Document text
CT05 -GSOP -RF04
7.0PHA SE 3 CLINICA L STUDY INFORMED
CONSENT TEMPL ATE01-Jul-2019
Protocol Number: C4591020 ICD Version Date : 02 Feb 2021
Study
Country
SiteLanguage: English Center ID: Not Applicable Country: US
ICD Derived From: C4591020, ICD Version Date: 20 -Jan-2021
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/ Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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CONSENT DOCUMENT COVER LETTER
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01 -Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/ Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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This is a welcome letter to the study participant that explains the purpose of the consent
document, emphasizes that the study is voluntary, and generally introduces the participant
to the study. This letter should notbe edited to include technical study information contained
in the main consent document or in the Additional Consent Request. This letter may be
deleted if required by an IRB/IEC, regulatory agency, or other similar reviewer; the ICD
required elements lis ted below are also included in Section 2 of the ICD.
ICD required elements to be covered in this section: (1) participation is voluntary; (2) there
is time to decide and ask questions; and (3) a copy of the signed ICD is given to the
participant prior to p articipation.
Dear Sir or Madam,
Thank you for taking the time to consider joining this study. W e understand that this may
be a difficult decision. This consent document can help you make your decision by
explaining what you can expect to happen during t his study , also known as a clinical
trial or a research study.
Your participation in this study is completely voluntary (your choice) . Take as long as
you need to make your decision. You also can choose to take part in the study now, and
then change your m ind later at any time. Please keep in mind that even if you choose to
participate, it may turn out that you do not meet the study’s entry requirements.
We encourage you to have conversations with your family, caregivers, doctors, and
study team about takin g part in this study and whether it is right for you. The study team
will work with you to answer any questions that you may have about the study. The study
team includes the study doctor, nurses, and others who work with the study doctor.
If you choose to participate in this study, you will be asked to sign this consent
document prior to the study to let the study team know your decision.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your r eference.
We appreciate that you are thinking of taking part in this study.
Sincerely,
___________________
Study Doctor
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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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 I participate in this study? 6
5. How many people will take part in this study? 6
6. What will happen during this study? 6
7. Are there any special instructions to follow for this study? 10
8. What are the possible risks and discomforts of this study? 10
9. What are the possible benefits of this study? 13
10. What will happen to my blood and nasal swab samples? 13
11. What other choices do I have if I do not join this study? 13
12. What happens if I am injured during this study? 13
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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13. What if I join this study and then change my mind? 14
14. What will I have to pay for if I take part in this study? 14
15. Will I be paid for taking part in this study? 15
16. What will happen to my personal information? 15
17. Where can I find additional information about this study or the
study results?15
18. Signatures 16
PRIVACY SUPPLEMENT
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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1. Key Study Information and Contact Information
The study team will address any questions, concerns or complaints you may have
before, during and after you complete the study. The study team includes the study
doctor, nurses, and others who work with the study doctor.
Phone numbers for the study team are listed below under “Study Site Contact
Information.” You also will be given a card with important emergency contact
information, including
a 24-hour number. Show this card to any doctor, nurse or
other health care provider ifyou seek emergency care while you are taking part in this
study. This card includes information about the study that will help them treat you.
If you have any general qu estions about your rights as a study participant, or would like
to obtain information from, offer suggestions to, or speak with someone notdirectly
involved in the study, you may contact [For the site -level ICD, include as appropriate:
the Institutional Review Board orthe Independent Ethics Committee, patient rights
advocate, and/or bioethicist ]listed below.
Name of Study: A PHA SE 3, RA NDOMIZED, OBSERVER -BLIND STUDY TO
EVALUATE THE SA FETY, TOLERA BILITY, A ND IMMUNOGENICITY OF A
LYOPHILIZED FORMUL ATION OF THE VACCINE CA NDIDA TE BNT162b2
AGAI NST COVID -19 IN HEA LTHY ADULTS 18 THROUGH 55 YEA RS OF A GE
Sponsor Consent Version Number (Study/Country/Site): / /
[Institution] Study Number:
Sponsor Study Number: C4591020
Name of Company Sponsoring the Study: BioNTech. Pfizer is conducting the study
for BioNTech
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 orIndependent Ethics Committee ]Contact
Information:
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Contact Person:
Address:
Phone Number:
Patient Rights A dvocate:
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 [the stud y doctor/institution] will be paid
to conduct this study.
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. There are no
currently licensed (approved for sale) vaccines for COVID
-19.The investigational
vaccine in this study received the first approval for emergency use in the United
Kingdom on December 2nd2020 and in the U.S. on December 12th2020. Other
countries have also authorized temporary or emergency use.
Your study doctor can
provide you with more information about the availability of this vaccine and other
COVID -19 investigational vaccines that are approved for emergency use .
Vaccines help your body to produce antibodies to help you to fight off a disease .This
research study involves an investigational vaccine to prevent COVID -19, that will be
given to healthy volunteers . The vaccine is given by injection. The purpose of this study
is to learn about the safety ,and amount of antibodies made after injection (immune
responses) ,of up to 3separate versions of this vaccine. The three versions are; the
frozen liquid multi dose vial that has been granted emergency use in the U.S. and other
countries, a lyophilized (freeze -dried) single dose vial, and a lyophilized (freeze dried)
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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multi -dose vial that may contain a preservative. The lyophilized version will allow for
storage at standard refrigerator temperatures. When the study begins (first participant
enrolled) ,participants will receive either the lyophilized single -dose version or the frozen
liquid multi dose vial that has been granted emergency use in the U.S. and other
countries. The lyophilized multi dose vial version (which may contain a preservative) will
not be available when the study begins and may not be studied. Each participant will
receive one of the vaccine versions . There is no placebo in this study (a placebo does
not contain any active ingredients).
This inves tigational vaccine , called BNT162b2 ,is a RNA vaccine anddoes not contain
the whole virus, or the parts of the virus that can make you ill ;instead ,the vaccine is
made up of part of the virus’s genetic code (RNA) , surrounded by fatty particles called
lipids. It usesyour own cells’ protein -making machinery to produce the spike protein
seen on the outside of the virus. This spike protein, made by your own body, may help
your body to produce antibodies to fight agai nst COVID -19. W e will check how many
antibodies you make by taking blood samples and testing them .
Up until the end of 2020, the safety of BNT162b2 has been studied in clinical trials that
have included 21,744 people 16 yrs of age and older who have received at least one
dose of the vaccine. In addition, since the vaccine has been approved for emergency
use in many countries, about 26 million doses have been distributed. Based on the
available data, the following risks have been determined to be cause d by BNT162b2
vaccine: Injection site pain, injection site swelling, fatigue (tiredness), increased body
temperature (fever), chills, headache, joint aches, muscle aches, feeling sick (nausea),
injection site redness, enlarged lymph glands, allergic reacti on (symptoms may include
rash, itching, hives, and swelling of the face or lips), pain in arm, feeling weak or unwell,
and severe allergic reaction (anaphylaxis). .
Although not seen to date, it cannot yet be ruled out that the study vaccine could make
a later COVID -19 illness more severe .
This study is different from your regular medical care. The purpose of regular medical
care is to improve or otherwise manage your health, but the purpose of research is to
gather information to advance science and medicine and does not replace your regular
medical care. If you need medical care during your time in the study, you should contact
your regular provider andinform the study team, as described later in this document.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Taking part in this study is voluntary (your choice). There is no penalty or change to
your regular medical care if y ou decide not to participate. You can choose 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 are entitled. We encourage you to have conversations with
your family, caregivers, doctors, and study team about taking part in this study and
whether it is right for you. The study team will work w ith you to answer any questions
that you may have about the study.
You will receive a signed copy of this consent document for your records. Please keep
this consent document for your reference.
3. What is the purpose of this study ?
The World Health Organiza tion ( 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.
The purpose of this study is toevaluate a lyophilized and frozen liquid version of this
investigational vaccine (BNT162b2) . We would like to collect more information about the
safety of the vaccine and the amount of antibodies that it produce s, and see whether all
the different versions produce a similar response. The vaccine will only be given in this
study to adults 18through 55 years of age who have not previously received any
vaccine against COVID- 19.
Thestudy doctor will determine whether you are eligible for the study. This study will
require you to visit the study doctor to undergo study procedures and to provide
information about your health.
4. How long w ill I participate in this study ?
You will be in this study for about 2 months . You will need to visit the study siteat3
planned times
during the study . The study doctor may ask you to visit the site (or have
a phone or video call) in between planned visits ,if needed.
5. How many people will take part in this study ?
There will be about 550 (or 1100 if the lyophilized multidose vial is studied) healthy
people takingpartin this study. This study is being done at about 20different study
sites across the United States.
6. What w ill happen during this study ?
Before any study procedures begin, or before you begin preparing for the study, you will
be asked to read and sign this consent document.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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After signing this consent document, the study doctor will check if you meet all of the
requiremen ts to take part in this study. If you do not meet the requirements, you will not
be able to take part in the study and the study doctor will explain why this is the case.
Study Vaccine s
Once the study doctor has confirmed you meet the study requirements, you will be
randomly assigned (like flipping a coin) to receive 1of the 2 study vaccine versions ,
either the freeze -dried refrigerated type or the frozen type .
Half of the people in the
study will receive the freeze -dried refrigerated type and the other half will receive the
frozen type . As there is no placebo in this study, all participants will receive the study
vaccine.
This is a n ‘observer -blind study’ , which means that you and the study doctor will not
know which version ofthe study vaccine you are receiving ,but the person who gives
you the vaccine will know .However, the syringe will be covered with a label so the
contents are not visible and the person who gives you the vaccine will not be able to talk
about it with you. In case of urgent need, the study doctor can learn quickly which
version of study vaccine you have received .
The study vaccine will be given to you through an injection into themuscle in your upper
arm. Everyone will receive 2 injections, approximately 3 weeks apart. On the days you
receive the study vaccine, you will be asked to wait atthe study site for at least 30
minutes for observation after receiving the study vaccine .
Overview ofStudy Procedures and A ssessments
The table below lists the tests and procedures or assessments that you will have done
in this research study. In addition to the visits listed, your study doctor may ask you to
come in for extra visit(s) if necessary, to protect your well
-being.
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CONSENT TO TAKE PART IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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The study doctor or nurse will:
Visit Number 1 2 3
(19-23 days after Visit 1) (28 to 35 days after Visit 2)
Visit Description Study Vaccine 1 Study Vaccine 2 1-Month Follow -up Visit
Ask about Medical histor y as well as date of birth,
sex, race and ethnicityX
Perform clinical assessment or physical exam X
Measure height and weight X
Measure body temperature X X
Urine pregnancy test (if appropriate) X X
Check contraceptives (if appropriate) X X X
Ask about other vaccinations you have had X X X
Ask about medicines you are currently taking X X
Check y ou meet all the study requirements X X
Collect blood sample to test antibody levels ~20 mL ~20 mL
Take a nasal swab for COVID -19 virus detection X X
Givethe study injection, followed by a 30 -minute
observation periodX X
Give you an e -diary or help you download one X X
Explain the vaccination e -diary completion for
participants to self -report potential side effects for
7 days following each vaccinationX X
Ask how you are feeling generally X X X
Collect e -diary or help you to delete the
applicationX
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Blood samples for antibody testing
You will have blood taken 2times during the planned visits of the study at Visit 1 and at
Visit 3 . This will be used to test if you already had antibodies against the coronavirus
that causes COVID -19 when you enrolled in the study and will be used to test your
antibody levels after vaccination . About 20mL of blood (about 4teaspoons) will be
collected from your arm using a needle at these visits. These tests will not be run until
after your participation in the study has ended; therefore, the results will not be available
until after the study has finished and will have no effect on your taking part in the study .
Nasal swabs for COVID -19 virus detection
Nasal swabs obtained during the study (at Visit 1 and Visit 3) will be tested in a
research laboratory. They will be used to detect the COVID -19 virus. The swab (which
looks like a long pointed Q -tip)will be inserted into your nose and rotated 2 -3 times for
approximately 10 seconds , the swab will need to be inserted quite far into your nose to
ensure that a good sample is taken .Your sample will not be run until after your
participation in the study has ended ; therefore, the results will not be available until after
the study has finished and will have no effect on your taking part in the study .
E-Diary
At Visit 1, the study team will show you how to fill in an electronic diary (or e -Diary). W e
will either give you a device (a bit 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 confidentiality will be maintained.
You will be instructed by the study team to complete the e -Diary for 7 days after each
vaccination, once a day in the evening with the first day being the day of the
vaccination.
You will be given a thermometer and a measuring device to take home. You will use
the thermometer to measure your temperature under your tongue and you will use the
measuring d evice to measure any redness or swelling where the injection was given.
You will need to record these measurements in the e -Diary.
The e -Diary will also ask other questions about potential side -effects you may have after
the injection. If you have any se vere symptoms after your vaccination, you should
contact your study doctor and the study doctor or nurse may schedule an extra visit.
It is very important that you complete the e -Diary regularly as instructed. If you do not,
your study doctor or nurse will contact you to check how you are.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Reporting changes to your health
It is important that you report to the study team all symptoms and side effects, whether
or not you consider them to be related to the vaccine or COVID -19. If you experience
any changes t o your health during the study, please tell your study doctor at the earliest
opportunity (eg, at your next planned visit).
Should you visit the Emergency Room or are admitted to the hospital, please contact
your study doctor as soon as possible.
You w ill be given a Study C45910 20Emergency Contact Card. Please show this to any
healthcare provider that you seek medical care from.
Phone numbers for the study team are listed in [Section 1] of this consent document.
Urine pregnancy test
If you’re a woman who is able to have children , you will have a urine pregnancy test to
check you are not pregnant before you get each of the 2 study injections .
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 you follow all the instructions given to you by the study nurse or doctor
and tell them if:
You don’t understand anything about the study
You are not able to comply with the study requirements
There are changes in your health
You take any new medications or receive any other vaccines
You are going away for a long period
You wish to take part in another research study
8. What are the possible risks and discomforts of this study ?
Any re search has some risks, which may include negative effects that could make you
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 effect s;
however, the study team does not know all the effects that the study vaccine may have
on you.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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If you take part in this study, the most likely risks or discomforts to happen to you are
discussed below.
If you become unwell and seek medical treatment ,for the purposes of the study, the
study doctor may contact your usual provider, and any facility where you are treated, to
obtain details and collect medical records: by signing this informed consent document,
you agree to this.
Study Vaccine Risks
Up u ntil the end of 2020, the safety of BNT162b2 has been studied in clinical trials that
have included 21,744 people 16 yrs of age and older who have received at least one
dose of the vaccine. In addition, since the vaccine has been approved for emergency
usein many countries, about 26 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 th an 1 in 10 people): injection site pain, injection site
swelling, fatigue (tiredness), increased body temperature (fever, more common after the
second dose), chills, headache, joint aches, and muscle aches.
Common (between 1 in 10 and 1 in 100 people): fee ling sick (nausea), 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, and swelling of the face or lips),
pain in arm, and feeling weak or unw ell.
Frequency cannot be estimated from available data: severe allergic reaction
(anaphylaxis).
As in all research studies, the COVID -19 vaccines may involve risks that might be
expected based on results from studies of similar vaccines, as well as risks t hat are
currently unknown.
.
Therefore, it is important that you report all symptoms and side effects that you
experience 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 I catch COVID -19 disease, could the vaccine make it worse?
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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For some other vaccines tested in animals against similar viruses (but not the
coronavirus that causes COVID- 19), there have been reports of the illnes s 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 to contact your study doctor
if you develop symptoms that might be caused by COVID -19 (for ex ample, fever, cough,
shortness of breath).
Risks from Study Procedures
Risks and possible discomforts you 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. You may feel dizzy or
may faint. If you have a previous history of feeling dizzy or fainting during blood
sample collection, you should talk to the s tudy doctor.
Nasal S wabs : The risks and possible discomforts 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 you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you
should not join this study.
If you are able to have children and you are sexually active, you must use birth control
consistently and correctly from the signing of t he informed consent document until at
least 28 days after you receive your last injection. This applies to men as well as
women who take part in the research study. The study doctor will discuss with you the
methods of birth control that you should use w hile you are in this research study and will
help you select the method(s) that is appropriate for you. The study doctor will also
check that you understand how to use the birth control method and may review this with
you at each of your research study vi sits.
Birth control methods, even when used properly are not perfect. If you or your partner
becomes pregnant during the research study, or you want to stop your required birth
control during the research study, you should tell the study doctor immediat ely. You
may b ewithdrawn from the research study if you stop using birth control or you become
pregnant.
Pregnancy Follow -up
If you or your partner become pregnant during the study, up until 1 month after you rlast
study injection , please tell the study doctor immediately . Please also tell the doctor who
will be taking care of you/your partner during the pregnancy that you took part in this
study. The study doctor will ask if you/your partner or your pregnancy doctor is willing to
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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provide updates on the progress of the pregnancy and its outcome. If you/your partner
agree, this information will be provided to 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. However , you should still follow local
recommendations about how to avoid COVID -19. In addition, i nformation learned from
the researc
h study may help other people in the future .
10. What w ill happen to my blood and nasal swab samples?
Your blood and nasal swab 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 you are. Some of the samples may be stored for future testing and
may be kept for up to 15 ye ars 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 DNA will be performed.
You may request that your 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 shar ed with other
researchers as long as confidentiality is maintained ,and no testing of your DNA will be
performed. You will not be told of additional tests, nor will you receive results of any of
these tests.
11. What other choices do I hav e if I do not join this study ?
This study is for research purposes only. Your alternative is to not take part in this
study .
12. What happens if I am injured during this study ?
If you experience a research injury, <investigator or institution name> will provide or
arrange for
medical treatment. BioNTech/Pfizer will cover the costs of this treatment. A
research injury is any physical injury or illness caused by your participation in the
study. If you are injured by a medical treatment or procedure that you would have
received even if you weren't in the study, that is not a research injury. There are no
plans to offer you payment for such things as lost wages, expenses other than medical
care, or pain and suffering. To help avoid injury, it is very important to follow all stu dy
directions. You are not giving up any of your legal rights by signing this form.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
14of 23
If you are treated for a research injury that is paid for by BioNTech/Pfizer,
BioNTech/Pfizer or its representative will collect your name, date of birth, gender, and
Medicare Health Insurance Claim Number or Social Security Number to determine your
Medicare status. If you are a Medicare beneficiary, BioNTech/Pfizer will report the
payment and information about the study you are in to the Centers for Medicare &
Medicaid S ervices, in accordance with CMS reporting requirements. BioNTech/Pfizer
will not use this information for any other purpose.
NOTE: All U.S. Veterans Administration sites are exempt from mandatory CMS language
requirement .
13. What if I join this study and t hen change my mind?
If you agree to participate and then change your mind for any reason, you are free to
stop participating at any time. Your decision will not affect your regular medical care or
any benefits to which you are entitled. Tell the study doc tor if you are thinking about
stopping or decide to stop so that you can end participation in the study in the safest
way.
While you are 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 mind about
continuing in this study. If you decide to withdraw from the study, you may be asked to
continue to participate in the study procedures even though you would n o longer receive
the study vaccine.
If you agree to continue with the study, information about your health will continue to be
collected as described in [Section 6].
If you decide to stop participating in this study, you must notify the study doctor. The
study team will explain what other procedures or discussions would occur.
Sometimes the study doctor or BioNTech/ Pfizer may decide to take you out of the study
(even if you do not agree )if:
•You are unable or unwilling to follow the instructions of the study team;
•The study doctor decides that the study is not in your best interest or that you are no
longer eligible to participate; or
•The study is stopped by BioNTech/Pfizer ,the institutional review board (IRB) or
independent ethics committee (IEC) (a group of people who review the study to
protect your 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 personal information (including
your biological samples) and how it may be used if you withdraw from the study.
14. What w ill I have to pay for if I take part in this study ?
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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You will not need to pay for the study vaccine, study -related procedures, or study visits.
15. Will I be paid for taking part in this study ?
You will not receive any payment for taking part in this study. However, fo r each visit
you complete, you will be reimbursed by the study site to cover reasonable expenses
(for example, parking, meals, travel) that you have as a result of taking part in this
study. You will be reimbursed by [enter, as applicable, method of reimbu rsement;
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 they may make a profit. There are no plans to pay you or provide
you with any products developed from this research. BioNTech/Pfizer will own all
products or processes that are developed using information from the study.
16. What w ill happen to my personal information?
The study team will give you a Privacy Supplement, which is considered part of this
consent document. The Privacy Supplement tells you about:
What personal information may be collected from you during the study;
How your personal information will be used and by whom (including by the study
site, BioNTech/Pfizer , and others outside the study site);
How your biological samples and images will be handled (if collected);
How your personal information might be used for other research;
How your personal information will be protected during transfer;
Your data protection rights, and whom you may contact about these rights or any
related concerns or complaints; and
What happens to your personal information if you decide to stop taking part in the
study.
17. Where can I find additional information about thi s 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 you.
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.
These Web sites arein English only. If you need assistance understanding these Web
sites, please ask a member of the study team.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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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 individual
study results may be given to you or your doctor (if different from the st udy doctor) in
accordance with applicable law , but will notbe given to your 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 individuals, including you. BioNTech/Pfizer does not
plan to return information from any exploratory research to you, the study doctor, or
your doctor (if different from the study doctor).
18. Signatures
Agreement to Participate and to Process Data
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 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 to participate.
2. I have read and understand the Privacy Supplement. I understand that taking
part in the study will require the processing (including colle ction, use, transfer,
storage, analysis and reporting) of my personal information, as explained in the
Privacy Supplement. I understand and agree to the processing of my personal
information within and outside my country of residence for health care, medic al
research and/or regulatory purposes.
3. I understand that taking part is voluntary and that I am free to stop taking part
in this study or to withdraw my consent to the processing of my personal
information at any time. I do not need to give any reaso n and my regular medical
care and legal rights will not be affected. However, even if I withdraw my consent
to processing, my 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 biological samples may not be able to be destroyed because
they may no longer be traceable to me, may have already been used, or may have
been given to a third party.
4. I agree to the study team accessing my medical history, including information
from medical records and test results and any medical treatment I receive during
the course of the study, and if necessary, contacting my doctor or any other health
care providers treating me for access to such information.
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CONSENT TO TAKE PA RT IN STUDY
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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5. I und erstand that BioNTech/Pfizer and/or others working with or on behalf of
BioNTech/Pfizer , institutional review boards (IRBs) or independent ethics
committees (IECs) , and regulatory agencies may need access to personal
information about me generated at the s tudy site or collected by the study team for
the study and any other research. I agree that they may have access to my
personal information.
6. I do not give up any of my legal rights by signing this consent document. I have
been told that I will receive a signed and dated copy of this document.
7. I agree to take part in the study described in this document.
_________________________________________
Printed name of participant
________________________________________________ ______________
Signature of participant Date of signature§
(If no legally acceptable representative is used)
§Participant must personally date their signature.
Person Obtaining Consent :
____________________________________
Printed Name of the Person Conducting the Consent Discussion
________________________________________ _______________
Signature of the Person Conducting the Consent Discussion†Date of signature
†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 signs the consent
document .
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PRIVA CY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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PRIVA CY SUPPLEMENT
This Privacy Supplement describes how we will collect, use, and share your personal
information. It also describes your privacy rights.
You are not required to authorize the use and disclosure of your personal information as
described below. If you do not agree, you cannot participate in this study, but there
will
be no penalty or change to your regular medical care or payment for that car e.
A.What personal information may we collect about y ou during this study ?
Your study team and others assisting with your study -related care will collect or provide
information about you, some of which is sensitive. This information may include:
Infor mation that directly identifies you such as your name, address, telephone
number, email address and date of birth.
Sensitive personal information such as your medical history, data from this
study (including study results from tests and procedures), demogr aphics (for
example, age and gender) and other sensitive information that is needed for this
study such as HIV status, race and ethnicity.
Data from testing and analy sis of biological samples (such as blood or urine)
and images (such as X
-rays, CT -Scans, and medical photographs). This may
also include genetic information.
Data captured from electronic devices if you complete the consent process
using the eConsent tablet or if you use a mobile application or other digital tool
during the study. This information may include data about your use of the
eConsent tablet, application or tool, such as the length of time it takes you to
complete the consent process, the number of times you scroll between pages or
click on the hyperlinked
items, and your electronic signature. Mobile applications
and other digital tools used in the study may have their own privacy policies.
Those policies provide additional information about the data processing activities
performed by the digital tools.
B.Who will use my personal information, how will they use it, and where will it be
stored?
Any personal information collected about you during this study will be entered into
records, including health records, maintained by the study team at your study site. Your
medical records that include information that directly identifies youmay be uploaded to
secure systems maintained by a third party engaged by BioNTech/Pfizer so that
BioNTech/Pfizer and/or BioNTech/Pfizer representatives can review and verify study
data. Some of the uploaded records will be kept for 15years. The remaining records
that are uploaded will be temporary and removed/deleted after the study is over. The
study team must keep your personal information private. A U.S. privacy law called HIPAA
(the Health Insurance Portability and Accountability Act of 1996) protects the privacy of
your personal health information. [Name of Covered Entity] must get your permission
to use and share with others any personal health information that could identify you.
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FDA-CBER-2021-5683-1073374
PRIVA CY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Your personal information will be accessed by:
Your study doctor and other study team members;
BioNTech/Pfizer and its representatives (including its affiliated companies);
People, or organizations providing services for, or collaborating with,
BioNTech/Pfizer ;
Any organization that obtains all or part of BioNTech’s/Pfizer’s business or rights
to the product und er study;
Government or regulatory authorities (including the U.S. Food and Drug
Administration and authorities in other countries); and
Institutional Review Board(s) (IRB) or Independent Ethics Committee(s) (IEC)
overseeing this study.
The individuals an
d groups listed above will use your personal information to conduct this
study, and to comply with legal or regulatory requirements, including to:
determine if you are eligible for this study;
[include as applicable: provide you with reimbursement, as al lowed by the study,
for your time, effort and certain expenses related to your participation; ]
verify that the study is conducted correctly and that study data are accurate;
answer questions from IRB(s), IEC(s), or government or regulatory agencies;
assess your use of electronic devices in the study, for example, to determine how
long it takes you to complete any e -consent module used for the study and your
comprehension of the e -consent process;
contact you during and after the study (if necessary);
follow -up on your health status, including using publicly available sources should
the study team be unable to contact you using information held on file;
protect your vital interests or the interests of your pregnant partner (for example,
a critical medic al situation, such as providing information to an emergency
department of a hospital where you are being treated); and
answer your data protection requests (if any).
The study site will retain your personal information for the period necessary to fulfill the
purposes
outlined in the consent document(s), which could be up to 15 years after the
end of the study OR unless a different retention period is required or permitted by law].
If you provide someone else's personal information (for example, an emergency contact
or details of family medical history) you should make them aware that you have provided
the information to us. We will only use such personal information in accordance with this
informed consent and applicable law.
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PRIVA CY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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C.What happens to my persona l information that is sent outside the study site?
[Name of Covered Entity] is required by HIPAA to protect your personal
information. After your information is shared with others, such as BioNTech/Pfizer, it may
no longer be protected by HIPAA.
Before the study team transfers your personal information outside the study site, the study
site will replace your name with a unique code. We call this "Coded Information ." The
study site will keep the link between the code and your personal information confiden tial,
and BioNTech/Pfizer will not have access to that link. BioNTech/Pfizer employees and
representatives are required to protect your Coded Information and will not attempt to re -
identify you.
Your Coded Information will be used by the following:
BioNTech/Pfizer and its representatives (including its affiliated companies);
People and/or organizations providing services to or collaborating with
BioNTech/Pfizer;
Any organization that obtains all or part of BioNTech/Pfizer business or the rights
to the product under study;
Other researchers;
The IRB or IEC that approved this study; and
Government or regulatory authorities;
The above parties may use your personal information for the following purposes:
Conducting the study , including:
oExamining your re sponse to the study vaccine;
oUnderstanding the study and the study results and learning more about
COVID -19; and
oAssessing the safety and efficacy of the study vaccines.
Complying w ith legal and regulatory duties such as:
oEnsuring the study is conducted according to good clinical practice;
oMaking required disclosures to IRB(s), IEC(s), or government or regulatory
authorities;
oSeeking approval from government or regulatory authorities to market
study vaccine (it is possible that these government or regula tory
authorities may disclose your Coded Information to other researchers for
the conduct of future scientific research); and
oSharing study data with other researchers not affiliated with
BioNTech/Pfizer or study team (including through publication on the
internet or other ways. However, information that could directly identify
you will not be made available to other researchers).
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PRIVA CY SUPPLEMENT
CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
Protocol No: C4591020 / PFIZER CONFIDENTIALPage:
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Publishing summaries of the study results in medical journals, on the internet
or at educational meetings of other researchers. You will not be directly identified
in any publication or report of the study. But some journal representatives may
need access to your Coded Information to verify the study results and ensure the
research meets the journal's quality standards. Also, jour
nals may require that
genetic and other information from the study that does not directly identify you be
made available to other researchers for further research projects.
Improving the quality, design and safety of this study and other research
studies.
BioNTech/Pfizer will retain your Coded Information for the period necessary to fulfill the
purposes
outlined in the consent document(s), [Insert one of the following options as
appropriate: which could be up to [insert local requirements; e.g., 25 years] after the end
of the study, OR unless a different retention period is required or permitted by law].
D.How are my biological samples and images handled?
If biological samples or images of you are taken during the study, those samples and
images will be handled in the same way as your Coded Information. All samples will be
treated as required by law. Sometimes your study site may be unable to remove
informa tion that can identify you from your images before sending images to
BioNTech/Pfizer and its representatives.
E.Can my personal information be used for other research?
Your Coded Information may be used to advance scientific research and public health in
other projects that will occur in the future. At this time, we do not know the specific details
of these future research projects.
This other research may be conducted (1) in combination with data from other sources ,
(2) for additional scientific research purposes beyond objectives of this study, and (3)
subject to specific safeguards .
Other sources : Coded Information may be combined with data from other
sources that are taken from outside typical research settings. These sources may
include: code d electronic health records, claims and health care cost and
payment data or databases, product and disease registries, data gathered
through your phone, tablet, or other devices and mobile applications, social
media, pharmacy data, biobanks, or patient en gagement programs.
Additional scientific research: Coded Information may be used to understand
how to make new medicines, devices, diagnostic products, tools and/or other
therapies that treat diseases and to improve future research. It may also be used
to inform value, cost -effectiveness and pricing, and to optimize access to
medicines.
Specific safeguards will be used to protect your Coded Information, which may
include:
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CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
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oLimiting access to Coded Information to specific individuals who will be
obligated to keep this information confidential and will be prohibited from
attempting to re -identify your Coded Information.
oUsing security measures to avoid data alteration, loss and unauthorized
access.
oAnonymizing the data by removing and/or replacing information from the
Coded Information and/or destroying the link to the Coded Information.
oAssessing data protection systems to identify and mitigate privacy risks, if
any, associated to each additional scientific research purpose.
oWhen required by applicable law, e nsuring that the scientific research has
the approval of IECs, IRBs, or other similar review groups.
F. How will my personal information be protected when transferred from the
study site to BioNTech/Pfizer?
Your personal information will be treated in compliance with applicable data protection
laws, including requiring people and/or organizations providing
services to or
collaborating with BioNTech/Pfizer to use appropriate measures to protect the
confidentiality and security of your personal informatio n. Some of the people using your
personal information, including your Coded Information, may be based in countries other
than your country. Data privacy laws may be different in these countries. If your personal
information is transferred by BioNTech/Pfize r to other countries, BioNTech/Pfizer, and
people working with BioNTech/Pfizer, will take steps to maintain the confidentiality of your
personal information.
G.What are my data protection rights? Whom may I contact about these rights
or any concerns or complaints?
You have the right to access your personal information that is held about you by the study
team. To ensure the integrity of the study, you will not be able to review some of the data
until after the study has been completed.
If you wish to e xercise this right or have concerns about how your personal information is
being handled, it is best to contact the [Institution] and not BioNTech/Pfizer. Generally,
BioNTech/Pfizer will not know who you are (by name) because BioNTech/Pfizer usually
holds only your Coded Information, which does not include your name or other information
that can easily identify you. To contact the [Institution] or the study team representative,
please see the contact information at [Section 1] of the consent document.
H.What happens if I do not w ish to continue with the study ?
As noted in the main consent document, you are free to stop taking part in this study at
any time by telling the study team. Your authorization for the study site to disclose your
personal informat ion does not expire unless you withdraw your authorization.
If you stop taking part in the study and you do not tell the study team, your contact
information may be used by the study team to contact you and check whether you wish
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CT05 -GSOP -RF04 7.0 Phase 1/2/3/4 Clinical Study Informed Consent Template (01-Jul-2019)
TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study/Country/Site) 2/2/0, 02 Feb 2021
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to continue in the study. If the study site is unable to reach you, BioNTech/Pfizer may use
publicly available records about your health to monitor the long-term safety of the study
drug. This will only be done if allowed by the law.
If you stop taking part in the study but do notwithdraw your consent, your personal
information will continue to be used in accordance with this Privacy Supplement and
applicable law. No new information or samples will be collected about you or from you by
the study team, unless you have agreed to pro vide them.
If you decide to withdraw your consent:
You will no longer be able to participate in the study;
No new information or samples will be collected about you or from you by the
study team;
The study team may still need to report any safety event that you may have
experienced due to your participation in the study to BioNTech/Pfizer;
Your personal information, including Coded Information, that has already been
collected up to the time of you r withdrawal will be kept and used by
BioNTech/Pfizer to guarantee the integrity of the study, to determine the safety
effects of the study vaccine, to satisfy legal or regulatory requirements, and/or for
any other purposes permitted under applicable data protection and privacy laws;
Your personal information (including Coded Information) will not be used for
further scientific research. However, if your personal information has been
anonymized so that the information does not identify you personally, that
information may continue to be used for further scientific research (as described
in Section E of this Privacy Supplement), as permitted by applicable law; and
Biological samples that have been collected but not analyzed will no longer be
used, unless per mitted or required by applicable law.
You
have the additional right to request that any remaining samples that have been
collected from you as part of the study be destroyed. You may exercise this right by
communicating to the study team your wish to have the samples destroyed. The study
team will then send your coded request to BioNTech/Pfizer. Laws or regulations may
require that your samples be destroyed or de-identified if you withdraw from the study,
regardless of whether you specifically make such a request.
However, we cannot guarantee the destruction of samples because the sample may no
longer be traceable to you, they may have been used up, or they may have been
released to a third party. In those cases, it would not be possible to remove and destr oy
your biological samples and any related data.
090177e1962e63da\Approved\Approved On: 03-Feb-2021 16:41 (GMT)
FDA-CBER-2021-5683-1073379