Document text
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1005
10051413/
BNT162b2 (30
μg) 2 204 26JUL2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1005
10051441/
BNT162b2 (30
μg) 2 206 05AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1006
10061200/
Placebo 4 142 26AUG2021 FOLLOW-UP LOST TO FOLLOW-UP Lost to follow-up, noncompliant
C4591001 1006
10061206/
Placebo 2 147 18MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT parent requested to withdraw consent
C4591001 1006
10061207/
Placebo 2 147 18MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT participant withdrew consent
C4591001 1006
10061221/
BNT162b2 (30
μg) 2 218 02AUG2021 FOLLOW-UP OTHER enrolled in C4591031
C4591001 1006
10061265/
BNT162b2 (30
μg) 2 129 14MAY2021 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA RECEIVED COVID VACCINE OUTSIDE STUDY
C4591001 1006
10061280/
BNT162b2 (30
μg) 2 208 02AUG2021 FOLLOW-UP OTHER enrolled in C4591031
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 1
FDA-CBER-2022-5812-0224532
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1006
10061287/
Placebo 2 135 25MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Discontinued
C4591001 1006
10061288/
BNT162b2 (30
μg) 2 204 02AUG2021 FOLLOW-UP OTHER enrolled in C4591031
C4591001 1006
10061296/
Placebo 2 129 27MAY2021 FOLLOW-UP LOST TO FOLLOW-UP unable to contact
C4591001 1006
10061297/
BNT162b2 (30
μg) 2 129 27MAY2021 FOLLOW-UP LOST TO FOLLOW-UP unable to contact
C4591001 1007
10071593/
Placebo 1 24 20JAN2021 VACCINATION PROTOCOL DEVIATION receipt of non-study COVID vaccine prior to study end
1 47 12FEB2021 FOLLOW-UP PROTOCOL DEVIATION Receipt of non-stud y COVID vaccine prior to stud y end
C4591001 1007
10071622/
BNT162b2 (30
μg) 1 22 20JAN2021 VACCINATION OTHER Participant had COVID-19 prior to second vaccine
C4591001 1007
10071635/
Placebo 2 108 12MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Pfizer vaccine outside of study, participant verbalized
wanting to withdrawal from the study
C4591001 1007
10071639/
Placebo 2 128 01JUN2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Participant Moving
C4591001 1008
10081758/ 2 223 02AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 2
FDA-CBER-2022-5812-0224533
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
BNT162b2 (30
μg)
C4591001 1008
10081829/
Placebo 2 122 13MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN requested unblinding 5/12, withdrew consent 5/13
C4591001 1008
10081834/
Placebo 2 121 13MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN requested unblinding 5/12, withdrew consent 5/13
C4591001 1008
10081871/
Placebo 1 78 17MAR2021 VACCINATION OTHER 2nd vax not given due to confirmed covid illness prior
to vax #2
C4591001 1008
10081884/
Placebo 1 79 19MAR2021 VACCINATION OTHER 2nd vax not given due to confirmed covid illness prior
to vax #2
C4591001 1008
10081901/
Placebo 2 18 12FEB2021 VACCINATION OTHER the participant is willing/e ligible to receive Vaccination
3
C4591001 1009
10091227/
BNT162b2 (30
μg) 2 259 26JUL2021 FOLLOW-UP OTHER Subject enrolled in C4591031 study
C4591001 1009
10091287/
BNT162b2 (30
μg) 2 225 04AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1009
10091307/
BNT162b2 (30
μg) 2 245 31AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN subject moved to Texas
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 3
FDA-CBER-2022-5812-0224534
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1009
10091308/
Placebo 2 245 31AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN subject moved to texas
C4591001 1009
10091332/
BNT162b2 (30
μg) 2 216 02AUG2021 FOLLOW-UP OTHER participant enrolled in C4591031
C4591001 1009
10091338/
Placebo 1 19 01JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA exclusion #5
C4591001 1009
10091363/
Placebo 1 11 27DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA has tested positive for COVID-19
C4591001 1009
10091383/
BNT162b2 (30
μg) 2 193 05AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1013
10131830/
Placebo 2 141 12MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Wanted to get vaccine close r to home and now able to
do so.
C4591001 1013
10131846/
BNT162b2 (30
μg) 2 144 14MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Mother wanted unblinded did not want to continue in
study; wanted vaccine in community.
C4591001 1013
10131848/
Placebo 2 144 14MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Mother wanted unblinded did not want to continue in
study; wanted vaccine in community.
C4591001 1013
10131856/
BNT162b2 (30
μg) 2 133 11MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject no longer able to m ake appointments due to
drive.
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 4
FDA-CBER-2022-5812-0224535
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1013
10131862/
BNT162b2 (30
μg) 2 232 17AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT SUBJECT MOVED TO SEATTLE
C4591001 1013
10131868/
Placebo 2 127 18MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject received first dose in community.
C4591001 1013
10131869/
Placebo 2 141 02JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject wanted to get vac cine closer to home.
C4591001 1013
10131870/
Placebo 2 100 22APR2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject could not make the time commitment with 2
hour drive.
C4591001 1013
10131878/
Placebo 2 133 25MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Unable to make further ap pointments - vaccinated in
community.
C4591001 1016
10161316/
Placebo 1 17 01NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with positive covid-19
C4591001 1016
10161379/
Placebo 1 30 05FEB2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject with positive covid test
C4591001 1039
10391253/
BNT162b2 (30
μg) 2 225 09AUG2021 FOLLOW-UP LOST TO FOLLOW-UP Subject lost to follow up
C4591001 1039
10391264/
Placebo 3 16 08JUN2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT Subject has withdrawn from study.
3 16 08JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECTSubject has withdrawn from study.
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 5
FDA-CBER-2022-5812-0224536
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1039
10391332/
BNT162b2 (30
μg) 2 129 10JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject has withdrawn consent.
C4591001 1044
10441289/
Placebo 2 220 18AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT withdrew consent
C4591001 1044
10441293/
Placebo 3 39 21JUN2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION subject received dose outside of study
C4591001 1044
10441294/
Placebo 3 50 02JUL2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION subject received dose outside of study
C4591001 1044
10441322/
BNT162b2 (30
μg) 2 46 13MAR2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Refused further follow-up
C4591001 1044
10441344/
Placebo 2 11 08FEB2021 VACCINATION OTHER transitioning to open label
C4591001 1044
10441347/
Placebo 2 120 28MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Parent/guardian contacted the site to advise that her
daughter is no longer interested in continuing
C4591001 1044
10441371/
Placebo 2 183 03AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT subject moved from area
C4591001 1044
10441372/
BNT162b2 (30
μg) 2 183 03AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT subject moved from area
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 6
FDA-CBER-2022-5812-0224537
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1057
10571377/
Placebo 2 241 25AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT UNABLE TO DRIVE TO JACKSONVILLE FOR
STUDY VISITS
C4591001 1057
10571378/
BNT162b2 (30
μg) 2 241 25AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT UNABLE TO DRIVE TO JACKSONVILLE FOR
STUDY VISITS
C4591001 1057
10571385/
BNT162b2 (30
μg) 2 207 22JUL2021 FOLLOW-UP OTHER ENROLLED INTO C4591031
C4591001 1057
10571390/
BNT162b2 (30
μg) 2 215 30JUL2021 FOLLOW-UP OTHER PARTICIPANT ENROLLED INTO C4591031
C4591001 1057
10571392/
BNT162b2 (30
μg) 2 207 22JUL2021 FOLLOW-UP OTHER ENROLLED INTO C4591031
C4591001 1057
10571413/
BNT162b2 (30
μg) 21DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA DELAY CRITERIA MET
21DEC2020 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA DELAY CRITERIA MET
C4591001 1057
10571414/
Placebo 2 148 08JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT subject no longer wants to participate
C4591001 1057
10571418/ 2 229 27AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN father stated just didn't want daughter participating at
this time. no othe r reason disclose d
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 7
FDA-CBER-2022-5812-0224538
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
BNT162b2 (30
μg)
C4591001 1057
10571420/
Placebo 2 45 24FEB2021 VACCINATION WITHDRAWAL BY
PARENT/GUARDIAN mother stated she didn't w ant him to do it anymore
2 45 24FEB2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN mother stated she didn't w ant him to do it anymore
C4591001 1057
10571421/
Placebo 2 180 09JUL2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1057
10571425/
Placebo 2 185 15JUL2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT NO LONGER WISHES TO PARTICIPATE
C4591001 1057
10571426/
BNT162b2 (30
μg) 2 194 02AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT UNABLE TO COME IN FOR STUDY VISIT
C4591001 1057
10571446/
Placebo 2 213 01SEP2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT no longer interested
C4591001 1057
10571450/
Placebo 2 206 26AUG2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT no longer interested in revax V101, no longer interested
in study participation
C4591001 1066
10661408/
BNT162b2 (30
μg) 2 218 02AUG2021 FOLLOW-UP OTHER Subject enrolled in C4591031
C4591001 1066
10661428/
Placebo 2 17 11FEB2021 VACCINATION OTHER subject unblinded for vax 3 per protocol
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 8
FDA-CBER-2022-5812-0224539
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1066
10661431/
BNT162b2 (30
μg) 2 183 28JUL2021 FOLLOW-UP OTHER subject enrolled in C4591031
C4591001 1077
10771282/
Placebo 2 133 17MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Subject recieved covid-19 vaccine outside study and is
moving. Does not wish to continue in followup
C4591001 1077
10771289/
Placebo 2 127 14MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1077
10771290/
Placebo 2 127 14MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1077
10771292/
BNT162b2 (30
μg) 2 133 18MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1077
10771293/
Placebo 18DEC2020 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject withdrew consent prior to blood draw.
C4591001 1084
10841542/
Placebo 2 184 01JUL2021 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject received vaccine outside of study.
C4591001 1084
10841557/
Placebo 2 116 13MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1084
10841568/
Placebo 2 149 15JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT subject drop to due summer activities
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 9
FDA-CBER-2022-5812-0224540
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1084
10841579/
Placebo 2 118 24MAY2021 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA Subject received outside P fizer Vaccine 14May2021
C4591001 1091
10911409/
Placebo 2 150 26MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1091
10911451/
BNT162b2 (30
μg)
04JAN2021 FOLLOW-UP OTHER Subject was rescreened under #1462. Subject
randomized in error.
C4591001 1123
11231422/
Placebo 2 171 09JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Patient moved from the area and cannot be present for
scheduled visits
C4591001 1123
11231434/
Placebo 2 137 13MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Pt requested to be dropped from the study and refused to
elaborate
C4591001 1123
11231438/
Placebo 2 161 15JUN2021 FOLLOW-UP LOST TO FOLLOW-UP Could not reach patient via telephone to schedule
vaccination
C4591001 1123
11231441/
Placebo 2 127 10MAY2021 FOLLOW-UP LOST TO FOLLOW-UP Patient lost to follow up due to inability to be present for
appointments.
C4591001 1123
11231443/
BNT162b2 (30
μg) 2 184 06JUL2021 FOLLOW-UP LOST TO FOLLOW-UP Subject no-showed for V4, and site staff was unable to
contact them to reschedule
C4591001 1123
11231445/
Placebo 2 163 10JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Patient requested to be out of the study, did not want to
participate in crossover.
C4591001 1123
11231446/ 2 183 30JUN2021 FOLLOW-UP LOST TO FOLLOW-UP Subject no showed for V4, staff could not contact
subject
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 10
FDA-CBER-2022-5812-0224541
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
BNT162b2 (30
μg)
C4591001 1123
11231448/
Placebo 2 112 20APR2021 FOLLOW-UP LOST TO FOLLOW-UP Inability to contact patient reg arding reported symptoms
on illness diary
C4591001 1123
11231478/
Placebo 2 150 09JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Patient did not want to participate in the crossover and
requested to be dropped from the study.
C4591001 1123
11231479/
Placebo 2 124 14MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Patient requested to be dro pped because they did not
want to come into clinic for any more visits
C4591001 1123
11231483/
Placebo 2 151 10JUN2021 FOLLOW-UP LOST TO FOLLOW-UP Can't reach patient to schedule V101
C4591001 1123
11231486/
BNT162b2 (30
μg) 2 192 21JUL2021 FOLLOW-UP LOST TO FOLLOW-UP No Show for V4, can't reach subject
C4591001 1123
11231491/
Placebo 2 150 09JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to p articipate in the crossover
C4591001 1123
11231511/
BNT162b2 (30
μg) 2 112 10MAY2021 FOLLOW-UP LOST TO FOLLOW-UP Could not reach patient via telephone
C4591001 1123
11231512/
BNT162b2 (30
μg) 2 112 10MAY2021 FOLLOW-UP LOST TO FOLLOW-UP Couldn't reach patient via telephone.
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 11
FDA-CBER-2022-5812-0224542
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1123
11231515/
Placebo 2 131 28MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject requested withdrawal f rom study due to fears of
blood collection.
C4591001 1123
11231526/
Placebo 3 37 30JUN2021 FOLLOW-UP LOST TO FOLLOW-UP Patient consistently no-showed for V102.
C4591001 1124
11241236/
Placebo 2 149 01JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT OUT OF COUNTRY
C4591001 1124
11241242/
Placebo 2 168 21JUN2021 FOLLOW-UP LOST TO FOLLOW-UP Patient is Lost toFollow-up as of June 21, 2021
C4591001 1124
11241256/
Placebo 2 129 21MAY2021 FOLLOW-UP LOST TO FOLLOW-UP Multiple phone attempts mad e, certified letter sent.
Subject did not complete Visit 101
C4591001 1124
11241261/
BNT162b2 (30
μg) 2 162 23JUN2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject does not wish to continue in study
C4591001 1124
11241262/
BNT162b2 (30
μg) 2 180 09JUL2021 FOLLOW-UP LOST TO FOLLOW-UP Several voicemails left and Certified letter sent on 7/9
C4591001 1125
11251255/
BNT162b2 (30
μg) 2 181 26JUL2021 FOLLOW-UP LOST TO FOLLOW-UP Certified letter sent after mu ltiple attempts to contact for
potential revax contact
C4591001 1126
11261287/
Placebo 1 15 30DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject did not receive 2nd v accine due to Covid 19
disease.
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 12
FDA-CBER-2022-5812-0224543
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1131
11311302/
BNT162b2 (30
μg) 2 186 05AUG2021 FOLLOW-UP OTHER participant enrolled in C4591031
C4591001 1139
11391189/
Placebo 2 123 13MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject's decided to withdr aw and receive vaccine
elsewhere
C4591001 1139
11391201/
BNT162b2 (30
μg) 2 205 04AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1139
11391203/
Placebo 3 22 27APR2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject decided to receive 2nd dose elsewhere and
wanted to withdraw.
C4591001 1139
11391235/
Placebo 3 1 15FEB2021 VACCINATION OTHER Crossed over to Visit 101
C4591001 1139
11391261/
BNT162b2 (30
μg) 2 183 03AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1139
11391262/
BNT162b2 (30
μg) 2 182 04AUG2021 FOLLOW-UP OTHER Participant enrolled in C4591031
C4591001 1139
11391263/
Placebo 3 1 19FEB2021 VACCINATION OTHER Crossed-over
C4591001 1140
11401346/ 22DEC2020 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT TO BE DISCONTINUED DUE TO
UNABLE TO OBTAIN SPECIMEN
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 13
FDA-CBER-2022-5812-0224544
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
BNT162b2 (30
μg)
C4591001 1140
11401350/
BNT162b2 (30
μg) 2 182 13JUL2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1140
11401352/
BNT162b2 (30
μg) 2 182 13JUL2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1140
11401357/
Placebo 2 124 14MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1140
11401386/
BNT162b2 (30
μg) 2 187 01AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1142
11421333/
Placebo 2 217 11AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN Subject withdrawn due to move
C4591001 1147
11471280/
Placebo 1 50 22FEB2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Treatment discontinued due to COVID Illness
"exclusion 5"
C4591001 1147
11471327/
BNT162b2 (30
μg) 1 4 08JAN2021 VACCINATION ADVERSE EVENT ADVERSE EVENT/PYREXIA
C4591001 1150
11501199/
Placebo 2 141 19MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECT Subject does not want to complete mandatory nasal
swabs required at revacci nation visits 101 and 102
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
Page 14
FDA-CBER-2022-5812-0224545
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1152
11521635/
BNT162b2 (30
μg) 2 185 30JUN2021 FOLLOW-UP PROTOCOL DEVIATION Subject no longer willing to comply with study
requirements.
C4591001 1152
11521640/
BNT162b2 (30
μg) 2 150 26MAY2021 FOLLOW-UP OTHER Subject moved out of state. Pfizer could not provide
transfer site.
C4591001 1152
11521641/
BNT162b2 (30
μg) 1 54 29JAN2021 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
1 171 26MAY2021 FOLLOW-UP OTHER Subject moved out of state. Pfizer could not provide
transfer site.
C4591001 1152
11521650/
BNT162b2 (30
μg) 2 218 02AUG2021 FOLLOW-UP OTHER To participate in the C4591031 Booster Study
C4591001 1152
11521698/
Placebo 2 131 18MAY2021 FOLLOW-UP PROTOCOL DEVIATION Received nonstudy C OVID-19 Vaccine
C4591001 1152
11521726/
Placebo 2 149 15JUN2021 FOLLOW-UP PROTOCOL DEVIATION Received nonstudy COVID-1 9 vaccine, withdrawn from
study.
C4591001 1152
11521747/
Placebo 3 68 26JUL2021 FOLLOW-UP PROTOCOL DEVIATION Received nonstudy C OVID-19 Vaccine
C4591001 1152
11521751/
Placebo 2 106 18MAY2021 FOLLOW-UP PROTOCOL DEVIATION Received nonstudy C OVID-19 Vaccine
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
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FDA-CBER-2022-5812-0224546
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1152
11521754/
Placebo 2 110 21MAY2021 FOLLOW-UP PROTOCOL DEVIATION Received nonstudy C OVID-19 Vaccine
C4591001 1156
11561316/
Placebo 2 73 10MAR2021 VACCINATION PROTOCOL DEVIATION SUBJECT CAN NOT BE REACHED VIA PHONE.
CERTIFIED LETTER SENT. SUBJECT CONTINUES
TO COMPLETE eDIARY.
2 130 06MAY2021 FOLLOW-UP WITHDRAWAL BY
SUBJECTWITHDRAWAL OF CONSENT.
C4591001 1156
11561320/
Placebo 2 34 25JAN2021 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT AND FATHER STATED THAT THEY NO
LONGER WISHED TO PARTICIPATE IN THE
TRIAL.
2 34 25JAN2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN SUBJECT AND FATHER STATED THAT THEY NO
LONGER WISHED TO PARTICIPATE IN THE
TRIAL.
C4591001 1156
11561336/
Placebo 2 149 08JUN2021 FOLLOW-UP NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT NO LONGER MEETS ELIGIBILITY
BECAUSE THEY RECEIVED VACCINE OUTSIDE
OF STUDY.
C4591001 1156
11561353/
Placebo 3 54 09JUL2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION VACCINATED OFF SITE
C4591001 1156
11561359/
Placebo 3 48 30JUN2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION SUBJECT WAS VACCINATED OFF SITE.
C4591001 1156
11561365/
Placebo 2 190 09AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1156
11561366/
BNT162b2 (30
μg) 2 190 09AUG2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
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FDA-CBER-2022-5812-0224547
16.2.1 Listing of Subjects Discontinued From Vaccination and/or From the Study –
All Subjects 12 Through 15 Years of Age
Subject/
Vaccine Group
(as Randomized) Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001 1156
11561368/
BNT162b2 (30
μg) 2 178 28JUL2021 FOLLOW-UP OTHER PARTICIPANT ENROLLED IN C4591031
C4591001 1156
11561375/
Placebo 2 107 19MAY2021 FOLLOW-UP WITHDRAWAL BY
PARENT/GUARDIAN WITHDRAWAL BY PARENT/GUARDIAN
C4591001 1270
12701237/
Placebo 1 20 26JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA EC#55: Participant had a positive local COVID-19 test
before Vx2, symptomatic with test
3 56 13JUL2021 FOLLOW-UP WITHDRAWAL BY
SUBJECTSubject declines to participate in further study activities.
a. Relative day (Rel Day) = date of withdrawal - date of la st vaccination + 1. For a withdrawal that occurred before the d ate of the first study
vaccination, + 1 was not added to compute relative day.
b. MedDRA (v24.0) coding dictionary applied.
PFIZER CONFIDENTIAL SDTM Creation: 05OCT2021 (17:30) Source Dat a: adds Table Generation: 08NOV2021 (17:11)
(Data Cutoff Date: 02SEP2021, Database Snapshot Date: 27SEP2021 ) Output File: ./nda2 _unblinded/C4591001 _S_Peds/adds _l001_withd1 _ped6
090177e1988b770d\Final\Final On: 09-Nov-2021 04:11 (GMT)
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FDA-CBER-2022-5812-0224548