Spikevax

Pronunciation: SPIK-vax
Generic name: COVID-19 Vaccine, mRNA
Other brand names of COVID-19 Vaccine, mRNA include: Spikevax 2024-2025 Formula
Dosage form: suspension for intramuscular injection (0.25 mL, 0.5 mL)
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 14, 2025.

What is Spikevax?

Spikevax 2024-2025 Formula is an mRNA COVID-19 vaccine made by Moderna that may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19

• Approved for adults and adolescents aged 12 and older, and for children 6 months through 11 years at increased risk for COVID-19 disease. 
• Updated for 2024-2025 to cover Omicron KP.2.

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

Spikevax works by delivering modified messenger RNA (mRNA) into your cells, where it instructs them to produce a piece of the coronavirus called the spike protein. Your immune system then learns to recognize this spike protein, creating protection against COVID-19. Spikevax belongs to the drug class called mRNA vaccines.

Spikevax is an FDA-approved vaccine for adults and adolescents aged 12 years and older. 

• Spikevax is also approved for infants and children aged 6 months through 11 years at increased risk for COVID-19 disease. 

Spikevax side effects

The most common side effects of Spikevax in infants aged 6 months through 36 months are:

• Irritability/crying
• Pain at the injection site
• Sleepiness
• Loss of appetite
• Fever
• Erythema
• Swelling at the injection site
• Armpit (axillary) or groin swelling.

The most common side effects of Spikevax in children aged 37 months through 11 years are:

• Pain at the injection site
• Fatigue
• Headache
• Myalgia
• Chills
• Nausea/vomiting
• Armpit (axillary) or groin swelling/tenderness
• Fever
• Erythema
• Swelling at the injection site
• Joint pain (arthralgia).

The most common side effects of Spikevax in adolescents aged 12 through 17 years are:

• Pain at the injection site
• Fatigue
• Headache
• Muscle pain (myalgia)
• Arthralgia
• Nausea/vomiting
• Swelling at the injection site.

The most common side effects of Spikevax in adults aged 18 through 64 years are:

• Pain at the injection site
• Fatigue
• Headache
• Muscle pain (myalgia)
• Arthralgia
• Chills
• Armpit (axillary) or groin swelling/tenderness
• Nausea/vomiting.

The most common side effects of Spikevax in adults aged 65 and older are:

• Pain at the injection site
• Fatigue
• Myalgia
• Headache
• Arthralgia
• Chills
• Armpit (axillary) or groin swelling/tenderness.

Serious side effects and warnings

Serious allergic reactions have occurred in some people who have received Spikevax and Moderna COVID-19 vaccines. There is a very small chance that Spikevax 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 for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:

• Trouble breathing
• Swelling of your face and throat
• A fast heartbeat
• A rash all over your 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, including Spikevax and Moderna COVID-19 vaccines. Myocarditis and pericarditis following Spikevax have occurred most commonly in males aged 12 through 24 years. In most of these individuals, symptoms began within a week following vaccination. The estimated rate of this side effect in the week following vaccination is 8 cases per million doses in people 6 months through 64 years of age and approximately 27 cases per million doses in males 12 years through 24 years of age. You should seek medical attention right away if you or 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
• Feelings of having a fast-beating, fluttering, or pounding heart.

These may not be all the possible side effects of Spikevax. 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.

Related/similar drugs

Before receiving Spikevax

You should not get Spikevax if you have had a severe allergic reaction to a previous dose of Spikevax, a Moderna COVID-19 vaccine, or any of the components in the vaccine (see "Ingredients' below).

Tell your vaccination provider about all of your medical conditions, including if you:

• have any allergies
• had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
• 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
• are pregnant or plan to become pregnant
• are breastfeeding
• have received another COVID-19 vaccine
• have ever fainted in association with an injection.

Pregnancy

Spikevax is generally considered safe for use during pregnancy and major health organizations, including the CDC, ACOG, and AAP, recommend COVID-19 vaccination for pregnant individuals, which includes Spikevax.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to
Spikevax 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 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.

Breastfeeding

It is not known whether Spikevax is excreted in human milk or its effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.

How is Spikevax given?

Spikevax is given to you by a healthcare provider as an injection into a muscle, usually the deltoid muscle of the upper arm.

• 1 Spikevax injection is usually given. A single dose for patients 12 and older is 0.5 mL.
• For children aged 6 months through 11 years, the dose is 0.25 mL.
• For patients 2 years and older previously vaccinated with any COVID-19 vaccine, the dose of Spikevax should be administered at least 2 months after the last dose of the COVID-19 vaccine.

Dosing information

Dose of Spikevax for COVID-19 prevention (Infants 6 months through 23 months)

• No previous doses of Moderna COVID-19 vaccines: 2 doses of 0.25 mL each.
  • Dose 1: month 0
  • Dose 2: month 1
• 1 previous dose of Moderna COVID-19 vaccines: Single dose of 0.25 mL.
  • One month after receipt of a previous dose of the Moderna COVID-19 vaccine.
• 2 or more previous doses of Moderna COVID-19 vaccines: Single dose of 0.25 mL each
  • One month after receipt of a previous dose of the Moderna COVID-19 vaccine.

Note: Previous dose refers to a dose of any authorized Moderna COVID-19 vaccine.

Dose of Spikevax for COVID-19 prevention (Patients 2 years of age and older, irrespective of COVID-19 vaccination status)

• Age 2 years through 11 years: Single dose of 0.25 mL
• Aged 12 years and older: Single dose of 0.5 mL.

Note: If previously vaccinated with any COVID-19 vaccine, administer the dose ≥2 months after the last dose of COVID-19 vaccine.

What other drugs will affect Spikevax?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tell your healthcare provider if you take:

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

Also, tell your healthcare provider if you have received any other COVID-19 vaccines.

Spikevax ingredients

Spikevax 0.5 mL

Active ingredient: Each 0.5 mL dose of SPIKEVAX (2024-2025 Formula) contains 50 mcg nucleoside-modified
messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the
SARS-CoV-2 Omicron variant lineage KP.2. 

Inactive ingredients (0.5 mL dose, 2025-2025 Formula): Each dose also contains the following ingredients:
a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol
[DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose. 

Spikevax 0.25 mL

Active ingredient: Each 0.25 mL dose of SPIKEVAX (2024-2025 Formula) contains 25 mcg nucleoside-modified
messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the
SARS-CoV-2 Omicron variant lineage KP.2. 

Inactive ingredients (0.25 mL, 2024-2025 Formula): Each dose also contains the following ingredients:
a total lipid content of 0.50 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol
[DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.13 mg
tromethamine, 0.62 mg tromethamine hydrochloride, 0.011 mg acetic acid, 0.049 mg sodium
acetate trihydrate, and 21.8 mg sucrose. 

Spikevax 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

Who makes Spikevax

Moderna US, Inc. makes Spikevax.

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Further information

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

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