Document text
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
16-55 C4591001
1001
10011125 1 37 09SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Withdrew consent and decided not to continue in
study.
1 37 09SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1003
10031140
04AUG2020 FOLLOW -UP PROTOCOL DEVIATION Randomized in error.
C4591001
1003
10031143
04AUG2020 FOLLOW -UP PROTOCOL DEVIATION Randomized in error.
C4591001
1005
10051238 2 65 06JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WAS UNBLINDED AND FOUND OUT
HE RECEIVED PLACEBO. HE DECIDED TO
WITHDRAW
C4591001
1005
10051308 1 1 19OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT busy work schedule
1 1 19OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT busy work schedule
C4591001
1005
10051341 1 2 22OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested COVID positive between visits 1 and 2
C4591001
1005
10051381
28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject decided to withdraw consent after
randomized in IVRS but before given vaccine
C4591001
1005
10051407 2 16 18DEC2020 VACCINATION OTHER subject proceeded to open label prior to V3 in the
blinded Rx phase
C4591001
1006
10061078 2 128 15JAN2021 FOLLOW -UP PROTOCOL DEVIATION Non-study COVID -19 Vaccine
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Page 1
FDA-CBER-2021-5683-0224790
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1006
10061109 2 148 08FEB2021 FOLLOW -UP PROTOCOL DEVIATION Received non -study covid -19 vaccine
C4591001
1006
10061148 2 93 31DEC2020 FOLLOW -UP WIT HDRAWAL BY
SUBJECT withdrew consent to participate in a different
research study
C4591001
1006
10061161 2 91 15JAN2021 REPEAT
SCREENING 1 NO LONGER MEETS
ELIGIBILITY CRITERIA Participant is pregnant
C4591001
1006
10061174 2 113 22FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Inclusion 2
C4591001
1007
10071108 2 29 24SEP2020 VACCINATION PROTOCOL DEVIATION Missed visit 3
C4591001
1007
10071110 2 155 25JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071179 2 29 01OCT2020 VACCINATION PROTOCOL DEVIATION unable to contact subject
C4591001
1007
10071186 2 182 03MAR2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071212 2 117 02JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071218 2 120 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receip t of non -study COVID vaccine prior to study
end
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 2
FDA-CBER-2021-5683-0224791
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1007
10071225 2 134 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071243 2 120 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071250 2 174 08MAR2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071266 2 106 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071269 2 114 07JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071276 2 105 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071286 2 112 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071295 2 155 17FEB2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071339 2 100 10FEB2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071380 2 58 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 3
FDA-CBER-2021-5683-0224792
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1007
10071387 2 58 07JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1007
10071407 1 15 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion # 5; Subject has diagnosis of COVID -19
with positive PCR and symptoms
C4591001
1007
10071556 2 29 26JAN2021 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion #12; received COVID vaccine outside of
study
2 29 26JAN2021 FOLLOW -UP PROTOCOL DEVIATION Receipt of non -study COVID vaccine prior to study
end
C4591001
1008
10081480 2 115 04FEB2021 FOLLOW -UP LOST TO FOLLOW -UP site unable to make contact with subject despite
numerous attempts
C4591001
1008
10081698 2 69 25JAN2021 VACCINATION LOST TO FOLLOW -UP subject missed V3, no return calls/contact to date
despite numerous attempts per site
2 69 25JAN2021 FOLLOW -UP LOST TO FOLLOW -UP subject missed V3, no return calls/contact to date
despite numerous attempts per site
C4591001
1008
10081721 1 13 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject tested positive for COVID 19
C4591001
1009
10091133 2 111 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION Previously received COVID -19 vaccination on
1/5/2021
C4591001
1009
10091185 2 137 22FEB2021 FOLLOW -UP PROTOCOL DEVIATION Vaccinated outside research study with COVID -19
Vaccine
C4591001
1009
10091211 1 19 03NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive for COVID -19
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 4
FDA-CBER-2021-5683-0224793
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1009
10091235 2 107 25FEB2021 REPEAT
SCREENING 1 OTHER Visit 101 delayed due to recent vaccination
C4591001
1009
10091257 1 10 05NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA positive for COVID -19
C4591001
1009
10091286 2 13 04JAN2021 VACCINATION OTHER subject transitioned to open prior to visit 3
C4591001
1011
10111092 2 142 04FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew COnsent
C4591001
1012
10121078 2 66 19NOV2020 VACCINATION LOST TO FOLLOW -UP Call attempts: 10/20/2020, 10/28/2020 and
10/30/2020 No response to cert letter delivered
11/12/2020
2 66 19NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Call attempts: 10/20/2020, 10/28/2020 and
10/30/2020 No response to cert letter delivered
11/12/2020
C4591001
1012
10121096 2 65 24NOV2020 VACCINATION LOST TO FOLLOW -UP 19OCT2020, 27OCT2020 failed attempts to reach.
Cert letter sent 28OCT2020 returned to site.
2 65 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP 19OCT2020, 27OCT2020 failed attempts to reach.
Cert letter sent 28OCT2020 returned to site.
C4591001
1012
10121103 2 2 23SEP2020 VACCINATION MEDICATION ERROR
WITHOUT ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT/PRODUCT
ADMI NISTRATION ERROR
2 2 23SEP2020 FOLLOW -UP MEDICATION ERROR
WITHOUT ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT/PRODUCT
ADMINISTRATION ERROR
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0224794
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1012
10121119 2 154 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Multiple phone calls and certified letter sent; no
response from subject. Considered LTFU.
C4591001
1012
10121138 2 137 08FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrawn.
C4591001
1012
10121163 1 16 24SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE
DERMATITIS
1 39 17OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/INJECTION SITE
DERMATITIS
C4591001
1012
10121166 2 100 07JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Attempts to reach 23NOV2020, 24NOV20 20 and
25NOV2020. Certified letter sent 30Nov2020
C4591001
1013
10131017
30JUL2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM
STUDY.
C4591001
1013
10131046 2 70 27OCT2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up. certified letter sent and
emailed 10 -02-2020
2 70 27OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP.
C4591001
1013
10131048 2 28 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT New job
2 28 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT New Job
C4591001
1013
10131054 2 7 30AUG2020 VACCINATION LOST TO FOLLOW -UP Attempted contact
2 7 30AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempted
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0224795
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1013
10131116 2 191 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DISTANCE AND AVAILABILITY
C4591001
1013
10131131 2 36 07OCT2020 VACCINATION LOST TO FOLLOW -UP Certified letter sent
2 36 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent
C4591001
1013
10131138 1 23 02SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM THE
STUDY
1 23 02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT.
C4591001
1013
10131216 1 46 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew from study
1 46 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT DUE TO
FAMILY SITUATION.
C4591001
1013
10131332 2 56 09NOV2020 VACCINATION LOST TO FOLLOW -UP UNKOWN
2 56 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNKNOWN
C4591001
1013
10131395 2 45 04NOV2020 VACCINATION LOST TO FOLLOW -UP ATTEMPTED TO CONTACT.
2 45 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT SUBJECT AFTER
MULTIPLE ATTEMPTS.
C4591001
1013
10131426 1 1 03SEP2020 VACCINATION LOST TO FOLLOW -UP subject has not returned for next visit. is now
considered lost to follow up
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FDA-CBER-2021-5683-0224796
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1013
10131550 2 47 20NOV2020 VACCINATION LOST TO FOLLOW -UP CERTIFIED LETTER SENT.
2 47 20NOV2020 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT WITHOUT
RESPONSE.
C4591001
1013
10131552 2 39 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT SUBJECT. CERTIFIED
LETTER SENT WITHOUT RESPONSE.
2 131 12FEB2021 VACCINATION LOST TO FOLLOW -UP MULTIPLE ATTEMPTS TO CONTACT.
C4591001
1013
10131573 2 1 07OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT HAS ONLY COMPLETED VISIT 2. IS
NOW CONSIDERED A LOST TO FOLLOW UP.
2 45 20NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW. HAS NOT
RESPONSED TO CERTIFIED LETTER.
C4591001
1013
10131592 2 31 11NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent from study.
2 31 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED OUT OF STATE NO LONGER
WANTED TO PARTICIPATE.
C4591001
1013
10131605 2 1 15OCT2020 VACCINATION OTHER SUBJECT DID NOT COMPLETE V3POST VIS IT.
SUBJECT ENTERED V101VAX3.
C4591001
1013
10131670† 1 4 11OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA SUBJECT TESTED POSITIVE FOR COVID -19
C4591001
1013
10131683 2 129 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DID NOT WISH TO CONTINUE IN
STUDY.
C4591001
1013
10131701 2 29 01DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED THAT HE NO LONGER
WANTS TO BE A PART OF STUDY.
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FDA-CBER-2021-5683-0224797
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 29 01DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT FROM THE
STUDY.
C4591001
1013
10131740
15OCT2020 FOLLOW -UP OTHER randomized in error, needed to wait until course of
antibiotics was done.
C4591001
1013
10131746 1 22 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Currently taking corticosteroids
1 22 09NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW FROM THE STUDY.
C4591001
1013
10131756 2 84 03FEB2021 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longer wanted t o travel to the visits.
2 84 03FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to travel to visits.
C4591001
1013
10131791 2 120 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT NO LONGER WANTED TO
PARTICIPATE IN STUDY.
C4591001
1015
10151030 2 64 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after multiple contact
attempts and reciept of certified letter
2 64 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after multiple contact
attempts and reciept of certified letter
C4591001
1015
10151199 1 24 01OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject decided not to continue with study.
1 24 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent.
C4591001
1016
10161087 1 22 31AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE SWELLING
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FDA-CBER-2021-5683-0224798
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1016
10161126 1 39 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject declined further study vaccines,subject will
continue with rest of visits and procedures
1 194 23FEB2021 FOLLOW -UP OTHER non-compliance with study
C4591001
1016
10161280 2 112 21JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject received covid vaccine outside of the study
C4591001
1016
10161348 1 10 14NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject had positive pcr covid test
C4591001
1018
10181009 2 129 28DEC2020 FOLLOW -UP PROTOCOL DEVIATION reported received vaccine at work.
C4591001
1018
10181025 1 45 16SEP2020 VACCINATION LOST TO FOLLOW -UP Follow -up attempts made on 21 -Aug, 1 -Sep, and 4 -
Sep with no response.
1 45 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Follow -up att empts made on 21 -Aug, 1 -Sep, and 4 -
Sep. Certified letter sent 9 -Sep-2020.
C4591001
1018
10181027 2 156 26JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received non study covid vaccine
C4591001
1018
10181036 1 45 16SEP2020 VACCINATION LOST TO FOLLOW -UP Subject missed V2 and did not respond to 3 Follow -
up attempts.
1 45 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP no response to multiple follow up calls and contact
attempts
C4591001
1018
10181039 2 150 18JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received non study covid vaccine
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FDA-CBER-2021-5683-0224799
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1018
10181054 1 39 11SEP2020 VACCINATION LOST TO FOLLOW -UP patient returned to home country, did not respond to
outreach, certified letter sent
1 39 11SEP2020 FOLLOW -UP LOST TO FO LLOW -UP subject returned to home country, according to call to
emergency contact
C4591001
1018
10181058 2 114 16DEC2020 FOLLOW -UP PROTOCOL DEVIATION ,
received vaccine through her workplace.
C4591001
1018
10181105 2 115 18DEC2020 FOLLOW -UP PROTOCOL DEVIATION The subject had the vaccination at work prior to
being unblinded.
C4591001
1018
10181113 2 108 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Will get vaccine from work
C4591001
1018
10181127 2 96 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Will get vaccine from work.
C4591001
1018
10181141 2 106 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT scheduled to get vaccine at work.
C4591001
1018
10181142 1 33 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not arrive at scheduled second visit and
texted no longer wants to participate in study.
1 33 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not arrive at scheduled second visit and
texted no longer wants to participate in study.
C4591001
1018
10181151 2 174 23FEB2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT Subject does not want to continue in study.
2 174 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stated she does not want to continue in the
study.
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(b) (6)
FDA-CBER-2021-5683-0224800
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1018
10181164 2 111 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject will get vaccine at work.
C4591001
1018
10181170 2 97 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient wants to be vaccinated at her place of work
C4591001
1018
10181191 2 110 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Wanting to get out of study vaccination
C4591001
1018
10181204 2 102 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Received vaccine at work place.
C4591001
1018
10181214 2 98 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION she received Pfizer Covid 19 Vaccine at her
workplace on 18DEC2020
C4591001
1018
10181223 2 83 16DEC2020 FOLLOW -UP PROTOCOL DEVIATION informed us he received vaccine at his workplace
) on 16 -Dec-2020.
C4591001
1018
10181266 1 41 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT withdraw from study due to work schedule
1 41 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdraw from study due to work schedule
C4591001
1018
10181302 2 69 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Wanting to get out of study vaccination
C4591001
1018
10181306 2 95 14JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject re ceived vaccine prior to being unblinded
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(b) (6)
FDA-CBER-2021-5683-0224801
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1018
10181310 1 57 07DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject is unable to be on site for the following visits
due to personal reasons.
1 57 07DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is unable to be on site for the following visits
due to personal reasons.
C4591001
1018
10181311 1 57 07DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT unable to return to site for the following visits due to
personal reasons.
1 57 07DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is unable to return to site for the following
visits due to personal reasons.
C4591001
1018
10181313 1 57 07DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was no longer able to comply with study
1 57 07DEC2020 FOLLOW -UP WITHDRAWAL BY
SUB JECT Was no longer able to comply with study procedures.
C4591001
1018
10181319 2 44 16DEC2020 REPEAT
SCREENING 1 NO LONGER MEETS
ELIGIBILITY CRITERIA Subject received COVID vaccine from workplace
Saturday, 19- DEC -2020
2 49 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID vaccine from workplace
Saturday, 19 -DEC -2020
C4591001
1018
10181335 2 104 24FEB2021 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
2 104 24FEB2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1019
10191063 2 126 12JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject had Moderna vaccine elsewhere.
C4591001
1019
10191098 1 18 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Pt discontinued due to positive covid test. Will f/u
with pt
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FDA-CBER-2021-5683-0224802
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 175 15FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject
C4591001
1019
10191166 1 22 25SEP2020 VACCINATION WITHDRAW AL BY
SUBJECT Subject withdrew consent.
1 22 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent.
C4591001
1019
10191192 2 49 18NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 49 18NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1021
10211127 2 88 19DEC2020 FOLLOW -UP DEATH DEATH/CARDIAC FAILURE CONGESTIVE
C4591001
1021
10211223 2 82 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject requested to withdraw from study and be
unblinded.
C4591001
1024
10241026 2 129 15JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1024
10241036 2 127 14JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew their consent
C4591001
1027
10271105 1 15 11SEP2020 VACCINATION ADVERSE EVENT Subject has discontinued Study Drug. Subject has
agreed to continue with follow -up visits./DRUG
HYPERSENSITIVITY
C4591001
1028
10281003 2 109 21DEC2020 FOLLOW -UP PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1028
10281072 1 55 20OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter returned unclaimed 20oct2020
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 14
FDA-CBER-2021-5683-0224803
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 55 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter came back unclaime d on 20Oct2020
C4591001
1028
10281216 2 66 18DEC2020 VACCINATION LOST TO FOLLOW -UP multiple attempts made, certified letter signed for,
but no contact from patient. Lost to follow up
2 66 18DEC2020 FOLLOW -UP LOST TO FOLLOW -UP attempted multiple times to contact, certified letter
sent. Patient lost to follow up
C4591001
1028
10281 285 1 22 17NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive between visit 1 and visit 2
C4591001
1028
10281294 1 7 04NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA patient had positive covid test prior to V2
C4591001
1036
10361011 1 1 20AUG2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 1 20AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1036
10361032 2 48 03NOV2020 VACCINATION LOST TO FOLLOW -UP unreachable
2 48 03NOV2020 FOLLOW -UP LOST TO FOLLOW -UP unreachable
C4591001
1036
10361050
31AUG2020 FOLLOW -UP OTHER Subject randomized in error due to prohibitive drug.
C4591001
1036
10361061 2 155 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1036
10361062 2 136 03FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Subject didn't return for Convalescent visit &
multiple attempts to contact have been unsuccessful
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 15
FDA-CBER-2021-5683-0224804
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1036
10361073 2 151 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1036
10361096 2 43 16NOV2020 VACCINATION LOST TO FOLLOW -UP Subject is incarcerated.
2 43 16NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is incarcerated
C4591001
1036
10361100 2 143 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1036
10361118 2 113 22FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1036
10361127 1 61 15DEC2020 VACCINATION LOST TO FOLLOW -UP Subject didn't return for V2VX2L and didn't respond
to registered letter.
1 61 15DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Subject didn't return for V2VX2L and didn't respond
to registered letter.
C4591001
1036
10361128 1 61 15DEC2020 VACCINATION LOST TO FOLLOW -UP Subject didn't return for V2VX2L and didn't respond
to registered letter.
1 61 15DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Subject didn't return for V2VX2L and didn't respond
to registered level.
C4591001
1037
10371037 2 134 26JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT TO
PARTICIPATE
C4591001
1037
10371050 2 173 05MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT RECIEVED VAX IN COMMUNITY
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 16
FDA-CBER-2021-5683-0224805
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1037
10371077 1 66 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SPOKE WITH SUBJECT ON 30 OCT. DUE TO
SCHEDULE, HE CAN NO LONGER CONTINUE
WITH STUDY VISITS
1 66 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SPOKE WITH SUBJECT ON 30 OCT. DUE TO
SCHEDULE, HE CAN NO LONGER ATTEND
VISITS
C4591001
1037
10371078 1 44 08OC T2020 VACCINATION LOST TO FOLLOW -UP SITE ATTEMPTED CONTACT ON 22 SEP 30
SEP AND CERTIFIED LETTER SENT 8 OCT NO
RESPONSE
1 44 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 8 ONT. PT DID NOT
RESPOND
C4591001
1037
10371219 2 75 18DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PT GOT VACCINE IN COMMUNITY. DOES
NOT WISH TO CONTINUE IN TRIAL.
C4591001
1037
10371330 2 120 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJ ECT SUBJ WITHDREW CONSENT TO
PARTICIPATE. PT DOES NOT WANT VACCINE
C4591001
1039
10391021 1 24 17SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for COVID -19.
1 120 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient was able to receive vaccine outside of study
and withdrew to get vaccine
C4591001
1039
10391080 1 21 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient withdrew consent. Patient will not be
participating in follow -ups.
1 21 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew from study and follow up.
C4591001
1039
10391093 2 137 08FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Contacted multiple times via phone and email, and
was sent certified letter, all with no resp onse
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 17
FDA-CBER-2021-5683-0224806
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1039
10391124 2 97 05JAN2021 FOLLOW -UP PROTOCOL DEVIATION Patient received COVID vaccine outside of study
C4591001
1039
10391186 2 62 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient had to leave before vaccination and decided
to discontinue.
C4591001
1039
10391196 2 69 12JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew and reports she will be receiving
the vaccine outside of the study.
C4591001
1039
10391244 1 13 23NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for COVID -19.
C4591001
1042
10421008 2 110 08DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Personal Decision
C4591001
1042
10421028 2 161 02FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received vaccination outside of study
C4591001
1042
10421069 1 22 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 22 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1042
10421092 2 27 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject called the office in withdrew consent -they
will not be returning to the site for future visi
2 27 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from study participation
C4591001
1042
10421093 2 94 04DEC2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to
make contact.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 18
FDA-CBER-2021-5683-0224807
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 94 04DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up after unsuccessful attempts to
make contact.
C4591001
1042
10421106 2 120 30DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1042
10421112 2 111 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent
C4591001
1042
10421129 2 41 19OCT2020 VACCINATION OTHER subject was LTFU but re -joined the trial for open
label phase
C4591001
1042
10421250 1 58 13NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 58 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1042
10421251 1 58 13NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 58 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1042
10421262 2 52 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION Received Vaccine outside of study
C4591001
1044
10441151 2 67 21DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT discontinued
C4591001
1044
10441287 1 19 29DEC2020 VACCINATION OTHER subject proceeded to open label prior to Vax2 in the
blinded treatment phase.
C4591001
1046
10461040 1 15 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject chose to discontinue due to personal reasons.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 19
FDA-CBER-2021-5683-0224808
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 15 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1046
10461049 2 31 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Withdrew
2 31 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decision
C4591001
1046
10461099 1 64 27OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Decision
1 64 27OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1046
10461140 1 22 19SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject Decision
1 22 19SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Decision
C4591001
1046
10461290 2 119 25FEB2021 VACCINATION WITHDRAWAL BY
SUBJECT Subject Moved out of State
2 119 25FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew due to moving.
C4591001
1047
10471112 2 1 06OCT2020 VACCINATION OTHER Waiting for certified letter return to change staus to
lost to follow up
C4591001
1047
10471126 2 103 05JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent
C4591001
1047
10471166 2 134 10FEB2021 VACCINATION LOST TO FOLLOW -UP lost to follow up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 20
FDA-CBER-2021-5683-0224809
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 134 10FEB2021 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1047
10471221 1 44 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
1 44 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
C4591001
1047
10471234 2 127 11FEB2021 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up
2 127 11FEB2021 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1047
10471314 1 36 16NOV2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up
1 36 16NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1048
10481027 2 154 16FEB2021 FOLLOW -UP PROTOCOL DEVIATION protocol deviation non study covid 19 vaccine
C4591001
1048
10481070 2 144 11FEB2021 FOLLOW -UP PROTOCOL DEVIATION pt was vaccinated outside of the study.
C4591001
1048
10481085 2 87 20DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject re ceived non study vaccination under EUA
C4591001
1048
10481088 2 49 12NOV2020 VACCINATION OTHER out of state at time of visit 3
C4591001
1052
10521022 2 63 11NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 63 11NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 21
FDA-CBER-2021-5683-0224810
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1052
10521054 1 25 21SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521057 1 25 21SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent
1 25 21SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal by subject
C4591001
1052
10521058 1 25 21SEP2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
1 25 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1052
10521064 1 25 24SEP2020 VACCINATION LOST TO FOLLOW -UP n/a
1 25 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
C4591001
1052
10521080 1 28 29SEP2020 VACCINATION LOST TO FOLLOW -UP lost of follow up
1 28 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP lost of follow up
C4591001
1052
10521121 2 93 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED covid -19 VACCINE OUT
OF STUDY PROTOCOL
C4591001
1052
10521139 1 34 22OCT2020 VACCINATION LOST TO FOLLOW -UP lost to follow -up
1 34 22OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 22
FDA-CBER-2021-5683-0224811
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1052
10521155 2 136 24FEB2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT withdrawal by subject
2 136 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal by subject
C4591001
1054
10541007 2 130 15JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT unblinding of subject occurred due to future non -
study covid -19 vaccination
C45910 01
1054
10541022 1 64 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 64 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541023 1 64 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 64 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541033 1 21 11SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Per sponsor, participant met EXC #5, and should not
receive VAX2 but may remain in study.
C4591001
1054
10541055 1 59 23OCT2020 VACCINATION LOST TO FOLLOW -UP Pt deemed LTFU by site.
1 59 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Pt deemed LTFU by site.
C4591001
1054
10541064 1 78 12NOV2020 VACCINATION LOST TO FOLLOW -UP > 3 attempts at contacting pt via telephone; certified
letter sent
1 78 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP > 3 attempts at contacting pt via telephone; c ertified
letter sent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 23
FDA-CBER-2021-5683-0224812
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1054
10541076 2 152 19FEB2021 VACCINATION LOST TO FOLLOW -UP More than 3 phone contacts attempted & certified
letter was sent.
2 152 19FEB2021 FOLLOW -UP LOST TO FOLLOW -UP More than 3 phone contacts attempted & certified
letter was sent.
C4591001
1054
10541088 2 123 22JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT unblinding of subject occurred due to future non -
study covid -19 vaccination
C4591001
1054
10541110 2 96 29DEC2020 FOLLOW -UP PROTOCOL DEVIATION EXC 12 met: previous vaccination with any
coronavirus vaccine.
2 96 29DEC2020 REPEAT
SCREENING 1 NO LONGE R MEETS
ELIGIBILITY CRITERIA Pt. received non -study vaccination on 18Dec20.
C4591001
1054
10541138 1 23 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject doesn't want to continue in study.
1 23 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject doesn't want to continue in study.
C4591001
1054
10541150 1 22 05OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT No longer interested in study, and walked out of
clinic w/o talking to Investigator.
1 22 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt is no longer interested in study. Walked out of
clinic w/o seeing the Investigator.
C4591001
1054
10541154 2 90 13JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Unblinding of subject occurred due to future non -
study COVID -19 vaccination.
C4591001
1054
10541161 2 101 15JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received non -study covid -19 vaccination on
24Dec20.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 24
FDA-CBER-2021-5683-0224813
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1054
10541165 2 47 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subj. did not show up for V3, despite sending
certified letter and contacting pt via phone 3 times.
2 47 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subj. did not show up for V3, despite sending
certified letter and contacting pt via phone 3 times.
C4591 001
1054
10541190 2 90 01FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent.
C4591001
1054
10541201 2 112 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent on 11Mar21 over the phone.
C4591001
1055
10551152 2 107 05JAN2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION Subject received the second dose of vaccine (vax 4)
outside of the study.
2 107 05JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew from study to received COVID
vaccine outside of study
C4591001
1055
10551176 2 87 18DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from study prior to Subject
receiving Covid -19 vaccine outside of study
C4591001
1056
105610 27 1 35 25SEP2020 VACCINATION LOST TO FOLLOW -UP Subject couldn't be reached. Caregiver states he left
the house and nobody knows where he is.
1 35 25SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject couldn't be reached. Caregiver states he left
the house and nobody knows where he is.
C4591001
1056
10561129 1 24 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the
study
1 24 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states he doesn't want to continue in the
study
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 25
FDA-CBER-2021-5683-0224814
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561152 1 27 29SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE HIS PARTICIPATION IN THE
STUDY.
1 27 29SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT STATED HE DOES NOT WANT TO
CONTINUE HIS PARTICIPATION IN THE
STUDY.
C4591001
1056
10561245 2 93 08JAN2021 VACCINATION LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
2 93 08JAN2021 FOLLOW -UP LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
C4591001
1056
10561253 2 32 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT MOVED OUT OF STATE AND HE IS
UNABLE TO CONTINUE PARTICIPATING IN
THE STUDY .
2 32 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT MOVED OUT OF STATE AND HE IS
UNABLE TO CONTINUE PARTICIPATING IN
THE STUDY.
C4591001
1056
10561293 1 50 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 50 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561361 1 72 09DEC2020 VACCINATION LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
1 72 09DEC2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 26
FDA-CBER-2021-5683-0224815
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561372 1 38 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
1 38 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up after several unsuccessful
attempts to contact.
C4591001
1056
10561392 2 73 13JAN2021 VACCINATION LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
2 73 13JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
C4591001
1056
10561395 1 25 29OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT MOVED TO ANOTHER TOWN
1 25 29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject moved out of town.
C4591001
1056
10561411 2 75 08JAN2021 VACCINATION LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
2 75 08JAN2021 FOLLOW -UP LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
C4591001
1056
10561414 1 65 09DEC2020 VACCINATION LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
1 65 09DEC2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
C4591001
1056
10561445 2 136 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT the subject contacted us by phone to inform us about
her desire to withdraws her consen t.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 27
FDA-CBER-2021-5683-0224816
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561452 1 63 09DEC2020 VACCINATION LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
1 63 09DEC2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER MANY ATTEMPTS TO CONTACT THIS
SUBJECT AND A CERTIFIED LETTER SENT, PI
DECIDED TO D/C PT.
C4591001
1056
10561477 2 95 04FEB2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED A VACCINE OUTSIDE
THE STUDY.
C4591001
1056
10561511 2 103 12FEB2021 FOL LOW -UP WITHDRAWAL BY
SUBJECT Subject informed us he no longer wanted to continue
in the study.
C4591001
1056
10561516 1 87 08JAN2021 VACCINATION LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
1 87 08JAN2021 FOLLOW -UP LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
C459100 1
1056
10561550 1 84 11JAN2021 VACCINATION LOST TO FOLLOW -UP UNABLE TO CONTACT PT./EMERGENCY
CONTACT, CERTIFIED LETTER SENT. PI
DECIDED TO D/C PT AS A LTFU.
1 84 11JAN2021 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT PT./EMERGENCY
CONTACT, CERTIFIED LETTER SENT. PI
DECIDED TO D/C PT AS A LTFU.
C4591001
1056
10561554 1 86 13JAN2021 VACCINATION LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
1 86 13JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 28
FDA-CBER-2021-5683-0224817
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1056
10561569 1 85 13JAN2021 VACCINATION LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
1 85 13JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject was discontinued from study after several
unsuccessful TC and a Certified Letter.
C4591001
1056
10561570 2 75 22JAN2021 VACCINATION LOST TO FOLLOW -UP AFTER SEVERAL UNSUCCESSFUL ATTEMPTS
TO CONTACT PT VIA T.C. AND CERTIFIED
LETTER, PI DECIDED TO D/C.
2 75 22JAN2021 FOLLOW -UP LOST TO FOLLOW -UP AFTER SEVERAL UNSUCCESS FUL ATTEMPTS
TO CONTACT PT VIA T.C. AND CERTIFIED
LETTER, PI DECIDED TO D/C.
C4591001
1056
10561591 1 73 06JAN2021 VACCINATION LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
1 73 06JAN2021 FOLLOW -UP LOST TO FOLLOW -UP After multiple unsuccessful TCs to Pt. and
emergency contact, and a Certified letter, Pt. was
D/C.
C4591001
1056
10561592 2 81 18FEB2021 VACCINATION LOST TO FOLLOW -UP After many attempts to contact subject, Inves tigator
decided to discontinue Pt. as a LTFU
2 81 18FEB2021 FOLLOW -UP LOST TO FOLLOW -UP After many attempts to contact subject, Investigator
decided to discontinue Pt. as a LTFU
C4591001
1056
10561601 2 57 11JAN2021 VACCINATION LOST TO FOLLOW -UP UNABLE TO CONTACT PT./EMERGENCY
CONTACT, CERTIFIED LETTER SENT. PI
DECIDED TO D/C PT AS A LTFU.
2 57 11JAN2021 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT PT./EMERGENCY
CONTACT, CERTIFIED LETTER SENT. PI
DECIDED TO D/C PT AS A LTFU .
C4591001
1056
10561609 2 74 28JAN2021 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS DISCONTINUED AS A LTFU
AFTER MULTIPLE ATTEMPTS TO CONTACT
HIM.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 29
FDA-CBER-2021-5683-0224818
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 74 28JAN2021 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS DISCONTINUED AS A LTFU
AFTER MULTIPLE ATTEMPTS TO CONTACT
HIM.
C4591001
1056
10561634 2 76 01FEB2021 VACCINATION LOST TO FOLLOW -UP AFTER MANY UNSUCCESSFUL ATTEMPTS TO
CONTACT PT. INCLUDING CERTIFIED
LETTER PI DECIDED TO D/C SUBJECT
2 76 01FEB2021 FOLLOW -UP LOST TO FOLLOW -UP AFTER MANY UNSUCCESSFUL ATTEMPTS TO
CONTACT PT. INCLUDING CERTIFIED
LETTER PI DECIDED TO D/C SUBJECT
C4591001
1056
10561636 1 14 11NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive for COVID -19 during the
COVID- 19 illness visit (Onsite swab).
C4591001
1057
10571031
18AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA met delay criteria, reported by subject after su bject
was randomized, discontinued prior to vaccine
C4591001
1057
10571050 2 133 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED VACCINE OUTSIDE OF
THE STUDY.
C4591001
1057
10571177 2 113 25JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1057
10571198 2 98 13JAN2021 FOLLOW -UP OTHER patient moved out of state and received Pfizer
vaccine out in the community
C4591001
1057
10571201 2 98 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED VACCINE OUTSIDE OF
THE STUDY.
C4591001
1057
10571202 2 145 01MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVING OUT OF STATE
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 30
FDA-CBER-2021-5683-0224819
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1057
10571211
18SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject was randomized but failed to meet entry
criteria, no vaccine was given
C4591001
1057
10571212
18SEP2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA subject was randomized and then failed to meet
criteria, no vaccine was administered
C4591001
1057
10571215
18SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT refused further study procedures
C4591001
1057
10571216 2 30 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
2 30 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED TO SAN FRANCISCO
C4591001
1057
10571227 2 120 08FEB2021 REPEAT
SCREENING 1 OTHER PATIENT REFUSED VACCINE AS HE STATED
HE CHANGED HIS MIND AT TIME OF VISIT
C4591001
1057
10571230 2 56 23DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT PERSONAL REASONS
2 56 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PERSONAL REASONS
C4591001
1057
10571248 1 36 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject refused to return for Visit 2, withdrew
consent, No adverse events reported
1 36 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent from further study
participation
C4591001
1057
10571268
06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT w/d consent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 31
FDA-CBER-2021-5683-0224820
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1057
10571279 2 120 22FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT NO LONGER INTERESTED IN PARTICIPATING
BEIN G UNBLINDED OR ANY OTHER
VACCINES
C4591001
1057
10571319 2 47 28DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent due to transportation issues
2 47 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent due to transportation issues
C4591001
1066
10661121 2 147 11FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received moderna vaccine
C4591001
1066
10661198 1 107 22DEC2020 VACCINATION LOST TO FOLLOW -UP unable to reach patient after several attempts and
certified letter
1 107 22DEC2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subject after several attempts and
certified letter
C4591001
1066
10661332 1 56 08DEC2020 VACCINATION LOST TO FOLLOW -UP unable to reach subject after several phone attempts
and certified letter
1 56 08DEC2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subject after several phone attempts
and certified letter
C4591001
1066
10661335
14OCT2020 FOLL OW-UP WITHDRAWAL BY
SUBJECT subject withdrew consent to participate
C4591001
1066
10661396 1 22 22DEC2020 VACCINATION OTHER unblinded to assess eligibility for vaccination
C4591001
1071
10711021 2 171 17FEB2021 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW UP
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 32
FDA-CBER-2021-5683-0224821
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1071
10711034 2 193 12MAR2021 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW UP
C4591001
1071
10711095 1 61 24OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP
1 61 24OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LOST TO FOLLOW UP
C4591001
1071
10711162
11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1071
10711164 2 129 11FEB2021 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW UP
C4591001
1071
10711175 2 114 28JAN2021 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT LOST TO FOLLOW UP
C4591001
1071
10711185 1 60 16NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED FOR VISIT 2
1 60 16NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT LOST TO FOLLOW UP
C4591001
1071
10711211 1 32 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT TO 2ND
INJECTION BUT WILL RETURN FOR FOLLOW
UP VST
1 43 16NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1071
10711224 2 106 17FEB2021 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW UP
C4591001
1071
10711230 2 48 21DEC2020 VACCINATION LOST TO FOLLOW -UP SUBJECT LOST TO FOLLOW UP
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 33
FDA-CBER-2021-5683-0224822
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 48 21DEC2020 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT PER SITE SOP,
RETURNED AS UNDELIVERABLE
C4591001
1071
10711234 2 91 09FEB2021 VACCINATION PROTOCOL DEVIATION SUBJECT RECEIVED OTHER COVID
VACCINATION
2 118 08MAR2021 FOLLOW -UP PROTOCOL DEV IATION SUBJECT RECEVIED OTHER COVID VACC
C4591001
1071
10711235 1 50 08DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT REFUSED SECOND INJECTION AND
FURTHER STUDY PROCEDURES
1 50 08DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DECLINED SECOND INJECTION
AND FURTHER STUDY PROCEDURES
C4591001
1071
10711237 1 40 01DEC2020 VACCINATION LOST TO FOLLOW -UP SUBJECT LOST TO FOLLOW UP
1 40 01DEC2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT LOST TO FOLLOW UP
C4591001
1072
10721051 1 12 06SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA diagnosis COVID -19 exclusion 5
C4591001
1072
10721099 2 148 23FEB2021 REPEAT
SCREENING 1 OTHER Subject delayed on vaccination due to medication
C4591001
1073
10731022 2 163 03FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Not willing to continue
C4591001
1073
10731038 1 37 10SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was Discontinue
1 37 10SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Discontinue
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 34
FDA-CBER-2021-5683-0224823
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1073
10731067 2 157 05FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Withdrew Consent
C4591001
1073
10731120 2 94 18DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject in medical field was offer ed vaccine before
site was able to over IP. Withdrew consent.
C4591001
1077
10771077 2 119 06JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT BECAME AN EMPLOYEE AT
AND WILL NO LONGER CONTINUE IN
THE STUDY.
C4591001
1077
10771243 2 127 11MAR2021 VACCINATION LOST TO FOLLOW -UP Subject was contacted multiple times to reschedule
appt 3 with no response.
2 127 11MAR2021 FOLL OW-UP LOST TO FOLLOW -UP SUBJECT CONTACTE ATTEMPTED MULTIPLE
TIMES TO RESCHEDULE APPOINTMENT 3
WITH NO ANSWER.
C4591001
1079
10791004 1 23 20AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ADENOCARCINOMA
GASTRIC
1 30 27AUG2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/ADENOCARCINOMA
GASTRIC
C4591001
1079
10791040 2 45 07OCT2020 VACCINATION LOST TO FOLLOW -UP Subject has not returned calls, emails or letters
2 45 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is lost to follow up
C4591001
1079
10791109 2 75 16NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 75 16NOV2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up
C4591001
1079
10791130 1 1 17AUG2020 VACCINATION MEDICATION ERROR
WITHOUT ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT/WRONG PRODUCT
ADMINISTERED
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 35
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0224824
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1079
10791153 2 175 04MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawn
C4591001
1079
10791253 1 67 13NOV2020 VACCINATION LOST TO FOLLOW -UP patient unresponsive
1 67 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP patient unresponsive
C4591001
1080
10801019 2 155 01FEB2021 FOLLOW -UP PROTOCOL DEVIATION Patient received vaccine outside of the study.
C4591001
1080
10801055 2 105 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Patient was vaccinated for COVID by her employer
prior to being unblinded
C4591001
1080
10801205 2 139 24FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Patient is a LTFU. He moved to another state and
will not contact the site back to transfer.
C4591001
1081
10811006 2 142 19JAN2021 FOLLOW -UP LOST TO FOLLOW -UP no-showed for V101, never returned calls/emails.
unk if rec'd outside covid vax
C4591001
1081
10811071 1 48 05OCT2020 VACCINATION LOST TO FOLLOW -UP lack of follow -up, does not return calls & had
multiple no show appointments
1 48 05OCT2020 FOLLOW -UP LOST TO FOLLOW -UP unable to reach subj, multiple no -show appts. This
was the last scheduled visit that was a no -show.
C4591001
1081
10811087 2 123 15JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT received vax at job & refused to continue. then
retracted that he rec'd vax.
C4591001
1081
10811094 2 96 18DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent, via an email, since she
was offered vax @ work. She would not return calls
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 36
FDA-CBER-2021-5683-0224825
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1081
10811105
26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1081
10811114 2 94 18DEC2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Participant met exclusion criterion #16
C4591001
1081
10811186 2 81 18DEC2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Participant met exclusion criterion #16
C4591001
1081
10811194 2 37 04NOV2020 FOLLOW -UP DEATH DEATH/MYOCARDIAL INFARCTION
C4591001
1082
10821013
03AUG2020 FOLLOW -UP PROTOCOL DEVIATION Subject was randomized but left site prior to
receiving vaccination.
C4591001
1082
10821077 1 22 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT scheduling conflicts. live out of state.
1 22 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew co nsent
C4591001
1082
10821078 1 22 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT scheduling conflicts. live out of state.
1 22 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1082
10821145 2 30 23OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent due to occupation
2 30 23OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent due to occupation
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 37
FDA-CBER-2021-5683-0224826
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1082
10821149 2 63 24NOV2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/MALIGNANT MELANOMA
C4591001
1082
10821221 1 21 19NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1082
10821224 2 102 01MAR2021 VACCINATION LOST TO FOLLOW -UP subject did not respond to site contact attempts.
certified letter returned, unclaimed.
2 102 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP subject did not respond to site contact attempts.
certified letter returned, unclaimed.
C4591001
1083
10831029 1 20 23AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/ATRIAL FIBRILLATION
C4591001
1083
10831060 1 9 14AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIVERTICULAR
PERFORATION
C4591001
1083
10831068 2 141 18JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Certifie d letter sent and recieved no subject has not
contacted site
C4591001
1083
10831141 1 34 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longers wants to participate in the study
subject was offered safety F/U Sub Declined
1 162 29JAN2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1083
10831154 2 129 20JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject WOC not wanting to wait for his qualifying
Tier per CDC/ Sponsor Guidelines
C4591001
1083
10831162 2 164 26FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received outside COVID -19 Vaccine
21DEC2020
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 38
FDA-CBER-2021-5683-0224827
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1083
10831187 2 28 22OCT2020 VACCINAT ION WITHDRAWAL BY
SUBJECT SUBJECT MOVE OUT OF STATE
2 28 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT 22OCT2020 subject was contacted for V3
Appointment reminder 23OCT2020 and verbally
withdrew consent
C4591001
1083
10831219 2 37 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted to reschedule Visit 3 and he
withdrew consent
2 37 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT 05NOV2020 After mulitple attempts to contact subj
to reschedule V3 subj returned call and WC
C4591001
1083
10831242 2 98 05JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received non -study coronavirus vaccination
C4591001
1083
10831252 2 85 05JAN2021 FOLLOW -UP PROTOCOL DEVIATION Recieved outside of the study covid -19 vaccine
C4591001
1083
10831284 2 111 02MAR2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION Subjec t did not disclose she had already received
outside vaccine until after 30min post assessement
C4591001
1084
10841009 2 112 07DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent, no response from subject
C4591001
1084
10841017 2 117 18DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject withdrew due to receiving vaccine at work
C4591001
1084
10841023 2 149 21JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject state d that she no longer wishes to participate
in the study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 39
FDA-CBER-2021-5683-0224828
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1084
10841035 1 22 24AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT subject does not want to do study anymore; now
engaged and wants to start a family
1 22 24AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent because subject wants to start a
family
C4591001
1084
10841057 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP subject never answered phone calls; certified letter
sent
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject never answered phone calls; certified letter
sent
C4591001
1084
10841061 2 124 29DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna vaccination at work.
C4591001
1084
10841062 2 130 07JAN2021 FOLLOW -UP LOST TO FOLLOW -UP subject has not returned or followed up with site or
CRC for visits
C4591001
1084
10841119 2 38 07OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter sent
2 38 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU; certified letter sent
C4591001
1084
10841137 2 108 18DEC2020 FOLLOW -UP PROTOCOL DEVIATION Received vaccine at work on 18Dec2020
C4591001
1084
10841156 2 130 11JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna COVID -19 vaccine
C4591001
1084
10841187 2 65 12NOV2020 VACCINATION LOST TO FOLLOW -UP not able to reach subject, certifi ed letter went out.
2 65 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP not able to reach subject, certified letter went out.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 40
FDA-CBER-2021-5683-0224829
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1084
10841241 2 122 08JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna COVID -19 vaccine on
24Dec2020
C4591001
1084
10841272 1 32 22SEP2020 VACCINATION LOST TO FOLLOW -UP LTFU
1 32 22SEP2020 FOLLOW -UP LOST TO FOLLOW -UP LTFU
C4591001
1084
10841290 2 105 27DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received MODERNA COVID -19 VACCINE
C4591001
1084
10841333 2 27 28OCT2020 VACCINATION OTHER subject was initially thought to be LTFU on this date,
but rejoined for open label
C4591001
1084
10841358 2 86 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine outside of study
C4591001
1084
10841432 2 40 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subject has not returned calls from CRC, certified
letter was sent.
2 40 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject has not returned calls from CRC, certified
letter was sent.
C4591001
1084
10841439 2 92 11JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject received vaccine outside of study
C4591001
1084
10841450 2 43 25NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT subject has not returned calls to CRC, certified letter
will be sent today.
2 43 25NOV2020 FOLLOW -UP OTHER subject is a front line worker at a hospital and was no
longer able to make it for her visits.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 41
FDA-CBER-2021-5683-0224830
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1084
10841456 2 84 07JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna Covid -19 vaccination at
work.
C4591001
1084
10841480 2 67 07JAN 2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject prefers to have vaccine through employer
subject dropped
C4591001
1084
10841512 2 119 09MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject will not be available for follow -up
appointments.
C4591001
1085
10851064 2 152 01FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1085
10851069 2 110 21DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
C4591001
1085
10851081 2 87 30NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject no longer interested in the study.
2 87 30NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Site received call call from patient stating she was no
longer intere sted in the study.
C4591001
1085
10851129 2 168 24FEB2021 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/EXPOSURE DURING
PREGNANCY
C4591001
1085
10851137 2 104 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew Consent
C4591001
1085
10851237 2 108 09JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 42
FDA-CBER-2021-5683-0224831
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1085
10851244 2 97 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Received vaccine elsewhere
C4591001
1085
10851286 1 24 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion #5
1 174 01MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject was vaccinated outside of the study.
C4591001
1085
10851287 2 116 25JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent
C4591001
1085
10851332 1 37 20OCT2020 VACCINATION LOST TO FOLLOW -UP Contacted multiple times. Sent certified letter on
16Nov2020. Letter was returned to site last week.
1 37 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Patient unreachable. Certified letter mailed.
C4591001
1087
10871066 2 184 02MAR2021 FOLLOW -UP PROTOCOL DEVIATION COVID -19 Vaccine Received outside C4591001
study
C4591001
1087
10871085 2 13 20SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Pt moved to ano ther State for job. Closest Site 1+ hr
away from pt's new location. Withdrew consent.
2 13 20SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt moved to another State for job. Closest Site 1+ hr
away from pt's new location. Withdrew consent.
C4591001
1087
10871089 1 19 04SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria #5
C4591001
1087
10871146 2 124 11JAN2021 FOLLOW -UP OTHER Subject moving to Florida and closest Site < 2 hrs
away. Subject opted to withdraw from study.
C4591001
1087
10871209 1 7 31AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject has met exclusion #5
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 43
FDA-CBER-2021-5683-0224832
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 38 01OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study because felt
no longer necessary due to positive COVID dx.
C4591001
1087
10871279 2 156 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is unwilling to return for vaccine if in the
placebo group.
C4591001
1087
10871336 1 61 02NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up
1 61 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1087
10871354 1 10 17SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/MYALGIA
1 10 17SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/MYALGIA
C4591001
1087
10871356 1 54 31OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up.
1 54 31OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1087
10871363 2 56 23NOV2020 VACCINATION LOST TO FOLLOW -UP lost to follow up
2 56 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1087
10871525 2 131 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject unwilling to return for vaccination.
C4591001
1087
10871557 1 23 05NOV2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1087
10871562 1 100 21JAN2021 VACCINATION LOST TO FOLLOW -UP Lost to follow up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 44
FDA-CBER-2021-5683-0224833
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 100 21JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up.
C4591001
1089
10891050 2 197 10MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1089
10891054 2 60 23OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient withdrew consent
C4591001
1089
10891076 1 22 27AUG2020 VACCINATION LOST TO FOLLOW -UP 8/25-# out of service, sent email 8/27 -no response,
sent certified letter
1 22 27AUG2020 FOLLOW -UP LOST TO FOLLOW -UP number invaild and sent certified letter. no response
C4591001
1089
10891158 1 44 02OCT2020 VACCINATION OTHER site was notified that subject has been incarcerated
and will not be able to complete study visit
1 44 02OCT2020 FOLLOW -UP OTHER site was notified that subject has been incarcerated
and will not be able to complete study visit
C4591001
1089
1089117 9 2 157 18FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject moved, withdrew consent
C4591001
1089
10891182 1 91 23NOV2020 VACCINATION LOST TO FOLLOW -UP patient is lost to follow -up, no response on calls or
certified letter
1 91 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP subject is lost to follow up, 3 calls and certified letter
sent
C4591001
1089
10891186 2 42 29OCT2020 VACCINATION LOST TO FOLLOW -UP 3 calls-no response, certified letter sent
C4591001
1089
10891207 2 162 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts, certified letter sent and
returned.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 45
FDA-CBER-2021-5683-0224834
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1089
10891213 2 47 06NOV2020 VACCINATION LOST TO FOLLOW -UP 3 calls -no response, certified letter sent
2 47 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Patient has been contacted via phone 3x and certified
letter was sent with o response.
C4591001
1089
10891227 2 155 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts have ben made, certified letter
sent and returned to site.
C4591001
1089
10891231 2 39 29OCT2020 VACCINATION LOST TO FOLLOW -UP 3 calls -no response, certified letter sent
2 39 29OCT2020 FOLLOW -UP LOST TO FOLLO W-UP patient withdrew consent
C4591001
1089
10891289 2 79 19DEC2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/ACUTE HEPATIC FAILURE
C4591001
1089
10891294 2 151 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts and certified letter sent,
certified letter came back as not deliverable
C4591001
1089
10891334 2 141 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts have ben made, certified letter
sent and returned to site.
C4591001
1089
10891346
22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent prior to receiving vaccine
C4591001
1089
10891350 2 124 15FEB2021 VACCINATION LOST TO FOLLOW -UP lm 3x certified letter sent
2 124 15FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 attempts and certified letter sent LTFU
C4591001
1089
10891351
25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent, and left office prior to
vaccination
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 46
FDA-CBER-2021-5683-0224835
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1090
10901047 2 45 07OCT2020 VACCINATION LOST TO FOLLOW -UP Pt was not reachable the last 2 weeks. HE is in prison
per his sister. Pt will be discontinued.
2 45 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP pt in prison
C4591001
1090
10901052 2 158 28JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT planned to receive a non -study covid -19 vaccine
outside of study
C4591001
1090
10901067 2 122 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT unblinded per subject request
C4591001
1090
10901068 1 29 02SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT pt is not willing to come to any m visits
1 29 02SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject no longer interested in study
C4591001
1090
10901073 2 198 09MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient not willing to come in for mo 6 or any other
study visits.
C4591001
1090
10901328 2 63 25NOV2020 VACCINATION LOST TO FOLLOW -UP pt did not come for V3 and was unresponsive to calls
and certified letter
2 63 25NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Pt did not come for V3 and not responsive to calls or
certified letter
C4591001
1090
10901379 1 54 02NOV2020 VACCINATION LOST TO FOLLOW -UP pt never contacted us to reschedule V2
1 54 02NOV2020 FOLLOW -UP LOST TO FOLLOW -UP unable to contact
C4591001
1090
10901463 2 63 17DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject requested to be unblinded before eligibl e
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 47
FDA-CBER-2021-5683-0224836
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1090
10901507 1 20 04NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/URTICARIA
C4591001
1090
10901517 2 49 29DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject requested to be unblinded before eligibility
C4591001
1090
10901539 2 34 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject wanted to be unblinded
C4591001
1090
10901551 2 31 17DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject requested to be unblinded
C4591001
1091
10911039 1 50 22SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrew consent to future visits
1 50 22SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrew consent to further visits
C4591001
1091
10911077 1 22 27AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Patient agrees to stay in the trial for follow up but
denied second vaccination.
C4591001
1091
10911083 1 23 28AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Did not want to come to sche duled visits
1 23 28AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject no longer wanted to come to study
appointments
C4591001
1091
10911091 2 113 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject was vaccinated outside of study
C4591001
1091
10911122 2 169 16FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received moderna vaccine
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 48
FDA-CBER-2021-5683-0224837
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1091
10911215 2 142 10FEB2021 FOLLOW -UP PROTOCOL DEVIATION Study subject received Moderna Vaccine
C4591001
1091
10911333 2 29 09NOV2020 VACCINATION PROTOCOL DEVIATION Subject was no show for appointment. Site reached
out several times and no response.
C4591001
1091
10911352 1 23 28OCT2020 VACCINATION WITHDRA WAL BY
SUBJECT Subject was a NCNS for his V2 today. Stated over
the phone he would like to withdraw consent
1 23 28OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject was a NCNS for his V2. Stated over the
phone he would like to withdraw consent
C4591001
1092
10921055 2 138 29JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject is lost to follow -up
C4591001
1092
10921080 1 22 16SEP2020 VACCINATION OTHER Incarcerate d 09Sep2020
1 22 16SEP2020 FOLLOW -UP OTHER Incarcerated
C4591001
1092
10921082 2 35 20OCT2020 VACCINATION LOST TO FOLLOW -UP unable to make contact with subject
2 35 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is Lost to follow up
C4591001
1092
10921128
01SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt withdrew consent due to anxiety of having blood
drawn
C4591001
1092
10921188 2 154 08MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Subject canceled V101, site ma de 4 attempts to
reschedule and sent letter via mail
C4591001
1092
10921249 1 1 20OCT2020 VACCINATION LOST TO FOLLOW -UP Subject No Show for V2 and is Lost to Follow Up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 49
FDA-CBER-2021-5683-0224838
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 1 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject No Show for V2, subject Lost to Follow Up
C4591001
1093
10931055
31AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA UNABLE TO OBTAIN BLOOD FROM SUBJECT.
C4591001
1093
10931058 1 25 18SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
1 77 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was lost to follow up./EXPOSURE
DURING PREGNANCY
C4591001
1093
10931065 1 81 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
1 81 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
C4591001
1093
10931072 1 81 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
1 81 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AND WAS UNABLE TO BE CONTACTED
MULTIPLE TIMES.
C4591001
1093
10931094 1 76 14NOV2020 VACCINATION LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AFTER MULTIPLE ATTEMPTS TO CONTACT
THEM.
1 76 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT WAS SENT A CERTIFIED LETTER
AFTER MULTIPLE ATTEMPTS TO CONTACT
THEM.
C4591001
1093
10931100 2 79 10DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT STATED THEY WERE NOW TOO
BUSY WITH WORK TO TRAVEL TO
APPOINTMENTS.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 50
FDA-CBER-2021-5683-0224839
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 79 10DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT STATED THEY WERE NOW TOO
BUSY WITH WORK TO TRAVEL TO
APPOINTMENTS.
C4591001
1093
10931129 2 68 11DEC2020 VACCINATION PROTOCOL DEVIATION Visit 3 was missed.
C4591001
1093
10931216 2 33 22DEC2020 VACCINATION PROTOCOL DEVIATION SUBJECT RECEIVED AN OUTSIDE STUDY
COVID VACCINATION.
2 33 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED AN OUTSIDE STUDY
COVID VACCINATION.
C4591001
1094
10941167 2 124 22FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received the non study covid 19 vaccine
before being discontinued or withdrawing from study
C4591001
1094
10941169 2 120 23FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received the non study covid 19 vaccine
before being discontinued or withdrawing from study
C4591001
1095
10951031 2 114 15DEC2020 FOLLOW -UP PROTOCOL DEVIATION Participant received Pfizer COVID -19 vaccine
through employer
C4591001
1095
10951056 1 35 08SEP2020 VACCINATION OTHER not able to meet study requirements due to work
schedule
1 35 08SEP2020 FOLLOW -UP OTHER Participant not able to continue in study at this time.
Participant did not withdraw consent
C4591001
1095
10951141 1 22 16SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIABETIC FOOT
1 22 16SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/DIABETIC FOOT
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 51
FDA-CBER-2021-5683-0224840
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1095
10951144 2 23 22DEC2020 VACCINATION OTHER participant proceeded to crossover prior to Vt. 3,
group 1A
C4591001
1095
10951177 2 101 01JAN2021 VACCINATION LOST TO FOLLOW -UP Certified letter sent
2 101 01JA N2021 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent
C4591001
1095
10951270 2 1 28OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter sent
2 1 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent
C4591001
1095
10951271 2 1 28OCT2020 VACCINATION LOST TO FOLLOW -UP certified letter sent
2 1 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent
C4591001
1096
10961012 2 139 26JAN2021 FOLLOW -UP PROTOCOL DEVIATION Received monoclonal antibody/placebo treatment
through clinical trial
C4591001
1096
10961026 2 110 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION Covid -19 Vaccination outside of study
C4591001
1096
10961031 1 22 04SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1096
10961036 2 175 02MAR2021 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA inclusion/exclusion criteria not met/DEPRESSION
SUICIDAL
C4591001
1096
10961076 2 125 12JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject will receive Covid -19 Vaccination outside of
the study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 52
FDA-CBER-2021-5683-0224841
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1096
10961081 1 54 12OCT2020 VACCINATION LOST TO FOLLOW -UP LTFU, unresponsive to contact attempts
1 54 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP site unable to contact subject after multiple attempts
and certified letter sent
C4591001
1096
10961109 2 103 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION Covid -19 Vaccination Outside of study
C4591001
1096
10961141 1 22 16SEP2020 VACCINA TION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria #5
C4591001
1096
10961216 2 92 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION Covid -19 Vaccination outside of the study
C4591001
1096
10961256 2 145 16FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received COVID vaccine outside of trial
C4591001
1096
10961276 1 21 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT due to moving out of town unexpectedly
1 21 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT due to moving out of town unexpectedly
C4591001
1096
10961318 2 82 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION Covid -19 Vaccination outside of study
C4591001
1096
10961321 1 22 03OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject met exclusi on #1 on visit 2 (suicidal ideation)
so no vaccine was administered
C4591001
1096
10961344 1 80 04DEC2020 VACCINATION LOST TO FOLLOW -UP multiple calls made to subject and certified letter
sent.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 53
FDA-CBER-2021-5683-0224842
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 80 04DEC2020 FOLLOW -UP LOST TO FOLLOW -UP subject was lost to follow up
C4591001
1096
10961388 1 21 29OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject was diagnosed with COVID between
vaccination one and vaccination two
C4591001
1098
10981001 1 31 17SEP2020 VACCINATION LOST TO FOLLOW -UP Lost to followup
1 31 17SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter was sent. Site is unable t o contact the
subject. Thanks.
C4591001
1098
10981029 1 22 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject wanted to be discontinued from the study for
unknown reasons.
1 22 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject inform, it is due to wellbeing
C4591001
1098
10981106 2 163 05MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Discontinued due to loss to follow up.
C4591001
1098
10981200 1 46 05NOV2020 VACCINATION LOST TO FOLLOW -UP Subject called multiple times and certified letter was
sent. No response from subject
1 46 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject called multiple times and certified letter was
sent. No response from subject.
C4591001
1098
10981219 1 43 05NO V2020 VACCINATION WITHDRAWAL BY
SUBJECT withdraw by subject due to no longer wanting to take
part in the study.
1 43 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdraw by subject due to no longer wanting to take
part in the study.
C4591001
1098
10981224 2 82 04JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject got Pfizer vaccine at work.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 54
FDA-CBER-2021-5683-0224843
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1098
10981243 2 139 08MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Disconti nued
C4591001
1098
10981244 2 84 12JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Subject has been discontinued due to lost of
followup.
C4591001
1098
10981266 2 35 16DEC2020 VACCINATION LOST TO FOLLOW -UP 3 attempts to get hold of the pt. Sent the certified
letter but subject didnot answer.
2 35 16DEC2020 FOLLOW -UP LOST TO FOLLOW -UP 3 attempts to get hold of the pt. Sent the certified
letter but subject didnot answer.
C4591001
1101
11011024 1 21 29SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA the subject was diagnoses with COVID between
vaccination one and vaccination tw o
C4591001
1107
11071013 2 162 01FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna vaccine
C4591001
1107
11071065 2 84 18NOV2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1107
11071074 2 74 12NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT ON
12NOV2020
C4591001
1109
11091030 2 37 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED TO WITHDRAW FROM
TRIAL DUE TO TRANSPORTATION ISSUES AS
WELL AS BEING TO BUSY.
2 37 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT CALLED TO WITHDRAW FROM
TRIAL DUE TO TRANSPORTATION ISSUES AS
WELL AS BEING TO BUSY.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 55
FDA-CBER-2021-5683-0224844
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1109
11091041 2 133 29DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject was unblinded by own request not eligible
for unb linding by EUA
C4591001
1109
11091059 1 40 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS
OR RESPOND TO CERTIFIED LETTER.
1 40 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RETURNED PHONE CALLS
OR RESPOND TO CERTIFIED LETTER.
C4591001
1109
11091066 2 176 10FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate
C4591001
1109
11091068 1 40 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RETURNED NUMEROUS
CALLS OR CERTIFIED LETTER SENT TO HIM.
1 40 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO CALLS OR
CERTIFIED LETTER.
C4591001
1109
11091126 2 120 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdraw by subject
C4591001
1109
11091127 1 37 08SEP2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO
HER
1 37 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVE RESPONDED TO CALLS OR
CERTIFIED LETTER SENT TO HER.
C4591001
1109
11091148 2 33 26SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT CALLED AND WITHDREW
CONSENT
2 33 26SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT CALLED AND WITHDREW
CONSENT
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 56
FDA-CBER-2021-5683-0224845
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1109
11091197 2 129 07JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1109
11091234 1 25 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT WORK HAD GOTTEN TOO BUSY WITH
OPENING BACK UP AND SHE WAS UNABLE
TO CONTINUE HER PARTICIPATION.
1 25 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT WORK HAD GOTTEN TOO BUSY WITH
OPENING BACK UP AND SHE WAS UNABLE
TO CONTINUE HER PARTICIPATION.
C4591001
1109
11091275 2 125 11JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject withdrew due to getting vaccine at another
location.
C4591001
1109
11091335 1 43 07OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO
HER
1 43 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT TO
HER
C4591001
1109
11091349
28AUG2020 FOLLOW -UP PROTOCOL DEVIATION Subject randomized in error.
C4591001
1109
11091352 2 117 13JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate in study.
C4591001
1109
11091419 2 40 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject did not respond to multiple phone calls or
certified letter.
2 40 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to multiple phone calls or
certified letter.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 57
FDA-CBER-2021-5683-0224846
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1109
11091478 1 29 07OCT2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
1 29 07OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT NEVER RESPONDED TO MULTIPLE
CALLS AND CERTIFIED LETTER SENT
C4591001
1109
11091496 2 88 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT No longer wanted to participate
C4591001
1109
11091515 1 30 14OCT2020 VACCINATION LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
1 30 14OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never returned for visit, responded to call or
certified letter sent.
C4591001
1109
11091547 1 63 01DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 63 01DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wanted to participate in study
C4591001
1109
11091556 1 9 12OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1110
11101010 2 63 22OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not comply with inclusion criteria #2.
2 63 22OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not comply with inclusion criteria #2.
C4591001
1110
11101038 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP Subject was contact over the phone 3 times and a
certified letter was sent. Subject never reply.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow is status, subject has been withdrawn
from trial.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 58
FDA-CBER-2021-5683-0224847
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101039 1 35 08SEP2020 VACCINATION LOST TO FOLLOW -UP subject failed to contact site after many calls and
certified letter.
1 35 08SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to many phones calls from
site and did not respond to certified letter fromi
C4591001
1110
11101069 1 59 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject was called more the 3 times,was texted 2
times,email/certified letter were sent
1 59 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP we did more than 3 attempts via phone, 1 text
message, 4 emails and a certified letter.
C4591001
1110
11101075 2 97 09DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject states is in his best interest to participate in
other studies
C4591001
1110
11101085 1 58 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject was tried to contact by phone, text, email
and certified letter several times.
1 58 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP we did 4 phone call attempts, 1 text message, 1 email
and a certified letter.
C4591001
1110
11101102 2 182 08MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject is moving to London in two weeks
C4591001
1110
11101110 1 22 08SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 22 08SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1110
11101117 2 92 09DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject states is in his best interest not continue in
the study
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 59
FDA-CBER-2021-5683-0224848
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101141 2 56 12NOV2020 VACCINATION LOST TO FOLLOW -UP 4 attempts via phone call, 1 text message, 1 email
and 1 certified letter.
2 56 12NOV2020 FOLLOW -UP LOST TO FOLLOW -UP 4 attempts via phone call, 1 text message, 1 email
and 1 certified letter.
C4591001
1110
11101154 1 21 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted over the phone because she
missed visit 2 and subject withdraw consent.
1 21 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent verbally over the phone.
C4591001
1110
11101155 1 21 17SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject was contacted over the phone because she
missed visit 2 and subject withdraw consent.
1 21 17SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject verbally withdrew consent.
C4591001
1110
11101156 1 96 01DEC2020 VACCINATION LOST TO FOLLOW -UP Subject was attempt to contact by 2 text messages, 1
certified letter, 1 email and 8 phone call.
1 96 01DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Subje ct was attempt to contact by 2 text messages, 1
certified letter, 1 email and 8 phone call.
C4591001
1110
11101177 2 156 24FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna vaccine outside of study
trial.
C4591001
1110
11101229 1 21 30SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject meets exclusion criterion #5
C4591001
1110
11101244 2 122 03FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject do not want to continue in the study
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 60
FDA-CBER-2021-5683-0224849
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1110
11101247 1 22 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject WICF because he is unable to continue with
the visit due to work.
1 22 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject WICF because he is unable to continue with
the visit due to work.
C4591001
1110
11101250 1 22 06OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject did not provide a reason to be discontinued
from the study.
1 22 06OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not provide a reason to be discontinued
from the study.
C4591001
1110
11101326 2 83 12JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject wants to be discontinued from the study
because she can not comply with the study schedule
C4591001
1110
11101333 1 35 05NOV2020 VACCINATION LOST TO FOLLOW -UP we attempt 3 phone calls, 1 text message and 1
certified letter.
1 35 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP we attempt 3 phone calls, 1 text message and 1
certified letter.
C4591001
1110
11101342 1 31 05NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject sent and email, he state he will like to
withdraw from the study due to a private reason.
1 31 05NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject sent and email, he state he will like to
withdraw from the study due to a private reason.
C4591001
1110
11101380 2 38 29JAN2021 VACCINATION WITHDRAWAL BY
PARENT/GUARDIAN Parent discontinue subject because he states subject
is too busy with school.
2 38 29JAN2021 FOLLOW -UP WITHDRAWAL BY
PARENT/GUARDIAN Parent discontinued subject because he states subject
is too busy with school.
C4591001
1111
11111051 2 119 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine at work. As a
result, the subject is discontinued in the study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 61
FDA-CBER-2021-5683-0224850
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1112
11121054 2 43 07OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT sujbect withdrew consent due to work schedule
2 43 07OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew due to busy work schedule
C4591001
1112
11121058 1 22 25AUG2020 VACCINATION OTHER now employed by
1 22 25AUG2020 FOLLOW -UP OTHER now employed by
C4591001
1112
11121062 2 132 03JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject rec'd vaccine at her job
C4591001
1112
11121083 2 118 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccination offered to
her by employer.
C4591001
1112
11121135 2 111 28DEC2020 FOLLO W-UP PROTOCOL DEVIATION Subject rec'd Pfizer Covid vaccine at work on
12/23/2020
C4591001
1112
11121190 2 174 08MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject moved out of state, unable to make follow up
visits
C4591001
1112
11121192 1 34 30SEP2020 VACCINATION LOST TO FOLLOW -UP unable to reach subject for missed appts
1 34 30SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject for Vs 2
C4591001
1112
11121229
04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject left clinic after randomization and prior to
vaccination
C4591001
1112
11121243 2 97 06JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject rec'd vaccine outside of the trial
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 62
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2021-5683-0224851
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C45910 01
1112
11121259 2 112 15FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject in for Vacc 3, unwilling to wait required 30
mins post vaccine, withdrew consent
C4591001
1112
11121270† 1 1 08OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA unstable viral load and Hepatitis B
C4591001
1112
11121313 2 93 11FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT not interested in getting active vaccine or
participation in the study
C4591001
1114
11141015 2 184 05MAR20 21 FOLLOW -UP PROTOCOL DEVIATION Subject received vaccine outside study and Requests
Withdrawal
C4591001
1114
11141029 2 45 29OCT2020 VACCINATION LOST TO FOLLOW -UP Subject no show to apt and no response from
certified letter.
2 45 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject no show to apt and no response from
certified letter.
C4591001
1114
11141037 1 54 09OCT2020 VACCINATION LOST TO FOLLOW -UP no show to visit 2,two times.subject no responsive to
calls and voicemails and subjects emerg.contac
1 54 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP no show to visit 2,two times.subject no responsive to
calls and voicemails and subjects emerg.contac
C4591001
1114
11141054 2 104 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine outside the
protocol.
C4591001
1116
11161008 2 134 28JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject received emergency use vaccine outside of
study and does not want to be followed for safety
C4591001
1116
11161012 2 134 28JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject went to outside source for vaccine.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 63
FDA-CBER-2021-5683-0224852
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1116
11161015
26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent. Left site prior to IP
administration.
C4591001
1116
11161143 1 68 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 29SEP 30SEP 2OCT 13OCT
6NOV 9NOV
1 68 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 29SEP 30SEP 2OCT 13OCT
6NOV 9NOV
C4591001
1116
11161172 1 67 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT
23OCT 9NOV
1 67 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 2OCT 5OCT 7OCT 9OCT 13OCT
23OCT 9NOV
C4591001
1116
11161217 2 153 03MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject would like to get pregnant, does not want the
vaccine or to continue in the study
C4591001
1116
11161292 1 52 14NOV2020 VACCINATION LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV
4NOV 9NOV 10NOV
1 52 14NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Contact attempts 16OCT 22OCT 23OCT 3NOV
4NOV 9NOV 10NOV
C4591001
1116
11161322 2 55 07DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW FROM STUDY
2 55 07DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1116
11161323 2 136 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Attempts to Contact: 26Feb, 4Feb, 3Feb, 22Jan,
15Dec
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 64
FDA-CBER-2021-5683-0224853
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1116
11161326 2 122 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Attempted contacts: 26Feb, 3Feb, 25Jan , 22Jan,
19Jan, 7Jan, 28Dec, 21Dec
C4591001
1117
11171014 2 115 31DEC2020 VACCINATION LOST TO FOLLOW -UP UNABLE TO CONTACT/SCHEDULE
PARTICIPANT
2 115 31DEC2020 FOLLOW -UP LOST TO FOLLOW -UP UNABLE TO CONTACT AND SCHEDULE
C4591001
1117
11171015 2 183 10MAR2021 VACCINATION PROTOCOL DEVIATION OUT OF COUNTRY, EOT FOLLOW UP DONE
AT V4 -MONTH 6 VISIT
C4591001
1117
11171036 2 141 28JAN2021 REPEAT
SCREENING 1 NO LONGER MEETS
ELIGIBILITY CRITERIA INC 3, EXC 1
C4591001
1117
11171138 2 31 17DEC2020 VACCINATION PROTOCOL DEVIATION COULD NOT GET PARTICIPANT SCHEDULED
FOR V3
C4591001
1117
11171186 1 21 26OCT2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/SUICIDE ATTEMPT
1 119 01FEB2021 REPEAT
SCREENING 1 NO LONGER MEETS
ELIGIBILITY CRITERIA INC3 / EXC1/SUICIDE ATTEMPT
C4591001
1117
11171190 1 6 13OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject met exclusion 5 at the t ime of Visit 2
C4591001
1118
11181060 2 124 12JAN2021 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent to subject, returned back to site
unclaimed. unable to reach subject.
C4591001
1118
11181062 2 147 04FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Subject did not respond to numerous contact
attempts made by site staff
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 65
FDA-CBER-2021-5683-0224854
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1118
11181 064 2 133 21JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew from study
C4591001
1120
11201013 1 20 18AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states he no longer wants to be in study
1 20 18AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states he no longer wants to be in study
C4591001
1120
11201038
29OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdraw consent
C4591001
1120
11201058 2 197 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdraw from study
C4591001
1120
11201083 2 71 04NOV2020 VACCINATION LOST TO FOLLOW -UP certified letter sent and moved to lost to follow up
2 71 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up
C4591001
1120
11201085 1 79 23OCT2020 VACCINATION LOST TO FOLLOW -UP subject would not come in office for visit
1 79 23OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never showed to appointment.
C4591001
1120
11201096 2 164 04FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject was vaccinated outside of study with
Moderna
C4591001
1120
11201104 1 50 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject states no longer wishes to be in study about
to have weight lost surgery
1 50 24SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wished to be in study subject is
about to have weight lost surgery
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 66
FDA-CBER-2021-5683-0224855
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1120
11201119 2 197 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer able to make appointments
C4591001
1120
11201142 2 154 04FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdraw
C4591001
1120
11201240 2 163 20FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subje ct is moving out of town
C4591001
1120
11201252
09SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject was randomized, but had to leave for work.
Subject never return for next appointment
C4591001
1120
11201266 2 113 19JAN2021 FOLLOW -UP DEATH DEATH/LUNG CANCER METASTATIC
C4591001
1120
11201346 2 81 29JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject moving out of state
C4591001
1121
11211004 2 125 15JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT due to being a medical worker can no longer wait to
receive trial vaccine
C4591001
1121
11211009 2 40 22OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subje ct withdrew due to busy schedule.
2 40 22OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent due to busy schedule.
Does not want to be FU
C4591001
1121
11211010 2 180 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject asked to be withdrawn then hung up.
Attempted to reach her again, she answered then
hung up.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 67
FDA-CBER-2021-5683-0224856
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1121
11211018 2 163 23FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew to receive vaccine elsewhere
C4591001
1121
11211025 1 22 16SEP2020 VACCINATION OTHER Participants significant other notified the site,
participant is in jail for the foreseeable future
1 22 16SEP2020 FOLLOW -UP OTHER Subject incarcerated. Subject to be dropped from the
study.
C4591001
1121
11211057 2 170 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject received 2 moderna doses. See non study
vaccine page.
C4591001
1121
11211059 2 92 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent to receive vaccine at work.
C4591001
1121
11211061 2 109 08JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Have attempted to contact subject numerous times
via telephone and certified letter. No response.
C4591001
1121
11211067 2 100 30DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent to receive vaccine at work.
C4591001
1121
11211087 2 164 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject received Moderna vaccine. 1st dose on non
study vaccine page. 2nd dose not performed yet
C4591001
1121
11211096 2 101 08JAN2021 VACCINATION LOST TO FOLLOW -UP Have attempted to contact subject numerous times
via telephone and certified letter. No response.
2 101 08JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Have attempted to contact subject numerous times
via telephone and certified letter. No response.
C4591001
1121
11211108 2 165 11MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT After trying to schedule subject for 2 weeks, he
contacted site and asked to "opt out"
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 68
FDA-CBER-2021-5683-0224857
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1122
11221003 2 84 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject received COVID -19 vaccine outside of the
study
C4591001
1122
11221006
03SEP2020 FOLLOW -UP PROTOCOL DEVIATION Subject randomized in error
C4591001
1122
11221026
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/PRESYNCOPE
11SEP2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/VOMITING
C4591001
1122
11221038 2 70 24DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine outside of the
study.
C4591001
1123
11231027
04AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent after randomization prior
to vaccination.
C4591001
1123
1123103 1 2 197 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP no response to certified letter
C4591001
1123
11231051 2 43 08OCT2020 VACCINATION OTHER moved to hawaii
2 43 08OCT2020 FOLLOW -UP OTHER Moved to Hawaii
C4591001
1123
11231069 2 190 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent. Left voicemail with the patient.
C4591001
1123
11231091 2 146 25JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1123
11231104 2 175 24FEB2021 FOLLOW -UP PROTOCOL DEVIATION Pt. received covid -19 vaccine
C4591001
1123
11231137 2 1 14SEP2020 VACCINATION LOST TO FOLLOW -UP subject was lost to follow up after visit 2.
2 1 14SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject was LTF following V2
C4591001
1123
11231144 1 42 30SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criteria #5.
C4591001
1123
11231145 2 143 04FEB2021 FOLLOW -UP PROTOCOL DEVIATION pt received non -study vaccine
C4591001
1123
11231154 1 73 04NOV2020 VACCINATION LOST TO FOLLOW -UP no response from subject after certified letter
1 73 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP no response from subject after certified letter
C4591001
1123
11231168 1 72 04NOV2020 VACCINATION LOST TO FOLLOW -UP Pt is LTF
1 72 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Pt is LTF
C4591001
1123
11231249 2 122 05FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received nonstudy covid -19 vaccine
C4591001
1123
11231290 1 29 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subejct withdrew consent.
1 29 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 70
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1123
11231301
24SEP2020 FOLLOW -UP PROTOCOL DEVIATION subject randomized in error
C4591001
1123
11231313 1 13 06OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exc. criterion 5 COVID -19 positive
C4591001
1123
11231386 1 22 09NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA exclusion no. 5 positive covid test
C4591001
1124
11241001 2 171 17FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject in Israel and not sure when will return to
United States
C4591001
1124
11241025 2 161 09FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject received Moderna vaccine through her work
C4591001
1124
11241038 2 106 16DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew to receive Covid -19 at workplace
C4591001
1124
11241049 1 26 11SEP2020 VACCINATION LOST TO FOLLOW -UP Subject not responding to any phone calls, certified
letter sent
1 26 11SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject not responding to any phone calls, certified
letter sent
C4591001
1124
11241052 2 128 14JAN2021 FOLLOW -UP PROTOCOL DEVIATION received additional vaccination outside of study
C4591001
1124
11241072 2 168 24FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Subject missed appointment on 2/17/21. Several
attempts were made to contact subject with no
success
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 71
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1124
11241084 1 10 02SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Previous clinical or Microbiological COVID 19
Diagnosis
1 18 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject not interested in participating any longer
C4591001
1124
11241103 2 97 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received Pfizer vaccine outside of study
C4591001
1124
11241120 2 121 15JAN2021 FOLLOW -UP PROTOCOL DEVIATION received Moderna vaccine outside of study
C4591001
1124
11241141 2 64 24NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up after multiple calls and certified
letter sent
2 64 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1124
11241167 2 136 04FEB2021 FOLLOW -UP PROTOCOL DEVIATION Received Moderna vaccine outside of trial
C4591001
1124
11241199 2 91 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1124
11241228 2 145 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Subject has not returned any phone calls; a certified
letter has been sent
C4591001
1125
11251019 1 48 29SEP2020 VACCINATION LOST TO FOLLOW -UP lost to follow
1 48 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP post to follow
C4591001
1125
11251022 2 57 28OCT2020 VACCINATION LOST TO FOLLOW -UP patient is a lost to follow
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 57 28OCT2020 FOLLOW -UP LOST TO FOLLOW -UP patient was a lost to follow
C4591001
1125
11251043 2 176 24FEB2021 FOLLOW -UP PROTOCOL DEVIATION Patient received vaccine elsewhere for COVID
C4591001
1125
11251059 2 76 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subject missed appt and diary entries. Multiple
contact attempts with subject were not returned.
2 76 24NOV2020 FOLL OW-UP LOST TO FOLLOW -UP Patient deemed lost to follow
C4591001
1125
11251142 2 154 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT moved from the area no longer able to make visits
C4591001
1125
11251159 1 1 03SEP2020 VACCINATION LOST TO FOLLOW -UP attempted to contact patient and sent certified letter
wih no response back
1 1 03SEP2020 FOLLOW -UP LOST TO FOLLOW -UP patient is a lost to follow
C4591001
1125
11251160 1 33 05OCT2020 VACCINATION LOST TO FOLLOW -UP Patient is a lost to follow
1 33 05OCT2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow
C4591001
1125
11251162 2 58 24NOV2020 VACCINATION LOST TO FOLLOW -UP unable to reach patient after multiple attempts and
certified letter
2 58 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to schedule visit 3 and certified
letter sent on 05/NOV/2020 with no resoponse bac
C4591001
1125
11251238 1 12 02NOV20 20 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Patient tested positive for Covid -19, EXC #5
C4591001
1125
11251243 1 2 09DEC2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADACHE
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 73
FDA-CBER-2021-5683-0224862
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 2 09DEC2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/INJECTION SITE PAIN
C4591001
1126
11261017 2 150 28JAN2021 OPEN LABEL
TREATMENT ADVERSE EVENT ADVERSE EVENT/ALLERGY TO VACCINE
C4591001
1126
11261045 2 104 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED PFIZER COVID19
VACCINE OUTSIDE OF STUDY ON 17DEC2020
C4591001
1126
11261074
25AUG2020 FOLLOW -UP PROTOCOL DEVIATION During enrollment, after consent signed, inc/exc
criteria reviewed, serology/nasal swab completed
C4591001
1126
1126 1080 2 112 05JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject got vaccinated with COVID -19 vaccine
outside of the study.
C4591001
1126
11261135 2 91 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION SUBJECGT VACCINATED OUTSIDE OF STUDY
PROTOCOL DESPITE APPT FOR V101. Pfizer
BioNTech 23DEC2020
C4591001
1126
11261151 2 121 28JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Pfizer BioNTech Covid 19 Vaccine
outside of study 27JAN2021
C4591001
1127
11271022 1 62 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP after multiple TC attempts and certified letter and
returned 11/10/2020 subject is lost to follow up
C4591001
1127
11271078 2 137 11JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to followup
C4591001
1127
11271099 1 22 09SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject tested positive and symptoms for COVID
C4591001
1127
11271112 2 86 04DEC2020 FOLLOW -UP DEATH DEATH/CARDIO -RESPIRATORY ARREST
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 74
FDA-CBER-2021-5683-0224863
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1128
11281026 2 153 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION DROPPED -SUBJECT RECEIVED COVID -19
VACCINE OUTSIDE OF STUDY
C4591001
1128
11281055 2 65 29OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempt ed several times, certified
letter sent, no response
2 65 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP after several attempts and certified letter, subject has
not responded
C4591001
1128
11281083 2 113 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED COVID -19 VACCINE
OUTSIDE OF STUDY
C4591001
1128
11281086 2 43 13OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject wishes to discontinue from study
2 43 13OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject wished to discontinue study
C4591001
1128
11281112 2 129 08JAN2021 FOLLOW -UP PROTOCOL DEVIATION DROPPED -SUBJECT RECEIVED COVID -19
VACCINE OUTSIDE OF STUDY
C4591001
1128
11281146 1 64 21OCT2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up
1 64 21OCT2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO CONTACT,
CERTIFITED LETTER SENT 16SEP2020
C4591001
1128
11281159 2 49 29OCT2020 VACCINATION LOST TO FOLLOW -UP after several attempts and certified letter sent, subject
is lost to follow up
2 49 29OCT2020 FOLLOW -UP LOST TO FOLLOW -UP after several attempts and certified letter sent, subject
is lost to follow up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 75
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1128
11281164 2 61 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT, GOT A NEW
JOB AND CAN'T RETURN FOR VISITS
2 61 10NOV2020 FOLLOW -UP WITH DRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT, GOT A NEW
JOB AND CAN'T RETURN FOR VISITS
C4591001
1128
11281177 2 113 19JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED COVID -19 VACCINE
OUTSIDE OF STUDY
C4591001
1128
11281227 2 105 31DEC2020 FOLLOW -UP PROTOCOL DEVIATION DROPPED -SUBJECT RECEIVED COVID -19
VACCINE OUTSIDE OF STUDY
C4591001
1128
11281265 2 114 15JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED COVID -19 VACCINE
OUTSIDE OF STUDY
C4591001
1128
11281279 2 48 09NOV2020 VACCINATION LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO REACH
SUBJECT, CERTIFIED LETTER WAS SENT
WITH NO RESPONSE
2 48 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP AFTER SEVERAL ATTEMPTS TO REACH
SUBJECT, CERTIFIED LETTER WAS SENT
WITH NO RESPONSE
C4591001
1128
11281292 2 160 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP subject is lost to follow up
C4591001
1128
11281368 1 46 31OCT2020 VACCINATION LOST TO FOLLOW -UP SUBJECT DID NOT RETURN TO CLINIC FOR
V2. CERTIFIED LETTER SENT
1 46 31OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT DID NOT RETURN TO CLINIC FOR
V2. CERTIFIED LETTER SENT
C4591001
1129
11291048
04AUG2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA screen fail
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
04AUG2020 FOLLOW -UP PROTOCOL DEVIATION violation exclusion criteria 2.f.
immunocompromised. randomized but not dosed
C4591001
1129
11291064 2 118 23DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject rece ived Covid -19 vaccine outside of trial
C4591001
1129
11291072 2 111 19DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject received Covid -19 vaccine outside of trial
C4591001
1129
11291088 2 52 22OCT2020 VACCINATION OTHER no longer LTFU
C4591001
1129
11291089 2 52 22OCT2020 VACCINATION OTHER no longer LTFU
C4591001
1129
11291249 1 124 24FEB2021 VACCINATION WITHDRAWAL BY
SUBJECT Participant has relocated to another state and is not
willing to return for follow up
1 124 24FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal of consent, subject moved with no
intention of transferring to other site.
C4591001
1129
11291260 2 44 27JAN2021 OPEN LABEL
TREATMENT ADVERSE EVENT ADVERSE EVENT/ANAPHYLACTOID
REACTION
C4591001
1131
11311024 1 39 24SEP2020 VACCINATION LOST TO FOLLOW -UP subject received vax1 (17AUG2020) but no showed
for vax2. Now LTFU
1 39 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Multiple attempts made after no -show for V2,no
response.Certified letter sent. Signed 24SEP2020
C4591001
1131
11311193 1 32 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject did not returned office calls for follow up
1 32 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject did not returned office calls for follow up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1133
11331016 2 179 18FEB2021 FOLLOW -UP WITHDRAWAL B Y
SUBJECT Subject withdrew consent
C4591001
1133
11331023 2 36 25SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
2 36 25SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331037 1 27 26AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 27 26AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331042 1 21 20AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 21 20AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331047 2 8 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not want to continue in the study
2 8 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331052 1 10 12AUG2020 VACCINATION LOST TO FOLLOW -UP Certified Letter sent out Subject Lost to Follow up
1 10 12AUG2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter was sent
C4591001
1133
11331069 2 75 10NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 88 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331087 1 7 14AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent.
1 7 14AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331105 2 185 04MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331120 2 62 30NOV2020 VACCINATION LOST TO FOLLOW -UP Certiffied letter was sent.
2 62 30NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject never answered the phone. Certified letter
was sent
C4591001
1133
11331122 1 20 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject was called because he was not
complying with the diary. Subject withdrew consent
1 20 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331129 2 151 01FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT NO LONGER INTERESTED IN
PARTICIPATING IN STUDY
C4591001
1133
11331130 2 158 08FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject states he received the vaccine already but did
not provide any information
C4591001
1133
11331135 2 166 16FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent after unblinding.
Requested time to think about it. Made decision on
16/FEB
C4591001
1133
11331138 1 24 04SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated she is not happy with the study
number of visits, number of vaccines, payments.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 24 04SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stated she is not happy with the study
number of visits, number of vaccines, payments.
C4591001
1133
11331158 2 176 26FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331162
14AUG2020 SCREENING OTHER DELAY CRITERIA MET
05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331170 1 67 19OCT2020 VACCINATION LOST TO FOLLOW -UP Subject did not aswer to any attempts. A certified
letter was sent.
1 67 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent
C4591001
1133
11331177 2 68 10NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject
2 81 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C4591001
1133
11331188 2 162 17FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent. Refused vaccination
C4591001
1133
11331207 1 43 30SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 43 30SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331209 2 171 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 19/FEB/21
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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FDA-CBER-2021-5683-0224869
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1133
11331256 2 111 04JAN2021 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Inclusion #2 - Not compliant with diary
C4591001
1133
11331278 2 162 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 19/FEB/2021
C4591001
1133
11331291 1 47 12OCT2020 VACCINATION LOST TO FOLLOW -UP Certified letter sent on 12/OCT/2020
1 47 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent on 12/OCT/2020
C4591001
1133
11331294 2 51 07NOV2020 VACCINATION LOST TO FOLLOW -UP Site sent certified letter on 03Nov2020. Received by
subject on 07Nov2020
2 51 07NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 3Nov2020. Subject
received on 7/NOV/20
C4591001
1133
11331295 1 44 09OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
1 44 09OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331338 1 50 17OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
1 50 17OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331340 2 155 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 19/FEB/2021
C4591001
1133
11331341 1 45 12OCT2020 VACCINATION LOST TO FOLLOW -UP Subject is LTF. Certified letter sent 12/OCT/20
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 45 12OCT2020 FOLLOW -UP LOST TO FOLLOW -UP SUBJECT IS LTF. CERTIFIED LETTER SENT
12/OCT/20
C4591001
1133
11331348 2 51 10NOV2020 VACCINATION LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
2 51 10NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Site sent certified letter on 10Nov2020
C45910 01
1133
11331354 2 62 23NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331357 2 148 17FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331378 2 157 26FEB2021 FOLLOW -UP OTHER Subject was dropped due to non -compliance with
study visits.
C4591001
1133
11331388 2 169 12MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent 26/FEB/2021
C4591001
1133
11331414 2 157 05MAR2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1133
11331418 2 150 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent 19/FEB/21
C4591001
1133
11331438 2 114 21JAN2021 FOLLOW -UP PROTOCOL DEVIATION SUBJECT RECEIVED COVID -19 VACCINE AT
WORK
C4591001
1133
11331441 2 111 18JAN2021 VACCINATION OTHER Subject in Japan. Not compliant with visits.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 111 18JAN2021 FOLLOW -UP OTHER Subject is in Japan. He is not able to compliant with
visits.
C4591001
1133
11331450 2 53 30NOV2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
2 53 30NOV2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1133
11331480 2 127 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 08/FEB/2021
C4591001
1133
11331483 2 136 26FEB2021 FOLLOW -UP LOST TO FOLLOW -UP certified letter sent 19/FEB
C4591001
1133
11331490 2 29 11NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
2 29 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent. No longer interested in coming
for Follow -up visits
C4591001
1133
11331492 2 29 11NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
2 29 11NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrew consent. No longer interested in coming
for Follow -up visits
C4591001
1133
11331499 2 17 30OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject does not wish to continue with study,he
asked us to please do notcall him again.
2 17 30OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject does not want to be contacted anymore
C4591001
1133
11331509 1 26 20OCT2020 VACCIN ATION LOST TO FOLLOW -UP Unable to contact subject
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 26 20OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject
C4591001
1133
11331510 1 20 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject doesn't feels comfortable receiving the
second vaccine.
1 20 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT DOES NOT FEEL COMFORTABLE
RECEIVING 2ND VACCINE. Subject wishies to no
longer be contacted.
C4591001
1133
11331512 1 26 20OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Meets exclusion 5
C4591001
1133
11331553 2 78 01FEB2021 VACCINA TION LOST TO FOLLOW -UP CERTIFIED LETTER SENT 22/JAN/2021
2 78 01FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 22/JAN/2021
C4591001
1133
11331555 2 36 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine at Hospital
C4591001
1133
11331557 2 87 10FEB2021 VACCINATION LOST TO FOLLOW -UP CERTIFIED LETTER SENT
2 87 10FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT
C4591001
1133
11331561 2 95 18FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1133
11331562 1 20 14NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA EXCLUSION CRITERIA 5
C4591001
1133
11331568 1 24 18NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 84
FDA-CBER-2021-5683-0224873
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 24 18NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject no longer wants to be contacted.
C4591001
1133
11331583 1 68 04JAN2021 VACCINATION LOST TO FOLLOW -UP Certified letter sent 15/DEC/2020
1 68 04JAN2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 15/DEC/2020
C4591001
1133
11331594 2 84 10FEB2021 VACCINATION LOST TO FOLLOW -UP Certified letter 17/DEC/20
2 84 10FEB2021 FOLLOW -UP LOST TO FOLLOW -UP CERTIFIED LETTER SENT 17/DEC/20
C4591001
1133
11331598 1 68 04JAN2021 VACCINATION LOST TO FOLLOW -UP Certified letter sent 15/DEC/2020
1 68 04JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent 15/DEC/2020
C4591001
1133
11331635 1 67 04JAN2021 VACCINATION LOST TO FOLLOW -UP Certified letter sent 15/DEC/2020
1 67 04JAN2021 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent 15/DEC/2020
C4591001
1133
11331644 2 76 02FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331645 2 76 02FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1133
11331647 2 31 23DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject leaving and does not want to come in for any
future visits.
C4591001
1134
11341033 1 35 14SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Dropped
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 85
FDA-CBER-2021-5683-0224874
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 35 14SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1134
11341153 1 2 25AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/EYE PAIN
C4591001
1134
11341174 1 5 30AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/HEADACHE
C4591001
1134
11341210 2 1 18SEP2020 VACCINATION LOST TO FOLLOW -UP subject is lost to follow up
2 1 18SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject has been called 08OCT2020 -23OCT2020
with no response. A certified letter was sent on
Nov30.
C4591001
1135
11351029 2 131 04JAN2021 FOLLOW -UP OTHER subject moved out of state
C4591001
1135
11351061 1 57 02OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 57 02OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1135
11351132 2 38 08OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times, certified
letter mailed on 08OCT2020.
2 38 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up
C4591001
1135
11351199 1 39 01OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up, certified letter sent to patient.
1 39 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter sent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 86
FDA-CBER-2021-5683-0224875
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1135
11351200 1 54 16OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up, certified letter sent to patient.
1 54 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter was sent
C4591001
1135
11351212 1 35 28SEP2020 VACCINATION LOST TO FOLLOW -UP patient was lost to follow up. certified letter was
sent.
1 35 28SEP2020 FOLLOW -UP LOST TO FOLLOW -UP subject lost to follow -up, certified letter was sent
C4591001
1135
11351241 2 148 16FEB2021 FOLLOW -UP PROTOCOL DEVIATION subject dropped due to receiving Moderna vaccine
C4591001
1135
11351389
19SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT during screening visit, subject withdrew consent
after randomization
C4591001
1135
11351420 1 27 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified
letter sent 19OCT2020
1 27 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified
letter sent on 19OCT2020
C4591001
1135
11351428 1 27 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified
letter was sent on 19OCT2020
1 27 19OCT2020 FOL LOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified
letter was sent on 19OCT2020
C4591001
1135
11351430 1 26 19OCT2020 VACCINATION LOST TO FOLLOW -UP subject contact attempted several times and certified
letter sent on 19OCT2020
1 26 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP subject contact attempted several times and certified
letter sent on 19OCT2020
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 87
FDA-CBER-2021-5683-0224876
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1135
11351436 2 37 20NOV2020 VACCINATI ON LOST TO FOLLOW -UP subject LTFU, certified letter was mailed
2 37 20NOV2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU, certified letter was mailed
C4591001
1135
11351523 1 18 10NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 18 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1135
11351555 2 61 16JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject dropped from trial
C4591001
1135
11351564 2 1 17NOV2020 VACCINATION OTHER subject moved out of state, EOT updated with V2
visit DOV
C4591001
1136
11361043 1 89 20NOV2020 VACCINATION LOST TO FOLLOW -UP Certified letter returned unclaimed
1 89 20NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject unable to be contacted.
C4591001
1136
11361045 1 75 06NOV2020 VACCINATION LOST TO FOLLOW -UP Unable to contact subject after multiple attempts and
certified letter sent
1 75 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Unable to contact subject after multiple attempts and
certified letter.
C4591001
1139
11391042 2 156 29JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decided to receive vaccine elsewhere after
being unblinded.
C4591001
1139
11391109 2 44 18DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decided to get vaccine at place of
employment after being unblinded
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 88
FDA-CBER-2021-5683-0224877
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1140
11401176 2 135 23JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna Vaccine outside of the
clinical trial. Withdrawn from the study.
C4591001
1140
11401177 2 155 12FEB2021 VACCINATION PROTOCOL DEVIATION Missed Visit 3 as contact with subject could not be
made and could not return to clinic in ti me.
C4591001
1140
11401301 1 86 12JAN2021 VACCINATION WITHDRAWAL BY
SUBJECT Contact was made on 12Jan2021 after multiple
attempts. Subject confirmed to withdraw consent.
1 86 12JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject states that he no longer would like to
participate in trial.
C4591001
1140
11401306 1 23 13NOV2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/AMNESIA
1 125 23FEB2021 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/PARAPARESIS
1 125 23FEB2021 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/VISUAL IMPAIRMENT
C4591001
1141
11411027 2 106 17DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Participant withdrew to receive EUA vaccine outside
of the study.
C4591001
1141
11411077 2 118 04JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew to receive EUA vaccine outside of
the study.
C4591001
1141
11411193 2 82 21DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew to receive EUA vaccine outside of
the study.
C4591001
1142
11421084 2 62 04NOV2020 VACCINATION NO LON GER MEETS
ELIGIBILITY CRITERIA Discontinued d/t medical history discovered after
enrollment per instructions of CRA
2 62 04NOV2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Discontinued d/t medical history discovered after
enrollment per instructions of CRA
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 89
FDA-CBER-2021-5683-0224878
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1142
11421112 2 147 01FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Moderna vaccine.
C4591001
1142
11421141 2 111 30DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Discontinued
C4591001
1142
11421303 2 1 12NOV2020 VACCINATION OTHER Subject left on an extended trip out of state and is not
sure if/when he will return
C4591001
1145
11451037 2 121 13JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal of consent
C4591001
1146
11461140 2 178 13MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew
C4591001
1146
11461195 2 173 13MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal by subject
C4591001
1146
11461240 2 88 01JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Discontinued
C4591001
1147
11471001 2 173 09FEB2021 FOLLOW -UP PROTOCOL DEVIATION Non-study COVID -19 Vaccine
C4591001
1147
11471047 2 178 19FEB2021 FOLLOW -UP PROTOCOL DEVIATION Non-study COVID -19 Vaccine (Moderna)
C4591001
1147
11471212 1 21 23SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject withdrew consent
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 90
FDA-CBER-2021-5683-0224879
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
1 21 23SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
C4591001
1149
11491005 1 21 25AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT patient will be out of state for a long period of time
so unable to return for study visits
1 21 25AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT pt withdrew consent from study. unable to return for
visits due to upcoming scheduling conflicts
C4591001
1149
11491007 2 18 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to
continue in study citing personal r easons
2 18 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to
participate in the study due to personal reasons
C4591001
1149
11491031 1 68 16OCT2020 VACCINATION LOST TO FOLLOW -UP Lost to follow up left several VM and certified letter
send 09oct2020.
1 68 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP patient has been unresponsive to repeated site
contacts via phone, email and certified letter
C4591001
1149
11491040 2 169 16FEB2021 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Subject took non -study covid vaccine.
C4591001
1149
11491065 1 31 11SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT pt is withdrawing consent from study due to personal
reasons
1 31 11SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and does not wish to
continue in study citing personal reasons
C4591001
1149
11491067 1 21 01SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrew consent from the study
1 21 01SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent and no longer wishes to
participate in the study
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 91
FDA-CBER-2021-5683-0224880
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1149
11491108
20AUG2020 VACCINATION REFUSED FURTHER
STUDY PROCEDURES REFUSED FURTHER STUDY PROCEDURES
20AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent right before vaccination
C4591001
1149
11491230 1 60 09NOV2020 VACCINATION LOST TO FOLLOW -UP Subject sent LTFU certified letter 30OCT2020.
1 60 09NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject is non responsive. Certified letter sent
30OCT2020.
C4591001
1149
11491285 2 50 03DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject didn't want to participate in study and wished
to withdraw.
C4591001
1149
11491332 2 23 03DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT subject moved out of State and will not be able to
committee to follow -ups
2 23 03DEC2020 FOLLOW -UP WITHDRAW AL BY
SUBJECT Subject moved out of state and withdrew from study.
C4591001
1149
11491344† 1 39 04DEC2020 VACCINATION LOST TO FOLLOW -UP No response from patient following visit 1. LTFU
certified letter was sent on 04 -Dec- 2020.
1 39 04DEC2020 FOLLOW -UP LOST TO FOLLOW -UP No response from subject following visit 1. LTFU
certified letter was sent 04 -Dec-2020.
C4591001
1152
11521030 1 22 02SEP2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
C4591001
1152
11521034 1 41 21SEP2020 VACCINATION LOST TO FOLLOW -UP Several phone messages were left for subject.
Certified letter was sent.
1 41 21SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Certified letter sent; return receipt received back
signed by someone other than the subject.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 92
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1152
11521043 2 10 10SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Now has 2 jobs and has no time to do study.
2 10 10SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Withdrawal by subject due to time constraints.
C4591001
1152
11521077 2 1 03SEP2020 VACCINATION OTHER Subject had both vaccinations and then moved out of
state. No Visit 3 was or ever will be done.
2 33 05OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT MOVED TO ARIZONA
C4591001
1152
11521085 1 8 26AUG2020 VACCINATION DEATH DEATH/DEATH
1 8 26AUG2020 FOLLOW -UP DEATH DEATH/DEATH
C4591001
1152
11521137 2 103 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION Received alternative COVID -19 Vaccine, withdrawn
from study.
C4591001
1152
11521138 2 78 04DEC2020 VACCINATION PROTOCOL DEVIATION Non-compliant with attending study visits.
2 78 04DEC2020 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DE CISION
C4591001
1152
11521192 2 180 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Received alternative COVID -19 Vaccine, withdrawn
from study.
C4591001
1152
11521208 2 81 04DEC2020 VACCINATION PROTOCOL DEVIATION Non-compliant with attending study visits.
2 115 07JAN2021 FOLLOW -UP PHYSICIAN DECISION PHYSICIAN DECISION
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 93
FDA-CBER-2021-5683-0224882
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1152
11521394 2 64 30NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT MOVED TO TEXAS.
2 64 30NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT MOVED TO TEXAS.
C4591001
1156
11561006 1 20 08SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1156
11561015 1 39 28SEP2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1156
11561033 1 16 10SEP2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criteria 5
C4591001
1156
11561124 2 32 02NOV2020 VACCINATION DEATH DEATH/RESPIRATORY ARREST
2 32 02NOV2020 FOLLOW -UP DEATH DEATH/OVERDOSE
C4591001
1157
11571003 1 56 06OCT2020 VACCINATION LOST TO FOLLOW -UP All attempts to contact subject have not been
successful.
1 56 06OCT2020 FOLLOW -UP LOST TO FOLLOW -UP All attempts to contact subject have been
unsuccessful
C4591001
1157
11571070 1 38 01OCT2020 VACCINATION LOST TO FOLLOW -UP All attempts to contact subject have been
unsuccessful
1 38 01OCT2020 FOLLOW -UP LOST TO FOLLOW -UP All attempts to contact sub ject have been
unsuccessful
C4591001
1157
11571077 2 30 14OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject W/C due to moving
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 30 14OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
C4591001
1157
11571090 2 162 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP Multiple attempts to contact subject for Revax,
certified letter sent. No response
C4591001
1157
11571092 2 136 28JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT voluntary withdrawal not due to an AE or SAE
C4591001
1157
11571109 2 94 17DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject could not wait to receive vaccine at the site
level
C4591001
1157
11571118 2 87 17DEC2020 FOLLO W-UP WITHDRAWAL BY
SUBJECT Subject withdrew consent due to imminent receipt of
Pfizer vaccine at an outside facility
C4591001
1157
11571121 2 169 08MAR2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to contact regarding scheduling for
V101. Certified letters sent. No response.
C4591001
1157
11571135 1 23 24SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an adverse event
1 156 04FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Voluntary withdrawal not due to an AE or SAE
C4591001
1157
11571174 2 104 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to contact subject for vaccination.
Certified letter sent. No response
C4591001
1161
11611002 1 85 23OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion 5
1 218 05MAR2021 FOLLOW -UP LOST TO FOLLOW -UP 3 unsuccessful contacts and a certified letter sent and
returned.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 95
FDA-CBER-2021-5683-0224884
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1161
11611005 1 127 04DEC2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
1 183 29JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1161
11611006 1 111 18NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study
1 111 18NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to withdraw from study.
C4591001
1161
11611007 1 103 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA No longer meets an eligibility criteria per exclusion
#5. VAX2 is not given but FUP will be complete
1 146 23DEC2020 FOLLOW -UP LOST TO FOLLOW -UP unable to contact, certified letter was sent and no
response.
C4591001
1161
11611008 1 103 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
C4591001
1161
11611010 1 134 11DEC2020 VACCINATION PHYSICIAN DECISION PHYSICIAN DECISION
1 216 03MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject stated he did not want to continue in study.
C4591001
1161
11611018 1 115 23NOV2020 VACCINATION LOST TO FOLLOW -UP multiple calls and cert. letter sent. No response from
subject.
1 115 23NOV2020 FOLLOW -UP LOST TO FOLLOW -UP multiple calls and certified letter sent. no response
from subject
C4591001
1161
11611020 2 99 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP unable to contact 3 phone calls and cert. letter sent
on 08FEB2021
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1161
11611023 1 72 13OCT2020 VACCINATION LOST TO FOLLOW -UP subject had several contact attempts by site along
with certified letter. Unable to contact subject.
1 72 13OCT2020 FOLLOW -UP LOST TO FOLLOW -UP cert. letter sent and signed by subject. unable to
contact and subject has not called site.
C4591001
1161
11611024 1 107 17NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT unable to contact subject. certified letter return ed, no
response from subject
1 107 17NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject did not want to continue in study
C4591001
1161
11611028 2 83 02FEB2021 FOLLOW -UP LOST TO FOLLOW -UP 3 phone call attempts and certified letter sent with no
response.
C4591001
1162
11621005 1 32 31AUG2020 VACCINATION WITHDRAWAL BY
SUBJECT The subject prematurely withdrew from study.
1 32 31AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject prematurely withdrawn from study.
C4591001
1162
11621024
06AUG2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject Randomized in error
C4591001
1162
11621044 2 194 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow -up
C4591001
1162
11621074 2 73 13NOV2020 VACCINATION LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
2 73 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
C4591001
1162
11621080 2 64 04NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 97
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 64 04NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
C4591001
1162
11621118 1 35 16SEP2020 VACCINATION LOST TO FOLLOW -UP SUBECT WITHDREW,CERTIFIED LETTER
SENT 9/16/2020
1 35 16SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Subject withdrew from study
C4591001
1162
11621137 2 66 13NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU after multiple contact attempts.
2 66 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after multiple contact attempts.
C4591001
1162
11621164 2 66 13NOV2020 VACCINATION LOST TO FOLLOW -UP subject LTFU after multiple contact attempts.
2 66 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after multiple contact attempts.
C4591001
1162
11621168 2 54 13NOV2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 54 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621224 2 70 29NOV2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 70 29NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621254 2 30 21OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Early termination by subject after visit 2 due to work
schedule
2 30 21OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Early termination by subject after visit 2 due to work
schedule
C4591001
1162
11621294 1 60 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU after many contact attempts
1 60 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 98
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621308 2 1 29SEP2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 1 29SEP2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621310 1 60 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 60 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU
C4591001
1162
11621336 2 31 30OCT2020 VACCINATION OTHER Subject was initially Lost to Follow -up but rejoined
the study to receive vaccination 3
C4591001
1162
11621356 1 61 13NOV2020 VACCINATION LOST TO FOLLOW -UP subject LTFU; did not return to site
1 61 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up
C4591001
1162
11621374 1 54 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU
1 54 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTFU after many contact attempts.
C4591001
1162
11621381 1 54 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject lost to follow up
1 54 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject lost to follow up
C4591001
1162
11621391 1 51 06NOV2020 VACCINATION LOST TO FOLLOW -UP Subject Lost to Follow Up after many attempts to
contact.
1 51 06NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject Lost to Follow Up after many attempts to
contact.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 99
FDA-CBER-2021-5683-0224888
16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621393 2 1 09OCT2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 1 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621434 2 1 19OCT2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 1 19OCT2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621477
30SEP2020 FOLLOW -UP PROTOCOL DEVIATION Randomized in error
C4591001
1162
11621480 2 32 28NOV2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 32 28NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621514 1 1 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 1 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1162
11621515 1 1 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT subject withdrew consent
1 1 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent
C4591001
1162
11621524 1 30 13NOV2020 VACCINATION LOST TO FOLLOW -UP subject LTFU
1 30 13NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject Lost to follow -up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 100
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1162
11621540 2 31 11DEC2020 VACCINATION LOST TO FOLLOW -UP LOST TO FOLLOW -UP
2 31 11DEC2020 FOLLOW -UP LOST TO FOLLOW -UP LOST TO FOLLOW -UP
C4591001
1162
11621566 1 34 24NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU, certified letter sent
1 34 24NOV2020 FOLLOW -UP LOST TO FOLLOW -UP LTFU - letter mailed to subject
C4591001
1163
11631006 1 21 20AUG2020 VACCINATION MEDICATION ERROR
WITHOUT ASSOCIATED
ADVERSE EVENT MEDICATION ERROR WITHOUT ASSOCIATED
ADVERSE EVENT/PRODUCT
ADMINISTRATION ERROR
C4591001
1163
11631059 1 2 08AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVE NT/DRUG HYPERSENSITIVITY
C4591001
1163
11631123 2 58 04NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
2 58 04NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT SUBJECT WITHDREW CONSENT
C4591001
1166
11661037 2 37 15OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject refused further procedures.
2 37 15OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient refused further study procedures. Updated per
DM.
C4591001
1166
11661044 2 99 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PT W/D CONSENT DURING V101 (VAX3).
AFTER ALL PROCEDURES BUT
IMMEDIATELY BEFORE VACCINE.
2 99 28DEC2020 REPEAT
SCREENING 1 OTHER PATIENT WITHDREW CONSENT
IMMEDIATELY PRIOR TO VACCINATION.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 101
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1166
11661047 1 1 31AUG2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/DIZZINESS
C4591001
1166
11661051 2 92 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT PT WITHDREW AFTER CONSENTING TO
VAX3 ONLY AFTER PROCEDURES,
IMMEDIATELY PRIOR TO VAX3 ITSELF.
2 92 22DEC2020 REPEAT
SCREENING 1 OTHER WOC
C4591001
1167
11671003
14AUG2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Did not meet inclusion criteria #3
C4591001
1167
11671071 2 113 04JAN2021 FOLLOW -UP PROTOCOL DEVIATION Received COVID vaccine outside the study
C4591001
1167
11671111 1 38 08OCT2020 VACCINATION LOST TO FOLLOW -UP Subject is lost to follow up tried multiple calls and
certified letter
1 38 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP no answer after multiple calls and sent certified letter
C4591001
1167
11671132 2 98 28DEC2020 FOLLOW -UP PROTOCOL DEVIATION subject received out of study covid vaccine
C4591001
1168
11681030
15AUG2020 VACCINATION PROTOCOL DEVIATION randomized in error
15AUG2020 FOLLOW -UP PROTOCOL DEVIATION subject randomized in error
C4591001
1168
11681032 2 128 14JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrew consent to receive vaccine at work
C4591001
1168
11681039 2 106 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal by subject
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 102
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1168
11681070 2 29 02NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Pt. will no longer complete study visits due to her
schedule and withdrew consent to participate
2 29 02NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt would not return for visits as required and chose
to no longer participate Verbal WOC
C4591001
1168
11681077 2 28 12OCT2020 VACCINATION WITHDRAWAL BY
SUBJECT PATIENT WITHDREW CONSENT
2 28 12OCT2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Patient withdrew consent
C4591001
1168
11681094 2 117 11JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawal by subject
C4591001
1168
11681097 2 1 15SEP2020 VACCINATION OTHER The subject is unable to complete V3 due to his
work. Pt will complete the rest of the study visits
C4591001
1168
11681104 1 70 05NOV2020 VACCINATION LOST TO FOLLOW -UP multi ple attempts to reach patient for missed Visit 2
and no response.
1 70 05NOV2020 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts to reach patient after missed Visit
2 and no response.
C4591001
1168
11681116 2 101 30DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt chose to longer complete any study procedures
C4591001
1168
11681178 2 34 10NOV2020 VACCINATION WITHDRA WAL BY
SUBJECT The patient chose to no longer participate due to
distance and an assumption of placebo group
2 34 10NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT the subject withdrew consent to participate
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 103
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1168
11681212 2 1 15OCT2020 VACCINATION OTHER The visit was missed due to pt working out of state.
The subject will continue on in the study.
C4591001
1168
11681221 2 54 21DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT subject chose to no longer participate, complete
study procedures, or respond to follow up requests.
2 54 21DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject chose to no longer participate, complete
study procedures, or respond to follow up requests.
C4591001
1168
11681227 1 37 17NOV2020 VACCINATION LOST TO FOLLOW -UP Subject LTF after several attempts to contact and
certified letter sent
1 37 17NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Subject LTF after several attempts to contact and
certified letter sent
C4591001
1169
11691014 2 104 04JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject did not want to wait 28 days to receive study
vaccine after receiving HPV vaccine 12/21/20
C4591001
1169
11691023 2 93 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received covid vaccine outside of the study -
withdrawn
C4591001
1169
116910 34 2 113 20JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject withdrew consent, received Covid Vaccine
outside of Study
C4591001
1169
11691057 2 84 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received covid vaccine outside of the study,
prior to unblinding - withdrawn from study
C4591001
1169
11691058 1 17 02OCT2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Covid +
C4591001
1169
11691060 2 36 17NOV2020 VACCINATION LOST TO FOLLOW -UP Lost to Follow Up
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
2 36 17NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Lost to follow up
C4591001
1169
11691069 2 85 30DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received a covid vaccine outside of the study
prior to unblinding - withdrawn
C4591001
1170
11701013 2 119 04JAN2021 FOLLOW -UP PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1170
11701026 2 101 17DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received vaccine outside of study.
C4591001
1170
11701045 2 127 14JAN2021 FOLLOW -UP PROTOCOL DEVIATION subject received vax outside of study
C4591001
1170
11701048 2 166 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701076 2 163 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701077 2 163 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701081 2 99 22DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject vaccinated outside the study.
C4591001
1170
11701089 2 161 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701110 2 96 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received vaccine outside of study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
Page 105
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1170
11701146 2 168 09MAR2021 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up subject contacted multiple times for
scheduling
C4591001
1170
11701171 2 112 12JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Received vaccine outside of study
C4591001
1170
11701209 2 141 12FEB2021 OPEN LABEL
TREATMENT PROTOCOL DEVIATION subject got his second vaccine outside the trial
2 141 12FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject got his second vaccine outside the trial
C4591001
1170
11701231 2 84 21DEC2020 FOLLOW -UP PROTOCOL DEVIATION received vaccine outside of study before
withdrawing consent
C4591001
1170
11701296 2 91 31DEC2020 FOLLOW -UP PROTOCOL DEVIATION received vaccine elsewhere while in study
C4591001
1170
11701311 1 33 16OCT2020 VACCINATION LOST TO FOLLOW -UP Subject contacted multiple times, never responded.
1 33 16OCT2020 FOLLOW -UP LOST TO FOLLOW -UP lost to follow -up subject s subject didnt come for
visit.
C4591001
1170
11701359 2 92 11JAN2021 FOLLOW -UP LOST TO FOLLOW -UP lost to follow up subject contacted a couple times
and subject didnt contact the site
C4591001
1170
11701393 2 78 27JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject decided to get vaccine through employer
C4591001
1170
11701413 2 38 18DEC2020 FOLLOW -UP PROTOCOL DEVIATION Subject received vaccine outside the study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1170
11701427† 1 51 11DEC2020 FOLLOW -UP LOST TO FOLLOW -UP Subject has multiple times rescheduled. Last time did
not contact and was a no show
1 59 19DEC2020 VACCINATION LOST TO FOLLOW -UP Subject has multiple times rescheduled. Last time did
not contact and was a no show
C4591001
1170
11701487 2 99 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1170
11701494 2 99 23FEB2021 VACCINATION LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
2 99 23FEB2021 FOLLOW -UP LOST TO FOLLOW -UP multiple attempts have been made to contact subject
with no response
C4591001
1171
11711004 2 29 28SEP2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject stated they do not want to participate in the
study anymore. Subject withdrew consent.
2 29 28SEP2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject stated they do not want to participate in the
study anymore. Subject withdrew consent.
C4591001
1171
11711023 2 189 09MAR2021 OPEN LABEL
TREATMENT ADVERSE EVENT ADVERSE EVENT/ANGIOEDEMA
2 189 09MAR2021 OPEN LABEL
TREATMENT ADVERSE EVENT ADVERSE EVENT/URTICARIA
C4591001
1171
11711042 1 39 24SEP2020 VACCINATION LOST TO FOLLOW -UP Per PI instructions subject LTFU
1 39 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI instructions subject LTFU
C4591001
1171
11711046 2 171 25FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject was unblinded and is not interested in
continuing with the study
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1171
11711071 2 178 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received MRNA 1273 outside of study
C4591001
1171
11711072 1 37 24SEP2020 VACCINATION LOST TO FOLLOW -UP Per PI instructions subject is LTFU
1 37 24SEP2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI instructions subject LTFU
C4591001
1171
11711077 2 184 12MAR2021 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA Subject moved and will no longer be able to continue
with the study
C4591001
1171
11711131 1 45 09OCT2020 VACCINATION LOST TO FOLLOW -UP Subject LTFU.
1 45 09OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI instructions, subject LTFU.
C4591001
1171
11711159 1 39 08OCT2020 VACCINATION LOST TO FOLLOW -UP Per PI, subject LTFU.
1 39 08OCT2020 FOLLOW -UP LOST TO FOLLOW -UP Per PI, subject LTFU
C4591001
1171
11711181 2 171 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received MRNA 1273 outside of the study
C4591001
1171
11711183 2 171 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received MRNA 1273 outside of the study
C4591001
1171
11711186 2 171 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received MRNA 1273 outside of the study
C4591001
1171
11711247 2 165 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received MRNA 1273 outside of study
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1171
11711250 2 165 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received a covid -19 vaccine outside of the
study
C4591001
1171
11711256 2 158 12MAR2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT Subject will proceed with v102VAX4 but has
decided to continue without receiving the vaccine
C4591001
1171
1171 1261 2 158 12MAR2021 FOLLOW -UP PROTOCOL DEVIATION Subject received COVID -19 vaccine outside of study
without informing site - MRNA 1273
C4591001
1171
11711301 1 62 30NOV2020 VACCINATION LOST TO FOLLOW -UP Per PI, subject LTFU
1 62 30NOV2020 FOLLOW -UP LOST TO FOLLOW -UP Multiple attempts to reschedule subject made,Per
PI's instructions, this subject is considered LTFU
C4591001
1177
11771139 1 74 06NOV2020 VACCINATION OTHER Subject was initially lost to follow up but then
rejoined the trial at a later date
C4591001
1177
11771332 2 144 22FEB2021 FOLLOW -UP OTHER Subject moved out of state and will no longer be able
to complete study visits
C4591001
1177
11771369 2 126 09FEB2021 FOLLOW -UP PROTOCOL DEVIATION Subject received a non study COVID -19 vaccination
outside of the study
C4591001
1177
11771449 2 84 05JAN2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT Subject withdrew consent on 05 Jan 2021
2 84 05JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent on 05 Jan 2021
C4591001
1178
11781065 2 120 18JAN2021 FOLLOW -UP PROTOCOL DEVIATION Received Moderna vaccine outside study.
090177e196af71f7\Final\Final On: 01-Apr-2021 13:33 (GMT)
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1178
11781107 1 22 25SEP2020 VACCINATION ADVERSE EVENT ADVERSE EVENT/LYMPHADENOPATHY
C4591001
1179
11791115 2 106 08FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject chose to receive vaccine out of study upon
learning they received placebo initially.
C4591001
1179
11791138 1 11 03NOV2020 VACCINATION NO LON GER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5. VAX2 is not given but FUP
will be completed.
C4591001
1185
11851055 2 90 16FEB2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT subject withdrawal informed consent
C4591001
1194
11941088 2 41 22DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Possibility of regular vaccination was given
C4591001
1195
11951029 2 78 20JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT the upcoming visits is to stressful for the patient at
this time.
C4591001
1195
11951061 1 21 06NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT patient withdrawal consent. she is afraid about the
second vaccination
1 21 06NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT patient is afraid for the second vaccination
C4591001
1204
12041094 2 95 04JAN2021 FOLLOW -UP PROTOCOL DEVIATION Participant was vaccinated outside study with Pfizer
vaccine.
C4591001
1204
12041197† 1 37 13NOV2020 VACCINATION WITHDRAWAL BY
SUBJECT Participant has chosen to withdraw from the study.
1 37 13NOV2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT Subject withdrew consent
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1204
12041280 2 116 08MAR2021 FOLLOW -UP PROTOCOL DEVIATION Received COVID vaccine outside of study
C4591001
1205
12051028
30OCT2020 FOLLOW -UP ADVERSE EVENT ADVERSE EVENT/BLOOD PRESSURE
INCREASED
C4591001
1205
12051078 1 9 18NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Volunteer was diagnosed with Covid -19 illness on
18Nov2020 then VAX2 can not be performed.
C4591001
1207
12071045 2 64 26JAN2021 FOLLOW -UP PROTOCOL DEVIATION Subject received Covid -19 vaccine outside the study
2 64 26JAN2021 REPEAT
SCREENING 1 NO LONGER MEETS
ELIGIBILITY CRITERIA RECEIVED CORONAVAC OUTSIDE THE
STUDY
C4591001
1208
12081012 2 63 18JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT She voluntarily withdrew her consent because she
had received a non -study vaccine.
C4591001
1209
12091013 1 9 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5. VAX2 won't given but follow -
up will be completed.
1 57 28DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT The subject did not withdraw his consent from the
study.
C4591001
1210
12101019 1 17 12NOV2 020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Subject is diagnosed with symptomatic COVID19.
C4591001
1210
12101053 1 18 22NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA subject is diagnosed with symptomatic COVID -19
C4591001
1212
12121023
03NOV2020 FOLLOW -UP NO LONGER MEETS
ELIGIBILITY CRITERIA After PI judgement, subject was not vaccinated.
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1212
12121035 2 30 25DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT Subject didn't want to continue to study, withdrawn
his consent.
C4591001
1213
12131002 2 75 26JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawl cosent for no any further contact with
subject
C4591001
1213
12131038 2 107 10MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawl consent for no any further contact with
subject
C4591001
1213
12131046 1 39 14DEC2020 VACCINATION WITHDRAWAL BY
SUBJECT withdrawl consent for no any further contact With
subject
1 39 14DEC2020 FOLLOW -UP WITHDRAWAL BY
SUBJECT withdrawl consent for no any further contact With
subject
C4591001
1217
12171031 1 39 07DEC2020 VACCINATION PREGNANCY PREGNANCY/EXPOSURE DURING
PREGNANCY
C4591001
1217
12171044 1 7 10NOV2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion criterion 5
1 121 04MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT He withdrew from the study because he give up
vaccinated.
C4591001
1218
12181011 2 99 02MAR2021 VACCINATION WITHDRAWAL BY
SUBJECT We made contact with participant 02MAR2021, she
was informed of her vaccine status but withdrew.
2 99 02MAR2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Participant requested to withdraw from study as they
have moved out of state
C4591001
1218
12181018 2 26 29DEC2020 VACCINATION OTHER Subject proceeded to open label prior to V3 in the
blinded Rx phase.
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Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C45910 01
1218
12181026 2 85 01MAR2021 VACCINATION LOST TO FOLLOW -UP Participant has missed 4 scheduled VAX 3 visits and
will not answer nor return our phone calls.
2 85 01MAR2021 FOLLOW -UP LOST TO FOLLOW -UP Participant has missed 4 scheduled VAX 3 visits and
will not answer nor return our phone calls.
C4591001
1218
12181027 2 22 29DEC2020 VACCINATION OTHER Subject proceeded to open label prior to V3 in the
blinded Rx phase.
C4591001
1218
12181036 2 5 18DEC2020 VACCINATION OTHER Subject proceeded to open label prior to V3 in the
blinded Rx phase.
C4591001
1218
12181041 1 22 22DEC2020 VACCINATION NO LONGER MEETS
ELIGIBILITY CRITERIA Exclusion Criterion 5
C4591001
1218
12181042 1 21 21DEC2020 VACCINATION OTHER unblinded at this time for VAX3
C4591001
1218
12181044 2 7 28DEC2020 VACCINATION OTHER Subject proceeded to open label prior to V3 in the
blinded Rx phase.
C4591001
1218
12181048 1 20 22DEC2020 VACCINATION OTHER Subject proceeded to open label prior to Vax2 in
blinded treatment phase
C4591001
1218
12181050 1 21 23DEC2020 VACCINATION OTHER Subject proceeded to open label prior to Vax2 in
blinded treatment phase
C4591001
1218
12181052 1 21 23DEC2020 VACCINATION OTHER Subject proceeded to open label prior to Vax2 in
blinded treatment phase
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1218
12181057 1 46 22JAN2021 VACCINATION OTHER VAX 2 delayed due to SAE hospitalization. Then
unblinded and received placebo, moved to VAX 3
C4591001
1219
12191024 2 77 25JAN2021 OPEN LABEL
TREATMENT LOST TO FOLLOW -UP participant out of country doing medical service
unable to contact or emergency contact
C4591001
1219
12191035 2 17 18DEC2020 VACCINATION OTHER subject proceeded to open label prior to visit 3
C4591001
1219
12191048 2 22 06JAN2021 VACCINATION OTHER subject proceeded to open label prior to visit 3
C4591001
1219
12191050 2 23 12JAN2021 VACCINATION OTHER subject proceeded to open label prior to visit 3
C4591001
1219
12191053 2 25 15JAN2021 VACCINATION OTHER subject proceeded to open label prior to visit 3
C4591001
1219
12191056 1 20 22DEC2020 VACCINATION OTHER subject proceeded to open label prior to Vax 2 in the
blinded treatment phase
C4591001
1219
12191062 1 11 18DEC2020 VACCINATION OTHER subject proceeded to open label prior to vax 2 in the
blinded treatment phase
C4591001
1220
12201029 2 58 14JAN2021 OPEN LABEL
TREATMENT WITHDRAWAL BY
SUBJECT Participant did not want to wait 28 days from oral
steroid use to receive vax 4.
2 58 14JAN2021 FOLLOW -UP WITHDRAWAL BY
SUBJECT Pt. wanted to get second vaccine from employer. Pt.
not willing to continue in study activities.
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16.2.1.1 Listing of Subjects Discontinued From Vaccination and/or From the Study – All Subjects ≥16 Years of Ag e
Age
Group
(Years) Subject Dose
No. Rel
Daya Withdrawal
Date Study Phase Withdrawal Reason Commentb
C4591001
1220
12201032 2 25 17DEC2020 VACCINATION OTHER Participant was unblinded for emergency use
authorization of COVID vaccine for healthcare
workers.
C4591001
1220
12201036 1 44 17DEC2020 VACCINATION LOST TO FOLLOW -UP unable to contact participant due to multiple attempts
1 44 17DEC2020 FOL
…[truncated]