The Vaccine Is Authorized for Individuals 5 Through 11 Years of Age
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."
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.
How is the vaccine given?
The 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.
What should you mention to your child’s vaccination provider before your child gets the vaccine?
Tell the vaccination provider about all of your child's medical conditions, including if your child:
What are the risks of 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:
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:
Side effects that have been reported with the vaccine include:
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.
What should I do about side effects?
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 “Pfizer-BioNTech COVID-19 Vaccine EUA” in the first line of box #18 of the report form.
In addition, you can report side effects to Pfizer Inc. at the contact information provided below.
Fax number: 1-866-635-8337
Telephone number: 1-800-438-1985
Who should not get the vaccine?
You should not get the the vaccine if you:
What are the ingredients in the vaccine vial orange cap?
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.
Has the vaccine been used before?
Millions of individuals 12 years of age and older have received the 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.
Will the vaccine give my child COVID-19?
No. The vaccine does not contain the virus that causes COVID-19.
Where can I learn more?
For more information about COVID-19 vaccination, please visit the CDC website.
Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800‐822‐7967. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Indication & Authorized Use
You should not get the vaccine if you or your child:
Tell the vaccination provider about all medical conditions, including if you or your child:
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, you can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Indication & Authorized Use