COVID-19 (12y+) vaccine, Comirnaty (2026-2027)

COVID-19 is a serious illness caused by a coronavirus named SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 spreads from one person to another through the air.

COVID-19 can impact your lungs or other organs. Symptoms can be mild or severe and may include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.

Comirnaty vaccine is used to prevent COVID-19 in people who have never been vaccinated before or who have already received a COVID-19 vaccine.

Comirnaty vaccine is used to prevent COVID-19 in people:

• age 65 and older; or
• 12 years through 64 years of age and at high risk for severe COVID-19.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, the COVID-19 vaccine may not provide protection in every person.

Read all vaccine information sheets provided to you.

Comirnaty COVID-19 vaccine is given as an injection into a muscle.

Comirnaty COVID-19 vaccine for people aged 12 years and older is given:

• to unvaccinated individuals: a single dose of Comirnaty COVID-19 vaccine.
• to people who have already received a dose of any COVID-19 vaccine: a single dose of Comirnaty COVID-19 vaccine is given at least 2 months after the last dose of any COVID-19 vaccine.

The doctor or vaccination provider will decide if an immunocompromised person needs extra doses.

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face coverings, disinfecting surfaces you touch often, and not sharing personal items with others.

Getting a COVID-19 vaccine will not make you test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to check for immunity in the body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from COVID-19 infection. It is also not known how long immunity lasts for someone who has been infected with and recovered from COVID-19. The COVID-19 vaccine is still being studied, and not all of its risks are known yet. Updated federal public health recommendations may be found at https://www.cdc.gov/covid/index.html

Getting infected with COVID-19 may pose a much greater risk to your health than getting this vaccine.

You should not receive this vaccine if you have ever had a severe allergic reaction to Comirnaty, Pfizer COVID-19 vaccine, or if you have or have ever had:

• an allergy to any of the ingredients in this vaccine.

If you are infected with COVID-19, waiting for test results, or have been exposed to someone with COVID-19: you may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period is over. Getting this vaccine will not make you less contagious to others if you are infected with COVID-19 but do not have symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you have received.

Tell your vaccination provider if you:

• have any allergies;
• have had inflammation in or around your heart (myocarditis or pericarditis);
• have a fever;
• have bleeding problems or are using a blood thinner;
• have a weak immune system due to a disease or certain medicines (this vaccine may not work as well if you are immunosuppressed);
• are pregnant, plan to become pregnant, or are breastfeeding;
• have received any other COVID-19 vaccine or are scheduled to receive a vaccine; or
• have fainted after receiving an injection.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, or swelling of your face, lips, tongue, or throat.

The vaccination provider may monitor you for a short time after the injection to ensure you do not have an allergic reaction or faint. You will receive prompt treatment if a reaction occurs right after getting the vaccine.

You should not receive this vaccine if you had an allergic reaction to any dose of a COVID-19 vaccine. The doctor or vaccination provider will decide if you can safely get this vaccine.

Not all possible side effects are known. Getting infected with COVID-19 may pose a greater risk to your health than receiving this vaccine.

Some people (most often males aged 12 to 24 years) have experienced inflammation of the heart muscle or the lining around the heart after vaccination, usually within the first week. Seek medical help immediately if you experience any of the following symptoms, especially within the first two weeks:

• chest pain;
• shortness of breath; or
• fast or pounding heartbeats, or fluttering in your chest.

Common side effects of the COVID-19 (12y+) vaccine, Comirnaty may include:

• fever, chills, feeling tired;
• nausea, vomiting, diarrhea, loss of appetite;
• dizziness, headache, muscle pain, joint pain;
• pain, swelling, redness, or arm pain where the injection was given; or
• swelling or tenderness under the arm where the injection was given.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

You can also use a smartphone program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health issues you have after receiving a COVID-19 vaccine: www.cdc.gov/vsafe

Usual Adult Dose for COVID-19:

GRAY LABEL: 0.3 mL IM ONCE, at least 2 months after receiving the last previous dose of COVID-19 vaccineComments:-Each 0.3 mL dose of the gray labeled syringe contains 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUses:-Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 to 64 years of age with at least 1 underlying condition that puts them at high-risk for severe outcomes from COVID-19-Active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 65 years and older

Usual Pediatric Dose for COVID-19:

5 to 11 years:-BLUE CAP/LABEL: 0.3 mL IM ONCE, at least 2 months after receiving the last previous dose of COVID-19 vaccine12 years and older:-GRAY LABEL: 0.3 mL IM ONCE, at least 2 months after receiving the last previous dose of COVID-19 vaccineComments:-Each 0.3 mL dose of the blue capped and labeled single-dose vial contains 10 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1.-Each 0.3 mL dose of the gray labeled syringe contains 30 mcg of a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant sublineage LP.8.1.-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorizationUse: Active immunization to prevent COVID-19 caused by SARS-CoV-2 in patients 5 to 18 years of age with at least 1 underlying condition that puts them at high-risk for severe outcomes from COVID-19

If you miss a dose, contact your vaccination provider or health department.

An overdose of this vaccine is unlikely to happen.

Do not receive other vaccines without getting medical advice first.

Before getting this vaccine, inform your vaccination provider about all other vaccines you have had. Other medications may interact with this vaccine, including prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all other medicines you are using.