Pronunciation:

SARS-COV-2 (COVID-19), VAX-een, mRNA (FYE-zer)

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

COVID-19 Vaccine

Uses of This Medicine:

SARS-CoV-2 vaccine (mRNA-LNP, spike protein) is used 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.

Monovalent Pfizer-BioNTech COVID-19 vaccine is no longer authorized for use in the United States.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of SARS-CoV-2 (COVID-19) vaccine supplied in vials with gray caps or vials with purple caps in children 12 years of age and older, vials with orange caps in children 5 to 11 years of age, and vials with maroon caps in children 6 months to 4 years of age. Safety and efficacy have been established.

Appropriate studies have not been performed on the relationship of age to the effects of SARS-CoV-2 (COVID-19) vaccine supplied in vials with gray caps or vials with purple caps in children younger than 12 years of age. Safety and efficacy have not been established.

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.

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.

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.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• 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.

Primary series (for vaccines supplied in vials with maroon caps): This vaccine is usually given in 3 doses. The first 2 doses are given at least 3 weeks apart followed by a third dose given at least 8 weeks after the second dose. It is usually given to patients 6 months to 4 years of age. Tell your doctor if your child will turn from 4 years to 5 years of age between any doses in the primary series.

Primary series (for vaccines supplied in vials with orange caps): This vaccine is usually given in 2 doses at least 3 weeks apart. Patients who have a weak immune system may receive a third dose at least 28 days after the first 2 doses. It is usually given to patients 5 to 11 years of age.

Primary series (for vaccines supplied in vials with gray or purple caps): This vaccine is usually given in 2 doses at least 3 weeks apart.

First booster dose (for vaccines supplied in vials with gray, purple, or orange caps): You may be given a first booster dose of Pfizer-BioNTech COVID-19 vaccine at least 5 months after your primary series with this vaccine. It is usually given to patients 5 years of age and older. A first booster dose of this vaccine may also be given to patients 18 years of age and older who have received primary vaccination with another authorized or approved COVID-19 vaccine (eg, Janssen COVID-19 vaccine or Moderna COVID-19 vaccine).

Second booster dose (for vaccines supplied in vials with gray or purple caps): You may be given a second booster dose of Pfizer-BioNTech 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 12 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.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects (eg, feeling faint, especially in teenagers) that occur after you receive this vaccine.

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 cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires 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), especially after you receive the second dose. 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.

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

diarrhea

fever

headache

irritability

joint or muscle pain

swollen, painful, or tender lymph glands in the neck, armpit, or groin

unusual tiredness or weakness

Less common

Nausea

vomiting

Rare

Decreased appetite

general feeling of discomfort or illness

pain in the arms

rash

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

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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:

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 healthcare professional.

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