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FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT

MODERNA COVID-19 VACCINE (2023-2024 FORMULA)

WHICH HAS EMERGENCY USE AUTHORIZATION (EUA) TO PREVENT 

CORONAVIRUS DISEASE 2019 (COVID-19) IN 

INDIVIDUALS 6 MONTHS THROUGH 11 YEARS OF AGE

Your child is being offered Moderna COVID-19 Vaccine (2023-2023 Formula)1to prevent 

coronavirus disease 2019 (COVID-19), which is caused by the virus SARS-CoV-2. This fact sheet 

contains information to help you understand the risks and benefits of Moderna COVID-19 Vaccine

(2023-2024 Formula), hereafter referred to as Moderna COVID-19 Vaccine, which your child may 

receive because there is currently a pandemic of COVID-19. Talk to your child’s vaccination 

provider if you have questions.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please see

www.modernatx.com/covid19vaccine-eua.

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization 

(EUA) to make Moderna COVID-19 Vaccine available during the COVID-19 pandemic (for 

more details about an EUA please see “What is an Emergency Use Authorization?” at the end 

of this document). Moderna COVID-19 Vaccine is not an FDA-approved vaccine for ages 6 

months through 11 years of age in the United States. Read this Fact Sheet for information about 

Moderna COVID-19 Vaccine.

WHAT IS COVID-19?

COVID-19 is caused by a coronavirus called SARS-CoV-2. You can get COVID-19 through 

close contact with another person who has the virus. 

It is predominantly a respiratory illness that can affect other organs. People with COVID-19 

have had a wide range of symptoms reported, ranging from mild 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; diarrhea.

WHAT IS MODERNA COVID-19 VACCINE?

Moderna COVID-19 Vaccine is a vaccine for use in individuals 6 months through 11 years of age 

to prevent COVID-19. The FDA has authorized the emergency use of Moderna COVID-19 

Vaccine under an EUA.

Moderna COVID-19 Vaccine may not protect everyone.

1 Moderna COVID-19 Vaccine (2023-2024 Formula) encodes the spike protein of the Omicron XBB.1.5 SARSCoV-2.
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WHAT SHOULD YOU MENTION TO THE VACCCINATION PROVIDER BEFORE 

YOUR CHILD GETS MODERNA COVID-19 VACCINE?

Tell the vaccination provider about all of your child’s medical conditions, including if your 

child:

• has any allergies

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

the lining outside the heart)

• has a fever

• has a bleeding disorder or is on a blood thinner

• is immunocompromised or is on a medicine that affects your child’s immune system

• is pregnant

• is breastfeeding

• has received another COVID-19 vaccine

• has ever fainted in association with an injection

HOW IS THE VACCINE GIVEN?

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

Individuals 6 months through 4 years of age: 

• Unvaccinated individuals: Two doses of Moderna COVID-19 Vaccine are 

administered. The second dose is administered 1 month after the first.

• Individuals who have received one dose of Moderna COVID-19 Vaccine (Original 

monovalent)2 or Moderna COVID-19 Vaccine, Bivalent:

3 A single dose of Moderna 

COVID-19 Vaccine is administered 1 month after Moderna COVID-19 Vaccine

(Original monovalent) or Moderna COVID-19 Vaccine, Bivalent. 

• Individuals who have received two or more doses of Moderna COVID-19 Vaccine

(Original monovalent) or Moderna COVID-19 Vaccine, Bivalent: A single dose of 

Moderna COVID-19 Vaccine is administered at least 2 months after the last previous

dose of Moderna COVID-19 Vaccine (Original monovalent) or Moderna COVID-19 

Vaccine, Bivalent. 

Individuals 5 years through 11 years of age:

• Unvaccinated individuals: A single dose of Moderna COVID-19 Vaccine. 

• Individuals who have received one or more doses of a monovalent COVID-19 

vaccine4 or a bivalent COVID-19 vaccine:5 A single dose of Moderna COVID-19 

Vaccine is administered at least 2 months after the last previous dose of any monovalent

COVID-19 vaccine or bivalent COVID-19 vaccine. 

2 Original monovalent Moderna COVID-19 Vaccine encodes the spike protein of only the Original SARS-CoV-2, 

no longer authorized for use in the U.S.

3 Moderna 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.

4 Monovalent refers to a COVID-19 vaccine that encodes the spike protein of only the Original SARS-CoV-2.

5 Bivalent refers to a COVID-19 vaccine that encodes the spike protein of the Original SARS-CoV-2 and the 

Omicron BA.4/BA.5 SARS-CoV-2.
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Immunocompromised individuals 6 months through 11 years of age: 

Additional doses of Moderna COVID-19 Vaccine may be administered. For more information, talk 

to your child’s healthcare provider.

WHO SHOULD NOT GET MODERNA COVID-19 VACCINE?

Your child should not get Moderna COVID-19 Vaccine if your child had:

• a severe allergic reaction after a previous dose of any Moderna COVID-19 vaccine.

• a severe allergic reaction to any ingredient in these vaccines.

WHAT ARE THE INGREDIENTS IN THIS VACCINE?

Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid 

(mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], 

cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, 

tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.

HAS THIS VACCINE BEEN USED BEFORE?

Millions of individuals 6 months of age and older have received a Moderna COVID-19 vaccine 

under EUA. In clinical trials, approximately 5,000 individuals 6 months through 5 years of age,

4,000 individuals 6 years through 11 years of age, and 30,000 individuals 12 years of age and older 

have received at least 1 dose of Moderna COVID-19 Vaccine (Original monovalent).

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

WHAT ARE THE BENEFITS OF MODERNA COVID-19 VACCINE?

FDA has authorized Moderna COVID-19 Vaccine to provide protection against COVID-19.

The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF MODERNA COVID-19 VACCINE?

There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic 

reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, 

the vaccination provider may ask your child to stay at the place where your child received the 

vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include: 

• Difficulty breathing

• Swelling of the face and throat

• A fast heartbeat

• A bad rash all over the body

• Dizziness and weakness 

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside 

the heart) have occurred in some people who have received mRNA COVID-19 vaccines. 

Myocarditis and pericarditis following Moderna COVID-19 vaccines have occurred most

commonly in young adult males 18 years through 24 years of age. In most of these individuals, 

symptoms began within a few days following vaccination. The chance of having this occur is very 
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low. You should seek medical attention right away if your child has any of the following symptoms 

after receiving the vaccine, particularly during the 2 weeks after your child receives a dose of the 

vaccine: 

• Chest pain

• Shortness of breath or difficulty breathing

• Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

• Fainting

• Unusual and persistent irritability

• Unusual and persistent poor feeding 

• Unusual and persistent fatigue or lack of energy

• Persistent vomiting

• Persistent pain in the abdomen

• Unusual and persistent cool, pale skin

Side effects that have been reported in clinical trials with Moderna COVID-19 vaccines include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm 

of the injection or in the groin, swelling (hardness), and redness

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, 

fever, rash, irritability/crying, sleepiness, and loss of appetite

Side effects that have been reported during post-authorization use include:

• Severe allergic reactions

• Urticaria (itchy rash/hives)

• Myocarditis (inflammation of the heart muscle)

• Pericarditis (inflammation of the lining outside the heart)

• Fainting in association with injection of the vaccine

These may not be all the possible side effects. Serious and unexpected side effects may occur. The 

possible side effects are still being studied.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 

Call the vaccination provider or your child’s healthcare provider if your child has any side 

effects that bother your child or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). 

The VAERS toll-free number is 1-800-822-7967 or report online to 

https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine (2023-2024 

Formula) EUA” in the first line of box #18 of the report form. 

In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-

3762).
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WHAT IF I DECIDE NOT TO HAVE MY CHILD GET MODERNA COVID-19 

VACCINE?

Under the EUA, there is an option to accept or refuse receiving this vaccine. Should you decide 

for your child not to receive this vaccine, it will not change the standard medical care.

ARE THERE OTHER VACCINES FOR PREVENTING COVID-19 BESIDES 

MODERNA COVID-19 VACCINE?

Other vaccines to prevent COVID-19 may be available under EUA, including vaccines that 

encode the spike protein of the SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron 

XBB.1.5). 

CAN MY CHILD RECEIVE MODERNA COVID-19 VACCINE AT THE SAME TIME AS 

OTHER VACCINES?

Data have not yet been submitted to FDA on administration of Moderna COVID-19 Vaccine at the 

same time as other vaccines. If you are considering having your child receive Moderna COVID-19 

Vaccine with other vaccines, discuss your options with your child’s healthcare provider. 

WHAT IF MY CHILD IS IMMUNOCOMPROMISED?

Immunocompromised individuals 6 months through 11 years of age may receive additional doses

of Moderna COVID-19 Vaccine (see HOW IS THE VACCINE GIVEN? above).

Vaccinations may not provide full immunity to COVID-19 in people who are 

immunocompromised; therefore, your child should continue to maintain physical precautions to 

help prevent COVID-19. Your child’s close contacts should be vaccinated as appropriate.

WHAT ABOUT PREGNANCY OR BREASTFEEDING?

If your child is pregnant or breastfeeding, discuss the options with your child’s healthcare 

provider.

WILL THIS VACCINE GIVE MY CHILD COVID-19?

No. This vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19.

ADDITIONAL INFORMATION

If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Moderna COVID-19 Vaccine website Telephone number

www.modernatx.com/covid19vaccine-eua 1-866-MODERNA

(1-866-663-3762)
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-legalregulatory-and-policy-framework/emergency-use-authorization

• Contact your state or local public health department

WHERE WILL VACCINATION INFORMATION BE RECORDED? 

The vaccination provider may include your child’s vaccination information in your state/local 

jurisdiction’s Immunization Information System (IIS) or other designated system. For more 

information about IISs, visit: https://www.cdc.gov/vaccines/programs/iis/about.html. 

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.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

The FDA has made Moderna COVID-19 Vaccine available under an emergency access 

mechanism call an EUA. An EUA is supported by a Secretary of Health and Human Services 

(HHS) declaration that circumstances exist to justify the emergency use of drugs and biological 

products during the COVID-19 pandemic. A product authorized for emergency use has not 

undergone the same type of review by FDA as an FDA-approved product. 

FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, 

approved, and available alternatives. In addition, the FDA decision is based on the totality of the 

scientific evidence available showing that the product may be effective to prevent COVID-19 

during the COVID-19 pandemic and that the known and potential benefits of the product 

outweigh the known and potential risks of the product. All of these criteria must be met to allow 

for the product to be used under EUA during the COVID-19 pandemic. 

The EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency 

use of this product, unless terminated or revoked (after which the product may no longer be 

used).

Moderna US, Inc.

Princeton, NJ 08540

©2023 ModernaTX, Inc. All rights reserved.

Patent(s): www.modernatx.com/patents

Revised: September/11/2023

Scan to capture that this Fact Sheet was provided to vaccine 

recipient for the electronic medical records/immunization 

information systems. 

GDTI: 0886983000615

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