COVID-19 (5y-11y) vaccine, Pfizer (2024-2025)

Generic name: COVID-19 (5y-11y) vaccine, Pfizer (2024-2025) [ KOE-vid-19 VAX-een ]
Brand names: Pfizer-BioNTech COVID-19 (2024-2025) Vaccine PF (cvx 310), Pfizer-BioNTech COVID-19 (2023-2024) Vaccine PF (cvx 310)
Dosage form: intramuscular suspension (preservative-free 10 mcg/0.3 mL)

What is the COVID-19 vaccine?

COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.

COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and 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.

The COVID-19 vaccine is used to help prevent COVID-19 caused by SARS-CoV-2.

The FDA has authorized emergency use of the Pfizer vaccine in people who are 5 years to 11 years old.

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

This vaccine side effects

Get emergency medical help if your child has signs of an allergic reaction: hives, rash, dizziness, weakness, fast heartbeats, difficult breathing, swelling of the face, lips, tongue, or throat.

The vaccination provider may want to watch your child for a short time after the shot, to make sure your child does not have an allergic reaction. Your child will be treated quickly if there is a reaction right after receiving the vaccine.

Your child should not receive this vaccine if the first shot of COVID-19 vaccine caused an allergic reaction. The doctor or vaccination provider will determine if your child can safely receive this vaccine.

Not all possible side effects are known. Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine.

Some people receiving this vaccine had inflammation of the heart muscle or the lining around the heart within the first couple weeks after receiving this vaccine, but the risk of this side effect is very low. Seek medical attention right away if your child has:

chest pain;
shortness of breath or breathing problems; or
fast or pounding heartbeats or fluttering in your chest.

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

fainting;
irritability;
loss of appetite;
fever, cool or pale skin, chills;
pain, redness or a hardness and swelling where the shot was given;
swelling or tenderness under the arm;
stomach pain, nausea, vomiting, diarrhea;
feeling tired; or
headache, muscle pain, joint pain.

This is not a complete list of side effects and others may occur. Call the doctor for medical advice about side effects. You may 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 problems your child has after receiving a COVID-19 vaccine: www.cdc.gov/vsafe.

Warnings

Becoming infected with COVID-19 is much more dangerous to your child's health than receiving this vaccine.

Before taking this medicine

Your child should not receive this vaccine if your child has ever had a severe allergic reaction to a Pfizer COVID-19 vaccine.

If your child is infected with COVID-19, is waiting for testing results, or is exposed to someone infected with COVID-19: Your child may not be able to receive this vaccine until your child has no symptoms and/or the required quarantine period has ended. Receiving this vaccine will not make your child less contagious to other people if your child is infected with COVID-19 but has no symptoms.

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

Tell the vaccination provider if your child:

is pregnant or breastfeeding;
has a fever;
has any allergies;
has had inflammation in or around the heart (myocarditis or pericarditis);
has bleeding problems, or if your child uses a blood thinner (warfarin, Coumadin, Jantoven);
has a weak immune system caused by disease or by using certain medicine;
has received any other COVID-19 vaccine or if your child is scheduled to receive a vaccine; or
has fainted after receiving an injection.

How is this vaccine given?

Read all vaccine information sheets provided to you.

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

The Pfizer COVID-19 vaccine is given to:

unvaccinated children: a single dose of Pfizer COVID-19 vaccine.
children who have received one or more doses of any COVID-19 vaccine: a single dose of Pfizer COVID-19 vaccine is given at least 2 months after the last previous dose of any monovalent or bivalent COVID-19 vaccine.

The doctor or vaccination provider will determine whether an immunocompromised child needs additional doses.

You will receive a reminder card showing the date and type of each injection. Take this card with you each time your child receives a COVID-19 vaccine.

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 covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause your child to test positive on a coronavirus test. However, once the body develops immunity to COVID-19, your child could test positive on an antibody test (a test to detect immunity in the body from previous exposure to coronavirus).

It is not known how long this vaccine will protect your child from infection with COVID-19. It also is not known how long immunity will last in a child who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines.

COVID-19 (5y-11y) vaccine, Pfizer dosing information

Usual Pediatric Dose for COVID-19:

For investigational use only

BLUE CAP/BORDER COLOR:
5 years to 11 years:
-All Patients (Irrespective of COVID-19 Vaccine Status): 0.3 mL IM once, at least 2 months after receiving the last previous dose of COVID-19 vaccine.

Patients With Certain Immunocompromising Conditions Who Are Not Previously Vaccinated with A COVID-19 Vaccine:
-Dose 1: 0.3 mL IM ONCE on Week 0
-Dose 2: 0.3 mL IM ONCE on Week 3
-Dose 3: 0.3 mL IM ONCE at least 4 weeks after Dose 2

Patients Previously Vaccinated with Pfizer-BioNTech Monovalent or Bivalent COVID-19 Vaccine:
1 PREVIOUS DOSE: 0.3 mL IM for 2 doses, with the first doses administered 3 weeks after receipt of the previous vaccine, then the third dose administered at least 4 weeks after the first bivalent vaccine dose.

2 OR MORE PREVIOUS DOSES: 0.3 mL IM once, administered at least 2 months after receipt of the last previous dose of the vaccine.

Comments:
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this unapproved product for active immunization to prevent COVID-19. This product is not approved by the US FDA for this use.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For the emergency use for the active immunization to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including the COVID-19 Omicron variant lineage KP.2

What happens if I miss a dose?

Contact the vaccination provider or health department if your child misses a dose.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving this vaccine?

Avoid receiving other vaccines without first seeking medical advice.

What other drugs will affect this vaccine?

Before your child receives this vaccine, tell the vaccination provider about all other vaccines your child has received and all medicines your child uses. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Further information

The vaccination provider, pharmacist, or doctor can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer