Sars-cov-2 (covid-19) vaccine, protein subunit, adjuvanted (novavax) (Intramuscular)

SARS-CoV-2 (COVID-19) vaccine (protein subunit, adjuvanted) is being studied as a way to protect against COVID-19 caused by the SARS-CoV-2 virus in patients 12 years old and above. The SARS-CoV-2 (COVID-19) vaccine helps 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 someone directly supervised by your doctor.

Be sure to tell your doctor about any side effects (for example, feeling faint) that happen after you get this vaccine.

Fainting may happen after you get this vaccine. Your doctor may want you to be watched after the injection to prevent and manage fainting.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and needs immediate medical help. 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 getting the vaccine.

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

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 lower 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 need to consider the risks and benefits. For this medicine, keep the following in mind:

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 been done on how the SARS-CoV-2 (COVID-19) vaccine affects children younger than 12 years old. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the effectiveness of the SARS-CoV-2 (COVID-19) vaccine.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while you are receiving this medicine. The following interactions are based on their potential significance and are not necessarily a complete list.

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 the frequency of use for one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to 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 may worsen the condition.

• Immune system problems – This may reduce the effectiveness of the vaccine.

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

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

More common

• Fever
• Headache
• Joint or muscle pain
• Nausea
• Unusual tiredness or weakness
• Vomiting

Rare

• Swollen, painful, or tender lymph glands in the neck, armpit, or groin

Incidence not known

• Anxiety
• Blue or pale skin
• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• Chest discomfort or tightness
• Chest pain, possibly moving to the left arm, neck, or shoulder
• Chills
• Cough
• Difficulty swallowing
• Dizziness
• Fainting
• Fast heartbeat
• Hives, itching, skin rash
• 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 how 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:

More common

• Pain, redness, or swelling at the injection site

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

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

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.

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 the last previous dose of COVID-19 vaccine.

Patients 12 years of age and older who have not received any COVID-19 vaccine: Given in 2 doses 3 weeks apart.

Patients 12 years of age and older who have a weak immune system: 1 additional dose of Novavax COVID-19 vaccine, Adjuvanted may be given at least 2 months after the last dose of COVID-19 vaccine. 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.