Pronunciation:

SARS-COV-2 (COVID-19), VAX-een, mRNA (moe-DER-na)

Brand Names:

• Spikevax

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

COVID-19 Vaccine

Uses of This Medicine:

SARS-CoV-2 vaccine, mRNA (Moderna) is under investigation as an active immunization against COVID-19 caused by the SARS-CoV-2 virus in patients 6 months of age and older. SARS-CoV-2 (COVID-19) vaccine is used to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of SARS-CoV-2 (COVID-19) vaccine in children younger than 6 months of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Spikevax® vaccine in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of SARS-CoV-2 (COVID-19) vaccine in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution for patients receiving this vaccine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Rituximab
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease (eg, myocarditis, pericarditis), history of—Use with caution. May make this condition worse.

• Immune system problems (eg, patients who received an organ transplant)—This condition may decrease the useful effects of the vaccine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.

Spikevax®:

• Patients 12 years of age and older who have not received any COVID-19 vaccine—Given as a single dose.
• Patients 12 years of age and older who have received any COVID-19 vaccine—Given as a single dose at least 2 months after receiving COVID-19 vaccine.

Patients 6 months of age and older who have not received any COVID-19 vaccine:

• 6 months through 4 years of age—2 doses 1 month apart (Dose 1 given at month 0 and Dose 2 given at month 1).
• 5 through 11 years of age—Given as a single dose.

Patients 6 months through 4 years of age and older who have received Moderna COVID-19 vaccine:

• 6 months through 4 years of age who have received 1 previous dose—Given as a single dose 1 month after receiving Moderna COVID-19 vaccine.
• 6 months through 4 years of age who have received 2 previous doses—Given as a single dose at least 2 months after receiving Moderna COVID-19 vaccine. .

Patients 5 years of age and older who have received 1 or more doses of any monovalent COVID-19 vaccine:

• 5 through 11 years of age—Given as a single dose at least 2 months after receiving monovalent COVID-19 vaccine.

Patients who have a weak immune system:

• 6 months through 11 years of age who have not received any COVID-19 vaccine—Given in 3 doses 1 month apart.
• 6 months through 11 years of age who have received 1 or 2 previous doses of Moderna COVID-19 vaccine, monovalent or bivalent—Given in 1 or 2 more doses.
• 6 months through 11 years of age who have received 3 or more previous doses—1 additional dose of Moderna COVID-19 vaccine may be given at least 2 months after the most recent dose. Your doctor may give you an additional dose depending on your condition.

This vaccine comes with a Fact Sheet for Recipients and Caregivers. Read and follow the information in the Fact Sheet carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine may increase your risk of serious heart problems (eg, myocarditis, pericarditis). Check with your doctor right away if you have anxiety, blue or pale skin, chest pain, possibly moving to the left arm, neck, or shoulder, fever, chills, a fast heartbeat, trouble breathing, or unusual tiredness or weakness.

Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent and manage fainting.

This vaccine may not protect everyone who receives it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease. It is very important that you take precautions to reduce the risk of COVID-19.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

difficulty in moving

headache

joint pain

muscle aches, cramps, pains, or stiffness

nausea

swollen joints

unusual tiredness or weakness

vomiting

Less common

Fever

Incidence not known

Anxiety

blue or pale skin

chest discomfort or tightness

chest pain, possible moving to the left arm, neck, or shoulder

cough

difficulty swallowing

dizziness

fast heartbeat

fainting

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.