125742 45 S211 M5 c4591001 interim ado iec irb consent form

Collection

Pfizer Documents (PHMPT/FDA)

Case

Pfizer Bla Submission

Sub-case

Pfizer 12 15 Documents

Pages

202

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C4591001 Page 1of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMT16.1.3.1 LIST OF INDEPENDENT ETHICS COMMITTEE (IEC) OR INSTITUTIONAL REVIEW BOARD (IRB)
ARGENTINA
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1231 Com ité Institucional de Revisión de Ensayos Clínicos (C.I.R.E.C.) del Hospital Militar Central
"Cirujano Mayor Dr Cosme Argerich"
Av. Luis María Campos 726, Edificio PACE Piso 5
CABA, 1426
ARGENTINA
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Page 1
FDA-CBER-2022-5812-0223874
C4591001 Page 2of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTBRAZIL
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1226 CONEP (Comissao Nacional de Etica em Pesquisa)
SRTV 701, Via W 5 Norte, lote D, Edificio PO 700, 3º andar - Asa Norte
Brasilia, DF 70719 -040
BRAZIL
Com ite de Etica em Pesquisa da Faculdade de Medicina do ABC \Fundacao do ABC -- FMABC
Avenida Lauro Gomes, 2000 -Vila Sacadura Cabral
Santo Andre/SP, 09060 -870
BRAZIL
1241 Com ite de Etica em Pesquisa do Hospital Santo Antonio /Obras Sociais Irma Dulce
Avenida Luiz Tarquínio, snº, portao 9, 1º andar, sala 1, Roma
Salvador, BA 40414 -120
BRAZIL
CONEP (Comissão Nacional de Ética em Pesquisa)
SRTV 701, Via W 5 Norte, lote D, Edifício PO 700, 3° andar -Asa Norte
Brasília/DF, 70719 -040
BRAZIL
090177e196a1cc59\Approved\Approved On: 29-Mar-2021 02:13 (GMT)
Page 2
FDA-CBER-2022-5812-0223875
C4591001 Page 3of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTGERMANY
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1185 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1194 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1195 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1197 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1202 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
1203 Landesaerztekammer Baden -Wuerttemberg
Liebknechtstr. 33
Stuttgart, 70565
GERMANY
090177e196a1cc59\Approved\Approved On: 29-Mar-2021 02:13 (GMT)
Page 3
FDA-CBER-2022-5812-0223876
C4591001 Page 4of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTSOUTH AFRICA
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1229 Pharm a Ethics Independent Research Ethics committee
123 Amcor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1230 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1246 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
1247 Pharm a-Ethics (Pty) Ltd
123 Amkor Road, Lyttelton Manor
Centurion, 0157
SOUTH AFRICA
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Page 4
FDA-CBER-2022-5812-0223877
C4591001 Page 5of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTTURKEY
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1205 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1207 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakü ltesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1208 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1209 Kocaeli Ü niversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1210 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1212 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1213 Kocaeli Ü niversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
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Page 5
FDA-CBER-2022-5812-0223878
C4591001 Page 6of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1214 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
1217 Kocaeli Üniversitesi Klinik Arastirmalar Etik Kurulu
Kocaeli Üniversitesi Tip Fakültesi Klinik, Arastirmalar Birimi Umuttepe Yerleskesi
Kocaeli
TURKEY
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Page 6
FDA-CBER-2022-5812-0223879
C4591001 Page 7of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTUNITED STATES
Study Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1001 NYU Langone Grossman School of Medicine IRB
One Park Ave, 6th Fl
New York, NY 10016
UNITED STATES
1002 Western Institutional Review Board
1019 39th Ave., SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1003 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1005 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1006 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1007 Cincinnati Children’s Hospital Medical Center IRB
3333 Burnet Ave, MLC 5020
Cincinnati, OH 45229
UNITED STATES
1008 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1009 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1011 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1012 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1013 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1015 WCG IRB
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1016 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1018 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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FDA-CBER-2022-5812-0223881
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1019 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1021 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1022 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1024 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1027 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1028 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1030 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 9
FDA-CBER-2022-5812-0223882
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1036 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1037 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1038 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1039 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1042 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1044 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1046 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1047 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1048 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1052 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1054 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1055 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1056 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1057 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
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Page 11
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1066 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1068 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1071 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1072 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1073 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1077 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1079 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1080 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1081 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1082 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1083 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1084 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1085 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1087 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 13
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1088 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1089 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1090 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1091 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1092 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1093 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1094 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 14
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1095 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1096 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1097 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1098 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1101 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1107 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1109 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
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Page 15
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C4591001 Page 16of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1110 WCG IRB
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1111 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1112 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1114 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1116 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1117 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1118 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
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Page 16
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1120 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1121 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1122 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave S.E, Ste 120
Puyallup, WA 98374
UNITED STATES
1123 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1124 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1125 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1126 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1127 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1128 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1129 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1130 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1131 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1133 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1134 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 18
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1135 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1136 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1139 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave SE, Ste 120
Puyallup, WASHINGTON 98374 -2115
UNITED STATES
1140 WESTERN INSTITUTIONAL REVIEW BOARD
1019 39th Ave S.E, Ste 120
Puyallup, WA 98374
UNITED STATES
1141 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1142 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1145 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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Page 19
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1146 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1147 WCG IRB
1019 39th Ave Se, Ste 120
Puyallup, WASHINGTON 98374
UNITED STATES
1149 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1150 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1152 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1156 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1157 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1161 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1162 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1163 Copernicus Group IRB
5000 CentreGreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1166 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1167 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1168 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1169 Lehigh Valley Health Network/Institutional Review Board/Research Participant Office
1255 S Cedar Crest Blvd, Ste 3200
Allentown, PA 18103
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1170 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED ST ATES
1171 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1174 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1177 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1178 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1179 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1204 Western Institutional Review Board
1019 39th Ave SE, Ste 200
Puyallup, WA 98374 -2115
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1218 Indian Health Service National IRB
5600 Fishers Ln, MS 09E10D
Rockville, MARYLAND 20857
UNITED STATES
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
1219 Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
1220 Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
1221 Johns Hopkins Bloomberg School of Public Health
615 N. Wolfe St, Rm E1100
Baltimore, MARYLAND 21205
UNITED STATES
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CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
Navajo Nation Human Research Review Board
Window Rock Blvd, Administration Bldg #2, Division of Health, P.O. Box 1390
Window Rock, ARIZONA 86515
UNITED STATES
1223 Yale University Human Research Protection Program (Human Investigation Committee)
25 Science Park, 3rd Fl, 150 Munson St
New Haven, CT 06520
UNITED STATES
1224 Copernicus Group IRB
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1232 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1235 Western Institutional Review Board
1019 39th Ave. SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1248 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1251 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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C4591001 Page 25of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1252 Copernicus Group Institutional Revie w Board
5000 Centregreen Way, Ste 200
Cary, NORTH CAROLINA 27513
UNITED STATES
1254 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1258 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1260 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1261 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1264 Western Institutional Review Board
1019 39th Ave SE, Ste 120
Puyallup, WA 98374
UNITED STATES
1265 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
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FDA-CBER-2022-5812-0223898
C4591001 Page 26of 26
CONFIDENTIAL 26-Mar-2021 09:43:07 GMTStudy Site Number Independent Ethics Committee or Institutional Review Board Address(es)
1269 Copernicus Group Institutional Revie w Board
5000 CentreGreen Way, Ste 200
Cary, NC 27513
UNITED STATES
1270 Kaiser Permanente Northern California Institutional Review Board
1800 Harrison St, 10th Fl
Oakland, CA 94612
UNITED STATES
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FDA-CBER-2022-5812-0223899
CLINICAL STUDY INF ORMED CONSENT
ADD ENDUM Page:
1 of 3
Protocol Number:
C4591001 Associ ated ICD Version Date :
NA
ICD Addendum Version Date :
Phase 3, Blood Draws for PBMCs and
HLA Typing, 02Mar2021
Study
Country Site Languag e: Englis h
Center ID: Not Appli cable
Country: Not Applicable

CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF
Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) INFORMED CONSENT ADDENDUM FOR
A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY,
IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA VACCINE
CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Protocol Number: C4591001

You have already signed a consent form to participate in the research study mentioned
above. This addendum is part of the consent procedure. It has been written to provide
you with information on additional blood draws at your planned study visits .
Please note you do not need to consent to this document to remain part of the study. If
you agree to give the additional blood samples and then change your mind for any
reason, you are free to stop partici pating at any t ime. All ot her information in the main
consent form that you already signed, which is not addressed in this addendum still
applies.

Additional blood draws

You are being asked by the study site whether you would consider taking part in a sub-
study where a small group of selected participants will be asked to provide additional
blood samples. This could be because you are recei ving a third, “booster ” dose of
BNT1 62b2 or BNT1 62b2
SA, or because you are newly part of the study and will receive
2 doses of BNT162b2 SA. Pleas e ask your study doctor if you aren’ t sure which group
you are in.

These blood samples will be used to look very care fully at your body ’s immune
response to the vaccine . The tes ts will check the number and type of immune cells your
body makes af ter vacci nation: these cells are thought to be an important component of
the protection that the vaccine produces . The tests are done by isolating a type of blood
cells called peripheral blood mononuclear cells (PBMCs). To hel p us understand your
body ’s own immune system make-up, we will also do human leukocyte antigen (HLA)
typing with your first sample. You may have heard of this referred to as ‘tissue typing’.
If you choose to take part in this sub-study, you will need to read, sign and date this
consent addendum before starting any new set of study -related procedures.

After signing and dating this consent addendum , the study doctor will check if y ou meet
all the requirements to give the additional blood samples . The total volume o f extra
blood samples is about 485 mL (around 1 pint ) through 6 months after your last dose of
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CLINICAL S TUDY I NFORMED CONSENT
ADDENDUM Page:
2 of 3
Protocol Number:
C4591001 Associ ated ICD Version Date :
NA ICD Addendum Version D ate:
Blood Draws for PBMCs an d HLA
Typing, 02 Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appl icable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc
ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
study vaccine; a bout 120 mL (around 4 fl oz) at each visit . This is the same whether you
are in the “booster” group, or are newly enrolled, but the visit schedules will differ
slightly.

If you are receiving a “booster ” dose of BNT162b2 or BNT162b2 SA:

The blood samples will be collec ted as part of your planned visit s and will be collected
from a vein in your arm using a needle at the same time as the regular blood sample, so
no additional needlestick should be required. You can see in the table below how much
blood will be taken at each visit .

Visit Number 301 302 303 306
Visit Description Vax 3 1-Week
Follow -up Visit
(After Vax 3) 1-Month Follow -
up Visit
(After Vax 3) 6-Month Follow -
up Visit (Afte r
Vax 3)
Blood sample for PBMC isolation
collected ~120 mL ~120 mL ~120 mL ~120 mL
Blood sample for HLA typing
collected ~5 mL
If you are newly enrolled to receive two ( 2) dose s of BNT162b2
SA:
The bl ood samples will be collec ted as part of your planned visit s and will be collected
from a vein in your arm using a needle at the same time as the regular blood sample, so
no additional needlestick should be required. You can see in the table below how much
blood will be taken at each vis it.

Visit Number 401 403 404 405
Visit Description Vax 1 1-Week
Follow -up Visit
(After Vax 2) 1-Month Foll ow-
up Visit
(After Vax 2) 6-Month Follow -
up Visit (After
Vax 2)
Blood sample for PBMC isolation
collect ed ~120 mL ~120 mL ~120 mL ~120 mL
Blood s ample for HLA typing
collected ~5 mL
Please take as much time as you need to ask questions from the research study t eam
before agreeing t o continue. If after receivi ng this information you agree to continue
taking part in this r esearch study, please sign and date below.

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CLINICAL S TUDY I NFORMED CONSENT
ADDENDUM Page:
3 of 3
Protocol Number:
C4591001 Associ ated ICD Version Date :
NA ICD Addendum Version D ate:
Blood Draws for PBMCs an d HLA
Typing, 02 Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appl icable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF Doc
ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
SIGNATURES:
• I have read the information in this addendum to the informed c onsent document.
• I have had an opportunit y to ask questions and all of my questions have been
answered to my satisfaction.
• I have been given enough t ime to decide whether or not I want to continue in the
study.
• I voluntarily agree to continue taking part in this st udy.
• I do not give up any of my legal right s by si gning this consent document.
• I have been told that I will receive a signed and dat ed copy of this doc ument.

_________________________________________
Printed name of participant

_________________________________________ ______________
Signat ure of participant Date of signature§
(If no legally acceptable representative is used)

§Participant must personally date their signature.

_________________________________________
Printed name of legally acceptable representat ive
and relationship

___________________________________________________ ______________
Signature of legally acceptable representative Date of signature§

PERSON OBTAINI NG CONSENT

____________________________________
Printed Name of the P erson Conducting the
Consent Discuss ion

_____________________________________ ______________
Signature of the Person Conducting the Date of signatu re
Consent Discussion †

†The inves tigator, 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
interview when the subj ect signs the consent document .

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CLINICAL STUDY INF ORMED CONSENT
ADDENDUM Page:
1 of 9
Protocol Number:
C4591001 Associated ICD Version Date :
Phase 2/3, Adult ICD (03Feb2021)
ICD Addendum Version Da te:
Phase 3, Booster Dose (s), 02Mar2021

Study
Country Site Language: Englis h
Center ID: Not Applicable
Country: Not Applicable

CONFIDENTIAL
TMF Doc ID
: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) INFORMED CONSENT ADDENDUM FOR
A PHASE 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY,
IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA VACCINE
CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Protocol Number: C4591001

You have already signed a consent form to participate in the research study mentioned
above. You are being provided with this addendum because you were enrolled in the
Phase 3 part of this study and originally received the BNT1 62b2 COVID -19 vaccine.
This addendum is part of the consent procedure. It has been written to provide you with
additional information on a booster dose of BNT162b2 or BNT162b2
SA (a modified
versio n of BNT1 62b2 targeted against the Coronav irus variant firs t found in South
Africa). Further, you may also receive an additional dose of BNT162b2 SA if you are a
part of selected subset of participants . This addendum contains information on a new
schedule of study visit s, study procedures and reimburs ement to cover any reasonable
expenses (for example, parking, meals, travel) associated with these new visits . It also
provides the latest information on BNT162b2 vaccine risks that you will want to know .
Please note you do not need to consent to this document to rem ain part of the study. If
you agree to participate and then change your mind for any reason, you are free to stop
participating at any time. All other information in the main consent form that you already
signed, which is not addressed in this addendum sti ll applies.

Administ ration of an Additional Dose of BNT 162b2 or BNT162b2
SA

You originally receiv ed 2 doses of the investigational vaccine (B NT162b2) as part of
your participation in Phase 3 part of this study . As the study has progressed through
Phase 3, it has been determined that 2 doses of BNT162b2 at 30µg is highly effective at
preventing COVID -19 in people 16 years of age and older. In the past couple of months,
you may have heard of the emergence of new variant s (mutations) of Coronavirus ,
which may be more easily transmitted and/or less ea sily neutralized by immunity from
the current vaccine s. One such variant first arose in South Africa and so is called ‘ South
African variant ’. In response to this, a version of the investigational vacc ine BNT162b2
has been slightly modified in such a manner so that it uses your own cells’ protein
making machinery to produce some, or all, of the spike protein seen on the outside of
this South African variant . This modified vaccine will be referred as BNT 162b2 SA
throughout this addendum . It is also possible that a 3rd dose of the existing version of
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CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
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CLINICAL S TUDY I NFORMED CONSENT
ADDENDUM Page:
2 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
the BNT162b2 vaccine may be able to provide better protection against the South
African variant than 2 doses.

In light of this new i nformation, the study team would like to learn quickly if an additional
vaccine dose (booster dose) can further enhance immune protection against COVID -19
disease for those who already received two doses of BNT162b2 va ccine. Once the
study doctor has confirmed you meet t he study requirements, you will be randomly
assigned (like flipping a coin) to receive one booster dose of either BNT162b2 or
BNT162b2 SA. This will be your third dose. For every 1 person who receive s BNT162b2,
1 perso n will recei ve BNT162b2 SA. No one (including you, your personal doctor and the
study team) can choose this assignment.

As part of this random assignment, a small subset of participants will be selected to
receive a further dose of BNT162b2 SA as a fourth dose but only if they have received
BNT162b2 SA as their booster dose (third dose). Your study doctor will be able to find this
out and communicate it to you during Visit 303.

You are now being asked by the study s ite whether you would consider rec eiving the
booster dose(s) and to read, sign and date this consent addendum before starting any
new set of stu dy-related procedures.
After signing and dating this consent addendum , the study doctor will check if y ou meet
all of the requirements , and once confirmed you meet all the study requi rement s, you
will recei ve the b ooster vacci ne dose as an injection. This will be given into the muscle
in your upper arm in the same way as the f irst 2 doses and you will be asked to wait at
the study site for at least 30 minutes for observation after receivi ng the vaccin e
injection.
Overvi ew of Study P rocedures and Assessments:

The table below lists the tests and procedures or assessments that you will have done
for the remaining duration of the study. In addition to the v isits lis ted, your study doctor
may ask you t o come in for ex tra vis it(s) if necessa ry, to protect your wel l-being.
You will have blood taken 5 or 7 times during the remaining planned visits of the study.
This will be used to test your antibody levels . About 50mL of blood will be collec ted from
a vein in your arm us ing a needle at each of these v isits. Some participants may be
asked to take part in a sub-s tudy where additional blood samples will be collected for
further research. Your study doctor can t ell you if this research site is taking part in th e
sub-study and whether you may be asked take part .

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CLINICAL S TUDY I NFORMED CONSENT
ADDENDUM Page:
3 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)

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CLINICAL STUDY INF ORMED CONSENT
ADDENDUM Page:
4 of 9
Protocol Number:
C4591001 Associated ICD Version Date :
Phase 2/3, Adult ICD (03Feb2021)
ICD Addendum Version Da te:
Phase 3, Booster Dose (s), 02Mar2021

Study
Country Site Language: Englis h
Center ID: Not Applicable
Country: Not Applicable

CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF
Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) For participant s receiving the booster dose (s), the stu dy doctor or nurse will:

Visit Number 301 302 303 304 305 306 307
Visit Descriptio n Vax-3 1-Week
Follow -up
Visit from
Vax-3 1-Mont h Follow -
up Visit from
Vax-3
& Also, Vax-4 for
selected
participants)
1-Week
Follow -up Visit
from Vax-4
(only for
selected
participant s) 1-Month
Follow -up
Visit from
Vax-4
(only for
selected
participant s) 6-Month
Follow -up
Visit from
Vax-3 18-Month
Follow -up
Visit from
Vax-3
Obtain urine pregnancy test (if appropriate) X X
(only if you are
selected to receive
Vax-4)
Check contraceptives (if appropriate) X X X X X
Ask abo ut medicines you are cu rrently taking X X X X X X X
Ask about other v accinati ons you have had X X X X X X
Record latest CD4 count and HIV viral load (for
HIV positive participants only) X X X X
Measure body temperature X X
(only if you are
selected to receive
Vax-4)
Check you meet all the study requirements X
Collect a bloo d samp le to test antibody levels ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL
Take a nasal swab(s) X X
(only if you are
selected to receive
Vax-4)
Give you th e study in jection , followe d by 30
minutes observation p eriod X X
(only if you are
selected to receive
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CLINICAL S TUDY I NFORMED CONSENT
ADDENDUM Page:
5 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
Visit Number 301 302 303 304 305 306 307
Visit Descriptio n Vax-3 1-Week
Follow -up
Visit from
Vax-3 1-Mont h Follow -
up Visit from
Vax-3
& Also, Vax-4 for
selected
participants)
1-Week
Follow -up Visit
from Vax-4
(only for
selected
participant s) 1-Month
Follow -up
Visit from
Vax-4
(only for
selected
participant s) 6-Month
Follow -up
Visit from
Vax-3 18-Month
Follow -up
Visit from
Vax-3
Vax-4)
Check you are still able t o use your electronic d i ary
(e-Diary) X X
(only if you are
selected to receive
Vax-4)
Vaccination e -Diary compl etion to self -report
pote ntial side effects daily for 7 days foll owing the
vaccination (with Day 1 being the day of
vaccin ation) X X
(only if you are
selected to receive
Vax-4)
Give you thermometer and measuring device or
check if you still have th em X X
(only if you are
selected to receive
Vax-4)
COVID -19 illness e -Diary completio n X X X X X X X
Ask how you are feeling generally X X X X X X X
Confirm if you are selected to receive an additiona l
dose of BNT162b2 SA X
Request to return the e-Diary or as sist t o delete
the app X
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ADDENDUM Page:
6 of 9
Protocol Number:
C4591001 Associated ICD Version Date :
Phase 2/3, Adult ICD (03Feb2021)
ICD Addendum Version Da te:
Phase 3, Booster Dose (s), 02Mar2021

Study
Country Site Language: Englis h
Center ID: Not Applicable
Country: Not Applicable

CT05 -GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFIDENTIAL
TMF
Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site) E-Diary

You will remember that you were asked to complet e electronic diary (e-Diary) for 7 d ays
following your previous study injections . In a similar manner, you will be instructed by
the study team to complete the vaccin ation part of the e-Diary for 7 days after the study
vacci ne injection at Visit 301 (Vax 3) and also at Visit 303 if you are selected to receive
an additional dose of vaccine injection (Vax 4) . This is once a day in the evening with
the first day being the day o f your vaccination.

You will be given a thermometer and a measuri ng device to take home. You will use
the thermometer to measure your temperature under your tongue and y ou will use the
measuring device to measure any redness or swelling where the i njection was given.
You will need to record thes e measur ements in the vaccination part of the e-Diary.
The vaccination part of the e-Diary will also ask other questions about potential side
effects you may have after the injection. If you have any severe s ymptoms after your
vaccination, you should cont act your study doctor and the study doctor or nurse may
schedule an extra visit.
Pleas e note this 7-day vaccin ation e-D iary is separate to the COVID -19 illness e-Diary
which you will still need to complet e regularl y and follow the prompt s to record COVID -
19 symptoms every 7 days or at any time you have COVID -19 symptoms .
It is very imp ortant 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. You may also receive
text mes sages to t he provided device or your own smartphone (i n case you download
the e-Diary app), or emails (if you provide your emai l address) to remind you t o
complete the COVID -19 illness part of the e-Diary.

If, dur ing your part icipation in the study, should you visit the Emergency Room or
admitted to the hospital, please contact your study doctor as soon as possible.

Study Vaccin e (BNT162b2) Risks:

Up unti l the end of 2020, the safety of BNT162b2 has been studi ed in clinical trials that
have included 21,744 people 16 years of age and older who have received at least one
dose of the vacc ine. In addition, since the vaccine has been approved for emergency
use in many countries, about 26 million doses have been dis tributed.

Based on the clinical study results , and information gathered during general use, the
following risks have been determ ined to be caused by BNT162b2 vaccine:
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ADDENDUM Page:
7 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)

Very common (occurring in more t han 1 in 10 people): i njection site pain, injection sit e
swelling, fatigue (tiredness) , increased body temperat ure ( fever , more common after the
second dose), chills, headache, joint aches , and muscle aches.

Common (between 1 i n 10 and 1 in 100 people): f eeling sick (nausea) , and injection site
redness.

Uncommo n (between 1 in 100 and 1 in 1,000 people): e nlarged lymph glands , allergic
reactions (symptoms may include rash, itching, hiv es, and swelling of the face or lips ),
pain in arm, and feeling weak or unwell .

Frequency cannot be estimated from available data: severe allergic reaction
(anaphylaxis) .

BNT162b2 SA (modified version of BNT162b2) is expected to have a similar safety
profile. However, since this is the first time it will have been studied, we cannot be
certain of that until w e research further .

As in all research studies, the COVID -19 vaccine may involve risks that might be
expected based on results from studies of simi lar vaccines, as well as r isks that are
currently unknown.

Therefore, it is impor tant 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 catc h COVID -19 disease, could the v accine make it worse?
For some other vaccines tested in animals against similar v iruses (but not t he
coronavirus that causes COVID -19), there have been reports of the i llness 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 s ymptoms that might be caused by COVID -19 (f or example, fever, cough,
shortness of breath).

Will I be p aid for receiving the optional booster dose (s) and for the additional
visits t o the study site ?
You will not recei ve any payment for receiving the optional booster dose(s). However,
you will be reimbursed $XX.XX by the study site for the additional visit(s) you complete
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ADDENDUM Page:
8 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
as part of your new study schedule t o cover your out-of-pocket expenses, such as travel
and parking.
Please take as much time as you need to ask questions from the research study team
before agreeing to continue. If after receivi ng this information you agree to receiv e the
optional boos ter dose(s) as part of this r esearch study, please sign and date below.

SIGNAT URES:
• I have read the infor mation i n this addendum to the informed consent document.
• I have had an opportunity to ask questions and a ll of my questions have been
answered to my satisfaction.
• I have been given enough t ime to decide whether or not I want t o continue in the
study.
• I volunt arily agree to continue taking part in this study.
• I do not give up any of my legal right s by signing this consent document.
• I have been told that I will receive a signed and dat ed copy of this document .

_________________________________________
Printe d name of participant

_________________________________________ ______________
Signat ure of participant Date of signature§
(If no legally acceptable representative is used)

§Participant must personally date their signature.

_________________________________________
Printed name of legal ly acceptable representat ive
and relationship

___________________________________________________ ______________
Signature of legally acceptable repres entative Date of signature§

PERSON OBTAINING CONSENT

_________________________________ ___
Printed Name of the P erson Conducting the
Consent Discuss ion

_____________________________________ ______________
Signature of the Person Conducting the Date of signature
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ADDENDUM Page:
9 of 9
Protocol Number:
C4591001 Associ ated ICD Ve rsion Da te:
Phase 2/3, Adult ICD (03Feb20 21) ICD Adde ndum Version D ate:
Phase 3, Booster Dose (s), 02Mar2021
Study
Country Site Language: Englis h
Center ID: Not Appli cable
Country: Not Applica ble

CT05-GSOP -RF07 3.0 Addendum ICD Template ( 01-Jun- 2016)
CONFI DENTIAL
TMF Doc ID: 173.15 (Study); 173.09 (Country/Central); 173.2 4 (Site)
Consent Discussion †

†The investigator, or an appropriately qualified and trained person designated by the investigator to
conduct the informed consent pro cess, must sign and date the consent document d uring the same
interview when the subject signs the consent document .

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CT05 -GSOP -RF04
7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Phase 3, BNT162b2 Naïve
subjects, 02Mar2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not
Applicable

ICD Derived From: Not Applicable

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) Phase 3, 02Mar2021
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 20

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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 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will I participate in this study? 7
5. How many people will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 13
8. What are the possible risks and discomforts of this study? 13
9. What are the possible benefits of this study? 15
10. What will happen to my blood and nasal swab samples? 16
11. What other choices do I have if I do not join this study? 16
12. What happens if I am injured during this study? 16
13. What if I join this study and then change my mind? 16
14. What will I have to pay for if I take part in this study? 17
15. Will I be paid for taking part in this study? 17
16. What will happen to my personal information? 17
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17. Where can I find additional information about this study or the
study results? 17
18. Signatures 18
Privacy Supplement

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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 provi der if you 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 questions about your rights as a study participant, or would like
to obtain inform ation 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 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER-BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
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 or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
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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 B ioNTech. Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study 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.
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, and it will be
given to healthy volunteers by injection.
This investigational vaccine, called BNT162b2 SA is part of the BNT162 family of RNA
vaccines developed by BioNTec h. It is a modified version of BNT162b2 targeted against
the Coronavirus variant first found in South Africa. These vaccine s do not contain the
whole virus, or the parts of the virus that can make you ill, instead the vaccines are made
up of part of the virus’s genetic code, surrounded by fatty particles called lipids. They use
your own 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 own body , may help
your body to produce antibodies to fight against COVID -19. We will check how many
antibodies you make by taking blood samples and testing them .
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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 and inform the study team, as described later in this document.
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 with 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 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 as quickly as
possible, this study has been separated into 2 phases . In both the phases we will try to
see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choose which vaccines at which dose levels are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce.
BNT162b2 vaccine at dose level 30µg was selected as a potential vaccine candidate for
Phase 2/3 study. As the study has progressed through the Phase 2/ 3 part, it has been
determined that 2 doses of BNT162b2 is highly effective at preventing COVID -19 in
people 16 years of age and older. In the past couple of months, you may have heard of
the emergence of new variants (mutations) of Coronavirus, which may be more easily
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transmitted and/or less easily neutralized by immunity from the current vaccines. One
such variant first arose in South Africa and so is called ‘South African variant’. In response to this, a version of the investigational vaccine BNT162b2 has been slightly modified in such a manner so that it uses your own cells’ protein making machinery to produce some,
or all, of the spike protein seen on the outside of this South African variant. This modified
vaccine will be referred as BNT162b2
SA through the rest of this consent document . The
purpose of this sub-study is to learn about the safety and amount of antibodies (immune
response) your body produces after injection of BNT162b2 SA at the 30µg dose level .
You are now being asked to take part in Phase 3 part of the ongoing study . Every
participant who is selected to receive BNT162b2 SA will receive two injections of the study
vaccine and at the same dose level. There is no placebo in this study (a placebo does
not contain any active ingredients) and all participants will receive the study vaccine
(BNT162b2 SA).
The study 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. You will also be required to contact the study doctor if you
experience any of the COVID -19 symptoms (explained later in this document).

4. How long will I participate in this study?
You could be in this study for up to about 20 months . You will need to visit the study site
6 to 7 planned times during the study, and any time after you have experienced COVID -
19 symptoms and are feeling better in about a month’s time.
5. How many people will take part in this study?
Approximately 44,4 93 healthy people are taking part in all 3 phases of this study. In the
Phase 3 sub-study that you are being asked to join, approximately 300 people will take
part.
It is expected that about [number] people will participate in Phase 3 sub-study at this
location.
6. What will 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.
After signing this consent document, the study doctor will check if you meet all the
requirements 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.

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Study Vaccine
Once the study doctor has confirmed you meet the study requirements, you will receive
the study vaccine (BNT162b2 SA). As there is no placebo in this study, all participants will
receive the study vaccine.
The study vaccine will be given to you through an injection into the muscle 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 at the study site for at least 30 minutes
for observation after receiving the study vaccine.
Overview of Study Procedures and Assessments
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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For people taking part in this Phase 3 sub-study , the study doctor or nurse will:

Visit Number 401 402 403 404 405 406
Visit Description Study Vaccine
1 Study Vaccine
2 1-Week
Follow -up
Visit 1-Month
Follow -up
Visit 6-Month
Follow -up
Visit 18-Month
Follow -up
Visit
Ask about Medical history as well as date of birth,
sex, race and ethnicity X
Perform clinical assessment (and a physical exam
if required) 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 X
Ask about other vaccinations you have had X X X X X
Ask about medicines you are currently taking X X X X X
Record latest CD4 count and HIV viral load (for
HIV positive participants only) X X X X
Check you meet all the study requirements X X
Collect blood sample to test antibody levels ~50 mL ~50 mL ~50 mL ~50 mL ~50 mL
Take a nasal swab X X
Give you the study injection , followed by a 30mins
observation period X X
Give you an e -diary or help you download one X
Vaccination e -diary completion for 7 days (if you
are part of selected group to self-report potential
side effects daily for 7 days following each
vaccination) X X
Give you thermometer or check you have one. X X
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For people taking part in this Phase 3 sub-study , the study doctor or nurse will:

Visit Number 401 402 403 404 405 406
Visit Description Study Vaccine
1 Study Vaccine
2 1-Week
Follow -up
Visit 1-Month
Follow -up
Visit 6-Month
Follow -up
Visit 18-Month
Follow -up
Visit
Give you a measuring device (if you are part of
selected group to self -report potential side effects
daily for 7 days following each vaccination ). X X
COVID -19 illness e -diary completion X X X X X X
Ask how you are feeling generally X X X X X X
Request to return the e -Diary or assist to delete
the app X
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Blood samples for antibody testing
You will have blood taken 5 times during the planned visits of the study. 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 may be used to test your antibody levels after vaccination.
About 50mL of blood (about 10 teaspoons) will be collected f rom vein in your arm using
a needle at these visits.
Some participants may be asked to take part in a sub-study where additional blood
samples will be collected for further research. Your study doctor can tell you if this
research site is taking part in the sub-study and whet her you are allowed to take part.
E-Diary
At Visit 401, the study team will show you how to fill in an electronic diary (or e-Diary).
We 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.

There are 2 parts to the e-Diary. Everyone will need to complete the COVID -19 illness
part of the e-Diary on the device or app on your smartphone. The COVID -19 illness e-
Diary will prompt you to record any COVID -19 symptoms (see below) every 7 days or at
any time you have COVID -19 symptoms. You may also 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 illness part of the e-Diary.
If you are part of a subset of participants, you will also be instructed by the study team to
complete the vaccination part of 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 device to measure any redness or swelling where the injection was given. You
will need to record these measurements in the vaccination part of the e-Diary.
The vaccination part of the e-Diary will also ask other questions about potential side
effects you may have after the injection. If you have any severe 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 instruct ed. If you do not,
your study doctor or nurse will contact you to check how you are.
If, during your participation in the study, should you visit the Emergency Room or admitted to the hospital, please contact your study doctor as soon as possible.
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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 the study injection.

What happens if I have positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 401 and 402, and at the time of a
potential COVID -19 illness – see below) will be tested in a research laboratory. P ositive
results from the Visit 401 and 402 swabs, and all results from the illness visit sw abs, will
be provided to your study doctor, but this will take some time so you should not rely on
these for medical treatment .
If You Get COVID -19 Symptoms
If you get any of the following you must contact the study doctor straight away .
Note that this is not instead of your routine medical care. If you feel unwell enough
that you would normally see a healthcare professional, please contact your usual
provider , as well as the study doctor .

• A diagnosis of COVID -19;
• Fever;
• New or increased cough;
• New or increased shortness of breath;
• Chills ;
• New or increased muscle pain ;
• New l oss of taste/smell ;
• Sore throat ;
• Diarrhea;
• Vomiting.

The study doctor may ask you to have a telephone conversation, video call or to visit the
site to talk about how you are feeling and if you have needed any other medical care.
They will also ask you to take a nose swab or take one from you to check for the
coronavirus. We will give you separate instructions about how to take a nose swab
yourself and how to ship the swab to the study site or laboratory if needed. The result
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 you with COVID -19. This is why it is important
that you contact your usual provider if you have COVID -19 symptoms and think you need
medical care.

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If you are diagnosed with COVID -19, for the purposes of the study, the study doctor will
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 .

The study doctor will arrange an extra visit to the study site about a month after you
became unwell and you will give another 20 mL (about 4 teaspoons) blood sample to test
your antibody levels.
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 tak e 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 research 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 effects;
however, the study team does not know all the effects that the study vaccine may have
on you.
If you take part in this study, the most likely risks or discomforts to happen to you are discussed below.
It is important that you 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.

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, joint aches, and muscle aches.
Common (between 1 in 10 and 1 in 100 people): feeling 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 unwell.
Frequency cannot be estimated from available data: severe allergic reaction (anaphylaxis).
BNT162b2SA (modified version of BNT162b2) is expected to have a similar safety
profile. However, since this is the first time it will have been studied, we cannot be
certain of that until we research further.
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 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?
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 di d 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 example, fever, cough,
shortness of breath).

Risks from Study Procedures
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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 study doctor.
• Nasal S wabs: The risks and possible discomforts involv ed 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 for 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 while 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 visits.

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 immediately . You may
be withdrawn 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 6 months after you last
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
provide updates on the progress of the pregnancy and its outcome. If you/y our 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. H owever , it is not known yet whether the study
vaccine (BNT162b2 SA) may reduce the chance of you getting COVID -19 that is caused
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by South African variant. Because of this, y ou still need to follow local recommendations
about how to avoid COVID -19 (for example, social distancing and mask use). And
Information learned from the research study may help other people in the future.
10. What will 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 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
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 shared 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 have 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?
For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specific research injury language must be inc luded verbatim in the
country -level ICD .

13. What if I join this study and then 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 m edical care or any
benefits to which you are entitled. Tell the study doctor 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 no 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].
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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 will I have to pay for if I take part in this study?
You will not need to pay for the study vaccine (COVID -19 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, for 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 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 t hey 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.

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 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 Web sites 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 individual study results may be given to you or your doctor (if different from the study doctor) in
accordance with applicable law , but will not be 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. B ioNTech/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 collection, 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
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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 reason 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.
5. I understand 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 st udy 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:
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____________________________________ Printed Name of the Person Conducting the
Consent Discussion

________________________________________ _______________
Signature of the P erson Conducting the Date of signature

Consent Discussion
†

†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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PRIVACY SUPPLEMENT

PRIVACY SUPPLEMENT
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.
Who will use my personal information, how will they use it, and where will it be
stored?
[Mandatory study language – retain the below paragraph and delete this green text before
finalis ation]
Any personal information collected about you during this study will be entered into recor
ds, including health records, maintained by the study team at your study site. Your
records that include information that directly identifies you may 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 XX years. The remaining records that are uploaded will
be temporary and removed from the secure system after the study is over.
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7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not
Applicable

ICD Derived From: Study level, Phase 2/3, 08Dec2020

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) Phase 2/3, 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 20

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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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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 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will I participate in this study? 7
5. How many people will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 12
8. What are the possible risks and discomforts of this study? 12
9. What are the possible benefits of this study? 14
10. What will happen to my blood and nasal swab samples? 15
11. What other choices do I have if I do not join this study? 15
12. What happens if I am injured during this study? 15
13. What if I join this study and then change my mind? 15
14. What will I have to pay for if I take part in this study? 16
15. Will I be paid for taking part in this study? 16
16. What will happen to my personal information? 17
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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
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17. Where can I find additional information about this study or the
study results? 17
18. Signatures 17
Privacy Supplement

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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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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 if you 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 questions about your rights as a study participant, or would like
to obtain information from, offer suggestions to, or speak with someone not direc tly
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 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
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 or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
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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 B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this study. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study 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.
Vaccines help your body to produce antibodies to help you to fi ght off a disease . This
research study involves 2 investigational vaccines to prevent COVID -19, that will be
given to healthy volunteers . The vaccines are given by injection. The vaccines are
slightly different but work in the same way. The study will also test each of these
vaccines at different dose level s (amounts of vaccine).
These vaccines do not contain the whole virus, or the parts of the virus that can make
you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded
by fatty particles called lipids. They use your own 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 own body, may help your body to produce antibodi es to fight
against COVID -19. We will check how many antibodies you make by taking blood
samples and testing them .
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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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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 and inform the study team , as described later in this document.
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 with 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 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 as
quickly as possible, this study has been separated into 2 phase s. In both the phase s we
will try to see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choose which vaccines at which dose level s are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce .
You are being asked to take part in Phase 2/3.
The study will compare the results of the people who receive the study vaccine
(BNT162b2 ) with those who receive a placebo (a placebo does not contain any active
ingredients). In this study the placebo will be salt -water, also known as normal saline.
Every one in Phase 2/3 of the study will receive 2 injections of either:
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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) Phase 2/3, 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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• Study vaccine followed by study vaccine
• Placebo followed by placebo
In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at
the same dose, that was chosen based on the results from Phase 1.
The study 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. You will also be required to contact the study doctor if
you experience any of the COVID -19 symptoms (explained later in this document).

4. How long will I par ticipate in this study?
You could be in this study for up to about 26 months . You will need to visit the study site
6 to 7 planned times during the study, and any time after you have experienced COVID -
19 symptoms and are feeling better in about a month’s time .
5. How many people will take part in this study?
Approximately 44,193 healthy people could take part in the 2 phase s of this study. In
Phase 2/3 of the study up to 43,998 people will take part.
It is expected that about [number] people will participate in Phase 2/3 of the study at this
location.
6. What will 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.
After signing this consent document, the study doctor will check if you meet all of the
requirements 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 the study vaccine or placebo. For
every 1 person who receive the study vaccine, 1 person will receive the placebo. No
one (including you, your personal doctor and the study team) can choose this
assignment .
This is a n ‘observer -blind study’ , which means that you and the study doctor will not
know whether you are receiving the study vaccine or placebo , but the person who gives
you the vaccine will know because the vaccine and placebo do not look the same .
However, the syringe will be covered with a label so the contents are not visible and the
person that gives you the vaccine will not be able to talk a bout it with you. In case of
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3, 03Feb2021
Protocol No: C4591001
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urgent need, the study doctor can learn quickly whether you have received study
vaccine or placebo .
The study vaccine or placebo will be given to you through an injection into the muscle in
your upper arm. Everyone will receive 2 injections, approximately 3 weeks apart. On the
days you receive the study vaccine or placebo, you will be asked to wait at the study
site for at least 30 minutes for observation after receiving the study vaccine or placebo .
Overvie w of Study Procedures and Assessments
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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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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For people taking part in Phase 2/3, the study doctor or nurse will:

Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
Ask about Medical history as well as date of birth,
sex, race and ethnicity X
Ask about medicines you are currently taking X X X X X X
Perform clinical assessment X
Record latest CD4 count and viral load (for HIV
positive participants only) X X X X X
Measure body temperature X X
Measure height and weight X
Urine pregnancy test (if appropriate) X X
Ask about other vaccinations you have had X X X X
Check you meet all the study requirements X X
Check contraceptives (if appropriate) X X X
Collect blood sample to test antibody levels ~20 mL ~20 mL ~20 mL ~20 mL ~20 mL
Take a nasal swab X X
Get the study injection , followed by a 30mins
observation period X X
Give you an e -diary or help you download one X
Vaccination e -diary completion for 7 days (if you
are part of chosen group to self-report potential
side effects daily for 7 days following each
vaccination) X X
COVID -19 illness e -diary completion X X X X X X
Ask how you are feeling generally X X X X X X
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 , 03Feb2021
Protocol No: C4591001
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Blood samples for antibody testing
You will have blood taken 5 times during the planned visits of the study. 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 may be used to test your antibody levels after
vaccinat ion. About 20mL of blood (about 4 teaspoons) will be collected f rom your arm
using a needle at these visits.
E-Diary
At Visit 1, the study team will show you how to fill in an electronic diary (or e -Diary). We
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 sec ure and
your confidentiality will be maintained.

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 device to measure any redness or swelling where the i njection was given.
You will need to record these measurements in the vaccination part of the e-Diary.
The vaccination part of the e-Diary will also ask other questions about potential side
effects you may have after the injection. If you have any severe 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 .
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 the study injection .

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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 , 03Feb2021
Protocol No: C4591001
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What happens if I have positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 1 and 2, and at the time of a potential
COVID -19 illness – see below) will be tested in a research laboratory. P ositive results
from the Visit 1 and 2 swabs, and all results from the illness visit swabs, will be provided
to your study doctor, but this will take some time so you should not rely on these for
medical tre atment . If you has a positive nasal swab test result for the coronavirus that
causes COVID -19, either at Visit 1 or any time between Visit 1 and Visit 2 , but with no
potential COVID -19 related symptoms , you will continue to receive the second study
vaccine as normal. However, if the positive COVID -19 test result is accompanied by
potential COVID -19 related symptoms, you will not be given the second study vaccine
but will be requested to remain in the study.

If You Get COVID -19 Symptoms
If you get any of the following you must contact the study doctor straight away .
Note that this is not instead of your routine medical care. If you feel unwell
enough that you would normally see a healthcare professional, please contact
your usual provider , as well as the s tudy doctor .

The study doctor may ask you to have a telephone conversation , video call or to visit
the site to talk about how you are feeling and if you have needed any other medical
care. They will also ask you to take a nose swab or take one from you to check for the
coronavirus. We will give you separate instructions about how to take a nose swab
yourself and how to ship the swab to the laboratory if needed . The result from this swab
will be provided to the study doctor once it is available, but this wi ll take some time, and
cannot be used to diagnose you with COVID -19. This is why it is important that you
contact your usual provider if you have COVID -19 symptoms and think you need
medical care.

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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Phase 2/3 , 03Feb2021
Protocol No: C4591001
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If you are diagnosed with COVID -19, for the purposes of th e study, the study doctor will
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 .

7. Are there any special instructions to follow for this study?
It is impo rtant 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 medicat ions 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 research 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 effects;
however, the study team does not know all the effects that the study vaccine may have
on you.
If you take part in this study, the most likely risks or discomforts to happen to you are
discussed below.
It is important that you 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.

Study Vaccine Risks
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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
13 of 20

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 th e 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, joint aches, and muscle aches.
Common ( between 1 in 10 and 1 in 100 people ): feeling 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 unwell.
Frequency cannot be estimated from available data: severe allergic reaction (anaphylaxis).
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 risk s that 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?
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 anim als 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 example, fever, cough, shortness of breath).

Placebo Risks
As the placebo injection contain s salt -water and no active ingredients, the chances of
having the side effects mentioned above are less likely. In other studies using the same
placebo , some people who received the placebo injecti on reported pain, bruising,
swelling and redness at the site of injection.

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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
14 of 20

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 study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g 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 for 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 while you are in
this research study an d 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 visits.

Pregnancy Follow -up
If you or your partner become pregnant during the study, up until 6 months after you last
study injection , please tell the study doctor immediat ely. 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
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?
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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
15 of 20

Vaccination with BNT162b2 has been shown to be effective in preventing COVID -19 in
the groups of people already studied, but not yet in people like you. Because of this,
and the fact that you may receive the placebo vaccination, you still need to follow local
recommendations about how to avoid COVID -19 (for example, social distancing and
mask use).
10. What will 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 share d 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 have if I do not join thi s 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?
For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specific research injury language must be inc luded verbatim in the
country -level ICD .

13. What if I join this study and then 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 doctor 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
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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
16 of 20

continue to participate in the study procedures e ven though you would no 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 g overnment 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 will I have to pay for if I take part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.

15. Will I be paid for taking part in th is study?
You will not receive any payment for taking part in this study. However, for 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 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 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.

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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
17 of 20

16. What will happen to my personal information?
<click here > for language to be inserted into this section. This text must be inserted
verbatim. Any requested c hanges must be approved by Clinical Development Legal. Note
that the Privacy Supplement follows this consent document, after the signature section.
17. Where can I find additional information about this study or the
study results?
A description of this clinica l 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 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 availa ble using the following EU trial number for the
study: [ insert trial number ].
These Web sites 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 individual
study results may be given to you or your doctor (if different from the study doctor) in
accord ance with applicable law , but will not be 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. B ioNTech/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
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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
18 of 20

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, i ncluding 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.
5. I unde rstand 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 st udy 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§
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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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
19 of 20

(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 P erson Conducting the Date of signature

Consent Discussion †

†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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PRIVACY 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) Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
20 of 20

PRIVACY SUPPLEMENT
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.
Who will use my personal information, how will t hey use it, and where will it be
stored?
[Mandatory study language – retain the below paragraph and delete this green text before
finalis ation ]
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
records that include information that directly identifies you may be uploaded to se cure
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 XX years. The remaining records
that are up loaded will be temporary and removed from the secure system after the
study is over.
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

CT05 -GSOP -SD-GL11 Phase 1/2/3/4 Clinical Study Assent Template for Older Children 30 -Apr-2020
TMF Doc ID: 173.16 (Study); 173.10 (Country/Central); 173.20 (Site)
Sponsor Assent Version Number (Study/Country/Site) : Phase 2/3 , 03Feb2021
Protocol No. C4591001 / CONFIDENTIAL Page 1
of 9

• This template is used by informed consent document authors to develop the assent document for
11-year-olds through legal age of adulthood .
• Do not delete the header at the top of this page until the assent is customized at the country/site -
level.
• Before sending the assent to the institutional review board (IRB) /independent ethics committee
(IEC) , remove the header at the top of this page, rem ove all inapplicable text, remove all
instructional green text, and replace all blue text with appropriate language.
• The assent must be filed in the Pfizer Trial Master File .

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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

We are asking if you would like to be in a research study to see if a vaccine to prevent
COVID -19 is safe and if it can help prevent children and adults from getting COVID -19.
Research studies are the way we find out if test medicines or vaccines are safe and if they
work.
The study is being done with healthy children and adults and that is why the study doctor
wants to know if you want to take part in the research study .
WHY ARE WE DOING THIS STUDY ?
We are doing this study to collect information in children and adults to see if the vaccine is
safe and if it can help prevent people from getting COVID -19.

The study doctor and nurses will explain the study and answer any questions that you have.
You can circle or highlight things on this paper you want to know more about. If you don’t
understand something, just ask us. It is okay to ask questions now and anytime later that you
think of them.
If you decide to be in this study, you will be asked to sign this form. Your parent(s) or your
guardian(s ) will sign another form. You can talk to your parent(s) or your guardian(s) and ask
to read the information the study doctor gives them .
WHAT WILL HAPPEN TO ME IF I GO INTO THE STUDY ?
The study starts with a n appointment with the study doctor and some tests to see if you can
be in the study. If you decide to take part in the study you will be given an injection in your
arm at your first and second visit and will need to give at least 5 blood samples. There will be
at least 6 visits to the study clinic over roughly the next 2 years.
If you get ill with COVID -19 like symp toms you will need to visit the study clinic and give
another blood sample. This blood sample is 20 mL if you are 16 years of age or above , and it
is 10 mL if you are between 12 to 15 years of age . If you would like to know what 10 mL or 20
mL looks like please ask the study team and they will be able to show you the tubes they will
collect the blood in.
A RESEARCH STUDY TO SEE IF A VACCINE AGAINST COVID -19
IS SAFE AND WORKS
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

At your first visit, the study doctor or nurse will give you or your parent(s) / guardian (s) a
device (a bit like a mobile phone) or ask to download an application ( ‘app’) to smart phone if
you or your parent(s)/ guardian (s) have one. The device/app is secure and your information
will be maintained in con fidence. The study doctor will show you or your parent(s)/
guardian(s) on how to fill in the electronic diary (also called e -Diary).
There are 2 parts to the electronic diary . Everyone will need to complete the COVID -19
illness part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you or your parent(s)/ guardian(s) to record any COVID -19 symptoms every
7 days or at any time you have COVID -19 symptoms. You or your parent(s)/ guardian(s) may
also receive text messages to your / their device or your / their own smartphone, or emails (if
you or your parent(s)/ guardian(s) provide an email addre ss) to remind you or your parent(s)/
guardian(s) to complete the COVID -19 illness part of the e -Diary.
If you are part of a selected group of participants , you or your parent(s)/ guardian (s) will also
be asked to fill in an e-Diary about how you are feeling for 7 days afer your vaccine injections .
If you decide the take part t he following will happen:
At your first visit:
• Before you are given your injection , the study doctor or nurse will take your
temperature , measure your heigh t and weight, do a physical exam and ask you some
questions about your health.

• The study doctor or nurse will take a blood sample from your arm using a needle (this
will be either 20mL or 10 mL depending on your age group ) and take a sample from
your nose using a swab (like a Q -tip).

• You will then be given an injection into the muscle at the top of your arm.

• If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to complete an electronic diary about how you are feeling for 7 days after
the visit.

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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

At your second visit:

• You will be given your second injection , the study doctor or nurse will take your
temperature and ask you some questions about your health before they give your
inject ion in your arm.

• If you are part of the selected group of participants, y ou or your parent(s)/ guardian (s)
will be asked to comp lete an electronic diary about how you are feeling for 7 days after
the visit.

It is very important that you or your parent(s)/ guardian(s) , as appropriate, complete the
e-Diary regularly as instructed. If this was not completed , your study doctor or nurse will
contact you or your parent(s)/ guardian(s) to check how you are doing.
At the other 4 visits the study doctor or nurse will ask you some questions about your health
and will take a blood sample from your arm using a needle. Each blood sample will be either
about 2 0mL (4 teaspoons) or 10 mL (2 teaspoons) depending on your age group.

When you visit the study doctor, the study doctor will write down information about you. Only
people who are working on this study will see your informatio n. They are required to keep
your information private.

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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

What are the Study Injections ?
There are 2 types of injections in the study. The active study injection and a dummy placebo
injection. A dummy placebo is a pretend vaccine that looks just like the test vaccine but has
no active ingredients in it.
Once the study doctor has checked that it is OK for you to be in the study a computer will
decide if you will get the active study injection or the dummy placebo. You and your
parent(s)/guardian(s) will not be told which injection you will get.
For every 1 child/ young person who receive s the study vaccine, 1 child/ young person will
receive the placebo. No one (including you, your parents, your personal doctor or the study
team) can choose which injection you will get .

WHAT ARE THE POSSIBLE BENEFITS TO ME IF I AGREE TO BE IN THIS
STUDY?
Vaccination with BNT162b2 (which is active study injection) has been shown to be effective
in preventing COVID -19 in the groups of people already studied, but not yet in children/young
people like you. Because of this, and the fact that you ma y receive the placebo vaccination,
you still need to follow local recommendations about how to avoid COVID -19 (for example,
social distancing and mask use).

WHAT ARE THE POSSIBLE UNCOMFORTABLE OR HARMFUL THINGS
THAT COULD HAPPEN TO ME IF I AGREE TO BE IN THIS STUDY?
There is a chance that during the study you could feel pain or feel bad or uncomfortable.
Please let the study doctor know if you experience any of these things. The study team will
monitor you for risks or discomforts during the study. However, the study team does not
know all the effects that the vaccine, or your participation in this study, may have on you.
The injection could cause pain, swelling, and redness where it is given .
Other side effects could include fatigue (tiredness), increased body temperature (fever),
chills, headache, joint aches, muscle aches, feeling sick (nausea), enlarged lymph glands,
allergic reaction (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).
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

In addition,
• Taking a blood sample may:
o hurt when the needle goes into your arm.
o cause a red spot or bruise on your arm or your arm might feel sore.
o make you feel dizzy.
o cause an infection at the place where the needle went into your arm.
• Taking a swab from your nose may:
o hurt when the sample i s taken.
o Cause your nose to bleed .
• You may feel embarrassed by the questions the study doctor or nurse asks you.

You might also feel other things. Remember to tell your parent(s) or your guardian(s) and the
study doctor everything you are feeling while you are in the study including if you feel unwell .
Pregnancy, Contraceptives and Babies (do I ne ed to use birth control?)
If you are a girl :
If you are pregnant, planning to become pregnant or breast feeding a baby, you cannot be in
the study.
If you think you are pregnant during the study, you must 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.
If you have started to have periods, the study doctor or nurse will test your urine to make sure
you are not pregnant before you are given your injections . The doctor or nurse will tell you if
the test results show you are pregnant. Dependi ng on the laws of your area, the study doctor
or nurse may also tell your parent(s) or your guardian(s) about the results of the pregnancy
test.
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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

If you are sexually active, you must use birth control consistently and correctly during the
study and for at least 28 days after your second injection . Your study doctor or nurse will
discuss this with you if it is appropriate to do so.
If you are a boy :
If you are sexually active, you must use birth control (eg a condom) consistently and correctly
during the st udy and for at least 28 days after your second injection. Your study doctor or
nurse will discuss this with you if it is appropriate to do so.
If you think that you may have gotten a girl pregnant, you must tell your 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.
WHAT OTHER OPTIONS ARE THERE?
This study is for research purposes only. Your alternative i s to not take part in this study.
Taking part is voluntary and you do not have to be in the study if you don’t want to.
It is your choice if you want to be in this study or not. No one will be mad if you choose not to
take part.
Your doctors or you r parent(s) or your guardian(s) cannot make you be in the study if you
don't want to be in it. If you say okay now to being in the study and you change your mind
about it later, you can stop being in the study. Just tell the study doctor or your parent(s) or
your guardian(s) if you want to stop at any time . If you quit the study, you will be asked to
come in for one last visit.

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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

WHAT IF I HAVE QUESTIONS?
You can ask questions about the study at any time.
You can call the study doctor any time.
If you want to ask questions about what it means to be in a research study, you or your
parent(s) or your guardian(s) can call [insert IRB /IEC name ] (a group of people who review
the study to protect your rights) at [insert IRB /IEC number ].
For you to be in this study , you and your parent(s) or your guardian(s) must agree to you
being in it. But it is still up to you if you want to do it.

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SD-GL11 1.0 PHASE 1/2/3 CLINICAL STUDY ASSENT
TEMPLATE FOR OLDER CHILDREN 30-Apr-2020
Protocol Number: C4591001 Assent Version Date : Phase 2/3, 03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not Applicable

Assent Derived From: Older Children Assent, Phase 2/3, 07Dec2020

Please check one box below to show whether or not you want to be in this study .
 Yes, I want to be in this study .
 No, I do not want to be in this study .
______________________________________________________
Printed Name of Child/Young Person

_____________________________ __ ____________________ __________
Child/Young Person Signature Date Time
Statement of person conducting assent discussion:
1. I have explained all aspects of the research to the partic ipant to the best of his or her
ability to understand.
2. I have answered all questions of the partic ipant relating to this research.
3. I believe the partic ipant’s decision to enroll or not enroll is voluntary.
4. If the partic ipant decides to enroll, the study doctor and study staff agree to respect the
partic ipant’s physical or emotional dissent at any time during this research when that
dissent pertains to anything being done solely for the purpose of this research.

Printed Name of Person Obtaining Assent: ____________________________
Signature of Person Obtaining Assent: ________ _________ Date: ________ Time: ______
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7.0 PHASE 1/2/3 CLINICAL STUDY
INFORMED CONSENT TEMPLATE 01-Jul-2019
Protocol Number: C4591001 ICD Version Date : Parent ICD, P hase 2/3,
03Feb2021
 Study
 Country
 Site Language: English Center ID: Not Applicable
Country: Not
Applicable

ICD Derived From: Parent ICD, Phase 2/3 , 08Dec2020

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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
1 of 23

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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
2 of 23

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 4
2. Brief summary of this study 5
3. What is the purpose of this study? 6
4. How long will my child participate in this study? 7
5. How many adults and children will take part in this study? 7
6. What will happen during this study? 7
7. Are there any special instructions to follow for this study? 13
8. What are the possible risks and discomforts of this study? 13
9. What are the possible benefits of this study? 16
10. What will happen to my child’s blood and nasal swab samples? 16
11. What other choices do I have if I do not want my child join this
study? 16
12. What happens if my child is injured during this study? 16
13. What if I join this study and then change my mind? 17
14. What will I have to pay for if I take part in this study? 17
15. Will I be paid for taking part in this study? 17
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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16. What will happen to my child’s personal information? 18
17. Where can I find additional information about this study or the
study results? 18
18. Signatures 19
Privacy Supplement

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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
4 of 23

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 you r child 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 if your child seek s emergency care while taking part in this
study. This card includes information about the study that will help them treat you r child .
If you have any general questions about your child’s rights as a study participant, or
would like to obtain information from, offer sugges tions 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 1/2/3, PLACEBO -CONTROLLED, RANDOMIZED,
OBSERVER -BLIND, DOSE -FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICAC Y OF SARS -COV -2 RNA
VACCINE CANDIDATES AGAINST COVID -19 IN HEALTHY INDIVIDUALS
[Institution] Study Number:
Sponsor Study Number: C4591001
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 or Independent Ethics Committee ] Contact
Information:
Contact Person:
Address:
Phone Number:
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
5 of 23

Patient Rights Advocate:
Contact Person:
Address:
Phone Number:
Bioethicist:
Contact Person:
Address:
Phone Number:
2. Brief Summary of this Study
You are being asked to allow your child to take part in a research study that involves
comparing an investigational (study) vaccine against a placebo (injection with no active
ingredient) to see if the vaccine can prevent COVID -19. The vaccine is given by
injection.
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 take part 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 a n 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. Also, if your child
reach es the legally recognized age of majority (adulthood) during the study, they must
separately provide their consent to continue taking part in the study.
You are be ing asked to allow your child to be in this research study because your child
is healthy and over the age of 12.
This is a research study involving both Pfizer and B ioNTech . Pfizer and BioNTech are
separate companies who are cooperating to perform this stu dy. Pfizer is responsible for
conducting this study. B ioNTech is the regulatory sponsor of this study. Funding for this
study is provided by BioNTech and Pfizer and [the study 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.
Vaccines help your body to produce antibodies to help you to fight off a disease . This
research study involve s 2 investigational vaccines to prevent COVID -19, that will be
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
6 of 23

given to volunteers . The vaccines are given by injection. The vaccines are slightly
different but work in the same way. The study will also test each of these vaccines at
different dose level s (amounts of vaccine).
These vaccines do not contain the whole virus, or the parts 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 a pers ons 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 how many antibodies you r child
make s by taking blood samples and testing them .

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 you r child need s 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.
Allowing your child to t aking part in this study is voluntary (your choice). There is no
penalty or change to you or your child’s regular medical care if y ou decide not to allow
your child to participate. You can choose to let your child 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 to have conversations with your
family, friends , doctors , and study team about this study and whether it is right for your
child . The study team will work with 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.

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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
7 of 23

quickly as possible, this study has been separated into 2 phase s. In both the phase s we
will try to see if the vaccine works to prevent COVID -19, as well as :
• Phase 1 where we choos e which vaccines at which dose level s are safest and
make the most antibodies .
• Phase 2/3 where we look at one vaccine at one dose level in lots of people to
collect even more information about the safety of the vaccines and the amounts
of antibodies they produce .
Your child is being asked to take part in Phase 2/3.
The study will compare the results of the people who receive the study vaccine
(BNT162b2 ) with those who receive a placebo (a placebo does not contain any active
ingredients). In this study the placebo will be salt -water, also known as normal saline.
Everyone in Phase 2/3 of the study will receive 2 injections of either:
• Study vaccine followed by study vaccine
• Placebo followed by placebo
In Phase 2/3 everyone who receives the study vaccine will receive the same vaccine at
the same dose, that was chosen based on the results from Phase 1.
The study doctor will determine whether you r child is eligible for the study. This study
will require y our child to visit the study doctor to undergo study procedures and to
provide information about their health. You/your child will also be required to contact
the study doctor if your child experience any of the COVID -19 symptoms (explained
later in this document).

4. How long will my child participate in this study?
Your child could be in this study for up to about 26 months and will need to visit the
study site 6 or 7 planned times during the study . Your child will also need to visit the
study site if they experience COVID -19 symptoms and again after they have recovered
from those symptoms approximately in a month’s time .
5. How many adults and children will take part in this study?
Approximately 44,193 volunteers could take part in the 2 phase s of this study.
In Phase 2/3 of the study up to 43,998 volunteers will take part , in which approximately
2000 will be of 12 to 15 years of age and the remaining will be above the age of 16
years .

6. What will happen during this study?
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
8 of 23

Before any study procedures begin, or before you r child begin s preparing for the study,
you will be asked to read and sign this consent document. We may also ask your child
to read and sign a similar document.
After signing this consent document, the study doctor will check if you r child meet s all of
the requirements to take part in this study. If you r 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.
Study Vaccine s
Once the study doctor has confirmed you r child meet s the study requirements , you r
child will be randomly assigned (like flipping a coin) to receive the study vaccine or
placebo. For every 1 volunteer who receive s the study vaccine, 1 volunteer will receive
the placebo. No one (including you, your child, your child’s personal doctor or the study
team) can choose th is assignment .
This is a n ‘observer -blind study’ , which means that you , your child and the study doctor
will not know whether you r child will receiv e the study vaccine or placebo . The person
who gives you r child the vaccine will know because the vaccine and placebo do not look
the same . The syringe will be covered with a label so the co ntents are not visible and
the person that gives you r child the vaccine will not be able to talk about it. In case of
urgent need, the study doctor can learn quickly whether you r child received study
vaccine or placebo .
The study vaccine or placebo will b e given to you r child through an injection into the
muscle of the upper arm. All volunteers will receive 2 injections, approximately 3 weeks
apart. On the days you r child receive s the study vaccine or placebo, you and your child
will be asked to wait at the study site for at least 30 minutes for observation .
Overview of Study Procedures and Assessments
The table below lists the tests and procedures or assessments that will be done in this
research study. In addition to the visits listed, the study doctor may ask you r child to
come in for extra visit(s) if necessary, to protect their well-being.

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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
9 of 23

For people taking part in Phase 2/3, the study doctor or nurse will:

Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
Ask about Medical history as well as date of birth,
sex, race and ethnicity X
Ask about medicines you r child is currently taking X X X X X X
Perform clinical assessment X
Record latest CD4 count and viral load (for HIV
positive v olunteers only) X X X X X
Measure body temperature X X
Measure height and weight X
If your child is female and started her periods , she
will be asked to provide a urine sample for a
pregnancy test. X X
Ask about other vaccinations you r child has had X X X X
Check you r child meet s all the study requirements X X
If needed, we will discuss with your child about
appropriate birth control X X X
Collect blood sample to test antibody levelsa ~20 mL/
~10 mL ~20 mL/
~10 mL ~20mL/
~10 mL ~20 mL/
~10 mL ~20 mL/
~10 mL
Take a nasal swab X X
Get the study injection , followed by a 30mins
observations period X X
Give you /your child an e-diary or help you /your
child download one X
Vaccination e -diary completion for 7 days (if yo ur
child is part of a chosen group to report potential
side effects daily for 7 days following vaccination) X X
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
10 of 23

For people taking part in Phase 2/3, the study doctor or nurse will:

Visit Number 1 2 3 4 5 6
Visit Description Study Vaccine
1 Study Vaccine
2 1-Month Visit 6-Month Visit 12-Month Visit 24-Month Visit
COVID -19 illness e -diary completion X X X X X X
Ask how you r child is feeling generally X X X X X X
Abbreviation s: HIV = human immunodeficiency virus; e-diary = electronic diary.
a. 20 mL is to be collected from participants ≥16 years of age; 10 mL is to be collected from participants 12 to 15 years of age .

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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
11 of 23

Blood samples for antibody testing
Your child will have blood taken 5 times during the planned visits of the study. This will
be used to test if they already had antibodies against the coronavirus that causes
COVID -19 when they enrolled in the study and may be used to test their antibody levels
after vaccination . If you r child is 16 years of age or above , about 20 mL of blood (about
4 teaspoons) will be collected f rom their arm using a needle at these visits. Alternatively,
if your child is between 12 to 15 years of age , about 10 mL of blood (about 2 teaspoons)
will be collected from their arm using a needle at the above specified visits.
E-Diary
At Visit 1, the study team will show you or your child how to fill in an electronic diary (or
e-Diary). Parent(s)/ legal guardian (s), as appropriate, will be required to complete the e -
diary on behalf of y ounger age group children , whilst children in older age group might
not require similar level of support from their parent(s)/ legal guardian (s). Therefore,
older age group children (e.g. 16 years or above ) are expected to complete the e -diary
themselves.

We will either give you/ your child a device (a bit like a mobile phone) or ask to
download an application (‘app’) to smart phone if you or your child has one. The
device/app is secure, and your child ’s confidentiality will be maintained.

There are 2 parts to the e -Diary. Everyone will need to complete the COVID -19 illness
part of the e -Diary on the device or app on their smartphone. The COVID -19 illness e -
Diary will prompt you/ your child to record any COVID -19 symptoms (see below) every 7
days or at any time you r child has COVID -19 symptoms. You or your child may also
receive text messages to the device or your /your child’s own smartphone, or emails (if
you/they provide your /their email address) to remind you /your child to complete the
COVID -19 illness part of the e -Diary.
If you r child is part of a subset of participants, you/ your child will also be instructed by
the study team to complete the vaccination part of 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/ your child will be given a thermometer and a measuring device to take home. You/
your child will use the thermometer to measure temperature under the tongue and will
use the measuring device to measure any redness or swelling where the injection was
given. You/ your child will need to record these measurements in the vaccination part of
the e-Diary.
The vaccination part of the e-Diary will also ask other questions about potential side
effects you r child may have after the injection. If you r child has any severe s ymptoms
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
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after vaccination, you/ your child should contact your study doctor and the study doctor
or nurse may schedule an extra visit.
It is very important that you / your child, as appropriate, complete the e -Diary regularly
as instructed. If this was not completed , your study doctor or nurse will contact you / your
child to check how your child is doing .
Urine pregnancy test
If your child is female and has started her periods, she will be asked to provide a urine
sample to check she is not pregnant before given the study injection .

What happens if my child has positive nasal swab test result?
Nasal swabs obtained during the study (at Visits 1 and 2, and at the time of a potential
COVID -19 illness – see below) will be tested in a research laboratory. P ositive results
from the Visit 1 and 2 swabs, and all results from the illness visit swabs, will be provided
to your study doctor, but this will take some time so you should not rely o n these for
your child’s medical treatment . If your child has a positive nasal swab test result for the
coronavirus that causes COVID -19, either at Visit 1 or any time between Visit 1 and
Visit 2, but with no potential COVID -19 related symptoms, they will continue to receive
the second study vaccine as normal. However, if the positive COVID -19 test result is
accompanied by potential COVID -19 related symptoms, they will not be given the
second study vaccine but will be requested to remain in the study.
If You r Child Gets COVID -19 Symptoms
If you r child gets any of the following you must contact the study doctor straight
away . Note that this is not instead of routine medical care. If you r child feels
unwell enough that you would normally see a healthcare professional, please
contact your usual provider , as well as the study doctor .

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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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The study doctor may ask you /your child to have a telephone conversation , video call or
to visit the site 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 nose swab ,
or the study team may take a swab to check for the coronavirus. We will give you /your
child separate instructions about how to take a nose swab and how to ship the swab to
the laboratory if needed . The result 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 usual provider if you r child
has COVID -19 symptoms and think you r child need s medical care.

If your child is diagnosed with COVID -19, for the purposes of the study, the study doctor
will contact your child’s usual provider , and any facility where you child is treated , to
obtain details and collect medical records : by signing this informed consent document,
you agree to this .

The study team will arrange an extra visit to the study site about a month after you r child
became unwell and you r child will need to give another 20 mL (about 4 teaspoons) or
10 mL (about 2 teaspoons) of blood sample , as appropriate, to test their antibody levels.

After the study
The study vaccine is available only during this study and not after the study is over. If
you leave the study before receiving the study vaccine, it may be available to you
through an authorized healthcare professional.

7. Are there any special instructions to follow for this study?
It is important you and your child follow all the instructions given by the study nurse or
doctor and tell them if:
• You don’t understand anything about the st udy
• You /your child are not able to comply with the study requirements
• There are changes in your child’s health
• Your child takes any new medications or receive any other vaccines
• You or your child are going away for a long period
• Your child wish es to take part in another research study

8. What are the possible risks and discomforts of this study?
Any research has some risks, which may include negative effects that could make you r
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
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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effects; however, the study team does not know all the effects that the study vaccine
may have on you r child .
If you r 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.

Study Vaccine Risks
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 th e clinical study results, and information gathered during genera l 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 t he second dose),
chills, headache, joint aches, and muscle aches.
Common ( between 1 in 10 and 1 in 100 people ): feeling 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 unwell.
Frequency cannot be estimated from available data: severe allergic reaction (anaphylaxis).
As in all research studies, the COVID -19 vacc ine 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 / your child report all symptoms and side effects that your child
experience s 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 catch es 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
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Sponsor Consent Version (Study) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
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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 you r child develop
symptoms that might be caused by COVID -19 (for example, fever, cough, short ness of breath).
Placebo Risks
As the placebo injection contain s salt -water and no active ingredients, the chances of
having the side effects mentioned above are less likely. In other studies, using the same
placebo , some volunteers who received the placebo injection reported pain, bruising,
swelling and redness at the site of inj ection.

Risks from Study Procedures
Risks and possible discomforts 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 r child may feel dizzy
or may faint. If you r child has a previous history of feeling dizzy or fainting during
blood sample collection, you should talk to the study doctor.
• Nasal S wabs : The risks and possible discomforts invo lved in takin g 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,
they should not join this study.
If you r child is able to have children and is sexually active, they must use birth control
consistently and correctly for at least 28 days after they receive their last injection . This
applies to males as well as females who take part in the research study. The study
doctor will discuss with you r child the methods of bi rth control that they should use while
in this research study . The study doctor will help you r child select the method that is
appropriate for them . The study doctor will also check that you r child understand s how
to use the birth control method and may r eview this with them at each of their research
study visits.

Birth control methods, even when used properly are not perfect. If you r 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 . You r child may b e withdrawn from the research study if they stop using
birth control or they become pregnant.

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Sponsor Consent Version (Study) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
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Pregnancy Follow -up
If you r child or their your partner become pregnant during the study, up until 6 months
after their last study injection , please tell the study doctor immediately . 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 you r child /their partner or
their pregnancy doctor is willing to provide updates on the progress of the pregnancy
and its outcome. If you r child /their partner agree, this information will be pro vided 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, but not yet in the case of your child . Because of
this, and the fact that you r child may receive the placebo vaccination, they still ne ed to
follow local recommendations about how to avoid COVID -19 (for example, social
distancing and mask use).

10. What will happen to my child’s blood and nasal swab
samples?
Your child’s 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 r 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, and 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 the se tests.
11. 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 .
12. What happens if my child is injured during this study?
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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) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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For mandatory research injury language, < click here > (retain this link in the study -level
ICD). The country -specif ic research injury language must be included verbatim in the
country -level ICD .

13. Can I withdraw my child from the study?
Yes. You are free to withdraw your consent for your child and discontinue their
participation in the research study at any time . Your decision will not affect your or your
child’s regular medical care or any benefits to which you /your child is are entitled. Tell
the study doctor if you are thinking about stopping or decide to stop so that you r child
can end participation in the stud y in the safest way.
While you r 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 mind about
your child continuing in this study. If you decide to withdraw your child from the study,
your child may be asked to continue to participate in the study procedures even though
they would no longer receive the study vaccine.
If your child continue s with the study, i nformation about their 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 would occur.
Sometimes the study doctor or BioNTech/ Pfizer may decide to take you r 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 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 Pri vacy Supplement, which is considered part of this
consent document. It describes what happens to your child’s personal information
(including biological samples) and how it may be used if you withdraw your child from
the study.

14. What will I have to pay for if my child takes part in this study?
You will not need to pay for any of the study vaccines (COVID -19 Vaccine or placebo),
study -related procedures, or study visits.

15. Will my child be paid for taking part in this study?
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TMF Doc ID: 173.13 (Study); 173.07 (Country/Central); 173.23 (Site)
Sponsor Consent Version (Study) Parent, Phase 2/3 , 03Feb2021
Protocol No: C4591001
CONFIDENTIAL Page:
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You will not receive any payment for your child taking part in this study. However, for
each visit you /your child complete s, 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
reimbursement; amounts; and reimbursement schedule; note whether receipts are
required].
BioNTech/Pfizer may use information r esulting from the study to develop products or
proces
…[truncated]

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