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CT05-GSOP-RF05
7.0 PHASE 1/2/3 INFORMED CONSENT
PEDIATRIC STUDY TEMPLATE 01-Jul-2019
Protocol Number: C4591007 ICD Version Date : 06 02Aug Jul2021
Phase 2/3 Placebo-Controlled Selected Dose
Study
Country
Site Language: English Center ID: N/A
Country: N/A

ICD Derived From: 02 Jul 2021N/A

CT05-GSOP-RF05 7.0 Phase 1/2/3/4 Informed Consent Pediatric Study Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version Number (Study/Country/Site) : [ 54/0/0]
Phase 2/3 Placebo-Controlled Selected Dose (all age groups) 06 Aug 02 Jul 2021
Protocol No. C4591007/PFIZER CONFIDENTIAL Intro
Page:
1 of 2

C4591007 Study Level ICD PTMF Requirements:
 Follow the instructions under “Text Color Key” (below).
 Customize the ICD to meet study level, country level and site level requirements. Study
level drafters should not delete any instructional green text in sections that are to be
completed by country level and site level drafters.
 Do not delete the header at the top of this page until the ICD is customized at the
country/site level.
 Before sending the ICD to the institutional review board (IRB)/ independent ethics
committee (IEC), remove the header at the top of this page, remove all inapplicable text,
remove all instructional green text, replace all blue text with appropriate language, make
all text black, and update all references to specific section numbers as necessary
throughout the ICD (including the Table of Contents).
 Certain language may not be edited or changed without further approval ( e.g., Section 15
(What will happen to my personal information? ) and the Privacy Supplement). Such
language is noted by instructional green text. Refer to CT05 GSOP RF01 Informed
Consent Document (ICD) Global Review and Approval Form (GRAF) for appropriate
contacts.
 Section 2 ( Brief summary of this study ) must be updated any time relevant updates are
made to other parts of the ICD that are summarized in Section 2.
 For purposes of this template, note that the “study team” includes the study doctor,
nurses, and others who work with the study doctor.
 The ICD template version date, protocol number and “Pfizer Confidential” must be
included in the footer.
 The final version of the study/country/site specific ICD must be filed in the pTMF.
 Assent must be obtained from minor children beginning at about school age (or an age
determined by the IRB/IEC) unless the IRB/IEC determines that children in the study are
not capable of providing assent or that assent is not a necessary condition for proceeding
with the study, in accordance with local requirements. If assent is required, typically the
IRB/IEC mandates how assent must be documented. If the IRB/IEC determines that verbal
assent is acceptable, verbal assent must be documented in the study record. For assent
form templates, refer to the Pfizer Pediatric Council share point site, <click here> .
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CONSENT DOCUMENT COVER LETTER

Dear Sir or Madam,

Thank you for taking the time to consider permitting your child to join this study. We
understand that this may be a difficult decision. This consent document can help you
make your decision by explaining what you and your child can expect to happen
during this study , also known as a clinical trial or a research study.
Your child’s participation in this study is completely voluntary (your choice) . You can
take as long as you need to make your decision. You can also choose to allow your
child to take part in the study now and have the option to change your mind later at any
time. Please keep in mind that even if you allow your child to participate, it is possible
that your child may not meet the study’s entry requirements.
Depending on your child’s age, mental status and local laws, the study team may need
to verify your child’s agreement (called “assent”) to participate in this study .
We encourage you and your child to have conversations with family, caregivers,
doctors, and the study team about taking part in this study and whether it is the right
decision for your child. The study team will work with you and your child to answer all
questions that you or your child may have about the study. The study team includes the
study doctor, nurses, and other personnel who work with the study doctor.
If you choose to permit your child to participate in this study, you will be asked to sign
and date this consent document prior to the study to let the study team know your
decision.

You will receive a copy of signed and dated consent document for your records. Please
keep this consent document for your reference.
We appreciate that you are thinking of permitting your child to take part in this study.

Sincerely,

___________________
Study Doctor
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Table of Contents

This Table of Contents describes the different sections of this consent document. Be
sure to read through all sections of this consent document before making your decision
about whether or not to participate in this study.
Section Page
1. Key study information and contact information 3
2. Brief summary of this study 4
3. What is the purpose of this study? 6
4. How long will my child participate in this study? 87
5. How many children will take part in this study? 87
6. What will happen during this study? 97
7. Are there any special instructions to follow for this study? 2018
8. What are the possible risks and discomforts of this study? 2118
9. What are the possible benefits of this study? 2421
10. What other choices do I have if I do not want my child to join this
study? 2421
11. What happens if my child is injured during this study? 2421
12. What if my child joins this study and then changes his/her mind? 2421
13. What will I have to pay for if my child takes part in this study? 2522
14. Will my child be paid for taking part in this study? 2522
15. What will happen to my child’s personal information? 2622
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16. Where can I find additional information about this study or the
study results? 2623
17. Signatures 2623
Privacy Supplement

Field Cod
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1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you or your child
may have before, during and after your child completes the study. The study team
includes the study doctor, nurses, and other personnel who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You will be given a card with important emergency contact
information, including a 24-hour number. Please show this card to any doctor, nurse
or other health care provider if you seek emergency care for your child while they are
taking part in this study. This card includes information about the study that will help
them treat your child.
If you have any general questions about your child’s rights as a study participant, or
would like to obtain information from, offer suggestions to, or speak with someone not directly involved in the study, you may contact [For the site-level ICD, include as
appropriate: the Institutional Review Board or the Independent Ethics Committee,
patient rights advocate, and/or bioethicist ] listed below.

Name of Study: A Phase 1, Open-Label Dose-Finding study to Evaluate Safety,
Tolerability, and Immunogenicity and Phase 2/3 Placebo-Controlled, Observer-
Blinded Safety, Tolerability, and Immunogenicity Study of a SARS-CoV-2 RNA
Vaccine Candidate against COVID-19 in Healthy Children and Young Adults<12
Years of Age
Sponsor Consent Version Number (Study/Country/Site): 01 05 / 00 / 00
[Institution] Study Number:
Sponsor Study Number: C4591007
Name of Company Sponsoring the Study: BioNTech. Study conducted by Pfizer
Name of Principal Investigator (Study Doctor):
Study Site Contact Information:
Contact Person:
Address:
Phone Number (Normal Business Hours):
Phone Number (Off-Hours or Emergency):
[Complete the following entries for the site-level ICD as appropriate. ]
[Institutional Review Board or Independent Ethics Committee ] Contact
Information:
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Contact Person:
Address:
Phone Number:
Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
This is a research study involving both Pfizer and BioNTech. Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. BioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [study doctor/institution] will be paid to
conduct this study.
This study is different from your child’s regular medical care. The purpose of regular
medical care is to improve or otherwise manage your child’s health, but the purpose of
research is to gather information to advance science and medicine and does not replace
your child’s regular medical care. If your child needs medical care during their time in the
study, you should contact your regular provider and inform the study team, as described later in this document.
A new respiratory disease appeared in Wuhan, China in December 2019, and has since
rapidly spread to many other countries around the world. In January 2020, the cause of
this disease was found to be a new Coronavirus; and the disease it causes was named
COVID-19 (Coronavirus disease 2019). Since then, many companies around the world
have quickly started to look for treatments and ways to prevent COVID-19. Children have
been affected by primary COVID-19 disease and develop fever and dry cough over half
the time. Symptoms also can include GI (Gastrointestinal) symptoms, including diarrhea
and vomiting, and in some cases can be the only presenting features. In addition, children
have also been affected by a less common secondary inflammatory complications,
including MIS-C (Multi-Inflammatory Syndrome-Children). MIS-C is a condition with fever
and inflammation which can involve different organs of the body including heart, lungs,
kidneys, brain, skin, eyes or gastrointestinal organs. It is currently not known what causes
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MIS-C, however, many children with MIS-C had COVID-19 or were exposed to COVID-
19.

Vaccines help the body to produce antibodies to help fight off a disease. This research
study involves an investigational (not approved by health authorities in children of the age
being asked to volunteer for this study) vaccine to prevent COVID-19, that will be given
to volunteers. The vaccine is given by injection in 2 doses.

These vaccines do not contain the whole virus, or the part of the virus that can make your
child ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your child’s cells’ protein making machinery to
produce some, or all, of the spike protein seen on the outside of the virus. This spike
protein, made by your child’s body, may help your child’s body to produce antibodies to
fight against COVID-19. We will check the level of antibodies your child makes by taking
blood samples and testing them.

Up until June 2021, the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing in many countries, by the end of April 2021 about 400 million doses
have been distributed. Based on available data, the following risks have been determined
to be caused by BNT162b2 vaccine: Injection site pain, injection site swelling, fatigue
(tiredness), increased body temperature (fever), chills, headache, diarrhea, joint aches,
muscle aches, feeling sick (nausea), being sick (vomiting), injection site redness,
enlarged lymph glands, allergic reaction (symptoms may include rash, itching, hives, and
swelling of the face or lips), decreased appetite, lethargy, sweating and night sweats, pain
in arm, feeling weak or unwell, and severe allergic reaction (anaphylaxis).
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received BNT162b2. Cases
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have mainly been reported in males under 30 years of age and following the second
vaccination. Symptoms include: Chest pain, shortness of breath, or feelings of having a
fast-beating, fluttering or pounding heart. As a precaution, you should seek medical
attention right away if your child has any of those symptoms after receiving the vaccine.
The chance of having this occur is very low.
Although not seen to date, it cannot yet be ruled out that the study vaccine could make a
later COVID-19 illness more severe.
Allowing your child taking part in this study is voluntary (your and your child’s choice).
There is no penalty or change to you/your child or your child’s regular medical care if you
decide not to allow your child to participate. You can choose to allow your child to take
part in the study now, and then change your mind later at any time without losing any
benefits or medical care to which you or your child are entitled. We encourage you and
your child to have conversations with your family, caregivers, doctors, and study team
about taking part in this study and whether it is right for your child. The study team will
work with you and your child to answer any questions that you and your child may have
about the study.
You will receive a copy of this signed and dated consent document for your records.
Please keep this consent document for your reference.
You are being asked to allow your child to take part in a research study that will evaluate
whether the investigational (study) vaccine to prevent COVID-19 is safe, tolerable and
produces immune response to the virus causing COVID-19. This vaccine is given by an
injection. You are being asked to allow your child to be in this research study because
your child is healthy and meets the age requirement for this study.
Depending on your child’s age, mental status and local laws, the study team may need
to verify your child’s agreement (called “assent”) to participate in this study . Your
child may give assent verbally, or they may be asked to print or sign their name on an
assent document similar to this consent document. They may have an opportunity to meet
privately with a member of the study team to ask confidential questions. Your child will
also be able to decide not to take part for confidential reasons, which, if they request,
would not be shared with you unless required by local law.

3. What is the purpose of this study?
The World Health Organization (WHO) has declared COVID-19 to be a pandemic (a
disease that has spread all over the world and is affecting lots of people); finding a vaccine
to prevent COVID-19 is an urgent need. To test this investigational vaccine for children, this study will be conducted in the following three age groups of children separately:

 5 to less than 12 years of age,
 2 to less than 5 years of age, and
 6 months to less than 2 years of age
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The study will start with the oldest age group. The younger age groups will start depending
on the safety information and antibody responses seen in the older age groups above
them.

In each age group, the study will be done in two phases - Phase 1 and Phase 2/3.

 Phase 1 where we evaluate up to three different dose levels in a small group of
children to see which dose level is safe and makes the most antibodies. In this
phase, all participants will receive active vaccine.

 Phase 2/3 where we evaluate the appropriately selected dose level from Phase 1
in a large number of children to collect more information about the safety of the
vaccine and the amount of antibodies produced by the vaccine. In this Phase, all
participants will receive either active vaccine or placebo.

To test this investigational vaccine as quickly as possible, this study will be conducted in several steps. You are being asked to allow your child to take part in the Phase 2/3
Selected Dose step. The steps in the study are detailed below.

The Study has already started and all the children that are needed have already joined the first part of the study. The first part of the study was called Phase 1 Dose Finding .

There were 3 age groups in the Phase 1 Dose Finding part and the study looked at up to 3 dose levels in each age group. The children in this part of the study were:
 5 to less than 12 years of age,
 2 to less than 5 years of age, and
 6 months to less than 2 years of age.

Enrollment into this step has been completed .
Phase 1 Lower Dose Evaluation will be carried out in 3 age groups. In this step , the study will look at up to 2 dose levels. The following age groups will take part in this step
of the study:
 16 to less than 30 years of age,
 12 to less than 16 years of age, and
 5 to less than 12 years of age.

Phase 2/3 Selected Dose. In this step we will use a dose level selected from the Phase
1 Dose Finding part of the study. This is the part that you are being asked to allow
your child to take part in , as an additional 2,250 participants will be included to enlarge
the size of the pediatric safety database. This step of the study will collect information
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from a larger number of children about the safety of the vaccine and the amount of
antibodies produced by the vaccine. In this Phase, everyone will receive either active
vaccine or placebo . The children in this step of the study will be:
 5 to less than 12 years of age,
 2 to less than 5 years of age, and
 6 months to less than 2 years of age.

The remaining step of the study will be the Phase 2/3 Lower Dose Evaluation.
In this part of the study we will use a dose level selected from the Phase 1 part of the
study. This step of the study will collect information from a larger number of children and
young adults about the safety of the vaccine and the amount of antibodies produced by
the vaccine. In this part of the study, everyone will receive active vaccine. The age groups
taking part in this step of the study will be:
 16 to less than 30 years of age,
 12 to less than 16 years of age, and
 5 to less than 12 years of age.

You are being asked to allow your child to take part in Phase 2/3 Selected Dose.

This consent is for Phase 2/3 participants and you are being asked to allow your child to take part in this phase.

At approximately 6 months following the 2nd injection, you and your child will be
informed by the study team whether your child was given the placebo injection or
the active investigational COVID-19 vaccine at Visit 1 and Visit 2. If your child
originally received placebo, your child will be offered the COVID-19 investigational
vaccine.

If your child becomes eligible for a COVID-19 vaccine according to local or national
recommendations before they are unblinded your study doctor will explain your
options.

4. How long will my child participate in this study?
Your child will be in this study for about 26 months.
5. How many children will take part in this study?
The total number of children taking part in the whole study will depend on the results
seen during the study. It is expected that approximately 6750 children will take part in
the Phase 2/3 Selected Dose part of the study.
Approximately 48 children in the same age group as your child will be taking part in the
Phase 1 of the study. Phase 1 of this study will be conducted at about 4 different sites.
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This consent is for the Phase 2/3 and there will be approximately 4500 children
taking part in this phase. Phase 2/3 of this study will be conducted at
approximately 100 different study sites . [To be completed at site level: It is expected
that about [number] children will participate in Phase 2/3 of the study at this location. ]
This study will use competitive enrollment. This means that when a certain number of
people have enrolled in the study from all study sites combined, no one else will be
allowed to participate. So, it is possible that you may not be allowed to join the study.
6. What will happen during this study?
Before any study procedures begin, or before you begin preparing your child for the study,
you will be asked to read and sign this consent document. Depending on local law and
your child’s age, your child’s permission may be required for the study team to share
some of their test results with you.
After signing and dating this consent document, the study doctor will check if your child
meets all the requirements to take part in this study. If your child does not meet the
requirements, they will not be able to take part in the study and the study doctor will
explain why this is the case. Similarly, if your child qualifies to take part in this study, the
study doctor will explain this as well.
Study Vaccines
Once the study doctor has confirmed that your child meets the study requirements, your
child will be randomly assigned (like flipping a coin) to receive the study vaccine or
placebo. For every 2 volunteers who receive the investigational COVID-19 vaccine, 1
volunteer will receive placebo. No one (including you, your child, your child’s personal
doctor or the study team) can choose this assignment.
This phase of the study is a ‘placebo-controlled observer-blinded phase’ which means
that you, your child and the study doctor will not know whether your child will be receiving the investigational COVID-19 vaccine or placebo. The person who gives your child the
injection will know because the investigational COVID-19 vaccine and placebo do not look
the same. The syringe will be covered with a label so the contents are not visible and the
person that gives your child the injection will not be able to talk about it. In case of urgent
need, the study doctor can learn quickly whether your child received study vaccine or
placebo.
If your child is 2 years of age or older, the investigational COVID-19 vaccine or placebo will be given to your child through an injection into the muscle in their upper arm. If your
child is less than 2 years of age, the COVID-19 vaccine or placebo will be given to your
child through an injection into the muscle in their thigh.
Each participant will receive two injections, approximately three weeks apart. On the days
your child receives the injection, you will be asked to wait with your child at the study site
for at least 30 minutes for observation after they receive injection.
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Study Vaccines – after participating in the study for approximately 6 months after
receiving second injection
When you and your child come for your child’s visit at approximately 6-months after their
second injection, you and your child will be told if your child was given the investigational
COVID-19 vaccine (BNT162b2) or placebo injection.
If your child was given the investigational COVID-19 vaccine as their injection 1 and 2,
your child will not need any further injections in the study.
If your child was given the placebo injection as their injection 1 and 2, they will be offered
two doses of active vaccine. The first dose of investigational COVID-19 vaccine (active)
will be given as a third injection. Approximately 3 weeks later, your child will be given a
4th injection which is the second dose of the investigational COVID-19 vaccine. For this
part, the study will be ‘unblinded’, meaning that you, your child and your doctor will know
that your child is getting the investigational COVID-19 vaccine.
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that your child will have
done at each of their visits during this phase of the study. You will have the following tests,
procedures or assessments during this study. In addition to the visits listed, your child’s
study doctor may ask you to bring your child in for extra visit(s) if necessary, to protect
your child's well-being. It is important that your child and you attend each visit on the day
that your research study team arranges for your child.

Please note that Visit 3 is not shown in the table below a st it is optional and, if your child is invited to attend that visit, you will be provided with a separate consent document
explaining the optional procedures that will be conducted at that visit.

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For the participants taking part in Phase 2/3 Selected Dose , the study doctor or nurse will perform following
assessment and procedures:
Summary of Planned Study Visits and Procedures for ALL Participants up to 6-months after Vaccine 2:
Visit Number 1 2 4* 5
Types of Visit
Clinic Clinic Clinic or
Telephone Clinic
Visit Description and Visit Timing Study Vaccine
1 Study Vaccine
2 1-Month
Follow-up Visit 6-Month
Follow-up Visit
Review and sign informed consent document X
Ask about medical history as well as date of birth, sex,
race and ethnicity X
Measure pulse rate, respiratory rate, blood pressure (for
children 5 years of age or older), and body temperature X X
Perform a targeted physical exam, including measurement
of height and weight (height and weight information will be
collected at Visit 1 only). X X
If your child is HIV positive, ask for their latest CD4 counts
and HIV viral load X X X
If your child is a female and if able to have children, she
will be asked to provide a urine sample for a pregnancy
test X X
If needed, the study team will discuss and confirm the use
of appropriate birth control with your child X X X
Ask about medications your child is currently taking X X X
Ask about any other vaccines your child has been given X X X X
Check your child meets all the study requirements X X
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Visit Number 1 2 4* 5
Types of Visit
Clinic Clinic Clinic or
Telephone Clinic
Visit Description and Visit Timing Study Vaccine
1 Study Vaccine
2 1-Month
Follow-up Visit 6-Month
Follow-up Visit
Take a nasal swab for the detection of virus causing
COVID-19 X X
Collect blood sample (approximately 5 mL at each time) to
test antibody levels
X X
(Only if your child
is part of the group
participating in the
immunogenicity
assessment at this
visit) X
(Not required if
your child is
included in the
group added to
enlarge the size of
the pediatric
safety database)
Give vaccine injection in your child’s arm or thigh and
observe for 30-min following injection X X
You will be shown/reminded how to use the e-diary (or the
study team will assist you to download an app), and at
Visit 1 you will be given a thermometer and a caliper
(measuring device) X X
You will be asked to complete a vaccination e-diary for 7
days to record potential side effects following each
vaccination X X
Ask how your child is feeling or if your child is having any
potential side effects X X X X
Inform you and your child about which vaccine your child
was given at Visit 1 and Visit 2 X

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Summary of Planned Study Visits and Procedures for Participants who originally received Investigational
COVID-19 Vaccine at Visit 1 and Visit 2; or who originally received Placebo at these visits and prefer not to
receive the COVID-19 Vaccine:
Visit Number X Y
Types of Visit Clinic or Telephone Clinic or Telephone
Visit Description and Visit Timing 12-Month follow up 24-Month follow up
If your child is HIV positive, ask for their latest CD4
counts and HIV viral load X X
Ask about medications your child is currently taking X X
Collect blood sample (approximately 5 mL at each time)
to test antibody levels X
X

If your child had a blood sample collected, ask if your
child is having any potential side effects after blood
collection X X
You will be asked to return the e-diary or you will be
assisted in deleting the app from your own device X

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Summary of Planned study Visits and Procedures for Participants who originally received Placebo at Visit 1 and
Visit 2:
Visit Number A B C D E F
Types of Visit Clinic Clinic Telephone Telephone Telephone Clinic or
Telephone
Visit Description and Visit Timing Study
Vaccine 3 Study
Vaccine 4 1-Month
Follow-up
Visit after
vaccine 4 6-Month
Follow-up
Visit after
vaccine 4 12-Month
Follow-up
Visit after
vaccine 4 18-Month
Follow-up
Visit after
vaccine 4
Inform you and your child that your child originally
received placebo X
Measure pulse rate, respiratory rate, blood
pressure (for children 5 years of age or older), and
body temperature X X
Perform a targeted physical exam X X
If your child is HIV positive, ask for their latest CD4
counts and HIV viral load X X X X X
If your child is a female and if able to have children,
she will be asked to provide a urine sample for a
pregnancy test X X
If needed, the study team will discuss and confirm
the use of appropriate birth control with your child X X X
Ask about medications your child is currently taking X X X X X X
Take a nasal swab for the detection of virus
causing COVID-19 X X
Check your child meets all the study requirements X X
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Visit Number A B C D E F
Types of Visit Clinic Clinic Telephone Telephone Telephone Clinic or
Telephone
Visit Description and Visit Timing Study
Vaccine 3 Study
Vaccine 4 1-Month
Follow-up
Visit after
vaccine 4 6-Month
Follow-up
Visit after
vaccine 4 12-Month
Follow-up
Visit after
vaccine 4 18-Month
Follow-up
Visit after
vaccine 4
Give investigational COVID-19 vaccine injection in
your child’s arm and observe for 30-min following
injection X X
Ask how your child is feeling or if your child is
having any potential side effects X X X X
You will be asked to return the e-diary or you will
be assisted in deleting the app from your own
device X

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Description of Study Procedures and Assessments
Biological Samples
The following blood and nasal biological samples will be taken in this study. Your child
must provide these samples in order to take part in this study. The samples may be stored
in a facility located in a different country from your study site.
Your child’s blood and nasal samples will be used only for scientific research. Each
sample will be labeled with a code so that the laboratory workers testing the samples will
not know who your child is. Some of the samples may be stored for future testing and
may be kept for up to 15 years after the study ends, at which time they will be destroyed.
In addition to testing for this study, any samples left over after the study is complete may
be used for additional research related to the development of products. No testing of your
child’s DNA will be performed.
You may request that your child’s samples, if they can be identified, be destroyed at any
time. Any data already collected from those samples will still be used for the study. The
samples will remain the property of BioNTech/Pfizer and may be shared with other
researchers as long as confidentiality is maintained. No testing of your child’s DNA will
be performed. You and your child will not be told of additional tests, nor will you or your
child receive results of any of these tests except for nasal swab test results which will be
communicated to your child’s study team doctor ad described later in this section.
Blood Samples for antibody testing:
All participants will have a blood sample taken at the following 2 planned visits: Visit 1
and Visit 5.
Your child may be selected to give more blood samples:
 At Visit 2, the study team will inform you whether your child is part of a group
selected to provide a blood sample at 1 month after the second injection.
 At Visit 2 or a later visit, the study team will inform you whether your child is part
of a group selected to provide a blood sample at 12 months and/or 24 months
after second injection.
Each time your child becomes ill with potential COVID 19/MIS C like illness, an additional blood sample will be collected approximately a month after at an unplanned
convalescent visit.
If your child is part of the group that is scheduled to have a 3rd blood sample collected
either at 12 or 24 months after second injection and originally received the
investigational COVID 19 Vaccine at Visit 1 and Visit 2, this blood sample will not be
required if a blood sample was already collected in the last 42 days as part of a
convalescent visit.
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Each blood sample will be approximately 5 mL and will be collected using a needle.
Your child’s blood samples will be used to test if he/she already had antibodies against
the coronavirus that causes COVID-19 when your child was enrolled in the study and may
be used to test antibody levels after vaccination. and/or after potential COVID 19/MIS C like illness.
Nasal Swabs for detection of coronavirus causing COVID-19:
Your child will have a nasal swab collected from his/her nose at 2 planned visits at Visit
1 and Visit 2.
At Visit 5, you and your child will be informed whether your child originally received
placebo or COVID-19 investigational vaccine at Visit 1 and Visit 2. If your child originally
received placebo and goes on to receive the investigational vaccine as injections 3 and
4, your child will have a nasal swab collected from his/her nose visits A and B.
An additional nasal swab will be collected each time your child becomes ill with potential
COVID-19/MIS-C like illness. If your child becomes ill, you will be expected to contact
the study site and the study staff may ask you to collect your child’s nasal swab or ask
you to bring your child to the study site. A swab (which looks like a Q-tip) will be inserted
into your child’s nostril and rotated at least four times for a total of at least 15 seconds.
The same swab will then be inserted with the same steps as noted above for the other
nostril to collect any fluid or mucus. These samples will be tested to detect the presence
of coronavirus causing COVID-19. Results of nasal swabs collected at each
vaccination visit as well as from every illness visit will be provided to your child’s
study doctor, however, this will take some time so you should not rely on this
information for your child’s medical treatment . This is why, it is important that you
contact your child’s usual health care provider if your child has symptoms listed above
and you think that your child needs medical care.
Urine Samples:
If your child is female who is able to have children in the opinion of study doctor, your
child will need to provide urine sample for pregnancy testing to check she is not pregnant
before she is given the study vaccine injection. If your child has a positive urine pregnancy
test result, the study doctor will share the information with you and your child will not be
able to participant in the study.
E-Diary:
The e-diary includes a vaccination part and COVID-19/MIS-C illness part.
At Visit 1, the study team will explain what you need to do and show you how to fill in an
electronic diary (or e-diary). As a parent(s)/legal guardian(s), as appropriate, you will be
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required to complete the e-diary for your child. We will either give you a device (like a
mobile phone) or ask you to download an application (app) to your smart phone if you
have one. The device/app is secure, and your child’s confidentiality will be maintained.
You will also be given a thermometer and a measuring device (caliper).

Vaccination part of the e-diary

The e-diary will prompt you to answer questions about how your child is feeling after
receiving the injection. At the Visit 1 and Visit 2, you will be instructed by the study team
to complete the e-diary every evening for 7 days after each injection is given to your child.
Day 1 of the e-diary completion will begin on the evening your child receives the injection
and the following next 6 days (7 days in total). You will use the thermometer to measure
your child’s temperature. This temperature measurement will be oral (under his/her
tongue) for children 2 years of age and older, and axillary (under the arm) for children
less than 2 years of age. You will then enter the temperature reading into the e-diary.
The measuring device will be used to measure the size of any redness or swelling on
your child’s arm where the injection was given. You will need to enter these
measurements in the e-diary. It is important that all of the requested information is entered
in the e-diary.

The vaccination part of the e-diary will also ask other questions about potential side
effects your child may have after the injection. If your child has any severe symptoms
after vaccination, you should contact your child’s study doctor and the study doctor or
nurse may schedule an extra unplanned visit to evaluate your child.

COVID-19/MIS-C illness part of the e-diary

You will need to complete the COVID-19/MIS-C illness e-diary once a week which is
separate from the e-diary completed after each vaccination mentioned above. This will
continue for the entire duration of the time that your child is in the study . The
purpose is to report whether your child experiences any COVID-19/MIS-C illness like
symptoms (listed in section below) or is diagnosed with COVID-19. In addition to
completing this e-diary weekly, you will also need to complete this e-diary if your child
experiences any of the below listed symptoms at any time during participation in this
study.

You may receive text messages to the device or your own smartphone, or emails (if you
provide your email address) to remind you to complete the COVID-19/MIS-C illness part
of the e-diary.

It is very important that you complete the e-diary regularly as instructed. If this is
not completed, the study doctor or nurse will contact you to check how your child
is doing.
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Watch for following symptoms:
Children develop fever and dry cough over half the time and GI (Gastrointestinal)
symptoms, including diarrhea and vomiting, and in some cases can be the only
presenting features. If your child develops any of the symptoms below during their study
participation, contact your child’s study doctor immediately.

 A diagnosis of COVID-19
 Fever
 New or increased cough
 Diarrhea
 Vomiting
 New or increased shortness of breath
 Chills
 New or increased muscle pain
 New loss of taste/smell
 Sore throat
 Inability to eat/poor feeding;
 Abdominal pain;

A serious medical condition associated with COVID-19 in children is known as MIS-C.
The cause for MIS-C is unknown. If your child has a hospitalization for COVID-19 or
a severe illness without a known cause, contact the study doctor immediately .

Note contacting the study doctor is not in place of your child’s routine care. If your
child feels unwell enough that you would normally see a healthcare professional,
please contact your child’s usual provider as well as the study doctor.
The study doctor may ask you to have a telephone conversation, video call or to visit the
site with your child to talk about how they are feeling and if they have needed any other
medical care. The study team will also ask you to help your child to take a nasal swab, or
the study team may take a swab to check for the coronavirus. We will give you separate
instructions about how to take a nasal swab and how to ship the swab to the clinical site,
if needed. The results from this swab will be provided to the study doctor once it is
available, but this will take some time, and cannot be used to diagnose COVID-19.
This is why, it is important that you contact your child’s usual health care provider if your
child has symptoms listed above and you think that your child needs medical care.

If your child is diagnosed with COVID-19/MIS-C, for the purposes of the study, the study
doctor will contact your child’s usual provider, and any facility where your child is treated,
to obtain details and collect medical records: by signing this informed consent document,
you agree to this.
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The study team will arrange an unplanned convalescent visit to the study site about a
month after your child became unwell and a blood sample (approximately 5 mL) will be
collected to assess your child’s antibody level.

What happens if my child is participating and has a positive nose swab test result
after Visit 1 or Visit A (if your child originally received placebo and goes on to
receive investigational COVID-19 vaccine at Visit A and B) but before the next
planned injection visit?

If your child has any potential COVID-19/MIS-C symptoms with a positive nose swab test
result after the Visit 1 or Visit A (if your child received placebo), your child’s study team
may need to delay the planned injection until your child becomes well.

If your child has a positive nose swab test result after Visit 1, without the presence of any
potential COVID-19/MIS-C related symptoms, your child will be given the injection as
planned in the study.

Leaving the Study Early
You or your child, may withdraw from the study at any time at your own request, or your
child may be withdrawn at any time at the discretion of the investigator for safety,
behavioral, compliance, or administrative reasons. If you or your child decide to leave the
study, you/your child will be asked why you would like to withdraw.
After the study
The study vaccine is available only during this study and not after the study is over.

7. Are there any special instructions to follow for this study?

It is important that you and your child follow all the instructions given to you by the study
nurse or study doctor and tell them if:
 You or your child do not understand anything about the study
 You or your child will not be able to comply with the study requirements
 There are changes in your child’s health
 Your e-diary device or APP is not working properly
 Your child takes any new medications or receives any other vaccines
 You or your child are going away for a long period
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 Your child wishes to take part in another research study
 Your child previously took part in this study, have been in any other study in the
past 28 days, or is currently involved in any other study
 Notify the study team if you/your child moves and provide your/your child’s new
contact information.

8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make your
child unwell or uncomfortable and even potentially be serious or life-threatening. All
research participants taking part in the study will be watched carefully for any negative
effects; however, the study team does not know all the effects that the study vaccine may
have on your child.
If your child takes part in this study, the most likely risks or discomforts are discussed
below.
It is important that you/your child report to the study team all symptoms and side
effects as soon as they occur. Phone numbers for the study team are listed in
[Section 1] of this consent document.
Up until June 2021, the safety of BNT162b2 has been studied in clinical trials that have
included about 28,500 people who have received at least one dose of the vaccine. In
addition, since the vaccine has been approved for emergency use or received a
conditional marketing authorization in many countries, by the end of April 2021 about 400
million doses have been distributed.
Based on the clinical study results, and information gathered during general use, the
following risks have been determined to be caused by BNT162b2 vaccine:
Very common (occurring in more than 1 in 10 people): injection site pain, injection site
swelling, fatigue (tiredness), increased body temperature (fever, more common after the
second dose), chills, headache, diarrhea, joint aches, and muscle aches.
Common (between 1 in 10 and 1 in 100 people): feeling sick (nausea), being sick
(vomiting), and injection site redness.
Uncommon (between 1 in 100 and 1 in 1,000 people): enlarged lymph glands, allergic
reactions (symptoms may include rash, itching, hives), decreased appetite, lethargy,
sweating and night sweats, pain in arm, and feeling weak or unwell.
Rare (between 1 in 1,000 and 1 in 10,000 people): swelling of the face or lips.
Frequency that cannot be estimated from available data: severe allergic reaction
(anaphylaxis).
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining
outside the heart) have occurred in some people who have received BNT162b2. Cases
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have mainly been reported in males under 30 years of age and following the second
vaccination, however, there have been some cases reported in older males and females
as well as following the first vaccination. The chance of having this occur is very low and,
in most of these people, symptoms began within a few days to a week following
vaccination. As a precaution, 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
Please also notify study staff, when appropriate, if your child has any of these
symptoms as your child may need to come in for an assessment .
Whilst some severe cases have been reported, most cases have been associated with
full resolution of symptoms in the short term, however, long-term follow-up is limited. It is
not known whether the risk of myocarditis or pericarditis is increased following additional
doses of the vaccine, e.g. following a booster dose.
If your child has had myocarditis (inflammation of the heart muscle) or pericarditis
(inflammation of the lining outside the heart) previously, please tell your study doctor.
As in all research studies, the COVID-19 vaccine may involve risks that might be expected
based on results from studies of similar vaccines, as well as risks that are currently
unknown.
Therefore, it is important that you report all symptoms and side effects that your child
experiences as soon as they occur, whether or not you think they are caused by the study
vaccine.
Due to the way in which the study vaccines are made, they cannot cause COVID-19
disease.
If my child catches COVID-19 disease, could the vaccine make it worse?
For some other vaccines tested in animals against similar viruses (but not the coronavirus
that causes COVID-19), there have been reports of the illness being more severe in the
animals that received the vaccine than in those that did not. So far this has not been seen
with BNT162b2. It remains important for you/your child to contact your child’s study doctor
if your child develops symptoms that might be caused by COVID-19 (for example, fever,
cough, shortness of breath).
Placebo Risks
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As the placebo injection contains salt-water and no active ingredients, the chances of
having side effects mentioned above are less likely. In other studies, using the same
placebo injection, some people who received the placebo injection reported pain,
bruising, swelling and redness at the site of injection.
Risks from Study Procedures
Risks and possible discomforts your child might have from the study procedures
include:
 Blood Samples: The risks and possible discomforts involved in taking blood
include pain from inserting the needle, or less often, swelling, bruising, or
infection around the vein where the blood is collected. Your child may feel dizzy
or may faint. If your child has a previous history of feeling dizzy or fainting during
blood sample collection you should talk to the study doctor.
 Nasal Swabs: The risks and possible discomfort involved in taking nasal swabs
may include pain or general discomfort. Sometimes it may cause the nose to
bleed.
Pregnancy-Related Risks; Use of Birth Control
If your child is currently pregnant, plans to become pregnant, or is breastfeeding a child,
she should not join this study. If your child is a male, he should not father a baby while
taking part in this study.
If your child is able to have children and is sexually active, they must use birth control
consistently and correctly for the duration of the study including and for at least 28 days
after they receive their last planned injection. This applies to male participants as well as
female participants who take part in the research study. The study doctor will discuss
with your child the methods of birth control that they should use while in this research
study, if appropriate. The study doctor will help your child select the method that is
appropriate for them. The study doctor will also check that your child understands how to
use the birth control method and may review this with them at visits specified in the
Section 6 in the tables describing study visits, if appropriate.
Birth control methods, even when used properly, are not perfect. If your child or their
partner becomes pregnant during the research study, or if they want to stop their required
birth control during the research study, they should tell the study doctor immediately. Your child may be withdrawn from the research study if they stop using birth control or they
become pregnant.
If abstinence (not having sexual intercourse at all) is your child’s current lifestyle, and both
you/your child and the study doctor agree that it is your child’s selected method of
contraception, your child must continue not to have sexual intercourse for at least 28 days
after the last planned injection.

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As permitted by local law, the study doctor may: (a) provide confidential contraceptive
counseling to your child (not discussed with you) and (b) help your child to assess
additional reproductive services, if needed. The study doctor will instruct your child about
how to use their selected birth control method correctly and consistently and may review
this with your child at visits specified in the Section 6 in the tables describing study visits.
Pregnancy Follow-up
If your child or their partner become pregnant during the study, up until 28 days after your child’s last study injection, please tell the study doctor immediately . The study doctor
may ask for information about the pregnancy and the birth of the baby. The study doctor
may share this information with others who are working on this study. Please also tell the
doctor who will be taking care of your child/their partner during the pregnancy that your
child took part in this study. The study doctor will ask if your child/their partner or their
pregnancy doctor is willing to provide updates on the progress of the pregnancy and its
outcome. If your child/their partner agree, this information will be provided to the
BioNTech/Pfizer for safety follow-up.

9. What are possible benefits of this study?
Vaccination with BNT162b2 has been shown to be effective in preventing COVID-19 in
the groups of people already studied, but not yet in the age group of your child. Because
of this, they still need to follow local recommendations about how to avoid COVID-19 (for
example, social distancing and mask use). In addition, information learned from the
research study may help other people in the future.
10. What other choices do I have if I do not want my child to join
this study?
This study is for research purposes only. The only alternative is to not take part in this
study.
11. What happens if my child is injured during this study?
For mandatory research injury language, < click here > (retain this link in the study-level ICD). The country-specific research injury language must be included verbatim in the
country-level ICD.

12. What if my child joins this study and then changes his/her
mind?
You are free to withdraw your child from this research study at any time. Tell the study
doctor if you are thinking about this so that your child may end the research study in the
safest way. The research study team will also tell you if new information is learned that
could change your/your child’s mind about your child’s continuation in this research study. Field Cod
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Your decision will not affect the medical care your child receives, and your child will not
lose any benefits to which he/she would otherwise be entitled.
While your child is participating, the study team will tell you in a timely manner if new
information is learned during the course of the study that could change your/your child’s
mind about continuing. If you decide to withdraw your child from receiving vaccine or if
your child decides to withdraw from receiving vaccine, your child may be asked to
continue to participate in the study procedures even though they would no longer take the
study vaccine.
If your child continues with the follow-up part of the study, information about your child’s
health will continue to be collected as described in [Section 6] .
If you decide to stop your child participating in this study, you must notify the study doctor.
The study team will explain what other procedures or discussions should occur.
Sometimes the study doctor or BioNTech/Pfizer may decide to take your child out of the
study (even if you do not agree) if:
• You/your child are unable or unwilling to follow the instructions of the study team;
• The study doctor decides that the study is not in your child’s best interest or that they
are no longer eligible to participate; or
• The study is stopped by the BioNTech/Pfizer, the Institutional Review Board (IRB) or
Independent Ethics Committee (IEC) (a group of people who review the study to
protect your/your child’s rights), or by a government or regulatory agency.
The study team will give you a Privacy Supplement, which is considered part of this
consent document. It describes what happens to your/your child’s personal information
(including your child’s biological samples) and how it may be used if you withdraw your
child from the study or if your child withdraws from the study.

13. What will I have to pay for if my child takes part in this study?
You will not need to pay for the study vaccine, study-related procedures, or study visits.
14. Will my child be paid for taking part in this study?
You will not receive any payment for your child taking part in this study. However, for
each visit you/your child completes, you/your child will be reimbursed by the study site to
cover reasonable expenses (for example, parking, meals, travel) that you have as a result
of your child taking part in this study. You/your child will be reimbursed by [enter, as
applicable, method of reimbursement; amounts; and reimbursement schedule; note
whether receipts are required]. ]
BioNTech/Pfizer may use information resulting from the study to develop products or
processes from which it may make a profit. There are no plans to pay you/your child or
provide you with any products developed from this study. BioNTech/Pfizer will own all
products or processes that are developed using information from the study.
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15. What will happen to my child’s personal information?
<Click here > for language to be inserted into this section. This text must be inserted
verbatim. Any requested changes must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature section.
16. Where can I find additional information about this study or the
study results?
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as
required by U.S. Law. This Web site will not include information that can identify your
child. At most, the Web site will include a summary of the results. You can search this
Web site at any time.
The study results, when available, may also be found on www.pfizer.com and https://www.clinicaltrialsregister.eu/.
In addition, a plain summary of the study results will be made available in the EU database
at [insert link to the database]. This information will be provided no matter what the study’s
outcome. To the extent possible, you will be able to access these summaries in the EU
database soon after they become available using the following EU trial number for the
study: [insert trial number].
These websites are in English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
BioNTech/Pfizer will provide the study doctor with information about the study results
when all participants have completed the study. At that time, certain of your child’s
individual study results may be given to you or your child’s doctor (if different from the
study doctor) in accordance with applicable law, but will not be given to your/your child’s family, your employer or any insurance company.
If any exploratory research is done, it may not be possible to link any results from that
exploratory research to specific individual, including your child. BioNTech/Pfizer does not
plan to return information from any exploratory research to you/your child, the study
doctor, or your child’s doctor (if different from the study doctor).
17. Signatures
The column for subject initials in the table below may be removed if not required by the
IRB/IEC, regulatory agencies, and/or other similar reviewers.
Agreement to Participate and to Process Data Initials
1. I confirm I have read (or, if I cannot read, a study team
member has read to me) and understand this consent
document for the study described above and have had the Field Cod
Field Cod
Field Cod
Field Cod
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opportunity to ask questions. I have had enough time to
review this consent document. I also have had an opportunity
to ask about the details of the study and to decide whether or
not I want my child to participate.
2. I have read and understand the Privacy Supplement. I
understand that taking part in the study will require the
processing (including collection, use, transfer, storage,
analysis and reporting) of my child’s personal information, as
explained in the Privacy Supplement. I understand and agree
to the processing of my child’s personal information within
and outside my country of residence for health care, medical
research and/or regulatory purposes.
3. I understand that allowing my child to take part is voluntary
and that I am free to stop my child taking part in this study or
to withdraw my consent to the processing of my child’s
personal information at any time. I do not need to give any
reason and my child’s regular medical care and legal rights
will not be affected. However, even if I withdraw my consent
to processing, my child’s personal information held at that
time may be kept to comply with laws and regulations and to
maintain the integrity of the study. I also understand that my
child’s biological samples may not be able to be destroyed
because they may no longer be traceable to my child, may
have already been used, or may have been given to a third
party.
4. I agree to the study team accessing my child’s medical
history, including information from medical records and test
results and any medical treatment my child receives during
the course of the study, and if necessary, contacting my
child’s doctor or any other health care providers treating my
child for access to such information.
5. I understand that BioNTech/Pfizer and/or others working with
or on behalf of the BioNTech/Pfizer, Institutional Review
Boards (IRBs) or Independent Ethics Committees (IECs), and
regulatory agencies may need access to personal information
about my child generated at the study site or collected by the
study team for the study and any other research. I agree that
they may have access to my child’s personal information.
090177e197c3bf92\Approved\Approved On: 09-Aug-2021 16:44 (GMT)
FDA-CBER-2021-5683-1076863
CONSENT TO TAKE PART IN STUDY

6. I do not give up any of my child’s legal rights by signing and
dating this consent document. I have been told that I will
receive a copy of this signed and dated document.
7. I agree for my child to take part in the study described in this
document.

In the section below, the term “legally acceptable representative” should be replaced
with the term required per local regulation (country-level).

Signature Lines to be Included:

________________________________________________
Printed name of participant

As the consenting adult providing permission for this child to participate in the study, I
acknowledge that (Please check one of the following):
□ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable representative of the child.

[If neither option below is checked, then the consent of the second
parent/guardian/legally acceptable representative must be obtained. If there are two
parents/guardians/legally acceptable representatives available to give permission, and
they disagree about allowing the child to participate in the study, the child should not be
enrolled unless that disagreement can be resolved. ]
I also acknowledge that (Please check one of the following): □ I have sole legal responsibility for the care and custody of the child.
□ The other adult(s) with whom I share legal responsibility for the care and
custody of the child (for example, biological parent, adoptive parent, or legal
guardian or representative) is (1) aware of and agrees with my granting
permission for this child to participate in the study OR (2) deceased, unknown,
incompetent, or not reasonably available (someone is “not reasonably available”
when he/she cannot be reached by phone/mail/email because, for example,
he/she is on active military duty or is incarcerated).

________________________________________________
Printed name of parent/guardian/legally acceptable representative
090177e197c3bf92\Approved\Approved On: 09-Aug-2021 16:44 (GMT)
FDA-CBER-2021-5683-1076864
CONSENT TO TAKE PART IN STUDY

________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§

[Include the statements and signature lines below for a second parent/guardian/legally
acceptable representative if (1) required by the IRB/IEC; (2) required by local law ( e.g.,
parents are divorced and have shared custody of the child); or (3) the second
parent/guardian/legally acceptable representative is (or would like to be) involved in the
consent process and there is reason to believe that he/she may disagree with the
decision of the first parent/guardian/legally acceptable representative.
Consent of Second Parent/Guardian/Legally Acceptable Representative:
As the consenting adult providing permission for this child to participate in the study, I
acknowledge that (Please check one of the following): □ I am the biological or adoptive parent of the child.
□ I am the legal guardian or legally acceptable representative of the child.

_______________________________________________
Printed name of parent/guardian/legally acceptable representative

________________________________________________ ______________
Signature of parent/guardian/legally acceptable representative Date of signature§]

[If local IRB/IEC permits assent of older children to be obtained by co-signature, include
the following:
Participant’s Assent:

_____________________________________________ _____________
Signature of participant Date of signature§]

Person Obtaining Consent:

_______________________________ ______________
Printed name of person conducting the consent discussion

_______________________________ ______________ ______________
Signature of person conducting the consent discussion† Date of signature

090177e197c3bf92\Approved\Approved On: 09-Aug-2021 16:44 (GMT)
FDA-CBER-2021-5683-1076865
CONSENT TO TAKE PART IN STUDY

§ Parent/guardian/legally acceptable representative must personally date their
respective signatures.

† The investigator, or an appropriately qualified and trained person designated by the
investigator to conduct the informed consent process, must sign and date the consent
document during the same discussion when the participant’s parent/guardian/legally
acceptable representative signs the consent document.

090177e197c3bf92\Approved\Approved On: 09-Aug-2021 16:44 (GMT)
FDA-CBER-2021-5683-1076866
CONSENT TO TAKE PART IN STUDY

For mandatory country-specific data privacy language to be inserted in this Privacy
Supplement, < click here > (retain this link in the study-level ICD). The country-specific
data privacy language must be included verbatim in the country-level ICD. Any
requested changes must be approved by Clinical Development Legal. Field Cod
090177e197c3bf92\Approved\Approved On: 09-Aug-2021 16:44 (GMT)
FDA-CBER-2021-5683-1076867

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