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.
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.
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.
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
• tiredness
• headache
• muscle pain
4 Revised: 29 October 2021
• chills
• joint pain
• fever
• injection site swelling
• injection site redness
• nausea
• feeling unwell
• swollen lymph nodes (lymphadenopathy)
• decreased appetite
• diarrhea
• vomiting
• 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.
Website www.pfizersafetyreporting.com
Fax Number 1-866-635-8337
Telephone number 1-800-438-1985
You may also be given an option to enroll in v-safe. V-safe is a new voluntary
smartphone-based tool that uses text messaging and web surveys to check in with
people who have been vaccinated to identify potential side effects after COVID-19
vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19
vaccines. V-safe also provides second-dose reminders if needed and live telephone
follow-up by CDC if participants report a significant health impact following COVID-19
vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.
WHAT IF I DECIDE NOT TO HAVE MY CHILD GET THE PFIZER-BIONTECH COVID19 VACCINE?
Under the EUA, there is an option to accept or refuse receiving the vaccine. Should you decide for your child not to receive it, it will not change your child’s standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES
PFIZER-BIONTECH COVID-19 VACCINE?
For children 5 through 11 years of age, there are no other COVID-19 vaccines available under Emergency Use Authorization and there are no approved COVID-19 vaccines.
CAN MY CHILD RECEIVE THE PFIZER-BIONTECH COVID-19 VACCINE AT THE
SAME TIME AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of the Pfizer-BioNTech
COVID-19 Vaccine at the same time with other vaccines. If you are considering to have your child receive the Pfizer-BioNTech COVID-19 Vaccine with other vaccines, discuss the options with your child’s healthcare provider.
WHAT ABOUT PREGNANCY OR BREASTFEEDING?
If your child is pregnant or breastfeeding, discuss the options with your healthcare
provider.
WILL THE VACCINE GIVE MY CHILD COVID-19?
No. The vaccine does not contain SARS-CoV-2 and cannot give your child COVID-19.
KEEP YOUR CHILD’S VACCINATION CARD
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.
ADDITIONAL INFORMATION
If you have questions, visit the website or call the telephone number provided below.
www.cvdvaccine.com
1-877-829-2619
(1-877-VAX-CO19)
HOW CAN I LEARN MORE?
• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization.
• Contact your local or state public health department.
WHERE WILL MY CHILD’S VACCINATION INFORMATION BE RECORDED?
The vaccination provider may include your child’s vaccination information in your
state/local jurisdiction’s Immunization Information System (IIS) or other designated
system. This will ensure that your child receives the same vaccine when your child
returns for the second dose. For more information about IISs visit:
https://www.cdc.gov/vaccines/programs/iis/about.html.
CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THE COVID-19
VACCINE?
No. At this time, the provider cannot charge you for a vaccine dose and you cannot be
charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate
reimbursement from a program or plan that covers COVID-19 vaccine administration
fees for the vaccine recipient (private insurance, Medicare, Medicaid, Health
Resources & Services Administration [HRSA] COVID-19 Uninsured Program for noninsured recipients).
WHERE CAN I REPORT CASES OF SUSPECTED FRAUD?
Individuals becoming aware of any potential violations of the CDC COVID-19
Vaccination Program requirements are encouraged to report them to the Office of the
Inspector General, U.S. Department of Health and Human Services, at
1-800-HHS-TIPS or https://TIPS.HHS.GOV.
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?
The Countermeasures Injury Compensation Program (CICP) is a federal program that
may help pay for costs of medical care and other specific expenses of certain people
who have been seriously injured by certain medicines or vaccines, including this
vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit
www.hrsa.gov/cicp/ or call 1-855-266-2427.
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
The FDA may issue an EUA when certain criteria are met, which includes that there areno adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
This EUA for the Pfizer-BioNTech COVID-19 Vaccine will end when the Secretary of
HHS determines that the circumstances justifying the EUA no longer exist or when
there is a change in the approval status of the product such that an EUA is no longer
needed.