Moderna COVID-19 vaccine

Pronunciation: muh-DURR-nah kow-vid nine-teen vak-seen
Generic name: COVID-19 vaccine, mRNA
Brand name: Moderna COVID-19 vaccine 2024-2025 Formula
Dosage form: suspension for intramuscular injection
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 27, 2024.

What is the Moderna COVID-19 vaccine?

The Moderna COVID-19 vaccine 2024-2025 Formula is an mRNA COVID-19 vaccine that may help your child develop immunity to SARS-CoV-2, the virus that causes COVID-19.

• The number of doses depends on age, vaccination status, and immune system status.
• The Moderna COVID-19 vaccine has been updated for 2024-2025 to cover Omicron KP.2.

The Moderna COVID-19 vaccine does not contain any live virus particles, including those of SARS-CoV-2, the virus that causes COVID-19. It cannot give your child COVID-19, although it may not protect everyone who receives the vaccine.

The Moderna COVID-19 vaccine is an mRNA vaccine, which means its mechanism of action is to use messenger RNA (mRNA) to provide instructions for making the spike protein of the COVID-19 virus. Your body then recognizes this spike protein as foreign and produces antibodies and T cells to attack it. This helps your child's body prepare to fight off the real COVID-19 virus if they are exposed to it.

The Moderna COVID-19 vaccine has been granted Emergency Use Authorization (EUA) for children aged 6 months through 11 years. It is not an FDA-approved vaccine.

• Under the EUA, there is an option to accept or refuse to receive this vaccine. Should you decide for your child not to receive this vaccine, it will not change the standard medical care.
• Spikevax is the COVID-19 vaccine made by Moderna which is approved for adults and adolescents 12 years and older.

Moderna COVID-19 vaccine side effects

The most common side effects of the Moderna COVID-19 vaccine in children aged 6 months through 36 months (3 years) include:

• Injection site redness, swelling, and pain
• Armpit or groin swelling or tenderness
• Fever
• Irritability/crying
• Loss of appetite
• Sleepiness.

The most common side effects of the Moderna COVID-19 vaccine in children aged 3 through 11 years include:

• Injection site redness, swelling, and pain
• Joint pain
• Armpit or groin swelling or tenderness
• Chills
• Fatigue
• Fever
• Headache
• Muscle pain
• Nausea or vomiting.

Other side effects that have been reported with the Moderna COVID-19 vaccine include:

• Severe and non-severe allergic reactions (see below)
• Myocarditis and pericarditis (see below)
• Fainting in association with an injection of the vaccine
• Febrile seizures (convulsions during a fever).

Serious side effects and warnings

There is a remote chance that the Moderna COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

• Difficulty breathing
• Swelling of your face and throat
• A fast heartbeat
• A bad rash all over your body
• Dizziness and weakness.

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

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, including the Moderna COVID-19 and Spikevax vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in young adult males 18 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 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 receiving 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 of myocarditis or pericarditis, 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.

These may not be all the possible side effects of the Moderna COVID-19 vaccine. Ask your healthcare provider about any side effects that concern you. Report vaccine side effects to the 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 (2024-2025 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).

Before receiving the Moderna COVID-19 vaccine

You should not receive the Moderna COVID-19 vaccine if you have had:

• a severe allergic reaction to a previous dose of the Moderna COVID-19 vaccine, Spikevax, or any of the components of the vaccine (see Ingredients below).

Before receiving the Moderna COVID-19 vaccine, tell your vaccination provider about all of your medical conditions, including if your child:

• has any allergies
• has had a severe allergic reaction to any COVID-19 vaccine
• 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 are on a blood thinner
• is immunocompromised or are on a medicine that affects their immune system
• is pregnant
• is breastfeeding
• has received another COVID-19 vaccine
• has ever fainted in association with an injection.

The safety and effectiveness of the Moderna COVID-19 Vaccine 2024-2025 Formula has not been evaluated in children less than 12 years of age, but data is available for previous vaccine formulations that were manufactured using the same process.

Pregnancy

MRNA COVID-19 vaccines are generally considered safe for use during pregnancy and major health organizations, including the CDC, ACOG, and AAP, recommend COVID-19 vaccination for pregnant individuals.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Moderna COVID-19 Vaccine during pregnancy and women should enroll by calling 1-866-MODERNA (1-866-663-3762). There is insufficient data to inform vaccine-associated risks in pregnancy, but animal studies and observational studies have revealed no evidence of harm to the fetus. Pregnant women infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant women and vaccination during pregnancy can help protect both the mother and the baby. Antibodies generated by the vaccine can pass to the fetus, potentially providing some protection to the newborn.

Breastfeeding

It is not known whether mRNA COVID-19 vaccines are excreted in human milk or their effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.

How is the Moderna COVID-19 vaccine given?

The Moderna COVID-19 vaccine is given to your child as an injection into a muscle, usually the deltoid muscle of the upper arm.

• How many injections of the Moderna COVID-19 vaccine your child gets depends on their age, vaccination status, and health status.
• The duration of protection that the Moderna COVID-19 vaccine provides against COVID-19 is currently unknown.

Moderna COVID-19 vaccine dosage

Moderna COVID-19 vaccine (2024-2025) Formula is supplied as a single-dose prefilled syringe.

Children aged 6 months through 4 years of age

Unvaccinated children: 2 doses of the Moderna COVID-19 vaccine are recommended

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

Children who have received 1 previous dose of a Moderna COVID-19 vaccine: A single dose of the Moderna COVID-19 vaccine is recommended.

• Administer at least 1 month after the previous dose.

Children who have received 2 or more previous doses of a Moderna COVID-19 vaccine: 1 dose of the Moderna COVID-19 vaccine is recommended.

• A single dose is administered at least 2 months after the last previous dose of a Moderna COVID-19 vaccine.

Children aged 5 through 11 years of age

• A single dose of the Moderna COVID-19 vaccine is administered to children who have not yet received a COVID-19 vaccine (2024-2025 Formula).
• You must wait at least 2 months after the last previous dose of any COVID-19 vaccine.

Immunocompromised children aged 6 months through 11 years of age

Immunocompromised children may receive additional doses of the Moderna COVID-19 vaccine. Talk to your healthcare provider about this.

• 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 other drugs will affect the Moderna COVID-19 vaccine?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products your child takes. Tell your healthcare provider if your child takes:

• a blood thinner, such as warfarin
• a medicine that affects your immune system, such as cyclosporine

Also, tell your healthcare provider if your child has received any other COVID-19 vaccines.

Moderna COVID-19 vaccine ingredients

Active ingredients: messenger ribonucleic acid (mRNA) 50 mcg

Inactive ingredients: 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.

The Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers, rubber tip cap, and plunger used for the single-dose syringes are not made with natural rubber latex

The Moderna COVID-19 Vaccine does not contain SARS-CoV-2, the virus that causes COVID-19, and cannot give you COVID-19.

Who makes the Moderna COVID-19 vaccine?

Moderna US, Inc. makes the Moderna COVID-19 vaccine.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer