ABCDEFGHIJKLMNOPQRSTUVWXYZAAABACADAEAFAGAHAIAJAKALAMANAOAPAQARASATAUAVAWAXAYAZBABBBCBDBEBFBGBHBIBJBKBLBMBNBOBPBQBRBSBTBUBVBWBXBYBZCACBCCCDCECFCGCHCICJCKCLCM
1
SortOrderSubject(Country/Age in Years/Sex)Abstractor Vaccination Date 01
VAX101DT
Abstractor
Datetime of First Exposure to Treatment
TRTSDTM
Abstractor Vaccination 01
VAX101
Abstractor Vaccination Date 02
VAX102DT
Abstractor
Datetime of Last Exposure in Period 01
TR01EDTM
Abstractor Vaccination 02
VAX102
Vaccine Group
(as Randomized)
DoseRel DayStart Date of First SymptomStop Date of Last SymptomVisit 1
N-Binding
Assay/
Visit 1 NAAT/
Visit 2 NAAT
Visit 1
N-Binding
Assay
Visit 1 NAATVisit 2 NAATSigns and Symptoms SARS-CoV-2 NAAT
Result
(Central Lab/Local
Labb)
SARS-CoV-2 NAAT
Result
(Central Lab)
SARS-CoV-2 NAAT
Result
(Local
Labb)
Subject IDDose 1 DateDose 1 DayTime of Day (24 hr)Dose 2 DateDose 2 DayTime of Day (24 hr)DeltaElapsed Days / HrsNarrative / Comments#3 fa Interim Protocol Deviation Sensitive#4 Interim mth6 Protocol Deviation#5 fa Interim Excluded Patients#6 Fa Interim Excluded Patients Sensitive #7 Interim mth6 Excluded patients#8 Interim mth6 Excluded Patientrs Sensitive#9 fa Interim Dicontinued #10 Interim mth6 DiscontinuedAgeSexCcountrySubJidRaceBMI kg/m2EthnicityAge
2
1
C4591001 1003 10031122
(USA/48/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
7711/5/2020Neg/Neg/NegNegNegNegFever New or increased cough ChillsPos/Pos#REF!10031122#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Illness Visit 1 C-Neg/Local Neg; Illness Visit 2 C-Pos/L-Neg NoNoNoNoNoNoNoNo48MUSA
10031122
White37.4Non-Hispanic/non-Latino48Category
BNT162b2
PlaceboTotal16171819202122232425262728
3
6
C4591001 1006 10061012
(USA/53/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6811/6/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath New or increased muscle painPos/Pos#REF!10061012#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab positive/ Local lab SARS-CoV-2 NAAT not doneNoNoNoNoNoNoNoNo53MUSA
10061012
White33.9Non-Hispanic/non-Latino538080
BNT162b2
0000000000000
4
12
C4591001 1006 10061066
(USA/39/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5911/11/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!10061066#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Protocol deviation: Dose 2 > 23 days post Dose 1NoNoNoNoNoNoNoNo39FUSA
10061066
White26.5Non-Hispanic/non-Latino390Placebo0000000000000
5
15
C4591001 1006 10061084
(USA/27/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4810/27/2020Neg/Neg/NegNegNegNegFever New or increased coughPos/Pos#REF!10061084#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab positive/ Local lab SARS-CoV-2 NAAT indeterminate.NoNoNoNoNoNoNoNo27FUSA
10061084
White25.4Non-Hispanic/non-Latino2716 to 555050
BNT > 23
0000000000000
6
19
C4591001 1006 10061091
(USA/20/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5010/30/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!10061091#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitiveNoNoNoNoNoNoNoNo20FUSA
10061091
Asian36.4Non-Hispanic/non-Latino20>55 yr3030Plac >230000000000000
7
22
C4591001 1006 10061114
(USA/21/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3510/20/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle pain New loss of taste or smell Sore throatPos/Pos#REF!10061114#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitive; urgent care visit (once)NoNoNoNoNoNoNoNo21MUSA
10061114
White47.4Hispanic/Latino21>=65 yr101
8
29
C4591001 1008 10081011
(USA/55/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5210/22/202010/31/2020Neg/Neg/NegNegNegNegNew loss of taste or smellPos/Pos#REF!10081011#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab positive/ Local lab SARS-CoV-2 NAAT not doneNoNoNoNoNoNoNoNo55FUSA
10081011
White25.2Non-Hispanic/non-Latino55>=75 yr000
9
31
C4591001 1008 10081048
(USA/38/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6011/7/2020Neg/Neg/NegNegNegNegNew or increased cough Chills New or increased muscle pain New loss of taste or smell Sore throatPos/Pos#REF!10081048#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitive; unspecified swab test done at [redacted] employee (once)NoNoNoNoNoNoNoNo38FUSA
10081048
White57.3Non-Hispanic/non-Latino38
10
39
C4591001 1008 10081130
(USA/52/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3210/17/202010/29/2020Neg/Neg/NegNegNegNegNew or increased shortness of breathPos/Pos#REF!10081130#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitive; visit ER (once) see narrative screen shotNoNoNoNoNoNoNoNo52FUSA
10081130
White34.2Non-Hispanic/non-Latino52Male303
11
41
C4591001 1008 10081214
(USA/62/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4211/9/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased shortness of breath New or increased muscle painPos/Pos#REF!10081214#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitiveNoNoNoNoNoNoNoNo62MUSA
10081214
White25.7Non-Hispanic/non-Latino62Female505
12
49
C4591001 1008 10081319
(USA/79/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3111/4/2020Neg/Neg/NegNegNegNegChills Pos/Pos#REF!10081319#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitive; visit ER (once)NoNoNoNoNoNoNoNo79FUSA
10081319
White24.1Non-Hispanic/non-Latino79
13
51
C4591001 1008 10081356
(USA/63/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2510/31/202011/10/2020Neg/Neg/NegNegNegNegNew or increased cough New loss of taste or smellPos/Pos#REF!10081356#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab positive/ Local lab SARS-CoV-2 NAAT not doneNoNoNoNoNoNoNoNo63MUSA
10081356
White27.4Non-Hispanic/non-Latino63White707
14
55
C4591001 1009 10091128
(USA/51/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3010/15/2020Neg/Neg/NegNegNegNeg
New or increased cough New or increased shortness of breath Chills New or increased muscle pain New loss of taste or smell Sore throat
Pos/Pos#REF!10091128#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab pos / Local lab posisitiveNoNoNoNoNoNoNoNo51MUSA
10091128
White37.6Hispanic/Latino51Black000
15
65
C4591001 1013 10131288
(USA/53/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
119/25/202010/6/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath Chills New or increased muscle pain New loss of taste or smellPos/Pos#REF!10131288#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local LabPos; urgent care visitNoNoNoNoNoNoNoNo53MUSA
10131288
White31.1Non-Hispanic/non-Latino53Others101
16
74
C4591001 1013 10131475
(USA/49/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2310/22/202010/25/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle pain Sore throatPos/Pos#REF!10131475#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; went to govt test center onceNoNoNoNoNoNoNoNo49FUSA
10131475
White30.1Non-Hispanic/non-Latino49Hispanic303
17
79
C4591001 1016 10161003
(USA/23/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5710/14/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New loss of taste or smellPos/Pos#REF!10161003#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local LabPos; went to children-adolescent's clinic onceNoNoNoNoNoNoNoNo23FUSA
10161003
White22.1Non-Hispanic/non-Latino23Non-Hispanic505
18
86
C4591001 1016 10161004
(USA/51/F)#REF!#REF!#REF!#REF!#REF!#REF!
BNT162b2 (30 μg)
Dose 2
5810/15/202010/22/2020Neg/Neg/NegNegNegNegNew loss of taste or smell Sore throatPos/Pos#REF!10161004#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!1003 and 1004 dose 1 one min apart; Central lab Pos; Local Lab Pos/NegNoNoNoNoNoNoNoNo51FUSA
10161004
White24.2Non-Hispanic/non-Latino51
19
89
C4591001 1016 10161017
(USA/18/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
199/7/2020Neg/Neg/NegNegNegNegFever Chills New or increased muscle pain New loss of taste or smellPos/Pos#REF!10161017#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; urgent care visit (once)NoNoNoNoNoNoNoNo18FUSA
10161017
White24.2Non-Hispanic/non-Latino18Argentina101
20
96
C4591001 1016 10161035
(USA/70/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6710/29/202010/29/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!10161035#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; urgent care visit (once)NoNoNoNoNoNoNoNo70FUSA
10161035
White23.9Non-Hispanic/non-Latino70Brazil101
21
98
C4591001 1016 10161048
(USA/52/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
7511/6/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle pain Sore throatPos/Pos#REF!10161048#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; used drive-throu clinic (once)NoNoNoNoNoNoNoNo52FUSA
10161048
White33.7Non-Hispanic/non-Latino52USA606
22
103
C4591001 1016 10161183
(USA/31/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3210/16/202011/1/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle pain New loss of taste or smell Sore throat Diarrhea Vomiting
Pos/ (R1 Pos)
Pos (R1 Pos)#REF!10161183#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; urgent care visit (once)NoNoNoNoNoNoNoNo31FUSA
10161183
White36.1Non-Hispanic/non-Latino31808
23
115
C4591001 1016 10161207
(USA/62/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2710/14/2020Neg/Neg/NegNegNegNegNew or increased cough Chills New or increased muscle pain Sore throatPos/Pos#REF!10161207#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab Pos; subject went to her primary care (physician once)NoNoNoNoNoNoNoNo62FUSA
10161207
White37.4Non-Hispanic/non-Latino62
24
121
C4591001 1018 10181198
(USA/50/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5511/4/202011/5/2020Neg/Neg/NegNegNegNegFever New or increased coughPos/Pos#REF!10181198#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab was not doneNoNoNoNoNoNoNoNo50FUSA
10181198
White28.4Non-Hispanic/non-Latino50
25
125
C4591001 1019 10191038
(USA/47/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6111/3/2020Neg/Neg/NegNegNegNegFever New or increased cough New loss of taste or smellPos/Pos#REF!10191038#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo47FUSA
10191038
White32.5Hispanic/Latino47Others
BNT162b2
PlaceboTotal
26
131
C4591001 1019 10191184
(USA/52/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3611/5/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle pain VomitingPos/Pos#REF!10191184#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo52MUSA
10191184
White38.0Non-Hispanic/non-Latino52Asian101
27
136
C4591001 1028 10281038
(USA/53/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3110/10/202010/22/2020Neg/Neg/NegNegNegNegFever New or increased cough Sore throatPos/Pos#REF!10281038#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Cental Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo53FUSA
10281038
White49.0Non-Hispanic/non-Latino53Not Reported000
28
141
C4591001 1028 10281100
(USA/47/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1910/11/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!10281100#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo47FUSA
10281100
White23.6Non-Hispanic/non-Latino47American Indian or Alaska Native000
29
143
C4591001 1028 10281132
(USA/61/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1410/11/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle pain Sore throatPos/Pos#REF!10281132#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo61MUSA
10281132
White26.2Non-Hispanic/non-Latino61
Native Hawaiian or Other Pacific Islander
000
30
151
C4591001 1028 10281138
(USA/38/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2510/23/2020Neg/Neg/NegNegNegNegFever Chills Sore throat DiarrheaPos/Pos#REF!10281138#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!
Influenza vax 21 Oct 2020; Visit Illness 1 Central Lab Neg/Local Lab Neg; Visit 2 C-Pos/L-Neg, L-Pos
NoNoNoNoNoNoNoNo38FUSA
10281138
White27.2Non-Hispanic/non-Latino38Multiple000
31
156
C4591001 1037 10371036
(USA/62/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5210/31/2020Neg/Neg/NegNegNegNegFever New or increased cough ChillsPos/Pos#REF!10371036#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo62MUSA
10371036
Black or African American27.2Non-Hispanic/non-Latino62Total101
32
161
C4591001 1037 10371280
(USA/58/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2811/10/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle painPos/Pos#REF!10371280#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo58MUSA
10371280
White39.2Non-Hispanic/non-Latino58
33
168
C4591001 1038 10381051
(USA/69/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5111/7/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!10381051#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo69MUSA
10381051
White36.3Non-Hispanic/non-Latino69Obese
BNT162b2
PlaceboTotal
34
171
C4591001 1039 10391025
(USA/55/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4010/25/202011/3/2020Neg/Neg/NegNegNegNegNew loss of taste or smell Sore throatPos/Pos#REF!10391025#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo55FUSA
10391025
White21.9Non-Hispanic/non-Latino55Yes303
35
174
C4591001 1046 10461058
(USA/44/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6211/9/2020Neg/Neg/NegNegNegNegNew or increased muscle painPos/Pos#REF!10461058#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab SARS-CoV-2 NAAT was not done.NoNoNoNoNoNoNoNo44FUSA
10461058
White30.1Non-Hispanic/non-Latino44No 505
36
176
C4591001 1047 10471024
(USA/63/F)#REF!#REF!#REF!#REF!#REF!#REF!
BNT162b2 (30 μg)
Dose 2
3710/16/202010/18/2020Neg/Neg/NegNegNegNegFever Diarrhea VomitingPos/Pos#REF!10471024#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab Pos; urgent care visit (once)NoNoNoNoNoNoNoNo63FUSA
10471024
White38.2Non-Hispanic/non-Latino63808
37
180
C4591001 1068 10681082
(USA/58/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4211/1/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased shortness of breath Sore throatPos/Pos#REF!10681082#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!
Covid Ilness visit 1, C-pos/L-pos; #4 16.2.2 Protocol deviations and #3 16.2.23 Important Protocol Deviations
YesYesNoNoNoNoNoNo58MUSA
10681082
White28.2Non-Hispanic/non-Latino58Age group (years) and obese
38
187
C4591001 1068 10681110
(USA/30/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2210/16/2020Neg/Neg/NegNegNegNegNew or increased cough New loss of taste or smellPos/Pos#REF!10681110#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab Pos; urgent care visit (once)NoNoNoNoNoNoNoNo30FUSA
10681110
White35.3Non-Hispanic/non-Latino3016-64 not obese404
39
191
C4591001 1071 10711022
(USA/47/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
7211/10/2020Neg/Neg/NegNegNegNegFever Chills New or increased muscle pain Sore throatPos/Pos#REF!10711022#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab SARS-CoV-2 NAAT was not done.NoNoNoNoNoNoNoNo47MUSA
10711022
Multiple43.0Non-Hispanic/non-Latino4716-64 and obese303
40
197
C4591001 1071 10711058
(USA/72/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6011/6/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!10711058#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos; Local Lab PosNoNoNoNoNoNoNoNo72FUSA
10711058
White35.9Non-Hispanic/non-Latino72>=65 not obese101
41
200
C4591001 1072 10721057
(USA/70/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4110/26/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!10721057#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab pos; unblinded received BNT162b22 26Feb2021NoNoNoNoNoNoNoNo70MUSA
10721057
White31.6Non-Hispanic/non-Latino70>=65 and obese000
42
202
C4591001 1077 10771195
(USA/73/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4011/1/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased muscle painPos/Pos#REF!10771195#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab pos; unblinded BNT162b22 01Jan2021 & 11Feb2021NoNoNoNoNoNoNoNo73FUSA
10771195
White24.6Non-Hispanic/non-Latino73Total808
43
208
C4591001 1079 10791046
(USA/55/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6210/26/2020Neg/Neg/NegNegNegNegNew loss of taste or smellPos/Pos#REF!10791046#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab pos; unblinded BNT162b22 16Feb2021 & 12Mar2021NoNoNoNoNoNoNoNo55FUSA
10791046
White35.6Non-Hispanic/non-Latino55
44
210
C4591001 1079 10791054
(USA/28/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6310/29/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!10791054#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab pos / Local Neg, Pos; unblinded BNT162b2 22Dec2020 & 13Jan2021NoNoNoNoNoNoNoNo28FUSA
10791054
White33.5Non-Hispanic/non-Latino28
45
212
C4591001 1081 10811151
(USA/79/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
109/30/202010/14/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!10811151#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab not done; unblinded BNT162b2 26Jan2021 & 22Feb2021NoNoNoNoNoNoNoNo79FUSA
10811151
White37.4Non-Hispanic/non-Latino79
46
214
C4591001 1082 10821016
(USA/46/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4410/6/202010/27/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle pain New loss of taste or smellPos/Pos#REF!10821016#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab pos; unblinded BNT162b2 22Dec2020 & 12Jan2021NoNoNoNoNoNoNoNo46FUSA
10821016
White29.2Non-Hispanic/non-Latino46
47
223
C4591001 1085 10851293
(USA/63/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3711/7/2020Neg/Neg/NegNegNegNegFever New or increased cough New loss of taste or smellPos/Pos#REF!10851293#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab not done; unblinded BNT162b2 13Jan2021 & 03Feb2021NoNoNoNoNoNoNoNo63FUSA
10851293
Asian27.3Non-Hispanic/non-Latino63
48
229
C4591001 1088 10881219
(USA/63/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1710/25/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased muscle painPos/Pos#REF!10881219#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Control lab pos / Local lab pos; unblinded BNT162b2 22Dec2020 & 13Jan2021NoNoNoNoNoNoNoNo63MUSA
10881219
White28.0Non-Hispanic/non-Latino63
49
235
C4591001 1088 10881233
(USA/47/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1511/2/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills Sore throatPos/Pos#REF!10881233#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Protocol deviation: Dose 2 > 23 days post Dose 1NoNoNoNoNoNoNoNo47MUSA
10881233
Native Hawaiian or Other Pacific Islander
26.5Non-Hispanic/non-Latino47
50
241
C4591001 1089 10891235
(USA/29/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4711/8/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!10891235#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab posisitive / Local Lab positive; unblinded BNT162b2 12Feb, 9Mar2021NoNoNoNoNoNoNoNo29FUSA
10891235
Black or African American33.3Non-Hispanic/non-Latino29
51
244
C4591001 1090 10901121
(USA/58/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4910/18/202010/22/2020Neg/Neg/NegNegNegNegFever New loss of taste or smellPos/Pos#REF!10901121#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab posisitive / Local Lab positive; withdrawal by subject 16 Dec 2020NoNoNoNoNoNoNoYes58FUSA
10901121
White30.6Non-Hispanic/non-Latino58
52
248
C4591001 1090 10901353
(USA/63/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4011/8/2020Neg/Neg/NegNegNegNegFever New or increased coughPos/Pos#REF!10901353#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Illness Visit 1 Central lab pos / Local lab Pos: unblinded received BNT162b2 01Mar2021NoNoNoNoNoNoNoNo63MUSA
10901353
White28.7Non-Hispanic/non-Latino63
53
252
C4591001 1091 10911203
(USA/43/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4411/5/2020Neg/Neg/NegNegNegNegNew or increased Unk/Pos cough New or increased muscle pain#REF!10911203#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab: No SARS-CoV-2 Test / Local lab positive (71); primary care physician (once)NoNoNoNoNoNoNoNo43MUSA
10911203
White33.9Non-Hispanic/non-Latino43
54
256
C4591001 1092 10921021
(USA/60/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4810/27/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle painPos/Pos#REF!10921021#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab not doneNoNoNoNoNoNoNoNo60FUSA
10921021
White26.2Non-Hispanic/non-Latino60
55
263
C4591001 1092 10921130
(USA/53/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1810/9/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased shortness of breath New loss of taste or smell Sore throat DiarrheaPos/Pos#REF!10921130#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!16.2.1.4 - Listing of Subjects Withdrawn From the Study 12 Oct 2020*NoNoNoNoNoNoYesNo53MUSA
10921130
White31.3Non-Hispanic/non-Latino53
56
273
C4591001 1093 10931081
(USA/67/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1910/5/202010/19/2020Neg/Neg/NegNegNegNegSore throat Pos/Pos#REF!10931081#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab not doneNoNoNoNoNoNoNoNo67FUSA
10931081
White25.7Non-Hispanic/non-Latino67
57
275
C4591001 1095 10951238
(USA/63/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1911/2/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath Chills New or increased muscle pain Sore throat DiarrheaPos/Pos#REF!10951238#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo63FUSA
10951238
White29.0Hispanic/Latino63
58
284
C4591001 1095 10951260
(USA/25/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
911/5/2020Neg/Neg/NegNegNegNegNew or increased cough Chills New or increased muscle pain Sore throatPos/Pos#REF!10951260#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo25MUSA
10951260
White27.9Hispanic/Latino25
59
290
C4591001 1096 10961172
(USA/51/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4911/6/202011/8/2020Neg/Neg/NegNegNegNegFever New or increased coughPos/Pos#REF!10961172#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo51MUSA
10961172
White23.7Non-Hispanic/non-Latino51
60
294
C4591001 1096 10961258
(USA/55/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2510/22/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle pain Sore throatPos/PosPosPos#REF!10961258#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab Pos; Protocol deviation: Dose 2 > 23 days post Dose 1NoNoNoNoNoNoNoNo55FUSA
10961258
White21.8Non-Hispanic/non-Latino55
61
299
C4591001 1098 10981062
(USA/63/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3210/17/202010/20/2020Neg/Neg/NegNegNegNegNew or increased muscle painPos/Pos#REF!10981062#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab not doneNoNoNoNoNoNoNoNo63FUSA
10981062
Black or African American29.2Non-Hispanic/non-Latino63
62
301
C4591001 1101 11011095
(USA/60/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2011/2/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!11011095#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo60MUSA
11011095
White27.5Non-Hispanic/non-Latino60
63
303
C4591001 1107 11071171
(USA/39/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5811/10/2020Neg/Neg/NegNegNegNegFever ChillsPos/Pos#REF!11071171#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo39MUSA
11071171
White36.3Non-Hispanic/non-Latino39
64
306
C4591001 1109 11091067
(USA/42/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
8411/11/2020Neg/Neg/NegNegNegNegNew or increased shortness of breath Sore throatPos/Pos#REF!11091067#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab not doneNoNoNoNoNoNoNoNo42MUSA
11091067
White28.8Non-Hispanic/non-Latino42
65
309
C4591001 1109 11091092
(USA/18/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
7010/31/2020Neg/Neg/NegNegNegNegFever New or increased cough Sore throatPos/Pos#REF!11091092#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab PosNoNoNoNoNoNoNoNo18MUSA
11091092
White19.1Non-Hispanic/non-Latino18
66
314
C4591001 1109 11091323
(USA/64/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4710/31/202011/2/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle painPos/Pos#REF!11091323#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos; Local Lab not doneNoNoNoNoNoNoNoNo64MUSA
11091323
White28.5Non-Hispanic/non-Latino64
67
321
C4591001 1109 11091416
(USA/46/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4111/3/2020Neg/Neg/NegNegNegNegFever New or increased cough Sore throatPos/Pos#REF!11091416#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central lab positive / Local lab SARS-CoV-2 not done.NoNoNoNoNoNoNoNo46FUSA
11091416
White36.8Non-Hispanic/non-Latino46
68
326
C4591001 1109 11091448
(USA/46/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
910/6/202010/28/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased shortness of breath New or increased muscle pain Sore throat
Pos/ (R1 Pos)
Pos (R1 Pos)#REF!11091448#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Serious AE Hemiplegic migraine Grade 4; Covid ilness visit 1 (9) C- two Pos, L-PosNoNoNoNoNoNoNoNo46FUSA
11091448
White29.4Non-Hispanic/non-Latino46
69
335
C4591001 1109 11091482
(USA/63/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2810/29/2020Neg/Neg/NegNegNegNegNew or increased cough New loss of taste or smellPos/Pos#REF!11091482#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1, Central lab pos (55) / Local lab Neg (55)NoNoNoNoNoNoNoNo63MUSA
11091482
White25.8Non-Hispanic/non-Latino63
70
339
C4591001 1110 11101050
(USA/47/M)
#REF!#REF!#REF!#REF!#REF!#REF!
BNT162b2 (30 μg)
Dose 2
7611/10/2020Neg/Neg/NegNegNegNegNew or increased cough Chills Sore throatPos/Pos#REF!11101050#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (98) /L-pos (98)NoNoNoNoNoNoNoNo47MUSA
11101050
White24.4Non-Hispanic/non-Latino47
71
343
C4591001 1110 11101136
(USA/62/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5211/4/2020Neg/Neg/NegNegNegNegNew or increased cough Chills DiarrheaPos/Pos#REF!11101136#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (59) /L-pos (73)NoNoNoNoNoNoNoNo62MUSA
11101136
White37.8Hispanic/Latino62
72
347
C4591001 1110 11101162
(USA/51/M)#REF!#REF!#REF!#REF!#REF!#REF!
BNT162b2 (30 μg)
Dose 2
3410/24/2020Neg/Neg/NegNegNegNegNew or increased cough New loss of taste or smellPos/Pos#REF!11101162#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (57) /L-pos (73)NoNoNoNoNoNoNoNo51MUSA
11101162
White40.3Hispanic/Latino51
73
351
C4591001 1111 11111010
(USA/75/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4510/4/202010/5/2020Neg/Neg/NegNegNegNegFever ChillsPos/Pos#REF!11111010#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (68) /Local lab SARS-CoV-2 test was not doneNoNoNoNoNoNoNoNo75MUSA
11111010
White29.3Non-Hispanic/non-Latino75
74
354
C4591001 1116 11161075
(USA/73/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4311/3/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath ChillsPos/Pos#REF!11161075#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (66) /Local lab SARS-CoV-2 test was not doneNoNoNoNoNoNoNoNo73MUSA
11161075
White31.2Non-Hispanic/non-Latino73
75
359
C4591001 1117 11171010
(USA/72/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3410/11/202010/19/2020Neg/Neg/NegNegNegNegFever New or increased coughPos/Pos#REF!11171010#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (56) /Local lab SARS-CoV-2 NAAT test was not doneNoNoNoNoNoNoNoNo72FUSA
11171010
White29.7Non-Hispanic/non-Latino72
76
363
C4591001 1118 11181088
(USA/73/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3610/20/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle painPos/Pos#REF!11181088#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (64) /L-pos (63); subject visited health dept nurse (once)NoNoNoNoNoNoNoNo73MUSA
11181088
White28.4Non-Hispanic/non-Latino73
77
367
C4591001 1120 11201115
(USA/19/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
7311/6/2020Neg/Neg/NegNegNegNegFever New or increased muscle pain Sore throat DiarrheaPos/Pos#REF!11201115#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (95) /Local lab SARS-CoV-2 NAAT test was not doneNoNoNoNoNoNoNoNo19FUSA
11201115
White40.7Non-Hispanic/non-Latino19
78
373
C4591001 1122 11221025
(USA/40/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3211/1/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle painPos/Pos#REF!11221025#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid Ilness visit 1, C-pos (55) /L-pos (55); phone consultation and health clinic (once)NoNoNoNoNoNoNoNo40MUSA
11221025
White28.4Non-Hispanic/non-Latino40
79
380
C4591001 1123 11231073
(USA/25/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
109/10/202010/6/2020Neg/Neg/NegNegNegNegNew or increased cough Chills New or increased muscle pain Sore throatPos/PosPosPos#REF!11231073#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!COIVID Illness visit 1 10 Sep (Rel 10); C-Pos / L-Pos 11 Sep 2020: primary care physician (once)NoNoNoNoNoNoNoNo25FUSA
11231073
White23.9Non-Hispanic/non-Latino25
80
386
C4591001 1123 11231086
(USA/35/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5710/27/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased muscle painPos/Pos#REF!11231086#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local PosNoNoNoNoNoNoNoNo35FUSA
11231086
White22.4Non-Hispanic/non-Latino35
81
390
C4591001 1123 11231117
(USA/55/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
6411/10/2020Neg/Neg/NegNegNegNegChills New or increased muscle painPos/Pos#REF!11231117#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo55FUSA
11231117
White24.0Non-Hispanic/non-Latino55
82
394
C4591001 1123 11231214
(USA/60/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3410/26/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath Chills New loss of taste or smell Sore throatPos/Pos#REF!11231214#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local Pos; Discontinued from Study 05 Feb 2021NoNoNoNoNoNoNoYes60FUSA
11231214
White23.7Non-Hispanic/non-Latino60
83
402
C4591001 1123 11231255
(USA/76/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2010/24/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!11231255#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local PosNoNoNoNoNoNoNoNo76MUSA
11231255
White24.3Non-Hispanic/non-Latino76
84
404
C4591001 1123 11231256
(USA/72/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2410/28/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!11231256#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo72FUSA
11231256
White25.2Non-Hispanic/non-Latino72
85
406
C4591001 1123 11231284
(USA/67/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
1210/24/2020Neg/Neg/NegNegNegNegFever New or increased cough Chills New or increased muscle painPos/Pos#REF!11231284#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local PosNoNoNoNoNoNoNoNo67MUSA
11231284
White24.1Non-Hispanic/non-Latino67
86
413
C4591001 1125 11251006
(USA/35/M)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4210/11/2020Neg/Neg/NegNegNegNegFever New or increased cough ChillsPos/Pos#REF!11251006#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local PosNoNoNoNoNoNoNoNo35MUSA
11251006
White30.5Non-Hispanic/non-Latino35
87
418
C4591001 1125 11251014
(USA/45/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5910/30/2020Neg/Neg/NegNegNegNegFever New or increased cough New or increased shortness of breath Chills New or increased muscle pain DiarrheaPos/Pos#REF!11251014#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo45FUSA
11251014
White38.1Non-Hispanic/non-Latino45
88
428
C4591001 1125 11251023
(USA/49/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5610/27/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breath Chills New or increased muscle painPos/Pos#REF!11251023#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo49MUSA
11251023
White33.0Non-Hispanic/non-Latino49
89
435
C4591001 1125 11251028
(USA/39/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
279/29/202010/2/2020Neg/Neg/NegNegNegNegFever Chills New or increased muscle pain Sore throatPos/Pos#REF!11251028#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo39FUSA
11251028
White31.3Non-Hispanic/non-Latino39
90
441
C4591001 1125 11251049
(USA/52/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5010/27/2020Neg/Neg/NegNegNegNegNew loss of taste or smell Sore throatPos/Pos#REF!11251049#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo52MUSA
11251049
White32.6Non-Hispanic/non-Latino52
91
444
C4591001 1125 11251109
(USA/46/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5111/4/2020Neg/Neg/NegNegNegNegFever New or increased shortness of breath New or increased muscle pain DiarrheaPos/Pos#REF!11251109#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local not doneNoNoNoNoNoNoNoNo46FUSA
11251109
White56.1Hispanic/Latino46
92
451
C4591001 1125 11251114
(USA/59/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3810/22/2020Neg/Neg/NegNegNegNegFever Pos/PosPosPos#REF!11251114#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Central Lab Pos, Local PosNoNoNoNoNoNoNoNo59MUSA
11251114
White31.5Non-Hispanic/non-Latino59
93
453
C4591001 1125 11251124
(USA/39/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5311/8/202011/10/2020Neg/Neg/NegNegNegNegFever Chills New or increased muscle painPos/Pos#REF!11251124#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab SARS-CoV-2 not done.NoNoNoNoNoNoNoNo39MUSA
11251124
White23.7Non-Hispanic/non-Latino39
94
458
C4591001 1125 11251215
(USA/43/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
2511/6/2020Neg/Neg/NegNegNegNegNew or increased coughPos/Pos#REF!11251215#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab SARS-CoV-2 not done.NoNoNoNoNoNoNoNo43MUSA
11251215
White35.7Non-Hispanic/non-Latino43
95
460
C4591001 1126 11261017
(USA/34/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5010/20/2020Neg/Neg/NegNegNegNegFever New or increased muscle painPos/Pos#REF!11261017#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!AE Acute sinusitis (3); 16.2.1.1 Withdrawal from study 28 Jan 2021; AE allergy to vaccineNoNoNoNoNoNoNoYes34FUSA
11261017
White22.5Non-Hispanic/non-Latino34
96
464
C4591001 1128 11281165
(USA/26/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4610/29/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!11281165#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab positive; subject urgent care visit (once).NoNoNoNoNoNoNoNo26FUSA
11281165
White21.1Non-Hispanic/non-Latino26
97
467
C4591001 1131 11311100
(USA/64/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
5811/12/2020Neg/Neg/NegNegNegNegFever Chills New or increased muscle pain New loss of taste or smellPos/Pos#REF!11311100#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab indertiminate; urgent care visit (once)NoNoNoNoNoNoNoNo64MUSA
11311100
White32.1Non-Hispanic/non-Latino64
98
474
C4591001 1131 11311138
(USA/45/F)#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
4511/7/2020Neg/Neg/NegNegNegNegNew or increased cough New or increased shortness of breathPos/Pos#REF!11311138#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab SARS-CoV-2 not done.NoNoNoNoNoNoNoNo45FUSA
11311138
White22.4Non-Hispanic/non-Latino45
99
478
C4591001 1133 11331209
(USA/30/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
3210/10/2020Neg/Neg/NegNegNegNegNew or increased cough Sore throatPos/Pos#REF!11331209#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!
C-pos / Local lab SARS-CoV-2 not done; 16.2.1.1 Withdrawal from study 26 Feb 2021 Lost to follow up - certified letter sent 19 Feb 2021
NoNoNoNoNoNoNoYes30MUSA
11331209
Black or African American25.4Hispanic/Latino30
100
481
C4591001 1134 11341022
(USA/66/M)
#REF!#REF!#REF!#REF!#REF!#REF!Placebo
Dose 2
299/29/202010/3/2020Neg/Neg/NegNegNegNegNew or increased muscle pain Sore throatPos/Pos#REF!11341022#REF!#REF!#REF!#REF!#REF!#REF!#REF!#REF!Covid illness visit 1 Central Lab pos / Local lab SARS-CoV-2 not done.NoNoNoNoNoNoNoNo66MUSA
11341022
White31.3Non-Hispanic/non-Latino66