COVID-19 (5y-11y) vaccine, Comirnaty (2026-2027)

COVID-19 is a serious illness caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 spreads from person to person 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 children who have never been vaccinated before or who have already received a COVID-19 vaccine.

The Comirnaty vaccine is used to prevent COVID-19 in children 5 to 11 years old who are at high risk for severe COVID-19.

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

Like any vaccine, the COVID-19 vaccine may not provide protection for 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 in children 5 to 11 years old is given:

• to unvaccinated children: a single dose of Comirnaty COVID-19 vaccine.
• to children 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 child needs extra doses.

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

Getting a COVID-19 vaccine will not make your child test positive on a coronavirus test. However, once the body builds immunity to COVID-19, your child might test positive on an antibody test (a test to see if the body has immunity from past exposure to coronavirus).

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

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

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

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

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

Ask your child's doctor if you are unsure about any COVID-19 treatments your child has received.

Tell the vaccination provider if your child:

• has any allergies;
• has had inflammation in or around the heart (myocarditis or pericarditis);
• has a fever;
• has bleeding problems or is using a blood thinner;
• has a weak immune system caused by disease or by using certain medicines (this vaccine may not work as well if your child is immunosuppressed);
• has received any other COVID-19 vaccine or if they are scheduled to receive a vaccine; or
• has fainted after receiving an injection.

Get emergency medical help if your child shows signs of an allergic reaction: hives, trouble breathing, swelling of your child's face, lips, tongue, or throat.

The vaccination provider may want to observe your child for a short time after the injection to ensure your child does not have an allergic reaction or faint. Your child will receive quick treatment if there is a reaction right after getting the vaccine.

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

Not all possible side effects are known. Getting infected with COVID-19 may be much more harmful to your child's health than receiving this vaccine.

Some people who received this vaccine experienced inflammation of the heart muscle or the lining around the heart after vaccination, usually within the first week. Seek medical help immediately if your child has the following symptoms, especially within the first two weeks:

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

Common side effects of COVID-19 (5y-11y) vaccine, Comirnaty may include:

• fever, chills, feeling tired, cool or pale skin;
• stomach pain, nausea, vomiting, diarrhea, loss of appetite;
• dizziness, headache, muscle pain, joint pain;
• pain, redness, or swelling at the injection site; 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. Call your child's 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 may also use a smartphone-based program called V-safe to communicate with the Centers for Disease Control and Prevention (CDC) about any health issues your child experiences after receiving a COVID-19 vaccine: www.cdc.gov/vsafe

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 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.-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 less than 12 years of age with at least 1 underlying condition that puts them at high-risk for severe outcomes from COVID-19

Contact your vaccination provider or health department if your child does not receive a dose.

An overdose of this vaccine is not likely to happen.

Do not receive other vaccines before getting medical advice.

Before your child gets this vaccine, inform your vaccination provider about all the other vaccines your child has received. Other medications may impact this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Make sure to tell your doctor about all other medicines your child is using.