VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS ABOUT THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) FOR USE IN INDIVIDUALS
5 THROUGH 11 YEARS OF AGE
Your child is being offered the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.
This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 through 11 years of age.1
1 You may receive this Vaccine Information Fact Sheet even if your child is 12 years old. Children who will turn from 11 years to 12 years of age between their first and second dose in the primary regimen may receive, for either dose, either: (1) the Pfizer-BioNTech COVID-19 Vaccine formulation authorized for use in individuals 5 through 11 years of age; or (2) COMIRNATY or one of the Pfizer-BioNTech COVID-19 Vaccine formulations authorized for use in individuals 12 years of age and older.
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a two-dose primary series to individuals 5 through 11 years of age.
This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, which your child may receive because there is currently a pandemic of COVID-19. Talk to your child’s vaccination provider if you have questions.
This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.cvdvaccine.com.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD GETS THIS VACCINE
WHAT IS COVID-19?
COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.
For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
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:
• 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
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.
WHO SHOULD NOT GET THE VACCINE?
Your child should not get the vaccine if your child:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine.
WHAT ARE THE INGREDIENTS IN THE 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.
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.
WHAT ARE THE BENEFITS OF THE VACCINE?
The vaccine has been shown to prevent COVID-19.
The duration of protection against COVID-19 is currently unknown.
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:
• 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.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If your child experiences a severe allergic reaction, 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