Spikevax (Intramuscular)

SARS-CoV-2 vaccine (mRNA-LNP, spike protein) is being studied to help protect people aged 6 months and older from COVID-19 caused by the SARS-CoV-2 virus. The 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 should only be given by your doctor or under their direct supervision.

Monovalent Moderna COVID-19 vaccine is no longer allowed for use in the United States.

Be sure to tell your doctor about any side effects you notice after receiving this vaccine.

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

This vaccine may increase your risk of serious heart problems (for example, myocarditis, pericarditis), especially after the second dose. Contact your doctor immediately if you have anxiety, blue or pale skin, chest pain that may spread to the left arm, neck, or shoulder, fever, chills, a fast heartbeat, trouble breathing, or unusual tiredness or weakness.

Fainting may happen after you receive this vaccine. You might also notice changes in your vision, numbness or tingling in your arms, hands, or feet, or jerky movements of your arms and legs. Your doctor may want to observe you after you get the injection to help prevent and manage fainting.

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

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

In deciding to use a medicine, you need to think about the risks and benefits. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems in children 12 years and older that would limit the usefulness of the SARS-CoV-2 (COVID-19) vaccine in a vial with a red cap and a light blue border, in children 6 to 11 years in a vial with a dark blue cap and a purple or light blue border, and in children 6 months to 5 years in a vial with a dark blue cap and a magenta border. Safety and effectiveness have been confirmed.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the usefulness of the SARS-CoV-2 (COVID-19) vaccine. However, older patients are more likely to have liver, kidney, or heart issues related to age, which may require caution for those receiving this vaccine.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been selected based on 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 needed 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Heart disease (e.g., myocarditis, pericarditis)—Use with caution. May worsen these conditions.

• Immune system problems (e.g., patients who received an organ transplant)—This condition may reduce the effectiveness of the vaccine.

Along with its intended benefits, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Contact your doctor or nurse right away if you experience any of the following side effects:

More common

• Chills
• Difficulty in moving
• Fever
• Headache
• Joint pain
• Muscle aches, cramps, pains, or stiffness
• Nausea
• Swollen joints
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Anxiety
• Blue or pale skin
• Chest discomfort or tightness
• Chest pain, possibly radiating 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 happen that usually do not require medical attention. These may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also have suggestions on how to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects persist, 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, consult 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.

In the U.S.

• Spikevax

Available Dosage Forms:

• Suspension

Therapeutic Class: COVID-19 Vaccine

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 COVID-19 vaccine: This vaccine is given in 2 doses at least 1 month apart. If you have received 1 dose of Spikevax COVID-19 vaccine, you should receive a second dose of this vaccine to complete your vaccination series.

Moderna COVID-19 vaccine primary series (supplied in a vial with a dark blue cap and a label with a magenta border): This vaccine is given in 2 doses at least 1 month apart in children 6 months to 5 years of age. Patients who have a weak immune system may receive a third dose at least 1 month after the first 2 doses.

Moderna COVID-19 vaccine primary series (supplied in a vial with a dark blue cap and a label with a purple or light blue border): This vaccine is given in 2 doses at least 1 month apart in children 6 to 11 years of age. Patients who have a weak immune system may receive a third dose at least 1 month after the first 2 doses.

Moderna COVID-19 vaccine primary series (supplied in a vial with a red cap and a label with a light blue border): This vaccine is given in 2 doses at least 1 month apart in adults and children 12 years of age and older. Patients who have a weak immune system may receive a third dose at least 1 month after the first 2 doses.

Moderna COVID-19 vaccine first booster dose (supplied in a vial with a red cap and a label with a light blue border): You may be given a first booster dose of Moderna COVID-19 vaccine at least 5 months after your primary series with this vaccine. It is usually given to patients 18 years of age and older. You may also receive a first booster dose of this vaccine after your primary vaccination with another authorized or approved COVID-19 vaccine (eg, Janssen COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine).

Moderna COVID-19 vaccine second booster dose (supplied in a vial with a red cap and a label with a light blue border): You may be given a second booster dose of Moderna COVID-19 vaccine at least 4 months after your first booster dose with any authorized or approved COVID-19 vaccine. It is usually given to patients 18 years of age and older who have a weak immune system and to patients 50 years of age and older.

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.

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