Moderna COVID-19 Vaccine EUI Recipient Fact Sheet, ver 10/6/2023 Page 1 of 3

originally CDC-issued 2/11/2022; prior revisions in 2022 (2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12)

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

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

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 Moderna (Spikevax) 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 Moderna 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 Moderna, Pfizer-BioNTech (see the Pfizer-BioNTech 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 Moderna?

The updated COVID-19 vaccine by Moderna is an FDA-approved COVID-19 vaccine (brand name Spikevax, 

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 Moderna under the EUI?”). The updated COVID-19 

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

vaccine (see the Pfizer-BioNTech 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 Pfizer-BioNTech under EUI. In addition, 

the updated COVID-19 vaccine by Novavax is available 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 Moderna under the EUI?

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

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

The updated COVID-19 vaccine by Pfizer-BioNTech 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 Pfizer-BioNTech EUI 

Fact Sheet for Recipients). In addition, the updated COVID-19 vaccine by Novavax is available for persons 

ages 12 years and older (see the Interim Clinical Considerations or the Novavax EUA Fact Sheet).
Moderna COVID-19 Vaccine EUI Recipient Fact Sheet, ver 10/6/2023 Page 2 of 3

originally CDC-issued 2/11/2022; prior revisions in 2022 (2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12)

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 Moderna?

You should not get the vaccine if you:

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

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

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

Moderna?

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 Moderna given?

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

Has the COVID-19 vaccine by Moderna been used before?

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

available starting in mid-December 2020. Also, in clinical trials, approximately 30,000 people 12 ages years 

and older received at least 1 dose of the Moderna COVID-19 vaccine (original monovalent) .

The updated Moderna COVID-19 Vaccine is made in the same way as the Moderna COVID-19 Vaccine 

(original monovalent) and Moderna COVID-19 vaccine, Bivalent, but it encodes the spike protein of SARSCoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

What are the risks of the COVID-19 vaccine by Moderna?

Side effects that have been reported following administration of a Moderna COVID-19 vaccine include 

injection site pain, fatigue, headache, muscle pain, chills, axillary swelling or tenderness, joint pain, nausea 

or vomiting, and swelling at the injection site. Cases of myocarditis and pericarditis have rarely been 

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

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 Moderna can 

be found in the package insert for Spikevax.
Moderna COVID-19 Vaccine EUI Recipient Fact Sheet, ver 10/6/2023 Page 3 of 3

originally CDC-issued 2/11/2022; prior revisions in 2022 (2/22, 3/29, 5/20, 6/24, 9/02), 2023 (9/12)

What are the benefits of the COVID-19 vaccine by Moderna?

The COVID-19 vaccine by Moderna 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 Moderna 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 Moderna may not protect everyone.

What are the Risks and Benefits of the COVID-19 vaccine by Moderna?

The FDA approved Moderna 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 

Moderna 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 

Moderna?

Currently, the updated Pfizer-BioNTech COVID-19 vaccine (Comirnaty) and updated Moderna COVID19vaccine (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 for Use of COVID-19 Vaccines in 

the United States or the Novavax EUA Fact Sheet).

It is your choice to receive or not receive the updated COVID-19 vaccine by Moderna 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.