Document text
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1005 10051341
(USA/23/F) Dose 1/2 22OCT2020 Unk/Pos/Unk New or increased cough Pos
New or increased
shortness of breath
New loss of taste or smell
Sore throat
Diarrhea
C4591001 1006 10061084
(USA/27/F) Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
C4591001 1006 10061091
(USA/20/F) Dose 2/50 30OCT2020 Neg/Neg/Neg New or increased cough Pos
Sore throat
C4591001 1006 10061114
(USA/21/M) Dose 2/35 20OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1007 10071409
(USA/13/M) Dose 1/10 31OCT2020 Unk/Neg/Unk Fever Pos
C4591001 1008 10081011
(USA/55/F) Dose 2/52 22OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1008 10081130
(USA/52/F) Dose 2/32 17OCT2020 29OCT2020 Neg/Neg/Neg New or increased
shortness of breath Pos
C4591001 1008 10081338
(USA/53/M) Dose 2/1 06OCT2020 16OCT2020 Neg/Neg/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 1
FDA-CBER-2021-5683-0019510
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
New or increased
shortness of breath
Chills
New or increased muscle
pain
Sore throat
C4591001 1008 10081529
(USA/38/M) Dose 1/2 26SEP2020 Neg/Neg/Pos New or increased cough Pos
New loss of taste or smell
Sore throat
C4591001 1008 10081639
(USA/63/M) Dose 1/6 24OCT2020 Unk/Neg/Unk New or increased cough Pos
Sore throat
C4591001 1009 10091128
(USA/51/M) Dose 2/30 15OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1013 10131288
(USA/53/M) Dose 2/11 25SEP2020 06OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased
shortness of breath
Chills
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 2
FDA-CBER-2021-5683-0019511
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
New loss of taste or smell
C4591001 1013 10131475
(USA/49/F) Dose 2/23 22OCT2020 25OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1013 10131670
(USA/41/M) Dose 1/4 11OCT2020 Unk/Pos/Neg New loss of taste or smell Pos
C4591001 1016 10161003
(USA/23/F) Dose 2/57 14OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New loss of taste or smell
C4591001 1016 10161004
(USA/51/F) Dose 2/58 15OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
Sore throat
C4591001 1016 10161017
(USA/18/F) Dose 2/19 07SEP2020 Neg/Neg/Neg Fever Pos
Chills
New or increased muscle
pain
New loss of taste or smell
C4591001 1016 10161035
(USA/70/F) Dose 2/67 29OCT2020 29OCT2020 Neg/Neg/Neg New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 3
FDA-CBER-2021-5683-0019512
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1016 10161183
(USA/31/F) Dose 2/32 16OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
New loss of taste or smell
Sore throat
Diarrhea
Vomiting
C4591001 1016 10161207
(USA/62/F) Dose 2/27 14OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
Sore throat
C4591001 1016 10161316
(USA/15/M) Dose 1/17 01NOV2020 Unk/Neg/Unk New or increased cough Pos
Chills
New or increased muscle
pain
New loss of taste or smell
Sore throat
Diarrhea
C4591001 1016 10161341
(USA/44/F) Dose 1/10 31OCT2020 Unk/Neg/Unk New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
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FDA-CBER-2021-5683-0019513
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased
shortness of breath
Sore throat
Diarrhea
C4591001 1024 10241130
(USA/65/M) Dose 1/9 28OCT2020 Unk/Neg/Unk Fever Pos
New or increased muscle
pain
C4591001 1028 10281038
(USA/53/F) Dose 2/31 10OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Sore throat
C4591001 1028 10281100
(USA/47/F) Dose 2/19 11OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1028 10281132
(USA/61/M) Dose 2/14 11OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
Sore throat
C4591001 1028 10281138
(USA/38/F) Dose 2/25 23OCT2020 Neg/Neg/Neg Fever Pos
Chills
Sore throat
Diarrhea
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 5
FDA-CBER-2021-5683-0019514
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1028 10281193
(USA/60/F) Dose 2/7 14OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
C4591001 1028 10281229
(USA/45/M) Dose 2/3 17OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New loss of taste or smell
Sore throat
Vomiting
C4591001 1028 10281250
(USA/18/M) Dose 1/11 18OCT2020 Neg/Neg/Unk Sore throat Pos
C4591001 1036 10361078
(USA/20/M) Dose 2/2 01OCT2020 Neg/Neg/Pos New loss of taste or smell Pos
C4591001 1038 10381103
(USA/43/F) Dose 2/5 04OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1039 10391021
(USA/26/F) Dose 1/1 25AUG2020 14SEP2020 Neg/Pos/Pos Fever Pos
New or increased cough
New or increased
shortness of breath
New loss of taste or smell
Sore throat
C4591001 1039 10391025
(USA/55/F) Dose 2/40 25OCT2020 27OCT2020 Neg/Neg/Neg Sore throat Pos
C4591001 1047 10471024
(USA/63/F) Dose 2/37 16OCT2020 18OCT2020 Neg/Neg/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 6
FDA-CBER-2021-5683-0019515
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Diarrhea
Vomiting
C4591001 1047 10471252
(USA/63/M) Dose 1/22 12OCT2020 Neg/Neg/Unk Fever Pos
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
Diarrhea
C4591001 1068 10681033
(USA/65/M) Dose 1/23 15SEP2020 21OCT2020 Neg/Neg/Pos Fever Pos
New or increased cough
Chills
New or increased muscle
pain
Diarrhea
C4591001 1068 10681082
(USA/58/M) Dose 2/42 01NOV2020 Neg/Neg/Neg Fever Pos
New or increased cough
Sore throat
C4591001 1068 10681110
(USA/30/F) Dose 2/22 16OCT2020 Neg/Neg/Neg New or increased cough Pos
New loss of taste or smell
C4591001 1071 10711216
(USA/64/F) Dose 1/4 12OCT2020 Unk/Neg/Unk Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 7
FDA-CBER-2021-5683-0019516
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
Sore throat
C4591001 1072 10721051
(USA/47/F) Dose 1/12 06SEP2020 20SEP2020 Neg/Neg/Unk Fever Pos
New or increased cough
New loss of taste or smell
Sore throat
C4591001 1079 10791046
(USA/55/F) Dose 2/62 26OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1079 10791054
(USA/28/F) Dose 2/63 29OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1079 10791162
(USA/20/M) Dose 2/45 09OCT2020 Neg/Neg/Neg Fever Pos
Sore throat
C4591001 1081 10811151
(USA/79/F) Dose 2/10 30SEP2020 14OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1082 10821016
(USA/46/F) Dose 2/44 06OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 8
FDA-CBER-2021-5683-0019517
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New loss of taste or smell
C4591001 1085 10851286
(USA/52/F) Dose 1/24 02OCT2020 Neg/Neg/Unk Sore throat Pos
C4591001 1087 10871089
(USA/21/F) Dose 1/19 04SEP2020 30SEP2020 Neg/Neg/Unk Fever Pos
C4591001 1087 10871209
(USA/50/F) Dose 1/7 31AUG2020 03SEP2020 Neg/Neg/Unk Fever Pos
New or increased muscle
pain
New loss of taste or smell
C4591001 1088 10881219
(USA/63/M) Dose 2/17 25OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased muscle
pain
C4591001 1089 10891217
(USA/64/F) Dose 1/5 04SEP2020 12SEP2020 Neg/Neg/Pos New or increased cough Pos
New or increased
shortness of breath
C4591001 1090 10901121
(USA/58/F) Dose 2/49 18OCT2020 22OCT2020 Neg/Neg/Neg Fever Pos
New loss of taste or smell
C4591001 1091 10911014
(USA/52/M) Dose 2/76 03NOV2020 Neg/Neg/Neg Chills Pos
Diarrhea
C4591001 1092 10921021
(USA/60/F) Dose 2/48 27OCT2020 Neg/Neg/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 9
FDA-CBER-2021-5683-0019518
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
Chills
New or increased muscle
pain
C4591001 1092 10921130
(USA/53/M) Dose 2/18 09OCT2020 Neg/Neg/Neg Fever Pos
New loss of taste or smell
Sore throat
Diarrhea
C4591001 1092 10921158
(USA/23/M) Dose 1/10 12SEP2020 21SEP2020 Neg/Neg/Pos New or increased cough Pos
New loss of taste or smell
Sore throat
C4591001 1092 10921268
(USA/64/F) Dose 1/2 23OCT2020 Unk/Neg/Unk Fever Pos
New or increased muscle
pain
C4591001 1093 10931014
(USA/68/M) Dose 2/1 08SEP2020 16SEP2020 Neg/Neg/Neg New or increased
shortness of breath Pos
Chills
New or increased muscle
pain
C4591001 1093 10931050
(USA/62/M) Dose 1/24 16SEP2020 Neg/Neg/Unk New or increased cough Pos
New loss of taste or smell
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 10
FDA-CBER-2021-5683-0019519
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1093 10931081
(USA/67/F) Dose 2/19 05OCT2020 Neg/Neg/Neg Sore throat Pos
C4591001 1093 10931122
(USA/58/F) Dose 2/9 08OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
C4591001 1093 10931148
(USA/21/F) Dose 2/1 12OCT2020 Neg/Neg/Pos New loss of taste or smell Pos
Diarrhea
C4591001 1096 10961258
(USA/55/F) Dose 2/25 22OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1096 10961388
(USA/17/F) Dose 1/4 12OCT2020 Neg/Neg/Pos Sore throat Pos
C4591001 1097 10971103
(USA/72/F) Dose 1/18 25SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
New or increased muscle
pain
New loss of taste or smell
Diarrhea
C4591001 1097 10971104
(USA/73/M) Dose 1/18 25SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 11
FDA-CBER-2021-5683-0019520
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New loss of taste or smell
C4591001 1098 10981029
(USA/36/M) Dose 1/11 31AUG2020 01SEP2020 Neg/Neg/Unk Fever Pos
C4591001 1098 10981062
(USA/63/F) Dose 2/32 17OCT2020 20OCT2020 Neg/Neg/Neg New or increased muscle
pain Pos
C4591001 1101 11011024
(USA/54/F) Dose 1/11 19SEP2020 07OCT2020 Neg/Neg/Unk Fever Pos
New or increased cough
New or increased muscle
pain
C4591001 1109 11091448
(USA/46/F) Dose 2/9 06OCT2020 28OCT2020 Neg/Neg/Neg Fever Pos (R1 Pos)
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
Sore throat
C4591001 1109 11091556
(USA/41/M) Dose 1/8 11OCT2020 16OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1110 11101006
(USA/34/F) Dose 1/2 01AUG2020 16AUG2020 Neg/Neg/Pos New or increased cough Pos
Chills
New loss of taste or smell
Vomiting
C4591001 1110 11101072
(USA/42/M) Dose 2/4 28SEP2020 Neg/Neg/Pos New loss of taste or smell Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 12
FDA-CBER-2021-5683-0019521
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Sore throat
Diarrhea
C4591001 1110 11101162
(USA/51/M) Dose 2/34 24OCT2020 Neg/Neg/Neg New or increased cough Pos
New loss of taste or smell
C4591001 1111 11111010
(USA/75/M) Dose 2/45 04OCT2020 05OCT2020 Neg/Neg/Neg Fever Pos
Chills
C4591001 1116 11161253
(USA/61/M) Dose 1/8 25SEP2020 06OCT2020 Neg/Neg/Pos Fever Pos
New or increased cough
Chills
New or increased muscle
pain
C4591001 1116 11161322
(USA/23/M) Dose 2/7 20OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1117 11171010
(USA/72/F) Dose 2/34 11OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 13
FDA-CBER-2021-5683-0019522
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1118 11181088
(USA/73/M) Dose 2/36 20OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
C4591001 1122 11221025
(USA/40/M) Dose 2/32 01NOV2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
C4591001 1123 11231073
(USA/25/F) Dose 2/10 10SEP2020 06OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
Sore throat
C4591001 1123 11231085
(USA/20/M) Dose 1/4 16AUG2020 27AUG2020 Neg/Neg/Pos New or increased muscle
pain Pos
C4591001 1123 11231144
(USA/53/F) Dose 1/9 28AUG2020 19SEP2020 Neg/Unk/Unk Fever Pos
New or increased cough
New or increased
shortness of breath
Chills
New or increased muscle
pain
Sore throat
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 14
FDA-CBER-2021-5683-0019523
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1123 11231284
(USA/67/M) Dose 2/12 24OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
C4591001 1123 11231313
(USA/42/F) Dose 1/13 06OCT2020 Neg/Neg/Pos Fever Pos
Chills
New or increased muscle
pain
C4591001 1125 11251006
(USA/35/M) Dose 2/42 11OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
C4591001 1125 11251028
(USA/39/F) Dose 2/27 29SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos
Chills
New or increased muscle
pain
Sore throat
C4591001 1125 11251107
(USA/69/M) Dose 2/3 22OCT2020 Neg/Neg/Neg Fever Pos
Chills
C4591001 1125 11251114
(USA/59/M) Dose 2/38 22OCT2020 Neg/Neg/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 15
FDA-CBER-2021-5683-0019524
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1125 11251148
(USA/54/F) Dose 1/13 14SEP2020 23SEP2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1126 11261017
(USA/34/F) Dose 2/50 20OCT2020 Neg/Neg/Neg Fever Pos
New or increased muscle
pain
C4591001 1127 11271099
(USA/23/F) Dose 1/21 08SEP2020 16SEP2020 Neg/Neg/Pos New or increased cough Pos
New or increased
shortness of breath
Chills
New loss of taste or smell
Sore throat
C4591001 1133 11331209
(USA/30/M) Dose 2/32 10OCT2020 Neg/Neg/Neg New or increased cough Pos
Sore throat
C4591001 1133 11331512
(USA/36/M) Dose 1/17 11OCT2020 Neg/Neg/Unk Fever Pos
New loss of taste or smell
C4591001 1134 11341022
(USA/66/M) Dose 2/29 29SEP2020 03OCT2020 Neg/Neg/Neg New or increased muscle
pain Pos
Sore throat
C4591001 1135 11351148
(USA/35/M) Dose 2/3 10SEP2020 20SEP2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased muscle
pain
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 16
FDA-CBER-2021-5683-0019525
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Sore throat
C4591001 1135 11351207
(USA/33/F) Dose 2/30 13OCT2020 Neg/Neg/Neg New or increased muscle
pain Pos
New loss of taste or smell
Diarrhea
C4591001 1141 11411020
(USA/29/M) Dose 2/6 29AUG2020 04SEP2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1141 11411088
(USA/52/M) Dose 2/29 07OCT2020 Neg/Neg/Neg Fever Pos
Chills
Sore throat
C4591001 1147 11471004
(USA/62/M) Dose 1/22 24AUG2020 28AUG2020 Neg/Neg/Unk New or increased cough Pos
Sore throat
C4591001 1147 11471035
(USA/52/M) Dose 1/18 23AUG2020 11SEP2020 Neg/Neg/Unk New or increased cough Pos
Chills
Sore throat
C4591001 1149 11491066
(USA/40/M) Dose 1/13 24AUG2020 04SEP2020 Neg/Neg/Neg Fever Pos
New or increased cough
C4591001 1149 11491113
(USA/69/M) Dose 2/44 23OCT2020 24OCT2020 Neg/Neg/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 17
FDA-CBER-2021-5683-0019526
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Chills
Vomiting
C4591001 1152 11521363
(USA/19/M) Dose 2/9 06OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1152 11521372
(USA/28/F) Dose 2/33 30OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
Sore throat
C4591001 1156 11561006
(USA/45/M) Dose 1/11 30AUG2020 01SEP2020 Neg/Pos/Neg New or increased cough Pos
C4591001 1156 11561033
(USA/55/F) Dose 1/11 05SEP2020 26SEP2020 Neg/Neg/Pos New or increased cough Pos
New loss of taste or smell
C4591001 1156 11561044
(USA/63/M) Dose 1/6 01SEP2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased
shortness of breath
Chills
New or increased muscle
pain
Sore throat
Diarrhea
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 18
FDA-CBER-2021-5683-0019527
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1156 11561064
(USA/23/F) Dose 1/7 04SEP2020 18SEP2020 Neg/Neg/Pos Fever Pos
Chills
New or increased muscle
pain
New loss of taste or smell
Diarrhea
C4591001 1162 11621044
(USA/22/M) Dose 1/5 10AUG2020 Neg/Unk/Pos Fever Pos
Chills
New loss of taste or smell
Sore throat
C4591001 1163 11631113
(USA/25/M) Dose 2/43 14OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
Sore throat
C4591001 1163 11631135
(USA/42/M) Dose 2/21 30SEP2020 02OCT2020 Neg/Neg/Neg Fever Pos
New or increased muscle
pain
Diarrhea
C4591001 1167 11671152
(USA/41/F) Dose 2/26 20OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 19
FDA-CBER-2021-5683-0019528
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
New loss of taste or smell
Sore throat
Diarrhea
C4591001 1167 11671157
(USA/58/M) Dose 2/16 14OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
C4591001 1168 11681007
(USA/33/F) Dose 2/36 06OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased
shortness of breath
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1168 11681008
(USA/37/M) Dose 2/35 05OCT2020 Neg/Neg/Neg New or increased cough Pos
New loss of taste or smell
C4591001 1168 11681114
(USA/46/F) Dose 2/23 13OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 20
FDA-CBER-2021-5683-0019529
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
New loss of taste or smell
Sore throat
Diarrhea
C4591001 1169 11691007
(USA/28/F) Dose 2/19 11OCT2020 Neg/Unk/Neg New or increased
shortness of breath Pos
New loss of taste or smell
C4591001 1169 11691058
(USA/32/M) Dose 1/16 01OCT2020 11OCT2020 Neg/Neg/Pos Fever Pos
New or increased cough
Chills
C4591001 1170 11701089
(USA/25/F) Dose 2/16 01OCT2020 Neg/Neg/Neg Fever Pos
Sore throat
C4591001 1171 11711269
(USA/61/M) Dose 2/5 11OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
C4591001 1174 11741053
(USA/24/F) Dose 2/5 05OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1178 11781065
(USA/48/M) Dose 2/23 13OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 21
FDA-CBER-2021-5683-0019530
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Sore throat
C4591001 1178 11781238
(USA/60/F) Dose 2/16 29OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
New or increased muscle
pain
Sore throat
C4591001 1178 11781276
(USA/72/M) Dose 2/7 27OCT2020 Neg/Neg/Unk New or increased cough Pos
New or increased
shortness of breath
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1194 11941061
(DEU/51/M) Dose 1/6 24OCT2020 Unk/Pos/Unk New loss of taste or smell Pos
C4591001 1226 12261309
(BRA/61/M) Dose 2/40 20OCT2020 26OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1226 12261360
(BRA/26/M) Dose 2/1 11SEP2020 Neg/Neg/Pos New or increased cough Pos
New loss of taste or smell
C4591001 1226 12261363
(BRA/48/F) Dose 2/23 03OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 22
FDA-CBER-2021-5683-0019531
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
New loss of taste or smell
Sore throat
Vomiting
C4591001 1226 12261894
(BRA/28/M) Dose 1/5 29SEP2020 02OCT2020 Unk/Neg/Pos Fever Pos
Chills
New or increased muscle
pain
C4591001 1226 12262267
(BRA/27/F) Dose 1/2 18OCT2020 Unk/Pos/Unk New loss of taste or smell Pos
C4591001 1231 12311043
(ARG/46/M) Dose 2/40 10OCT2020 11OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
C4591001 1231 12311054
(ARG/37/M) Dose 1/8 18AUG2020 18AUG2020 Neg/Neg/Unk Fever Pos
C4591001 1231 12311087
(ARG/44/M) Dose 1/15 26AUG2020 15SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
New or increased muscle
pain
New loss of taste or smell
Diarrhea
Vomiting
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 23
FDA-CBER-2021-5683-0019532
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1231 12311147
(ARG/31/M) Dose 1/5 17AUG2020 30AUG2020 Neg/Neg/Neg New loss of taste or smell Pos
Sore throat
C4591001 1231 12311195
(ARG/53/M) Dose 1/16 29AUG2020 10OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1231 12311267
(ARG/67/M) Dose 2/24 26SEP2020 07OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Sore throat
C4591001 1231 12311356
(ARG/30/F) Dose 1/17 31AUG2020 18SEP2020 Neg/Neg/Unk New or increased muscle
pain Pos
New loss of taste or smell
C4591001 1231 12311391
(ARG/28/F) Dose 1/10 24AUG2020 Neg/Neg/Unk New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1231 12311407
(ARG/63/M) Dose 2/24 27SEP2020 06OCT2020 Neg/Neg/Neg Fever Pos
Chills
New or increased muscle
pain
Diarrhea
C4591001 1231 12311431
(ARG/21/M) Dose 1/3 17AUG2020 07SEP2020 Neg/Neg/Unk Fever Pos
New or increased cough
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 24
FDA-CBER-2021-5683-0019533
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Chills
New or increased muscle
pain
Sore throat
C4591001 1231 12311531
(ARG/35/M) Dose 2/9 16SEP2020 27SEP2020 Neg/Neg/Neg Fever Pos
New or increased
shortness of breath
New or increased muscle
pain
C4591001 1231 12311532
(ARG/50/M) Dose 1/8 23AUG2020 25AUG2020 Neg/Neg/Pos Fever Pos
New or increased cough
C4591001 1231 12311549
(ARG/58/F) Dose 1/13 28AUG2020 13SEP2020 Neg/Neg/Pos Fever Pos
New loss of taste or smell
C4591001 1231 12311556
(ARG/24/M) Dose 2/45 21OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1231 12311568
(ARG/43/M) Dose 1/6 21AUG2020 10SEP2020 Neg/Neg/Pos New or increased muscle
pain Pos
New loss of taste or smell
C4591001 1231 12311641
(ARG/25/M) Dose 1/10 25AUG2020 15SEP2020 Neg/Pos/Pos New loss of taste or smell Pos
C4591001 1231 12311651
(ARG/52/F) Dose 2/8 14SEP2020 01OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 25
FDA-CBER-2021-5683-0019534
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
Sore throat
Vomiting
C4591001 1231 12311656
(ARG/20/F) Dose 1/24 08SEP2020 20SEP2020 Neg/Neg/Pos New or increased muscle
pain Pos
New loss of taste or smell
Sore throat
C4591001 1231 12311664
(ARG/34/F) Dose 2/9 15SEP2020 03OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
C4591001 1231 12311754
(ARG/54/M) Dose 2/38 14OCT2020 25OCT2020 Neg/Neg/Neg Fever Pos
New or increased muscle
pain
Sore throat
C4591001 1231 12311911
(ARG/41/F) Dose 1/8 25AUG2020 30AUG2020 Neg/Neg/Neg New or increased muscle
pain Pos
Sore throat
C4591001 1231 12311982
(ARG/41/F) Dose 2/37 14OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1231 12312130
(ARG/64/F) Dose 1/3 20AUG2020 27AUG2020 Neg/Pos/Neg Fever Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 26
FDA-CBER-2021-5683-0019535
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
Sore throat
C4591001 1231 12312320
(ARG/51/F) Dose 1/61 18OCT2020 Neg/Neg/Unk New or increased cough Pos
New loss of taste or smell
C4591001 1231 12312334
(ARG/40/F) Dose 1/15 02SEP2020 Neg/Neg/Pos New loss of taste or smell Pos
C4591001 1231 12312339
(ARG/22/F) Dose 1/6 24AUG2020 23SEP2020 Neg/Neg/Neg New loss of taste or smell Pos
C4591001 1231 12312375
(ARG/43/F) Dose 1/9 27AUG2020 07SEP2020 Neg/Neg/Pos New loss of taste or smell Pos
Sore throat
Vomiting
C4591001 1231 12312479
(ARG/43/M) Dose 2/30 09OCT2020 Neg/Neg/Neg New or increased cough Pos
Chills
New or increased muscle
pain
New loss of taste or smell
C4591001 1231 12312507
(ARG/47/F) Dose 2/10 17SEP2020 28SEP2020 Neg/Neg/Neg New or increased muscle
pain Pos
Sore throat
C4591001 1231 12312571
(ARG/62/M) Dose 1/13 01SEP2020 13SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 27
FDA-CBER-2021-5683-0019536
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1231 12312630
(ARG/39/F) Dose 2/44 23OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
Sore throat
C4591001 1231 12312635
(ARG/71/M) Dose 2/27 04OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Chills
Sore throat
C4591001 1231 12312660
(ARG/35/M) Dose 1/23 11SEP2020 23SEP2020 Neg/Neg/Neg New or increased cough Pos
New loss of taste or smell
Sore throat
C4591001 1231 12312679
(ARG/32/M) Dose 2/4 14SEP2020 Neg/Neg/Neg Fever Pos
New or increased cough
Diarrhea
C4591001 1231 12312752
(ARG/36/M) Dose 1/17 06SEP2020 24SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
C4591001 1231 12312763
(ARG/43/F) Dose 1/19 08SEP2020 Neg/Neg/Pos New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 28
FDA-CBER-2021-5683-0019537
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New loss of taste or smell
C4591001 1231 12312805
(ARG/33/M) Dose 1/17 06SEP2020 08SEP2020 Neg/Pos/Unk New or increased cough Pos
C4591001 1231 12312867
(ARG/40/F) Dose 2/35 14OCT2020 Neg/Neg/Neg Fever Pos
New loss of taste or smell
Diarrhea
C4591001 1231 12312914
(ARG/50/M) Dose 2/43 26OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased muscle
pain
Sore throat
C4591001 1231 12313006
(ARG/50/F) Dose 1/2 22AUG2020 30AUG2020 Neg/Pos/Pos Fever Pos
Chills
Sore throat
C4591001 1231 12313068
(ARG/41/M) Dose 1/5 26AUG2020 31AUG2020 Neg/Neg/Pos New or increased muscle
pain Pos
New loss of taste or smell
C4591001 1231 12313069
(ARG/36/M) Dose 1/9 30AUG2020 19SEP2020 Neg/Neg/Pos New or increased cough Pos
New or increased muscle
pain
New loss of taste or smell
Sore throat
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 29
FDA-CBER-2021-5683-0019538
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 1231 12313090
(ARG/57/M) Dose 1/13 03SEP2020 28SEP2020 Neg/Neg/Neg Fever Pos
New or increased
shortness of breath
C4591001 1231 12313103
(ARG/73/M) Dose 1/10 31AUG2020 10SEP2020 Neg/Neg/Pos Fever Pos
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
Diarrhea
C4591001 1231 12313182
(ARG/33/M) Dose 2/10 20SEP2020 Neg/Neg/Neg New or increased
shortness of breath Pos
New loss of taste or smell
C4591001 1231 12313225
(ARG/55/F) Dose 1/3 24AUG2020 24AUG2020 Neg/Pos/Pos New loss of taste or smell Pos
C4591001 1231 12313296
(ARG/49/F) Dose 2/25 04OCT2020 20OCT2020 Neg/Neg/Neg New or increased cough Pos
New loss of taste or smell
C4591001 1231 12313357
(ARG/31/M) Dose 1/3 25AUG2020 30AUG2020 Neg/Neg/Pos Fever Pos
C4591001 1231 12313395
(ARG/39/M) Dose 1/2 24AUG2020 31AUG2020 Neg/Pos/Pos New loss of taste or smell Pos
C4591001 1231 12313400
(ARG/46/M) Dose 2/37 19OCT2020 28OCT2020 Neg/Neg/Neg New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 30
FDA-CBER-2021-5683-0019539
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased
shortness of breath
Chills
New or increased muscle
pain
Sore throat
C4591001 1231 12313422
(ARG/34/M) Dose 2/44 28OCT2020 Unk/Neg/Neg Fever Pos
New or increased cough
New or increased
shortness of breath
Diarrhea
C4591001 1231 12313457
(ARG/60/M) Dose 1/5 27AUG2020 18SEP2020 Unk/Neg/Pos Fever Pos
New or increased cough
New or increased muscle
pain
C4591001 1231 12313510
(ARG/29/F) Dose 1/13 04SEP2020 07SEP2020 Unk/Neg/Pos Fever Pos
New or increased cough
C4591001 1231 12313520
(ARG/28/F) Dose 2/8 22SEP2020 09OCT2020 Unk/Neg/Neg New or increased cough Pos
New loss of taste or smell
Sore throat
C4591001 1231 12313657
(ARG/48/F) Dose 1/11 03SEP2020 18SEP2020 Neg/Neg/Pos Chills Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 31
FDA-CBER-2021-5683-0019540
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
Sore throat
C4591001 1231 12313662
(ARG/27/M) Dose 1/8 31AUG2020 10SEP2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Diarrhea
C4591001 1231 12313668
(ARG/33/M) Dose 2/12 24SEP2020 02OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
Sore throat
C4591001 1231 12313709
(ARG/38/M) Dose 1/14 06SEP2020 03OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
Sore throat
C4591001 1231 12313895
(ARG/50/F) Dose 2/21 03OCT2020 17OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased muscle
pain
New loss of taste or smell
C4591001 1231 12314112
(ARG/52/M) Dose 2/42 28OCT2020 Neg/Neg/Neg New or increased cough Pos
C4591001 1231 12314301
(ARG/56/M) Dose 1/4 29AUG2020 30SEP2020 Neg/Neg/Pos New or increased muscle
pain Pos
New loss of taste or smell
C4591001 1231 12314308
(ARG/31/F) Dose 2/15 30SEP2020 11OCT2020 Neg/Neg/Neg New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 32
FDA-CBER-2021-5683-0019541
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased muscle
pain
Sore throat
Vomiting
C4591001 1231 12314314
(ARG/33/F) Dose 1/2 27AUG2020 29AUG2020 Neg/Pos/Unk Fever Pos
C4591001 1231 12314477
(ARG/36/M) Dose 2/16 03OCT2020 15OCT2020 Pos/Neg/Neg New or increased cough Pos
New loss of taste or smell
C4591001 1231 12314492
(ARG/23/F) Dose 1/2 28AUG2020 09SEP2020 Neg/Pos/Pos Fever Pos
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
New loss of taste or smell
C4591001 1231 12314534
(ARG/18/F) Dose 2/21 05OCT2020 09OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
Sore throat
C4591001 1231 12314622
(ARG/32/F) Dose 2/15 01OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New or increased
shortness of breath
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 33
FDA-CBER-2021-5683-0019542
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Chills
New or increased muscle
pain
New loss of taste or smell
C4591001 1231 12314700
(ARG/43/M) Dose 1/7 03SEP2020 04OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
Sore throat
C4591001 1231 12315636
(ARG/53/F) Dose 2/35 23OCT2020 Neg/Neg/Neg New or increased cough Pos
Sore throat
C4591001 1231 12315637
(ARG/40/F) Dose 2/11 29SEP2020 08OCT2020 Neg/Neg/Neg Fever Pos
Chills
New or increased muscle
pain
New loss of taste or smell
C4591001 1235 12351027
(USA/50/M) Dose 1/18 23SEP2020 03OCT2020 Neg/Neg/Unk Fever Pos
New or increased cough
New or increased
shortness of breath
Chills
Vomiting
C4591001 1235 12351071
(USA/50/M) Dose 1/8 21SEP2020 25SEP2020 Neg/Neg/Unk Fever Pos
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FDA-CBER-2021-5683-0019543
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
New or increased
shortness of breath
Chills
New or increased muscle
pain
Sore throat
C4591001 1235 12351187
(USA/23/F) Dose 1/8 23OCT2020 Unk/Neg/Unk Fever Pos
New or increased cough
Sore throat
C4591001 1235 12351188
(USA/36/F) Dose 1/6 21OCT2020 Unk/Neg/Unk Chills Pos
C4591001 1241 12411260
(BRA/39/M) Dose 1/12 30AUG2020 13SEP2020 Neg/Neg/Unk New or increased muscle
pain Pos
New loss of taste or smell
C4591001 1241 12411688
(BRA/29/M) Dose 1/13 27SEP2020 15OCT2020 Neg/Neg/Pos New or increased cough Pos
New or increased
shortness of breath
New or increased muscle
pain
New loss of taste or smell
Sore throat
C4591001 1241 12411695
(BRA/44/F) Dose 1/4 18SEP2020 05OCT2020 Neg/Neg/Neg Fever Pos
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FDA-CBER-2021-5683-0019544
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
New or increased cough
New or increased
shortness of breath
New or increased muscle
pain
C4591001 1241 12411885
(BRA/23/M) Dose 2/14 22OCT2020 Pos/Neg/Neg Sore throat Pos
C4591001 1241 12412355
(BRA/38/F) Dose 1/3 21OCT2020 Unk/Neg/Unk Diarrhea Pos
C4591001 1247 12471066
(ZAF/58/F) Dose 1/17 15OCT2020 Neg/Neg/Unk New or increased cough Pos
New or increased
shortness of breath
C4591001 1247 12471085
(ZAF/54/F) Dose 2/12 30OCT2020 03NOV2020 Neg/Unk/Neg New or increased cough Pos
Chills
Diarrhea
C4591001 1251 12511159
(USA/37/F) Dose 2/26 26OCT2020 29OCT2020 Neg/Neg/Neg New or increased cough Pos
New or increased muscle
pain
New loss of taste or smell
C4591001 1251 12511207
(USA/48/M) Dose 1/3 25SEP2020 29OCT2020 Neg/Neg/Pos New or increased cough Pos
C4591001 1251 12511209
(USA/62/M) Dose 2/7 19OCT2020 Neg/Neg/Neg New or increased cough Pos
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
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FDA-CBER-2021-5683-0019545
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
C4591001 4444 44441025
(ARG/51/M) Dose 1/8 28SEP2020 05OCT2020 Neg/Neg/Neg Fever Pos
New or increased cough
New loss of taste or smell
C4591001 4444 44441044
(ARG/35/F) Dose 1/13 03OCT2020 10OCT2020 Neg/Neg/Unk New or increased cough Pos
Diarrhea
C4591001 4444 44441224
(ARG/52/M) Dose 2/13 25OCT2020 Neg/Neg/Neg Fever Pos
New or increased muscle
pain
C4591001 4444 44441253
(ARG/49/M) Dose 1/5 25SEP2020 09OCT2020 Pos/Neg/Neg New or increased cough Pos
Sore throat
C4591001 4444 44441560
(ARG/38/F) Dose 1/7 29SEP2020 07OCT2020 Neg/Neg/Pos New or increased muscle
pain Pos
Sore throat
C4591001 4444 44441563
(ARG/38/M) Dose 2/8 21OCT2020 Neg/Neg/Neg New loss of taste or smell Pos
Diarrhea
C4591001 4444 44441787
(ARG/62/M) Dose 1/4 26SEP2020 27SEP2020 Pos/Neg/Neg New or increased cough Pos
C4591001 4444 44442188
(ARG/24/M) Dose 1/9 05OCT2020 Neg/Pos/Pos New or increased cough Pos
C4591001 4444 44442304
(ARG/49/M) Dose 2/12 26OCT2020 Neg/Neg/Neg New or increased muscle
pain Pos
Sore throat
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
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FDA-CBER-2021-5683-0019546
16.2.8.1.IA1 Listing of Subjects With Postvaccination SARS -CoV -2 NAAT -Positive Nasal Swab and COVID -19 Signs and
Symptoms – Dose 1 All -Available Efficacy Population – Interim Analysis 1
Subject
(Country/Age in Year s/Sex) Dose/Rel Daya Start Date Stop Date Visit 1
N-binding Assay/
Visit 1 NAAT/
Visit 2 NAAT Signs and
Symptoms SARS -CoV -2 NAAT
Result
(Central Lab/Local Labb)
Abbreviations: ARG = Argentina; BRA = Brazil; DEU = Germany; NAAT = nucleic acid amplification test; N -binding = SARS -CoV -2
nucleoprotein -binding; Neg = negative; Pos = positive; R1 = repeat central swab 1; SARS -CoV -2 = severe acute respiratory syndrome c oronavirus 2;
Unk = unknown; ZAF = South Africa.
Note: Data from subjects who are not confirmed 7 days post dose 2 cases are included in the analysis to comprehensively show all data reported and/or
contribute to the total surveillance time calculation bu t may be subject to change with additional follow -up.
a. Relative Day (Rel Day) = date of first symptom - date of last dose before first symptom + 1.
PFIZER CONFIDENTIAL SDTM Creation: 06NOV2020 (13:25) Source Data: adsympt Table Generation: 01DEC2020 (01:46)
(Cutoff Date: 04Nov2020, Snapshot Date: 04Nov2020) Output File: ./nda2_unblinded_ia/C4591001_IA_62_Renumbered/adsympt_l001_sy mpt_d1_aai
090177e195ab27aa\Final\Final On: 02-Dec-2020 06:02 (GMT)
Page 38
FDA-CBER-2021-5683-0019547
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
BNT162b1 18-55 10 μg C4591001 1001
10011004 Screening 01MAY2020 -3 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Co rpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.47
1/1-3 days 05MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 3.90 L
Hematocrit (L/L) 0.34-0.48 0.36
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 39
FDA-CBER-2021-5683-0019548
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.60
1/6-8 days 11MAY2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 3.90 L
Hematocrit (L/L) 0.34-0.48 0.36
Monocytes (10^9/L ) 0.12-0.92 0.42
1/19-23
days 26MAY2020 23 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 95.00
Erythrocytes (10^12/L) 4.1-5.6 3.60 L
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 40
FDA-CBER-2021-5683-0019549
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.34
Hemoglobin (g/L) 116-164 117.00 1
Monocytes (10^9/L) 0.12-0.92 0.48
2/6-8 days 02JUN2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.00 L
Hematocrit (L/L) 0.34-0.48 0.37
Monocytes (10^9/L) 0.12-0.92 0.44
C4591001 1001
10011006 Screening 04MAY2020 -2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 41
FDA-CBER-2021-5683-0019550
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 84.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 135.00 1
Monocytes (10^9/L) 0.12-0.92 0.35
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentrati on (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.32
1/6-8 days 13MAY2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 42
FDA-CBER-2021-5683-0019551
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 84.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.27
1/19-23
days 27MAY2020 22 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.29
2/6-8 days 02JUN2020 7 Basophils (10^9/L) 0-0.2 0.07
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 43
FDA-CBER-2021-5683-0019552
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.39
Hemoglobin (g/L) 127-181 134.00 1
Monocytes (10^9/L) 0.12-0.92 0.24
C4591001 1001
10011007 Screening 04MAY2020 -2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 26.00
Ery. Mean Corpuscular
Volume (fL) 79-96 82.00
Erythrocytes (10^12/L) 4.5-6.4 5.50
Hematocrit (L/L) 0.39-0.54 0.45
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 44
FDA-CBER-2021-5683-0019553
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.27
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 26.00
Ery. Mean Corpuscular
Volume (fL) 79-96 83.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.42
Hemoglobin (g/L) 127-181 135.00 1
Monocytes (10^9/L) 0.12-0.92 0.30
1/6-8 days 14MAY2020 9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 27.00
Ery. Mean Corpuscular
Volume (fL) 79-96 80.00
Erythrocytes (10^12/L) 4.5-6.4 5.30
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 45
FDA-CBER-2021-5683-0019554
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.29
1/19-23
days 28MAY2020 23 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 26.00
Ery. Mean Corpuscular
Volume (fL) 79-96 82.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hema tocrit (L/L) 0.39-0.54 0.41
Hemoglobin (g/L) 127-181 130.00 1
Monocytes (10^9/L) 0.12-0.92 0.26
2/6-8 days 03JUN2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 26.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 46
FDA-CBER-2021-5683-0019555
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 81.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 130.00 1
Monocytes (10^9/L) 0.12-0.92 0.18
C4591001 1001
10011008 Screening 04MAY2020 -2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.39
Hemoglob in (g/L) 127-181 135.00 1
Leukocytes (10^9/L) 3.8-10.7 3.48 L 1 (decrease)
Monocytes (10^9/L) 0.12-0.92 0.26
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 47
FDA-CBER-2021-5683-0019556
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Neutrophils (10^9/L) 1.96-7.23 1.84 L 1
Unplanned 05MAY2020 -1 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.55
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.42
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 48
FDA-CBER-2021-5683-0019557
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Leukocytes (10 ^9/L) 3.8-10.7 3.10 L 1 (decrease)
Lymphocytes (10^9/L) 0.91-4.28 0.81 L 1
Monocytes (10^9/L) 0.12-0.92 0.43
Neutrophils (10^9/L) 1.96-7.23 1.52 L 1
1/6-8 days 13MAY2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.39
1/19-23
days 27MAY2020 22 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 49
FDA-CBER-2021-5683-0019558
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes ( 10^9/L) 0.12-0.92 0.45
2/6-8 days 03JUN2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Me an Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.50
C4591001 1001
10011009 Screening 04MAY2020 -2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 50
FDA-CBER-2021-5683-0019559
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocyt es (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.39
Hemoglobin (g/L) 127-181 133.00 1
Monocytes (10^9/L) 0.12-0.92 0.46
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.50
1/6-8 days 13MAY2020 8 Basophils (10^9/L) 0-0.2 0.04
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FDA-CBER-2021-5683-0019560
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Me an Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.38
1/19-23
days 27MAY2020 22 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.26
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Page 52
FDA-CBER-2021-5683-0019561
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
2/6-8 days 02JUN2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.27
C4591001 1002
10021003 Screening 29APR2020 -5 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.43
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Page 53
FDA-CBER-2021-5683-0019562
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (1 0^9/L) 0.12-0.92 0.63
1/1-3 days 05MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mea n Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.54
1/6-8 days 11MAY2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
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Page 54
FDA-CBER-2021-5683-0019563
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.40
1/19-23
days 26MAY2020 23 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^ 9/L) 0.12-0.92 0.35
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
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Page 55
FDA-CBER-2021-5683-0019564
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.32
C4591001 1002
10021004 Screening 29APR2020 -5 Basophils (1 0^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.33
1/1-3 days 05MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
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Page 56
FDA-CBER-2021-5683-0019565
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.39
Lymphocytes (10^9/L) 0.91-4.28 0.73 L 2
Monocytes (10^9/L) 0.12-0.92 0.33
1/6-8 days 11MAY2020 8 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. M ean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.16
1/19-23
days 26MAY2020 23 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
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Page 57
FDA-CBER-2021-5683-0019566
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.00 L
Hematocrit (L/L) 0.34-0.48 0.37
Hemoglobin (g/L) 116-164 118.00 1
Monocytes (10^9/L) 0.12-0.92 0.24
2/6-8 days 01JUN20 20 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.21
C4591001 1002
10021007 Screening 30APR2020 -6 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corp uscular
HGB Concentration (g/L) 310-380 340.00
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Page 58
FDA-CBER-2021-5683-0019567
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocri t (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.38
Neutrophils (10^9/L) 1.96-7.23 2.00 1
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.49
1/6-8 days 12MAY2020 7 Basophils (10^9/L) 0-0.2 0.06
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Page 59
FDA-CBER-2021-5683-0019568
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.34
Neutrophils (10^9/L) 1.96-7.23 1.86 L 1
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscul ar
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.42
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Page 60
FDA-CBER-2021-5683-0019569
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.45
Neutrophils (10^9/L) 1.96-7.23 1.98 1
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.46
Neutrophils (10^9/L) 1.96-7.23 1.30 L 2
Unplanned 29JUN2020 35 Basophils (10^9/L) 0-0.2 0.04
Monocytes (10^9/L) 0.12-0.92 0.41
Neutrophils (10^9/L) 1.96-7.23 1.86 L 1
C4591001 1002
10021009 Screening 30APR2020 -6 Basophils (10^9/L) 0-0.2 0.02
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Page 61
FDA-CBER-2021-5683-0019570
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.39
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 98.00
Erythrocytes (10^12/L) 4.1-5.6 4.00 L
Hematocrit (L/L) 0.34-0.48 0.39
Lymphocytes (10^9/L) 0.91-4.28 0.49 L 3
Monocytes (10^9 /L) 0.12-0.92 0.44
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Page 62
FDA-CBER-2021-5683-0019571
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/6-8 days 12MAY2020 7 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean C orpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.34
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 98.00
Erythrocytes (10^12/L) 4.1-5.6 3.80 L
Hematocrit (L/L) 0.34-0.48 0.37
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Page 63
FDA-CBER-2021-5683-0019572
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hemoglobin (g/L) 116-164 118.00 1
Lymphocytes (10^9/L) 0.91-4.28 0.86 L 1
Monocytes (10^9/L) 0.12-0.92 0.30
2/6-8 days 01JUN2020 7 Basophils (1 0^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 100.00 H
Erythrocyt es (10^12/L) 4.1-5.6 4.00 L
Hematocrit (L/L) 0.34-0.48 0.40
Leukocytes (10^9/L) 3.8-10.7 3.06 L 1 (decrease)
Lymphocytes (10^9/L) 0.91-4.28 0.88 L 1
Monocytes (10^9/L) 0.12-0.92 0.17
Neutrophils (10^9/L) 1.96-7.23 1.90 L 1
Unplanned 02JUL2020 38 Basophils (10^9/L) 0-0.2 0.02
Monocytes (10^9/L) 0.12-0.92 0.45
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Page 64
FDA-CBER-2021-5683-0019573
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
C4591001 1002
10021011 Screening 30APR2020 -6 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.18
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.45
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Page 65
FDA-CBER-2021-5683-0019574
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.38
1/6-8 days 12MAY2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.28
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 66
FDA-CBER-2021-5683-0019575
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.21
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 310.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.12
COVID_A 25JUN2020 31 Basophils (10^9/L) 0-0.2 0.00
Erythrocytes (10^12/L) 4.2-5.5 4.84
Hematocrit (L/L) 0.38-0.5 0.41
Monocytes (10^9/L) 0.1-1.3 0.60
C4591001 1002
10021012 Screen ing 30APR2020 -5 Basophils (10^9/L) 0-0.2 0.02
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 67
FDA-CBER-2021-5683-0019576
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.26
1/1-3 days 06MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.30
1/6-8 days 12MAY2020 8 Basophils (10^9/L) 0-0.2 0.01
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FDA-CBER-2021-5683-0019577
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 26MAY2020 22 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.17
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Page 69
FDA-CBER-2021-5683-0019578
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.20
C4591001 1002
10021013 Screening 01MAY2020 -5 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Cor puscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 95.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.43
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Page 70
FDA-CBER-2021-5683-0019579
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.26
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 98.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.43
Lymphocytes (10^9/L) 0.91-4.28 0.75 L 1
Monocytes (10^9/L) 0.12-0.92 0.26
1/6-8 days 12MAY2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
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Page 71
FDA-CBER-2021-5683-0019580
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.41
Monocytes (10^9/L) 0.12-0.92 0.15
Neutrophils (10^9/L) 1.96-7.23 1.57 L 1
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 96.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.24
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
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Page 72
FDA-CBER-2021-5683-0019581
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 96.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/ L) 0.12-0.92 0.15
Neutrophils (10^9/L) 1.96-7.23 1.64 L 1
Unplanned 29JUN2020 35 Basophils (10^9/L) 0-0.2 0.04
Monocytes (10^9/L) 0.12-0.92 0.25
Neutrophils (10^9/L) 1.96-7.23 1.86 L 1
20 μg C4591001 1001
10011067 Screening 23JUN2020 -8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Co rpuscular
Volume (fL) 79-98 86.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.37
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Page 73
FDA-CBER-2021-5683-0019582
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.19
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.37
Hemoglobin (g/L) 116-164 118.00 1
Leukocytes (10^9/L) 3.8-10.7 3.03 L 1 (decrease)
Lymphocytes (10^9/L) 0.91-4.28 0.65 L 2
Monocytes (10^9/L) 0.12-0.92 0.22
1/6-8 days 07JUL2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
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Page 74
FDA-CBER-2021-5683-0019583
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscu lar
Volume (fL) 79-98 87.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.39
Leukocytes (10^9/L) 3.8-10.7 3.29 L 1 (decrease)
Monocytes (10^9/L) 0.12-0.92 0.12
Neutrophils (10^9/L) 1.96-7.23 1.57 L 1
1/19-23
days 22JUL2020 22 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.22
2/6-8 days 30JUL2020 9 Basoph ils (10^9/L) 0-0.2 0.07
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Page 75
FDA-CBER-2021-5683-0019584
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Corpuscular
Volume (fL) 79-98 87.00
Erythro cytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.37
Hemoglobin (g/L) 116-164 118.00 1
Leukocytes (10^9/L) 3.8-10.7 3.48 L 1 (decrease)
Monocytes (10^9/L) 0.12-0.92 0.10 L
Neutrophils (10^9/L) 1.96-7.23 1.70 L 1
C4591001 1001
10011068 Screening 23JUN2020 -6 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
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Page 76
FDA-CBER-2021-5683-0019585
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.28
1/1-3 days 30JUN2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
Lymphocytes (10^9/L) 0.91-4.28 0.88 L 1
Monocytes (10^9/L) 0.12-0.92 0.58
1/6-8 days 06JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
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Page 77
FDA-CBER-2021-5683-0019586
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.43
1/19-23
days 20JUL2020 22 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.53
2/6-8 days 27JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
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Page 78
FDA-CBER-2021-5683-0019587
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.30 L
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.44
C4591001 1001
10011070 Screening 23JUN2020 -8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-96 101.00 H
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.50
Monocytes (10^9/L) 0.12-0.92 0.45
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.04
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Page 79
FDA-CBER-2021-5683-0019588
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentra tion (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 34.00
Ery. Mean Corpuscular
Volume (fL) 79-96 101.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.45
Lymphocytes (10^9/L) 0.91-4.28 0.69 L 2
Monocytes (10^9/L) 0.12-0.92 0.56
1/6-8 days 07JUL2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-96 98.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.47
Monocyte s (10^9/L) 0.12-0.92 0.58
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Page 80
FDA-CBER-2021-5683-0019589
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/19-23
days 22JUL2020 22 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 34.00
Ery. Mean Corpuscular
Volume (fL) 79-96 102.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.47
Leukocytes (10^9/L) 3.8-10.7 3.49 L 1 (decrease)
Lymphocytes (10^9/L) 0.91-4.28 0.93 1
Monocytes (10^9/L) 0.12-0.92 0.45
2/6-8 days 29JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (p g) 26-34 35.00 H
Ery. Mean Corpuscular
Volume (fL) 79-96 101.00 H
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Page 81
FDA-CBER-2021-5683-0019590
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.51
Lymphocytes (10^9/L) 0.91-4.28 0.83 L 1
Monocytes (10^9/L) 0.12-0.92 0.69
C4591001 1001
10011071 Screening 24JUN2020 -7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.35
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
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Page 82
FDA-CBER-2021-5683-0019591
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.46
1/6-8 days 09JUL2020 9 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentrati on (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.29
1/19-23
days 22JUL2020 22 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 83
FDA-CBER-2021-5683-0019592
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.36
2/6-8 days 29JUL2020 8 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.27
C4591001 1001
10011076 Screening 25JUN2020 -6 Basophils (10^9/L) 0-0.2 0.02
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 84
FDA-CBER-2021-5683-0019593
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscu lar
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 85.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L /L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.38
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemog lobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.42
Lymphocytes (10^9/L) 0.91-4.28 0.77 L 1
Monocytes (10^9/L) 0.12-0.92 0.80
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 85
FDA-CBER-2021-5683-0019594
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/6-8 days 07JUL2020 7 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10^12/L) 4.5-6.4 4.30 L
Hematocrit (L/L) 0.39-0.54 0.37 L
Hemoglobin (g/L) 127-181 127.00 1
Monocytes (10^9/L) 0.12-0.92 0.23
1/19-23
days 21JUL2020 21 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
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Page 86
FDA-CBER-2021-5683-0019595
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 134.00 1
Monocytes (10^9/L) 0.12-0.92 0.50
2/6-8 days 27JUL2020 7 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.30 L
Hematocrit (L/L) 0.39-0.54 0.37 L
Hemoglobin (g/L) 127-181 126.00 L 1
Monocytes (10^9/L) 0.12-0.92 0.43
C4591001 1002
10021079 Screening 22JUN2020 -7 Basophil s (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 35.00 H
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Page 87
FDA-CBER-2021-5683-0019596
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 101.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.45
Monocytes (10^9/L) 0.12-0.92 0.46
1/1-3 days 30JUN2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/ L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 34.00
Ery. Mean Corpuscular
Volume (fL) 79-98 104.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.45
Monocytes (10^9/L) 0.12-0.92 0.54
1/6-8 days 07JUL2020 9 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 34.00
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Page 88
FDA-CBER-2021-5683-0019597
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 105.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.46
Monocytes (10^9/L) 0.12-0.92 0.38
1/19-23
days 21JUL2020 23 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 35.00 H
Ery. Mean Corpuscular
Volume (fL) 79-98 107.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.45
Monocytes (10^9/L) 0.12-0.92 0.38
2/6-8 days 28JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentr ation (g/L) 310-380 320.00
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Page 89
FDA-CBER-2021-5683-0019598
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 34.00
Ery. Mean Corpuscular
Volume (fL) 79-98 106.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.47
Monocytes (10^9/L) 0.12-0.92 0.35
C4591001 1002
10021080 Screening 22JUN2020 -9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscul ar
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.30 L
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 134.00 1
Monocytes (10^9/L) 0.12-0.92 0.44
Unplanned 24JUN2020 -7 Hemoglobin (g/L) 127-181 133.00 1
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Page 90
FDA-CBER-2021-5683-0019599
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.11
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 94.00
Erythrocytes (10^12/L) 4.5-6.4 4.00 L
Hematocrit (L/L) 0.39-0.54 0.38 L
Hemoglobi n (g/L) 127-181 124.00 L 2
Lymphocytes (10^9/L) 0.91-4.28 0.49 L 3
Monocytes (10^9/L) 0.12-0.92 0.60
1/6-8 days 08JUL2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L ) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 94.00
Erythrocytes (10^12/L) 4.5-6.4 4.10 L
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Page 91
FDA-CBER-2021-5683-0019600
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.38 L
Hemoglobin (g/L) 127-181 126.00 L 1
Lymphocytes (10^9/L) 0.91-4.28 0.85 L 1
Monocytes (10^9/L) 0.12-0.92 0.45
1/19-23
days 21JUL2020 21 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscu lar
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 95.00
Erythrocytes (10^12/L) 4.5-6.4 4.20 L
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 131.00 1
Lymphocytes (10^9/L) 0.91-4.28 0.92 1
Monocytes (10^9/L) 0.12-0.92 0.38
2/6-8 days 29JUL2020 9 Basophils (10^9/L) 0-0.2 0.05
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Page 92
FDA-CBER-2021-5683-0019601
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 97.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.20 L
Hematocrit (L/L) 0.39-0.54 0.41
Hemoglobin (g/L) 127-181 132.00 1
Lymphocytes (10^9/L) 0.91-4.28 0.98 1
Monocytes (10^9/L) 0.12-0.92 0.39
Unplanned 04AUG2020 15 Basophils (10^9/L) 0-0.2 0.04
Leukocytes (10^9/L) 3.8-10.7 3.42 L 1 (decrease)
Lymphocytes (10^9/L) 0.91-4.28 0.97 1
Monocytes (10^9/L) 0.12-0.92 0.32
C4591001 1002
10021081 Screening 22JUN2020 -9 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
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Page 93
FDA-CBER-2021-5683-0019602
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.30
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.32
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.48
Lymphocytes (10^9/ L) 0.91-4.28 0.77 L 1
Monocytes (10^9/L) 0.12-0.92 0.61
1/6-8 days 08JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
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Page 94
FDA-CBER-2021-5683-0019603
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemo globin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 5.40
Hematocrit (L/L) 0.39-0.54 0.50
Monocytes (10^9/L) 0.12-0.92 0.65
1/19-23
days 21JUL2020 21 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 5.50
Hematocrit (L/L) 0.39-0.54 0.52
Monocytes (10^9/L) 0.12-0.92 0.45
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Page 95
FDA-CBER-2021-5683-0019604
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
2/6-8 days 29JUL2020 9 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscul ar
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 96.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/ L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.65
C4591001 1002
10021082 Screening 22JUN2020 -9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Me an Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 88.00
Erythrocytes (10^12/L) 4.1-5.6 4.90
Hematocrit (L/L) 0.34-0.48 0.43
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Page 96
FDA-CBER-2021-5683-0019605
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.40
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volum e (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.80
Hematocrit (L/L) 0.34-0.48 0.44
Lymphocytes (10^9/L) 0.91-4.28 0.49 L 3
Monocytes (10^9/L) 0.12-0.92 0.46
Platelets (1 0^9/L) 140-400 134.00 L 1
1/6-8 days 08JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. M ean Corpuscular
Volume (fL) 79-98 90.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 97
FDA-CBER-2021-5683-0019606
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.1-5.6 4.90
Hematocrit (L/L) 0.34-0.48 0.44
Monocytes (10^9/L) 0.12-0.92 0.38
1/19-23
days 21JUL2020 21 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.80
Hematocrit (L/L) 0.34-0.48 0.45
Monocytes (10^9/L) 0.12-0.92 0.44
2/6-8 days 29JUL2020 9 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 98
FDA-CBER-2021-5683-0019607
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.90
Hematocrit (L/L) 0.34-0.48 0.46
Monocytes (1 0^9/L) 0.12-0.92 0.42
C4591001 1002
10021084 Screening 23JUN2020 -6 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 134.00 1
Monocytes (10^9/L) 0.12-0.92 0.23
Unplanned 25JUN2020 -4 Hemoglobin (g/L) 127-181 134.00 1
1/1-3 days 30JUN2020 2 Basophils (10^9/L) 0-0.2 0.03
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Page 99
FDA-CBER-2021-5683-0019608
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 95.00
Erythrocytes (10^12/L) 4.5-6.4 4.20 L
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 132.00 1
Lymphocytes (10^9/L) 0.91-4.28 0.80 L 1
Monocytes (10^9/L) 0.12-0.92 0.43
1/6-8 days 07JUL2020 9 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 4.30 L
Hematocrit (L/L) 0.39-0.54 0.40
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 100
FDA-CBER-2021-5683-0019609
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hemoglobin (g/L) 127-181 135.00 1
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 21JUL2020 23 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 97.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.00 L
Hematocrit (L/L) 0.39-0.54 0.39
Hemoglobin (g/L) 127-181 128.00 1
Monocytes (10^9/L) 0.12-0.92 0.41
2/6-8 days 28JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 101
FDA-CBER-2021-5683-0019610
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 94.00
Erythrocytes (10^12/L) 4.5-6.4 4.10 L
Hematocrit (L/L) 0.39-0.54 0.39
Hemoglobin (g/L) 127-181 125.00 L 1
Monocytes (10^9/L) 0.12-0.92 0.42
C4591001 1002
10021085 Screening 23JUN2020 -6 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscu lar
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.40
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.35
1/1-3 days 30JUN2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
090177e194d7855c\Final\Final On: 07-Sep-2020 03:53 (GMT)
Page 102
FDA-CBER-2021-5683-0019611
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.41
1/6-8 days 07JUL2020 9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 310.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 97.00 H
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.30
1/19-23
days 21JUL2020 23 Basophils (10^9/L) 0-0.2 0.03
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FDA-CBER-2021-5683-0019612
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscu lar
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.30
2/6-8 days 28JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.24
Neutrophils (10^9/L) 1.96-7.23 1.67 L 1
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FDA-CBER-2021-5683-0019613
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Unplanned 04AUG2020 15 Basophils (10^9/L) 0-0.2 0.02
Monocytes (10^9/L) 0.12-0.92 0.34
C4591001 1002
10021087 Screening 25JUN2020 -6 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.30
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
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FDA-CBER-2021-5683-0019614
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.43
Lymphocytes (10^9/L) 0.91-4.28 0.94 1
Monocytes (10^9/L) 0.12-0.92 0.50
1/6-8 days 08JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean C orpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hemato crit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.33
1/19-23
days 21JUL2020 21 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpusc ular
Hemoglobin (pg) 26-34 30.00
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FDA-CBER-2021-5683-0019615
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.28
2/6-8 days 28JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.24
30 μg C4591001 1001
10011011 Screening 05MAY2020 -6 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
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FDA-CBER-2021-5683-0019616
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Co rpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.15
1/1-3 days 12MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.38
Lymphocytes (10^9/L) 0.91-4.28 0.79 L 1
Monocytes (10^9/L) 0.12-0.92 0.31
1/6-8 days 18MAY2020 8 Basophils (10^9/L) 0-0.2 0.03
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FDA-CBER-2021-5683-0019617
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscula r
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 88.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L ) 0.34-0.48 0.37
Monocytes (10^9/L) 0.12-0.92 0.20
1/19-23
days 01JUN2020 22 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemo globin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.36
Monocytes (10^9/L) 0.12-0.92 0.16
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FDA-CBER-2021-5683-0019618
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
2/6-8 days 08JUN2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 87.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.36
Monocytes (10^9/L) 0.12-0.92 0.22
C4591001 1001
10011012 Screening 05MAY2020 -8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.41
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FDA-CBER-2021-5683-0019619
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.22
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.42
Lymphocytes (10^9/L) 0.91-4.28 0.83 L 1
Monocytes (10^9/L) 0.12-0.92 0.47
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
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FDA-CBER-2021-5683-0019620
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.26
1/19-23
days 03JUN202 0 22 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.28
2/6-8 days 11JUN2020 9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentra tion (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
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FDA-CBER-2021-5683-0019621
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.25
C4591001 1001
10011015 Screening 06MAY2020 -5 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.18
Neutrophils (10^9/L) 1.96-7.23 1.91 L 1
Unplanned 08MAY2020 -3 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
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Page 113
FDA-CBER-2021-5683-0019622
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.24
1/1-3 days 12MAY2020 2 Basophils ( 10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.44
Lymphocytes (10^9/L) 0.91-4.28 0.69 L 2
Monocytes (10^9/L) 0.12-0.92 0.30
1/6-8 days 18MAY2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
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Page 114
FDA-CBER-2021-5683-0019623
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.15
1/19-23
days 01JUN2020 22 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.29
2/6-8 days 08JUN2020 8 Basophils (10^9/L) 0-0.2 0.03
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Page 115
FDA-CBER-2021-5683-0019624
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.14
C4591001 1001
10011017 Screening 07MAY2020 -6 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 5.40
Hematocrit (L/L) 0.39-0.54 0.49
Monocytes (10^9/L) 0.12-0.92 0.24
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Page 116
FDA-CBER-2021-5683-0019625
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.44
Lymphocyte s (10^9/L) 0.91-4.28 0.67 L 2
Monocytes (10^9/L) 0.12-0.92 0.45
1/6-8 days 20MAY2020 8 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscu lar
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.43
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Page 117
FDA-CBER-2021-5683-0019626
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.26
1/19-23
days 03JUN2020 22 Basophils (10^9/L) 0-0.2 0.07
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.32
2/6-8 days 10JUN2020 8 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean C orpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10^12/L) 4.5-6.4 4.80
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Page 118
FDA-CBER-2021-5683-0019627
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hemato crit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.29
C4591001 1001
10011019 Screening 07MAY2020 -6 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 5.20
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.21
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscul ar
Volume (fL) 79-96 90.00
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Page 119
FDA-CBER-2021-5683-0019628
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 4.80
Hematocrit (L/L) 0.39-0.54 0.43
Lymphocytes (10^9/L) 0.91-4.28 0.69 L 2
Monocytes (10^9/L) 0.12-0.92 0.50
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 03JUN2020 22 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
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FDA-CBER-2021-5683-0019629
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.20
2/6-8 days 11JUN2020 9 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.90
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.27
C4591001 1001
10011020 Screening 07MAY2020 -6 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
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FDA-CBER-2021-5683-0019630
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL ) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.24
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mea n Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hem atocrit (L/L) 0.39-0.54 0.40
Lymphocytes (10^9/L) 0.91-4.28 0.89 L 1
Monocytes (10^9/L) 0.12-0.92 0.50
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.02
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FDA-CBER-2021-5683-0019631
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.36
1/19-23
days 03JUN2020 22 Basophils (10^9/L) 0-0.2 0.13
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 91.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.32
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FDA-CBER-2021-5683-0019632
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
2/6-8 days 11JUN2020 9 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.40
Hemoglobin (g/L) 127-181 135.00 1
Monocytes (10^9/L) 0.12-0.92 0.26
C4591001 1001
10011024 Screening 11MAY2020 -2 Basophils (10^9 /L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10 ^12/L) 4.5-6.4 4.90
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FDA-CBER-2021-5683-0019633
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.44
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.85
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 85.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
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FDA-CBER-2021-5683-0019634
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.23
1/19-23
days 03JUN2020 22 Basophils (10^9/L ) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^1 2/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.36
2/6-8 days 11JUN2020 9 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
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FDA-CBER-2021-5683-0019635
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.44
Mon ocytes (10^9/L) 0.12-0.92 0.22
C4591001 1002
10021006 Screening 30APR2020 -11 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 88.00
Erythrocytes (10^12/L) 4.1-5.6 4.70
Hematocrit (L/L) 0.34-0.48 0.41
Monocytes (10^9/L) 0.12-0.92 0.25
1/1-3 days 12MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 360.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
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FDA-CBER-2021-5683-0019636
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.39
Lymphocytes (10^9/L) 0.91-4.28 0.69 L 2
Monocytes (10^9/L) 0.12-0.92 0.42
1/6-8 days 18MAY2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 02JUN2020 23 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
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FDA-CBER-2021-5683-0019637
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 89.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9 /L) 0.12-0.92 0.25
2/6-8 days 08JUN2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean C orpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.37
Monocytes (10^9/L) 0.12-0.92 0.23
C4591001 1002
10021014 Screening 01MAY2020 -12 Basophils (1 0^9/L) 0-0.2 0.02
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FDA-CBER-2021-5683-0019638
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.42
Monocytes (10^9/L) 0.12-0.92 0.47
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 95.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.41
Lymphocytes (10^9/L) 0.91-4.28 0.68 L 2
Monocytes (10^9/L) 0.12-0.92 0.37
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Page 130
FDA-CBER-2021-5683-0019639
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. M ean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.28
1/19-23
days 02JUN2020 21 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.40
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Page 131
FDA-CBER-2021-5683-0019640
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.40
2/6-8 days 08JUN2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.00 L
Hematocrit (L/L) 0.34-0.48 0.37
Monocytes (10^9/L) 0.12-0.92 0.33
C4591001 1002
10021015 Screening 01MAY2020 -10 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
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Page 132
FDA-CBER-2021-5683-0019641
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.41
Monocyte s (10^9/L) 0.12-0.92 0.37
1/6-8 days 18MAY2020 8 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 94.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.23
Neutrophils (10^9/L) 1.96-7.23 1.87 L 1
1/19-23
days 02JUN2020 23 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
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Page 133
FDA-CBER-2021-5683-0019642
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-98 95.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.20
2/6-8 days 08JUN2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 95.00
Erythrocytes (10^12/L) 4.1-5.6 3.90 L
Hematocrit (L/L) 0.34-0.48 0.37
Leukocytes (10^9/L) 3.8-10.7 2.89 L 1 (decrease)
Monocytes (10^9/L) 0.12-0.92 0.15
Neutrophils (10^9/L) 1.96-7.23 1.37 L 2
Platelets (10^9/L) 140-400 139.00 L 1
Unplanned 01JUL2020 30 Basophils (10^9/L) 0-0.2 0.03
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FDA-CBER-2021-5683-0019643
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.30
C4591001 1002
10021017 Screening 01MAY2020 -12 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration ( g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 88.00
Erythrocytes (10^12/L) 4.1-5.6 4.90
Hematocrit (L/L) 0.34-0.48 0.43
Monocytes (10^9/L) 0.12-0.92 0.25
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.60
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Page 135
FDA-CBER-2021-5683-0019644
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.42
Monocytes (10^9/L) 0.12-0.92 0.18
1/6-8 days 19MAY2020 7 Basoph ils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythro cytes (10^12/L) 4.1-5.6 4.70
Hematocrit (L/L) 0.34-0.48 0.42
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 02JUN2020 21 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/ L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
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Page 136
FDA-CBER-2021-5683-0019645
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.1-5.6 4.60
Hematocrit (L/L) 0.34-0.48 0.42
Monocytes (10^9/L) 0.12-0.92 0.17
2/6-8 days 08JUN2020 7 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.23
Neutrophils (10^9/L) 1.96-7.23 2.00 1
Unplanned 01JUL2020 30 Basophils (10^9/L) 0-0.2 0.04
Monocytes (10^9/L) 0.12-0.92 0.27
Neutrophils (10^9/L) 1.96-7.23 1.78 L 1
C4591001 1002
10021020 Screening 01MAY2020 -12 Basophils (10^9/L) 0-0.2 0.02
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Page 137
FDA-CBER-2021-5683-0019646
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 90.00
Erythrocytes (10^12/ L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.41
Monocytes (10^9/L) 0.12-0.92 0.26
1/1-3 days 14MAY2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.0 0
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.38
Lymph ocytes (10^9/L) 0.91-4.28 0.46 L 3
Monocytes (10^9/L) 0.12-0.92 0.47
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FDA-CBER-2021-5683-0019647
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
1/6-8 days 19MAY2020 7 Basophils (10^9/L) 0-0.2 0.01
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Cor puscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.15
1/19-23
days 02JUN2020 21 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume ( fL) 79-98 93.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.39
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FDA-CBER-2021-5683-0019648
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.16
2/6-8 days 08JUN2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. M ean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.37
Monocytes (10^9/L) 0.12-0.92 0.32
Placebo 18-55 Placebo C4591001 1001
10011005 Screening 04MAY2020 -2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 100.00 H
Erythrocytes (10^12/L) 4.1-5.6 4.00 L
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FDA-CBER-2021-5683-0019649
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.34
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-98 101.00 H
Erythrocytes (10^12/L) 4.1-5.6 3.80 L
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.25
1/6-8 days 12MAY2020 7 Basophils ( 10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 98.00
Erythrocytes (10^12/L) 4.1-5.6 3.90 L
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FDA-CBER-2021-5683-0019650
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.34-0.48 0.38
Monocytes (10^9/L) 0.12-0.92 0.27
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.06
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 100.00 H
Erythrocytes (10^12/L) 4.1-5.6 3.90 L
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.20
2/6-8 days 02JUN2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 33.00
Ery. Mean Corpuscular
Volume (fL) 79-98 99.00 H
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FDA-CBER-2021-5683-0019651
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Erythrocytes (10^12/L) 4.1-5.6 4.10
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.32
C4591001 1001
10011066 Screen ing 22JUN2020 -7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.70
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.32
1/1-3 days 30JUN2020 2 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
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FDA-CBER-2021-5683-0019652
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 4.50
Hematocrit (L/L) 0.39-0.54 0.41
Monocytes (10^9/L) 0.12-0.92 0.40
1/6-8 days 06JUL2020 8 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.60
Hematocrit (L/L) 0.39-0.54 0.42
Monocytes (10^9/L) 0.12-0.92 0.66
1/19-23
days 20JUL2020 22 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
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FDA-CBER-2021-5683-0019653
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-96 92.00
Erythrocytes (10^12/L) 4.5-6.4 4.40 L
Hematocrit (L/L) 0.39-0.54 0.40
Monocytes (10^9/L) 0.12-0.92 0.32
2/6-8 days 27JUL2020 8 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 32.00
Ery. Mean Corpuscular
Volume (fL) 79-96 93.00
Erythrocytes (10^12/L) 4.5-6.4 4.10 L
Hematocrit (L/L) 0.39-0.54 0.38 L
Hemoglobin (g/L) 127-181 129.00 1
Monocytes (10^9/L) 0.12-0.92 0.35
C4591001 1001
10011069 Screening 23JUN2020 -8 Basophils (10^9/L) 0-0.2 0.06
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FDA-CBER-2021-5683-0019654
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentrat ion (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.50
Hematocrit (L/L) 0.34-0.48 0.41
Monocytes (10^9/L) 0.12-0.92 0.35
1/1-3 days 02JUL2020 2 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.20
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/L) 0.12-0.92 0.33
1/6-8 days 07JUL2020 7 Basophils (10^9/L) 0-0.2 0.00
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FDA-CBER-2021-5683-0019655
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.40
Monocytes (10^9/L) 0.12-0.92 0.27
Neutrophils (10^9/L) 1.96-7.23 1.19 L 2
1/19-23
days 22JUL2020 22 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-98 92.00
Erythrocytes (10^12/L) 4.1-5.6 4.40
Hematocrit (L/L) 0.34-0.48 0.41
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FDA-CBER-2021-5683-0019656
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Monocytes (10^9/L) 0.12-0.92 0.33
2/6-8 days 29JUL2020 8 Basophils (10^9/L) 0-0.2 0.05
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
Ery. Mean Corpuscular
Volume (fL) 79-98 91.00
Erythrocytes (10^12/L) 4.1-5.6 4.30
Hematocrit (L/L) 0.34-0.48 0.39
Monocytes (10^9/ L) 0.12-0.92 0.27
C4591001 1002
10021005 Screening 29APR2020 -5 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.20
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FDA-CBER-2021-5683-0019657
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.39
1/1-3 days 05MAY2020 2 Basophils (10^ 9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 320.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (1 0^12/L) 4.5-6.4 5.20
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.32
1/6-8 days 11MAY2020 8 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
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FDA-CBER-2021-5683-0019658
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Hematocrit (L/L) 0.39-0.54 0.44
Monocytes (10^9/L) 0.12-0.92 0.42
1/19-23
days 26MAY2020 23 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 30.00
Ery. Mean Corpuscular
Volume (fL) 79-96 90.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.46
Lymphocytes (10^9/L) 0.91-4.28 0.89 L 1
Monocytes (10^9/L) 0.12-0.92 0.39
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.03
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 350.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 31.00
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FDA-CBER-2021-5683-0019659
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.44
Lymphocytes (10^9/L) 0.91-4.28 0.96 1
Monocytes (10^9/L) 0.12-0.92 0.44
C4591001 1002
100210 08 Screening 30APR2020 -6 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 28.00
Ery. Mean Corpuscular
Volume (fL) 79-96 84.00
Erythrocytes (10^12/L) 4.5-6.4 5.30
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.21
1/1-3 days 07MAY2020 2 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corp uscular
HGB Concentration (g/L) 310-380 330.00
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FDA-CBER-2021-5683-0019660
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 88.00
Erythrocytes (10^12/L) 4.5-6.4 5.20
Hematocri t (L/L) 0.39-0.54 0.46
Monocytes (10^9/L) 0.12-0.92 0.23
1/6-8 days 12MAY2020 7 Basophils (10^9/L) 0-0.2 0.02
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 340.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 86.00
Erythrocytes (10^12/L) 4.5-6.4 5.00
Hematocrit (L/L) 0.39-0.54 0.43
Monocytes (10^9/L) 0.12-0.92 0.22
1/19-23
days 26MAY2020 21 Basophils (10^9/L) 0-0.2 0.04
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FDA-CBER-2021-5683-0019661
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
Ery. Mean Corpuscular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 87.00
Erythrocytes (10^12/L) 4.5-6.4 5.40
Hematocrit (L/L) 0.39-0.54 0.47
Monocytes (10^9/L) 0.12-0.92 0.19
2/6-8 days 01JUN2020 7 Basophils (10^9/L) 0-0.2 0.04
Ery. Mean Corpus cular
HGB Concentration (g/L) 310-380 330.00
Ery. Mean Corpuscular
Hemoglobin (pg) 26-34 29.00
Ery. Mean Corpuscular
Volume (fL) 79-96 89.00
Erythrocytes (10^12/L) 4.5-6.4 5.10
Hematocrit (L/L) 0.39-0.54 0.45
Monocytes (10^9/L) 0.12-0.92 0.17
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FDA-CBER-2021-5683-0019662
16.2.8.1.1 Listing of Laboratory Measurements – Hematology – Phase 1, 2 Doses, 21 Days Apar t
Vaccine
Candidate Age
Group
(Years) Vaccine Group
(as
Administered) Subject Dose/Visit Collection
Date Rel
Daya Labor atory Test (Unit) Reference
Range Result FDA Toxicity
Gradeb
C459
…[truncated]