The Vaccine Is Authorized as a 2-Dose Primary Vaccination Series for Individuals 5 Through 11 Years of Age
A third primary series dose at least 28 days following the second dose is authorized to be given to individuals 5 through 11 years of age who have certain kinds of immunocompromise.
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
The vaccine may not protect everyone.
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What you need to know about the vaccine
Frequently Asked Questions
What Is Emergency Use Authorization?
According to the FDA, “During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.”
Why You Should Consider Vaccinating Your Child
According to the CDC, although children are at a lower risk of becoming severely ill with COVID-19 compared with adults, children can
- Be infected with the virus that causes COVID-19
- Get very sick from COVID-19
- Have both short- and long-term health complications from COVID-19
- Spread COVID-19 to others
Children with underlying medical conditions are more at risk for severe illness from COVID-19 compared with children without underlying medical conditions.
Getting the Vaccine
Pfizer-BioNTech COVID-19 Vaccine will be given to your child as an injection into the muscle. The vaccine is administered as a 2-dose series, 3 weeks apart. The vaccine may not protect everyone.
When your child gets the first dose, you will get a vaccination card to show when to return for your child’s next dose(s) of the vaccine. Remember to bring the card when your child returns.
Tell the vaccination provider about all of your child's medical conditions, including if your child:
- has any allergies
- has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- has a fever
- has a bleeding disorder or is on a blood thinner
- is immunocompromised or is on a medicine that affects your child’s immune system
- is pregnant
- is breastfeeding
- has received another COVID-19 vaccine
- has ever fainted in association with an injection
Knowing More About the Vaccine
There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, your child’s vaccination provider may ask your child to stay at the place where your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of the face and throat
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low. You should seek medical attention right away if your child has any of the following symptoms after receiving the vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
- Severe allergic reactions
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Injection site pain
- Muscle pain
- Joint pain
- Injection site swelling
- Injection site redness
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Arm pain
- Fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials.
If your child experiences a severe allergic reaction or other severe symptom, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your child’s healthcare provider if your child has any side effects that bother your child or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include
In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
You should not get the the vaccine if you:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
The vaccine includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, sucrose, and sodium chloride.
Millions of individuals 12 years of age and older have received Pfizer-BioNTech COVID-19 Vaccine under EUA since December 11, 2020. In a clinical trial, approximately 3,100 individuals 5 through 11 years of age have received at least 1 dose of Pfizer-BioNTech COVID-19 Vaccine. In other clinical trials, approximately 23,000 individuals 12 years of age and older have received at least 1 dose of the vaccine. The vaccine that is authorized for use in children 5 through 11 years of age includes the same mRNA and lipids but different inactive ingredients compared to the vaccine that has been used under EUA in individuals 12 years of age and older and that has been studied in clinical trials. The use of the different inactive ingredients helps stabilize the vaccine under refrigerated temperatures and the formulation can be readily prepared to deliver appropriate doses to the 5- through 11-year-old population.
No. Pfizer-BioNTech COVID-19 Vaccine does not contain the live virus that causes
Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS) and Pfizer Inc.
Updates to non-English Fact Sheets may be delayed.Español - EUA Fact Sheet for Recipients & Caregivers (12 Years & Up) Español - EUA Fact Sheet for Recipients & Caregivers (5 Through 11 Years of Age)
- Patients should always ask their doctors for medical advice about adverse events.
- You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call