Pfizer-BioNTech COVID-19 Vaccine EUI Recipient 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, 9/22), 2023 (9/12) Page 1 of 3

Emergency Use Instructions (EUI) Fact Sheet for Recipients and Caregivers:

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

This Fact Sheet describes Emergency Use Instructions (EUI) that have been issued by the Centers for 

Disease Control and Prevention (CDC) to provide information about additional doses of the Updated

COVID-19 vaccine, 2023-2024 Formula (monovalent, XBB containing), by Pfizer-BioNTech (Comirnaty) that 

go beyond its FDA-approved labeling. These uses under EUI are for doses for people ages 12 years and 

older who are moderately or severely immunocompromised. See below for more information on the uses 

of the updated COVID-19 vaccine by Pfizer-BioNTech under EUI. 

If you are 12 years and older and you are receiving vaccination, you have a choice of receiving the updated 

COVID-19 vaccine by Pfizer-BioNTech, Moderna (see the Moderna EUI Fact Sheet for Recipients and 

Caregivers), or Novavax (see the Interim Clinical Considerations or Novavax Emergency Use Authorization 

[EUA] Fact Sheet). 

What are Emergency Use Instructions (EUI)?

EUI are issued by CDC to provide information about emergency use of FDA-approved (licensed) medical 

products that may not be included in or differ in some way from the information provided in the FDAapproved labeling (package insert). EUI consist of fact sheets for healthcare providers and recipients.

Why is CDC issuing EUI for the updated COVID-19 vaccine by Pfizer-BioNTech?

The updated COVID-19 vaccine by Pfizer-BioNTech is an FDA-approved COVID-19 vaccine (brand name 

Comirnaty, mRNA) to prevent COVID-19 in persons ages 12 years and older. CDC is issuing EUI to provide 

information about this vaccine for the below uses that extend beyond its FDA-approved labeling (see “Who 

can receive additional doses of the updated COVID-19 vaccine by Pfizer-BioNTech under the EUI?”). The 

updated COVID-19 vaccine by Moderna can also be used under EUI for similar uses as an alternative mRNA 

COVID-19 vaccine (see the Moderna EUI Fact Sheet for Recipients), and the same or similar 

recommendations in this EUI also apply to the use of the updated COVID-19 vaccine by Moderna under 

EUI. In addition, the updated COVID-19 vaccine by Novavax is authorized for persons ages 12 years and 

older (see the Interim Clinical Considerations or the Novavax EUA Fact Sheet)

What is COVID-19?

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by a coronavirus called SARS-CoV-2. It 

is predominantly a respiratory illness that can affect other organs. People with SARS-CoV-2 infection have 

reported a wide range of symptoms, from no symptoms to severe illness leading to death. 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 under the EUI?

People who can receive the updated COVID-19 vaccine by Pfizer-BioNTech under EUI are described below. 

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

The updated COVID-19 vaccine by Moderna can also be used under EUI for similar uses in persons ages 12

years and older as an alternative updated mRNA COVID-19 vaccine (see the Moderna EUI Fact Sheet for 

Recipients). In addition, the updated COVID-19 vaccine by Novavax is authorized under EUA for persons 

ages 12 years and older (see the Interim Clinical Considerations or the Novavax EUA Fact Sheet)
Pfizer-BioNTech COVID-19 Vaccine EUI Recipient 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, 9/22), 2023 (9/12) Page 2 of 3

Talk to your healthcare provider about if and when you should receive additional vaccine doses. See CDC’s 

Interim Clinical Considerations for additional information on people who are moderately and severely 

immunocompromised recommended for an additional doses.

Who should NOT get the updated COVID-19 vaccine by Pfizer-BioNTech?

You should not get the vaccine if you:

• Had a severe allergic reaction after a previous dose of the COVID-19 vaccine by Pfizer-BioNTech

• Had a severe allergic reaction to any ingredient of the COVID-19 vaccine by Pfizer-BioNTech

What should I mention to the vaccination provider before getting the updated COVID-19 vaccine by PfizerBioNTech?

Tell your vaccination provider the name, number of doses, and date(s) of COVID-19 vaccine(s) you received 

previously. Also, mention all of your medical conditions, including if you:

• Have any allergies 

• Have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining 

outside the heart)

• Have a fever

• Have a bleeding disorder or are on a blood thinner

• Are immunocompromised or are on a medicine that affects your immune system

• Have ever fainted in association with an injection

• Are pregnant 

• Are breastfeeding

How is the updated COVID-19 vaccine by Pfizer-BioNTech given?

COVID-19 vaccine by Pfizer-BioNTech is given as an injection into the muscle. 

Has the COVID-19 vaccine by Pfizer-BioNTech been used before?

Millions of people have received a Pfizer-BioNTech COVID-19 vaccine in the United States since it became 

available starting in mid-December 2020. Also, in clinical trials, approximately 23,000 people ages 12 years 

and older received at least 1 dose of a Pfizer-BioNTech COVID-19 vaccine (original monovalent).

The updated Pfizer-BioNTech COVID-19 Vaccine is made in the same way as the Pfizer‐BioNTech COVID-19 

Vaccine (original monovalent) and Pfizer-BioNTech COVID‐19 vaccine, Bivalent, but it encodes the spike 

protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

What are the risks of the COVID-19 vaccine by Pfizer-BioNTech?

Side effects that have been reported following administration of a Pfizer-BioNTech COVID-19 vaccine 

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

and injection site redness. Common side effects reported were mostly mild, but some people had side 

effects that affected their ability to do daily activities. Cases of myocarditis and pericarditis have rarely 

been reported in some people. Cases have occurred predominantly in adolescents and young adult males 

within the first week following vaccination. Anaphylaxis (severe allergic reaction to the vaccine) has been 

rarely observed following COVID-19 vaccines. These types of allergic reactions can rarely occur with any 

kind of vaccine or medical product.

Additional information on the common and serious side effects of the COVID-19 vaccine by Pfizer-BioNTech

can be found in the package insert for Comirnaty.
Pfizer-BioNTech COVID-19 Vaccine EUI Recipient 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, 9/22), 2023 (9/12) Page 3 of 3

What are the benefits of the COVID-19 vaccine by Pfizer-BioNTech?

The COVID-19 vaccine by Pfizer-BioNTech has been shown in multiple studies to be effective in preventing

severe illness and death from COVID-19. Additional doses of the updated COVID-19 vaccine by PfizerBioNTech as described under EUI may help to increase immune response in people who are moderately or 

severely immunocompromised, which could improve protection against COVID-19. The updated COVID-19 

vaccine by Pfizer-BioNTech may not protect everyone.

What are the Risks and Benefits of the updated COVID-19 vaccine by Pfizer-BioNTech?

The FDA approved Pfizer-BioNTech COVID-19 vaccines to prevent COVID-19 based on safety and efficacy 

data available from clinical trials. Based on available information, the use of the updated COVID-19 vaccine 

by Pfizer-BioNTech as described in this Fact Sheet could help improve or restore protection that may not 

have been sufficient or may have decreased over time after vaccination, and as such the known and 

potential benefits of vaccination outweigh the known and potential risks of the vaccine.

What alternative choices are available for additional doses other than the COVID-19 vaccine by PfizerBioNTech?

Currently, the updated Pfizer-BioNTech COVID-19 vaccine (Comirnaty) and updated Moderna COVID-19 

vaccine (Spikevax) are the only FDA-approved COVID-19 vaccines for which EUI provide information about 

additional doses for 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).

It is your choice to receive or not receive the updated COVID-19 vaccine by Pfizer-BioNTech as an additional

dose. Should you decide not to receive it, it will not change your standard medical care.

What is the Countermeasures Injury Compensation Program?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs 

of medical care and other specific expenses of certain people who have been seriously injured by certain 

medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one 

(1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/

or call 1-855-266-2427. 

How can I learn more?

• Ask the vaccination provider.

• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.

• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatoryand-policy-framework/emergency-use-authorization.

• Contact your local or state public health department.