ages 12 years and older who are moderately or severely 

immunocompromised, which include the following: 

o A 3-dose initial series for people ages 12 years and older who are moderately or severely 

immunocompromised and previously unvaccinated or who need revaccination. People who 

need revaccination are those who are moderately or severely immunocompromised who 

received COVID-19 vaccine dose(s) during treatment with B-cell-depleting therapies over a 

limited period or who received COVID-19 vaccine dose(s) prior to or during treatment involving 

hematopoietic cell transplant or chimeric antigen receptor (CAR)-T-cell therapy. 

o People ages 12 years and older who are moderately or severely immunocompromised and 

have previously received 1 original monovalent or bivalent mRNA COVID-19 vaccine doses are 

recommended to receive 2 homologous (i.e., from the same manufacturer) updated mRNA 

vaccine doses to complete the 3-dose initial series. 

o People ages 12 years and older who are moderately or severely immunocompromised and 

have previously received 2 original monovalent or bivalent mRNA COVID-19 vaccine doses are 

recommended to receive 1 homologous updated mRNA vaccine dose, at least 4 weeks after 

their last COVID-19 vaccine dose.

o For persons initiating or completing the 3-dose initial series with the Pfizer-BioNTech COVID-19 

vaccine, Dose 1 and Dose 2 are recommended with a 3-week interval; Dose 2 and Dose 3 are 

recommended with at least a 4-week interval.
Pfizer-BioNTech COVID-19 Vaccine EUI Healthcare Providers Fact Sheet, ver 10/6/2023; originally CDC-issued 11/17/2021; 

prior revisions in 2021 (12/9), 2022 (1/7, 2/11, 2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12) Page 3 of 5

o People ages 12 years and older who are moderately or severely immunocompromised and are 

previously vaccinated may receive more than 1 dose of the updated COVID-19 vaccine by 

Moderna, Pfizer-BioNTech, or Novavax, informed by the clinical judgement of a healthcare 

provider and personal preference and circumstances. 

Refer to CDC’s Interim Clinical Considerations for specific and the latest dosing recommendations (e.g., 

number of doses, dosing intervals, revaccination) that may vary for individuals with certain medical conditions 

and/or in certain circumstances, which differ from or extend beyond the FDA-authorized and/or FDA-approved 

labeling.

See Table 2 COVID-19 vaccination schedule for people ages 12 years and older who are moderately or severely 

immunocompromised in CDC’s Interim Clinical Considerations for the latest dosing recommendations. On a 

case-by-case basis, providers of moderately or severely immunocompromised patients who are ages 12 years 

and older may administer the updated COVID-19 vaccine by Pfizer-BioNTech outside of the FDA-approved 

labeling and CDC recommended dosing intervals based on clinical judgment when the benefits of vaccination 

are deemed to outweigh the potential and unknown risks for the recipient. 

What are the formulations of the COVID-19 vaccine by Pfizer-BioNTech that these EUI apply to?

The EUI apply to the FDA-approved 2023-2024 Formula of the Pfizer COMIRNATY mRNA COVID-19 Vaccines.

What are the common side effects with the COVID-19 vaccine by Pfizer-BioNTech?

Adverse reactions that have been reported following administration of Pfizer-BioNTech COVID-19 vaccines 

include pain at the injection site, fatigue, headache, chills, muscle pain, joint pain, fever, injection site swelling, 

and injection site redness.

What are possible serious side effects with the COVID-19 vaccine by Pfizer-BioNTech?

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, 

urticaria, angioedema), syncope, myocarditis and pericarditis have been reported following administration of 

Pfizer-BioNTech COVID-19 vaccines. Myocarditis and/or pericarditis are rare, serious adverse events that have 

been reported after receipt of mRNA COVID-19 vaccines, with the highest risk currently observed in males ages 

12–17 years. Anaphylaxis has been rarely observed following COVID-19 vaccines. These types of allergic 

reactions can rarely occur with any kind of vaccine or medical product.

Who should not receive the updated COVID-19 vaccine by Pfizer-BioNTech?

Do not administer the COVID-19 vaccine by Pfizer-BioNTech to persons with known history of a severe allergic 

reaction (e.g., anaphylaxis) to a previous dose or any component of the vaccine (see Contraindications, and 

Warnings and Precautions sections in the Comirnaty package insert as well as CDC’s Interim Clinical 

Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for 

additional considerations).

What information should be provided to persons receiving additional doses of the updated COVID-19 

vaccine by Pfizer-BioNTech as described in the EUI?

• Provide the EUI Fact Sheet for Recipients and Caregivers.

Risk‐Benefit of the COVID-19 vaccine by Pfizer-BioNTech as Additional Vaccine Doses for Individuals 

Described in the EUI

People who are moderately or severely immunocompromised and previously unvaccinated or in need of 

revaccination would be less likely to have protection from infection-induced immunity and thus the data 

supporting a single dose for those with evidence of pre-existing infection-induced immunity would be less 

applicable to this population. Therefore, the following evidence supports continuing a 3-dose initial series to 

ensure the optimal immune response to protect this population at high risk of severe outcomes with COVID-19 
Pfizer-BioNTech COVID-19 Vaccine EUI Healthcare Providers Fact Sheet, ver 10/6/2023; originally CDC-issued 11/17/2021; 

prior revisions in 2021 (12/9), 2022 (1/7, 2/11, 2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12) Page 4 of 5

and the need for additional updated COVID-19 vaccine doses in people who are moderately to severely 

immunocompromised and previously vaccinated. The original Pfizer-BioNTech and Moderna COVID-19 vaccine

randomized controlled trials from 2020 measured efficacy of a 2-dose initial series (previously called the 

primary series) among people without evidence of prior SARS-CoV-2 infection. Effectiveness of an additional 

primary series dose of the COVID-19 vaccine is inferred from immunogenicity data in immunocompromised 

adults who received a single additional primary series dose. These data were used to support EUA 

amendments on August 12, 2021, for the Pfizer-BioNTech original monovalent vaccine and support the CDC 

recommendations to support expanding the primary series for persons who are moderately or severely 

immunocompromised to 3 doses for mRNA vaccines in August 2021. Persons who are moderately or severely 

immunocompromised may have reduced protection after COVID-19 vaccination, compared with persons 

without immunocompromise. Historically, COVID-19 vaccine effectiveness has been lower and waned more 

quickly for adults with immunocompromise compared to adults without immunocompromise.

For data regarding safety, please see sections in the Comirnaty package insert . Based on available information, 

it appears reasonable to anticipate that known and potential risks of an additional doses of the COVID-19 

vaccine by Pfizer-BioNTech may be outweighed by its likely benefit to enhance or restore protection, which 

might have waned over time, especially in people who are moderately or severely immunocompromised.

Refer to the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines for additional information.

Available Alternatives 

Currently, the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine are the only FDA-approved 

vaccines for which EUI provide for dose administration to people who are moderately or severely 

immunocompromised. The updated Novavax COVID-19 vaccine is also available for persons who are 

moderately or severely immunocompromised under EUA (see the Interim Clinical Considerations or the 

Novavax EUA Fact Sheet).

Reporting Adverse Event or Medication Errors

The vaccination provider should report of the following to the Vaccine Adverse Event Reporting System 

(VAERS): 

• vaccine administration errors whether or not associated with an adverse event, 

• serious adverse events (irrespective of attribution to vaccination), 

• cases of myocarditis

• cases of pericarditis

• cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and 

• cases of COVID-19 that result in hospitalization or death. 

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. 

For further assistance with reporting to VAERS call 1-800-822-7967.

References 

Food and Drug Administration. Package Insert – COMIRNATY (purple cap) (fda.gov)

Food and Drug Administration. FDA briefing document: future vaccination regimens addressing COVID-19. 

Presented at the Vaccines and Related Biological Products Advisory Committee meeting, MD; June 15, 

2023.Vaccines and Related Biological Products Advisory Committee June 15, 2023 Meeting Briefing DocumentFDA

CDC. Science Brief: SARS-CoV-2 infection-induced and vaccine-induced immunity. 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/vaccine-induced-immunity.html
Pfizer-BioNTech COVID-19 Vaccine EUI Healthcare Providers Fact Sheet, ver 10/6/2023; originally CDC-issued 11/17/2021; 

prior revisions in 2021 (12/9), 2022 (1/7, 2/11, 2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12) Page 5 of 5

Polack FP, Thomas SJ, Kitchin N, et al; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 

mRNA COVID-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577 

Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, 

McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, 

Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, 

Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the 

mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. 

Epub 2020 Dec 30. PMID: 33378609; PMCID: PMC7787219. 

Hall VG, Ferreira VH, Ku T, Ierullo M, Majchrzak-Kita B, Chaparro C, Selzner N, Schiff J, McDonald M, Tomlinson 

G, Kulasingam V, Kumar D, Humar A. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant 

Recipients. N Engl J Med. 2021 Sep 23;385(13):1244-1246. doi: 10.1056/NEJMc2111462. Epub 2021 Aug 11. 

PMID: 34379917; PMCID: PMC8385563. 

Kamar N, Abravanel F, Marion O, Couat C, Izopet J, Del Bello A. Three Doses of an mRNA Covid-19 Vaccine in 

Solid-Organ Transplant Recipients. N Engl J Med. 2021 Aug 12;385(7):661-662. doi: 10.1056/NEJMc2108861. 

Epub 2021 Jun 23. PMID: 34161700; PMCID: PMC8262620. 

Food and Drug Administration. Fact sheet for healthcare providers administering vaccine: emergency use 

authorization of Moderna COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). Silver Spring, MD: US 

Department of Health and Human Services, Food and Drug Administration; 

2023. https://www.fda.gov/media/167208/download

Food and Drug Administration. Fact sheet for healthcare providers administering vaccine: emergency use 

authorization of Pfizer-BioNTech COVID-19 vaccine, bivalent (original and Omicron BA.4/BA.5). Silver Spring, 

MD: US Department of Health and Human Services, Food and Drug Administration; 

2023. https://www.fda.gov/media/167211/download

Link-Gelles R. Updates to COVID-19 vaccine effectiveness (VE) in the U.S. Atlanta, GA: US Department of Health 

and Human Services, CDC; 2023. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-

12/05-COVID-Link-Gelles-508.pdf