Spikevax

Pronunciation: SPIK-vax
Generic name: COVID-19 Vaccine, mRNA
Brand name: Spikevax 2024-2025 Formula
Dosage form: suspension for intramuscular injection
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 1, 2024.

What is Spikevax?

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

• Given as a single dose for adults and adolescents aged 12 and older.
• 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 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 body prepare to fight off the real COVID-19 virus if you're exposed to it.

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

• The Moderna COVID-19 vaccine has Emergency Use Authorization (EUA) for children aged 6 months through 11 years.
• The safety and effectiveness of Spikevax has not been established in children less than 12 years of age.

Spikevax side effects

The most common side effects of Spikevax include:

• Pain where you get the injection
• Tiredness or fatigue
• Headache
• Muscle pain
• Chills
• Tenderness and swelling of the lymph nodes in the same arm
  of the injection
• Joint pain
• Nausea or vomiting
• Injection site swelling.

Other side effects reported include fever, rash, and fainting soon after a Spikevax injection.

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 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 you or your child have 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 as an injection into a muscle, usually the deltoid muscle of the upper arm.

• 1 Spikevax injection is usually given. A single dose is 0.5 mL.
• For individuals 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.

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

Active: messenger ribonucleic acid (mRNA) 50 mcg

Inactive: 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.

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.

Further information

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

Medical Disclaimer