Exhibit (FDA Fact Sheet) — CHD v. FDA

Record facts

U.S. District Court for the Western District of Texas, Waco Division · No. 6:22-cv-00093-ADA-DTG · Doc. 18-3 · 2022-04-25 · Docket on CourtListener

Full text

Burk Declaration 
Exhibit 2 
 
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Revised: 03 January 2022
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:
x
has any allergies 
x
has had myocarditis (inflammation of the heart muscle) or pericarditis 
(inflammation of the lining outside the heart)
x
has a fever
x
has a bleeding disorder or is on a blood thinner
x
is immunocompromised or is on a medicine that affects your child’s immune 
system
x
is pregnant 
x
is breastfeeding
x
has received another COVID-19 vaccine
x
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. A third primary series 
dose may be administered at least 28 days after the second dose to individuals who are 
determined to have certain kinds of immunocompromise.
The vaccine may not protect everyone.
WHO SHOULD NOT GET THE VACCINE?
Your child should not get the vaccine if your child:
x
had a severe allergic reaction after a previous dose of this vaccine
x
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 
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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:
x
Difficulty breathing
x
Swelling of the face and throat
x
A fast heartbeat
x
A bad rash all over the body
x
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: 
x
Chest pain
x
Shortness of breath
x
Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
x
severe allergic reactions
x
non-severe allergic reactions such as rash, itching, hives, or swelling of the face
x
myocarditis (inflammation of the heart muscle)
x
pericarditis (inflammation of the lining outside the heart)
x
injection site pain
x
tiredness
x
headache
x
muscle pain
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x
chills
x
joint pain
x
fever
x
injection site swelling
x
injection site redness
x
nausea
x
feeling unwell
x
swollen lymph nodes (lymphadenopathy)
x
decreased appetite
x
diarrhea
x
vomiting
x
arm pain
x
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
Fax number
Telephone number
www.pfizersafetyreporting.com
1-866-635-8337
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.
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WHAT IF I DECIDE NOT TO HAVE MY CHILD GET THE PFIZER-BIONTECH COVID-
19 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 IF MY CHILD IS IMMUNOCOMPROMISED?
If your child is immunocompromised, you may be given the option to have your child 
receive a third dose of the vaccine. The third dose may still not provide full immunity 
to COVID-19 in people who are immunocompromised, and you should continue to 
have your child maintain physical precautions to help prevent COVID-19. In addition, 
your child’s close contacts should be vaccinated as appropriate.
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.
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