Spikevax

Pronunciation: SPIKE-vacs
Generic name: COVID-19 Vaccine, mRNA
Brand name: Spikevax (2023-2024 Formula)
Dosage form: intramuscular injection
Drug class: Viral vaccines

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 27, 2023.

What is Spikevax?

Spikevax 2023-2024 Formula (COVID-19 Vaccine, mRNA) is a vaccine that may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. Spikevax is an FDA-approved vaccine for adults and adolescents aged 12 years and also has emergency use authorization (EUA) for children aged 6 months to 11 years.

This updated vaccine contains messenger RNA (mRNA) encoding spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 and trials have shown it elicits robust immune responses across multiple XBB sublineages including XBB.1.5, XBB.1.16, and also against EG.5, FL.1.5.1, and BA.2.86. Vaccination with Spikevax may not protect all people who receive the vaccine.

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.

Spikevax (2023-2024 Formula) was FDA-approved and granted EUA on September 11, 2023.

Warnings

Contraindicated in people who have had a severe allergic reaction (such as anaphylaxis) to any component of Spikevax.

Postmarketing data has revealed there is an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination. The highest observed risk for Spikevax is in males aged 18 years through 24 years of age.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may
have less of a response to Spikevax.

Who should not receive Spikevax?

You should not receive Spikevax if you have had:

a severe allergic reaction to a previous dose of Spikevax (also called Moderna COVID-19 Vaccine) or any of the components of the vaccine (see below 'What are the ingredients in 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.

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.

Safety and effectiveness have not been established in children less than 12 years of age. Evidence from clinical studies strongly suggests that a single dose of Spikevax is ineffective in individuals younger than 2 years of age.

What should I tell my healthcare provider?

Tell your healthcare provider about all 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 any other COVID-19 vaccine
have ever fainted in association with an injection.

How is Spikevax given?

Spikevax is given as an injection into the muscle, usually the deltoid muscle of the arm.

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 are the side effects of Spikevax?

Severe allergic reactions have occurred in some people who have received Spikevax (also called Moderna COVID-19 Vaccine). 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 one hour after getting a dose of Spikevax. For this reason, your healthcare 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:

Difficulty 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 Spikevax (also called Moderna COVID-19 Vaccine), more commonly in males aged 18 years through 24 years of age than among females and older males. In most of these people, symptoms began within a week of Spikevax vaccination. The chance of this happening is very low. You should seek medical attention right away if you have any of the following symptoms after receiving Spikevax:

Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart.

The most common side effects reported with Spikevax include:

Pain at the injection site (up to 91%)
Fatigue (up to 58%)
Headache (up to 56%)
Muscle pain (up to 40%)
Chills (up to 30%)
Under the armpit swelling/tenderness (up to 28%)Joint pain (up to 24%)
Nausea/vomiting (up to 18%)
Swelling at the injection site (up to 13%).

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

Severe allergic reactions
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 of Spikevax. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov

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
a medicine that affects your immune system.

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

What are the ingredients in Spikevax?

Active ingredients: Each 0.5 mL dose of Spikevax (2023-2024 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 XBB.1.5.

Other ingredients: 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 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

Spikevax does not contain SARS-CoV-2, the virus that causes COVID-19. Spikevax cannot give you COVID-19.

Storage

Store frozen between -50°C to -15°C (-58°F to 5°F).

Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30
days before first use.
Vials should be discarded 12 hours after the first puncture.

Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.