Sars-cov-2 (covid-19) vaccine, mrna (moderna) (Intramuscular)

SARS-CoV-2 vaccine, mRNA (Moderna) is being studied as a way to help the body fight off COVID-19 caused by the SARS-CoV-2 virus in patients who are 6 months old and older. 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 must be given only by your doctor or under their direct supervision.

Be sure to tell your doctor about any side effects that happen after you get this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical help. Contact your doctor right away if you experience a rash, itching, a fast heartbeat, difficulty 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 issues (for example, myocarditis, pericarditis). Check with your doctor immediately if you feel anxious, have 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. Your doctor may want you to be monitored after the injection to help prevent and manage fainting.

This vaccine may not protect everyone who gets it. This vaccine will not treat symptoms of COVID-19 infection if you already have the disease. It is very important that you take steps to reduce the 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 and your doctor must consider the risks of taking the medicine against the benefits it may provide.

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 if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies to determine how age affects the use of SARS-CoV-2 (COVID-19) vaccine in children younger than 6 months. Its safety and effectiveness have not been established.

There have not been appropriate studies to determine how age affects the use of Spikevax® vaccine in children younger than 12 years. Its safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the usefulness of SARS-CoV-2 (COVID-19) vaccine. However, older patients may be more likely to experience serious unwanted effects, so caution may be needed for those receiving this vaccine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together. In some cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines while receiving this medicine. The following interactions are significant but not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Drinking alcohol or using 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 impact the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Heart disease (e.g., myocarditis, pericarditis)—Use with caution. This condition may worsen with the vaccine.

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

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you 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, possibly 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also 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, 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.

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®:

• 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.

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