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 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.

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.

Spikevax is given as an injection into the muscle. The Spikevax vaccination series is 2 doses given 1 month apart. If you receive one dose of Spikevax, you should receive a second dose of Spikevax 1 month later to complete the vaccination series.

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.

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.

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

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.