Document text
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 1 of 9
Date: 23 NOV 2020
RNA
VariantRNADS Batch
No.DP Batch
No.Packaging
Batch No.
(kit)Medication
No.Sequence
No.Expiry Date SO-No. CountryTrial site
No.
Pharmacy
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10002 2 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10003 3 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10004 4 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10005 5 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10006 6 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10007 7 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10008 8 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10009 9 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10010 10 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10011 11 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10012 12 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10013 13 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10014 14 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10015 15 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10016 16 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10017 17 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10018 18 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10019 19 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10020 20 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10021 21 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10022 22 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10023 23 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10024 24 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10025 25 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10026 26 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10027 27 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10028 28 25. Sep 20 SO-20-0022 Germany #1/Mannheim
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 1
FDA-CBER-2021-5683-0049334
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 2 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0001L 10002 2
E220195-0001L 10003 3
E220195-0001L 10004 4
E220195-0001L 10005 5
E220195-0001L 10006 6
E220195-0001L 10007 7
E220195-0001L 10008 8
E220195-0001L 10009 9
E220195-0001L 10010 10
E220195-0001L 10011 11
E220195-0001L 10012 12
E220195-0001L 10013 13
E220195-0001L 10014 14
E220195-0001L 10015 15
E220195-0001L 10016 16
E220195-0001L 10017 17
E220195-0001L 10018 18
E220195-0001L 10019 19
E220195-0001L 10020 20
E220195-0001L 10021 21
E220195-0001L 10022 22
E220195-0001L 10023 23
E220195-0001L 10024 24
E220195-0001L 10025 25
E220195-0001L 10026 26
E220195-0001L 10027 27
E220195-0001L 10028 28Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
19. Apr 20 21. Apr 20 276-01-0021, 276-01-0032, 276-01-0034
19. Apr 20 21. Apr 20 276-01-0028, 276-01-0031, 276-01-0038
19. Apr 20 21. Apr 20 276-01-0056
19. Apr 20 21. Apr 20 276-01-0096
19. Apr 20 21. Apr 20 276-01-0053
19. Apr 20 21. Apr 20 276-01-0067
19. Apr 20 21. Apr 20 276-01-0057
19. Apr 20 21. Apr 20 276-01-0007
19. Apr 20 21. Apr 20 276-01-0025, 276-01-0023, 276-01-0033, 276-01-0045
19. Apr 20 21. Apr 20 276-01-0083
19. Apr 20 21. Apr 20 276-01-0066
19. Apr 20 21. Apr 20 276-01-0016, 276-01-0020
19. Apr 20 21. Apr 20 276-01-0003, 276-01-0006, 276-01-0008, 276-01-0009, 276-01-0019, 276-01-0017
19. Apr 20 21. Apr 20 276-01-0011, 276-01-0005, 276-01-0004, 276-01-0001
19. Apr 20 21. Apr 20 276-01-0073
19. Apr 20 21. Apr 20 276-01-0055
19. Apr 20 21. Apr 20 276-01-0070
19. Apr 20 21. Apr 20 276-01-0049
19. Apr 20 21. Apr 20 276-01-0059
19. Apr 20 21. Apr 20 276-01-0037
19. Apr 20 21. Apr 20 276-01-0015, 276-01-0018
19. Apr 20 21. Apr 20 276-01-0007
19. Apr 20 21. Apr 20 276-01-0039, 276-01-0043, 276-01-0047
19. Apr 20 21. Apr 20 276-01-0011, 276-01-0010, 276-01-0005, 276-01-0004, 276-01-0001
19. Apr 20 21. Apr 20 276-01-0036, 276-01-0040, 276-01-0041, 276-01-0042, 276-01-0048, 276-01-0052
19. Apr 20 21. Apr 20 276-01-0003, 276-01-0006, 276-01-0008, 276-01-0009, 276-01-0019, 276-01-0017
19. Apr 20 21. Apr 20 276-01-0050
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 2
FDA-CBER-2021-5683-0049335
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 3 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0001L 10002 2
E220195-0001L 10003 3
E220195-0001L 10004 4
E220195-0001L 10005 5
E220195-0001L 10006 6
E220195-0001L 10007 7
E220195-0001L 10008 8
E220195-0001L 10009 9
E220195-0001L 10010 10
E220195-0001L 10011 11
E220195-0001L 10012 12
E220195-0001L 10013 13
E220195-0001L 10014 14
E220195-0001L 10015 15
E220195-0001L 10016 16
E220195-0001L 10017 17
E220195-0001L 10018 18
E220195-0001L 10019 19
E220195-0001L 10020 20
E220195-0001L 10021 21
E220195-0001L 10022 22
E220195-0001L 10023 23
E220195-0001L 10024 24
E220195-0001L 10025 25
E220195-0001L 10026 26
E220195-0001L 10027 27
E220195-0001L 10028 28Date usedDrug accountability
finally checked onDeviation
Yes/No
if yes
Deviation No.comments
05. Mai 20 08. Mai 20 N
07. Mai 20 08. Mai 20 N
13. Mai 20 15. Mai 20 N
19. Mai 20 20. Mai 20 N
12. Mai 20 15. Mai 20 N
15. Mai 20 15. Mai 20 N
15. Mai 20 15. Mai 20 N
14. Mai 20 15. Mai 20 N
05. Mai 20 08. Mai 20 N
20. Mai 20 20. Mai 20 N
19. Mai 20 20. Mai 20 N
29. Apr 20 30. Apr 20 N
28. Apr 20 30. Apr 20 N
15. Mai 20 15. Mai 20 N
15. Mai 20 15. Mai 20 N
13. Mai 20 15. Mai 20 N
15. Mai 20 15. Mai 20 N
12. Mai 20 15. Mai 20 N
13. Mai 20 15. Mai 20 N
05. Mai 20 08. Mai 20 N
29. Apr 20 30. Apr 20 N
23. Apr 20 30. Apr 20 N
07. Mai 20 08. Mai 20 N
24. Apr 20 30. Apr 20 N
08. Mai 20 08. Mai 20 N
19. Mai 20 20. Mai 20 N
15. Mai 20 15. Mai 20 N
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 3
FDA-CBER-2021-5683-0049336
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 4 of 9
Date: 23 NOV 2020
RNA
VariantRNADS Batch
No.DP Batch
No.Packaging
Batch No.
(kit)Medication
No.Sequence
No.Expiry Date SO-No. CountryTrial site
No.
Pharmacy
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10029 29 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10030 30 25. Sep 20 SO-20-0022 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10031 31 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10032 32 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10033 33 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10034 34 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10035 35 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10036 36 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10037 37 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10038 38 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10039 39 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10040 40 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10041 41 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10042 42 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10043 43 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10044 44 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10045 45 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0001L 10046 46 25. Sep 20 SO-20-0033 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10047 47 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10048 48 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10049 49 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10050 50 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10051 51 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10052 52 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10053 53 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10054 54 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10055 55 25. Sep 20 SO-20-0038 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0004L 10056 56 25. Sep 20 SO-20-0038 Germany #1/Mannheim
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 4
FDA-CBER-2021-5683-0049337
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 5 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0001L 10029 29
E220195-0001L 10030 30
E220195-0001L 10031 31
E220195-0001L 10032 32
E220195-0001L 10033 33
E220195-0001L 10034 34
E220195-0001L 10035 35
E220195-0001L 10036 36
E220195-0001L 10037 37
E220195-0001L 10038 38
E220195-0001L 10039 39
E220195-0001L 10040 40
E220195-0001L 10041 41
E220195-0001L 10042 42
E220195-0001L 10043 43
E220195-0001L 10044 44
E220195-0001L 10045 45
E220195-0001L 10046 46
E220195-0004L 10047 47
E220195-0004L 10048 48
E220195-0004L 10049 49
E220195-0004L 10050 50
E220195-0004L 10051 51
E220195-0004L 10052 52
E220195-0004L 10053 53
E220195-0004L 10054 54
E220195-0004L 10055 55
E220195-0004L 10056 56Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
19. Apr 20 21. Apr 20 276-01-0060
19. Apr 20 21. Apr 20 276-01-0068
11. Mai 20 13. Mai 20 276-01-0025, 276-01-0023, 276-01-0033, 276-01-0045
11. Mai 20 13. Mai 20 276-01-0084
11. Mai 20 13. Mai 20 276-01-0028, 276-01-0031, 276-01-0038
11. Mai 20 13. Mai 20 276-01-0021, 276-01-0032
11. Mai 20 13. Mai 20 276-01-0089
11. Mai 20 13. Mai 20 276-01-0075
11. Mai 20 13. Mai 20 276-01-0103
11. Mai 20 13. Mai 20 276-01-0104
11. Mai 20 13. Mai 20 276-01-0093
11. Mai 20 13. Mai 20 276-01-0078
11. Mai 20 13. Mai 20 276-01-0034, 276-01-0037
11. Mai 20 13. Mai 20 276-01-0015, 276-01-0018, 276-01-0015, 276-01-0018
11. Mai 20 13. Mai 20 276-01-0016, 276-01-0020
11. Mai 20 13. Mai 20 276-01-0085
11. Mai 20 13. Mai 20 276-01-0076
11. Mai 20 13. Mai 20 276-01-0039, 276-01-0043, 276-01-0047
26. Mai 20 28. Mai 20 276-01-0049, 276-01-0053
26. Mai 20 28. Mai 20 276-01-0178, 276-01-0179, 276-01-0181
26. Mai 20 28. Mai 20 276-01-0060, 276-01-0059
26. Mai 20 28. Mai 20 276-01-0171, 276-01-0172, 276-01-0173
26. Mai 20 28. Mai 20 276-01-0067, 276-01-0057
26. Mai 20 28. Mai 20 276-01-0036, 276-01-0052, 276-01-0048, 276-01-0042, 276-01-0041, 276-01-0040
26. Mai 20 28. Mai 20 276-01-0056, 276-01-0055
26. Mai 20 28. Mai 20 276-01-0070, 276-01-0068
26. Mai 20 28. Mai 20 276-01-0151, 276-01-0175, 276-01-0176,
26. Mai 20 28. Mai 20 276-01-0073
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 5
FDA-CBER-2021-5683-0049338
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 6 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0001L 10029 29
E220195-0001L 10030 30
E220195-0001L 10031 31
E220195-0001L 10032 32
E220195-0001L 10033 33
E220195-0001L 10034 34
E220195-0001L 10035 35
E220195-0001L 10036 36
E220195-0001L 10037 37
E220195-0001L 10038 38
E220195-0001L 10039 39
E220195-0001L 10040 40
E220195-0001L 10041 41
E220195-0001L 10042 42
E220195-0001L 10043 43
E220195-0001L 10044 44
E220195-0001L 10045 45
E220195-0001L 10046 46
E220195-0004L 10047 47
E220195-0004L 10048 48
E220195-0004L 10049 49
E220195-0004L 10050 50
E220195-0004L 10051 51
E220195-0004L 10052 52
E220195-0004L 10053 53
E220195-0004L 10054 54
E220195-0004L 10055 55
E220195-0004L 10056 56Date usedDrug accountability
finally checked onDeviation
Yes/No
if yes
Deviation No.comments
13. Mai 20 15. Mai 20 N
15. Mai 20 15. Mai 20 N
26. Mai 20 28. Mai 20 N
22. Mai 20 28. Mai 20 N
28. Mai 20 28. Mai 20 N
26. Mai 20 28. Mai 20 N
20. Mai 20 20. Mai 20 N
22. Mai 20 28. Mai 20 N
22. Mai 20 28. Mai 20 N
20. Mai 20 20. Mai 20 N
20. Mai 20 20. Mai 20 N
22. Mai 20 28. Mai 20 N
26. Mai 20 28. Mai 20 N
20. Mai 20 20. Mai 20 N
20. Mai 20 20. Mai 20 N
22. Mai 20 28. Mai 20 N
22. Mai 20 28. Mai 20 N
28. Mai 20 28. Mai 20 N
02. Jun 20 03. Jun 20 N
16. Jun 20 17. Jun 20 N
03. Jun 20 03. Jun 20 N
16. Jun 20 17. Jun 20 N
05. Jun 20 24. Jun 20 N
29. Mai 20 03. Jun 20 N
03. Jun 20 03. Jun 20 N
05. Jun 20 24. Jun 20 N
16. Jun 20 17. Jun 20 N
05. Jun 20 24. Jun 20 N
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 6
FDA-CBER-2021-5683-0049339
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 7 of 9
Date: 23 NOV 2020
RNA
VariantRNADS Batch
No.DP Batch
No.Packaging
Batch No.
(kit)Medication
No.Sequence
No.Expiry Date SO-No. CountryTrial site
No.
Pharmacy
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10103 103 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10104 104 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10105 105 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10106 106 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10107 107 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10108 108 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10109 109 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10111 111 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10112 112 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10113 113 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10115 115 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10116 116 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10117 117 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10118 118 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10119 119 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10120 120 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10124 124 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10125 125 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10126 126 25. Sep 20 SO-20-0058 Germany #1/Mannheim
V5modRNA RBP020.3 R425-P020.3-DS BCV10320-A E220195-0014L 10130 130 25. Sep 20 SO-20-0058 Germany #1/Mannheim
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 7
FDA-CBER-2021-5683-0049340
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 8 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0014L 10103 103
E220195-0014L 10104 104
E220195-0014L 10105 105
E220195-0014L 10106 106
E220195-0014L 10107 107
E220195-0014L 10108 108
E220195-0014L 10109 109
E220195-0014L 10111 111
E220195-0014L 10112 112
E220195-0014L 10113 113
E220195-0014L 10115 115
E220195-0014L 10116 116
E220195-0014L 10117 117
E220195-0014L 10118 118
E220195-0014L 10119 119
E220195-0014L 10120 120
E220195-0014L 10124 124
E220195-0014L 10125 125
E220195-0014L 10126 126
E220195-0014L 10130 130Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
14.06.2020 16.06.2020 276-01-0351, 276-01-0363, 276-01-0364
14.06.2020 16.06.2020 276-01-0366, 276-01-0365
14.06.2020 16.06.2020 276-01-0282, 276-01-0289
14.06.2020 16.06.2020 276-01-0181, 276-01-0179, 276-01-0178
14.06.2020 16.06.2020 276-01-273, 276-01-0274, 276-01-0283, 276-01-0292, 276-01-0320, 276-01-298
14.06.2020 16.06.2020 276-01-0194, 276-01-0200, 276-01-0204, 276-01-0198, 276-01-0209, 276-01-0212
14.06.2020 16.06.2020 276-01-0287, 276-01-0286, 276-01-0291, 276-01-0288,
14.06.2020 16.06.2020 276-01-0286, 276-01-0287, 276-01-0288, 276-01-0291
14.06.2020 16.06.2020 276-01-0352
14.06.2020 16.06.2020 276-01-0197, 276-01-0183,
14.06.2020 16.06.2020 276-01-0360, 276-01-0358
14.06.2020 16.06.2020 276-01-0182, 276-01-0183, 276-01-0187
14.06.2020 16.06.2020 276-01-0320, 276-01-0273, 276-01-0283, 276-01-0292, 276-01-0298, 276-01-0274
14.06.2020 16.06.2020 276-01-0361, 276-01-0350, 276-01-0362
14.06.2020 16.06.2020 276-01-0171, 276-01-0151, 276-01-0172,
14.06.2020 16.06.2020 276-01-0175, 276-01-0173, 276-01-0176,
14.06.2020 16.06.2020 276-01-0227, 276-01-0221, 276-01-0226, 276-01-0225, 276-01-0224, 276-01-0170
14.06.2020 16.06.2020 276-01-0282, 276-01-0289,
14.06.2020 16.06.2020 276-01-0194, 276-01-0198, 276-01-0200, 276-01-0204, 276-01-0209, 276-01-0212
14.06.2020 16.06.2020 276-01-0170, 276-01-0227, 276-01-0221, 276-01-0226, 276-01-0225, 276-01-0224,
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 8
FDA-CBER-2021-5683-0049341
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b1 Page 9 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0014L 10103 103
E220195-0014L 10104 104
E220195-0014L 10105 105
E220195-0014L 10106 106
E220195-0014L 10107 107
E220195-0014L 10108 108
E220195-0014L 10109 109
E220195-0014L 10111 111
E220195-0014L 10112 112
E220195-0014L 10113 113
E220195-0014L 10115 115
E220195-0014L 10116 116
E220195-0014L 10117 117
E220195-0014L 10118 118
E220195-0014L 10119 119
E220195-0014L 10120 120
E220195-0014L 10124 124
E220195-0014L 10125 125
E220195-0014L 10126 126
E220195-0014L 10130 130Date usedDrug accountability
finally checked onDeviation
Yes/No
if yes
Deviation No.comments
25. Sep 20 01. Oct 20 N
23. Sep 20 23. Sep 20 N
20. Aug 20 02. Sep 20 N
06. Aug 20 02. Sep 20 N
17. Sep 20 23. Sep 20 N
22. Jul 20 30. Jul 20 N
25. Aug 20 02. Sep 20 N
15. Sep 20 23. Sep 20 N
22. Sep 20 23. Sep 20 N
06. Aug 20 02. Sep 20 N
23. Sep 20 23. Sep 20 N
16. Jun 20 17. Jun 20 N
27. Aug 20 02. Sep 20 N
25.Sep.20 01.Oct 20 N
06. Aug 20 02. Sep 20 N
06. Aug 20 02. Sep 20 N
31. Jul 20 02. Sep 20 N
10. Sep 20 23. Sep 20 N
12. Aug 20 02. Sep 20 N
21. Aug 20 02. Sep 20 N
090177e195a37cb2\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 9
FDA-CBER-2021-5683-0049342
FDA-CBER-2021-5683-0049343
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b2Page: 2 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0004L 20001 10001
E220195-0004L 20003 10003
E220195-0004L 20004 10004
E220195-0004L 20005 10005
E220195-0004L 20006 10006
E220195-0004L 20007 10007
E220195-0004L 20008 10008
E220195-0004L 20009 10009
E220195-0004L 20010 10010
E220195-0004L 20011 10011
E220195-0004L 20012 10012
E220195-0004L 20013 10013
E220195-0004L 20014 10014
E220195-0004L 20016 10016
E220195-0004L 20018 10018
E220195-0004L 20019 10019
E220195-0004L 20021 10021
E220195-0004L 20022 10022
E220195-0004L 20023 10023
E220195-0004L 20024 10024
E220195-0004L 20025 10025
E220195-0004L 20027 10027
E220195-0004L 20029 10029
E220195-0004L 20030 10030
E220195-0004L 20031 10031
E220195-0004L 20032 10032
E220195-0004L 20033 10033Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
05. Jun 20 07. Jun 20 276-02-0103
05. Jun 20 07. Jun 20 276-02-0110, 276-02-0105, 276-02-0104, 276-02-0101, 276-02-0102
05. Jun 20 07. Jun 20 276-02-0118, 276-02-0116, 276-02-0121, 276-02-0111,276-02-0117, 276-02-0114
05. Jun 20 07. Jun 20 276-02-0149, 276-02-0127
05. Jun 20 07. Jun 20 276-02-0155, 276-02-0150
05. Jun 20 07. Jun 20 276-02-0137, 276-02-0128
05. Jun 20 07. Jun 20 145, 276-02-0143, 276-02-0134
05. Jun 20 07. Jun 20 276-02-0138, 276-02-0144, 276-02-0142
05. Jun 20 07. Jun 20 276-02-0154, 276-02-0166, 276-02-0163, 276-02-0157, 276-02-0160, 276-02-0153
05. Jun 20 07. Jun 20 276-02-0137, 276-02-0128, 276-02-0155
05. Jun 20 07. Jun 20 276-02-0153, 276-02-0157, 276-02-0163, 276-02-0166, 276-02-0154
05. Jun 20 07. Jun 20 276-02-0134, 276-02-0143, 276-02-0145
05. Jun 20 07. Jun 20 276-02-0142, 276-02-0144, 276-02-0138
05. Jun 20 07. Jun 20 276-02-0111
05. Jun 20 07. Jun 20 276-02-0118, 276-02-0121, 276-02-0117, 276-02-0114
05. Jun 20 07. Jun 20 276-02-0164, 276-02-0171, 276-02-0158
05. Jun 20 07. Jun 20 276-02-0183, 276-02-0180
05. Jun 20 07. Jun 20 276-02-0150, 276-02-0149, 276-02-0127
05. Jun 20 07. Jun 20 276-02-0159, 276-02-0168
05. Jun 20 07. Jun 20 276-02-0173, 276-02-0156, 276-02-0172
05. Jun 20 07. Jun 20 276-02-0105, 276-02-0103
05. Jun 20 07. Jun 20 276-02-0181, 276-02-0179, 276-02-0175
05. Jun 20 07. Jun 20 276-02-0174, 276-02-0177, 276-02-0178
05. Jun 20 07. Jun 20 276-02-0110, 276-02-0104, 276-02-0101, 276-02-0102
14. Jul 20 16. Jul 20 276-02-0159, 276-02-0168
14. Jul 20 16. Jul 20 276-02-0172, 276-02-0156, 276-02-0173
14. Jul 20 16. Jul 20 276-02-0175, 276-02-0178, 276-02-0177
090177e195a37cb3\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 11
FDA-CBER-2021-5683-0049344
FDA-CBER-2021-5683-0049345
FDA-CBER-2021-5683-0049346
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b2Page: 5 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0004L 20034 10034
E220195-0004L 20035 10035
E220195-0004L 20038 10038
E220195-0004L 20039 10039
E220195-0004L 20040 10040
E220195-0004L 20042 10042
E220195-0004L 20043 10043
E220195-0004L 20044 10044
E220195-0004L 20045 10045
E220195-0004L 20046 10046
E220195-0004L 20047 10047
E220195-0004L 20048 10048
E220195-0004L 20049 10049
E220195-0004L 20050 10050
E220195-0004L 20051 10051
E220195-0004L 20053 10053
E220195-0004L 20054 10054
E220195-0004L 20055 10055
E220195-0004L 20056 10056
E220195-0018L 20057 10057
E220195-0018L 20062 10062
E220195-0018L 20063 10063
E220195-0018L 20064 10064
E220195-0018L 20065 10065Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
14. Jul 20 16. Jul 20 276-02-0174
14. Jul 20 16. Jul 20 276-02-0188, 276-02-0189, 276-02-0181
14. Jul 20 16. Jul 20 276-02-0179
14. Jul 20 16. Jul 20 276-02-0185, 276-02-0193, 276-02-0176, 276-02-0194
14. Jul 20 16. Jul 20 276-02-0195, 276-02-0203, 276-02-0204
14. Jul 20 16. Jul 20 276-02-0158, 276-02-0171, 276-02-0164
14. Jul 20 16. Jul 20 276-02-0180, 276-02-0183
14. Jul 20 16. Jul 20 276-02-201, 276-02-191
14. Jul 20 16. Jul 20 276-02-0197, 276-02-0192
14. Jul 20 16. Jul 20 276-01-0201, 276-01-0191
14. Jul 20 16. Jul 20 276-01-0223
14. Jul 20 16. Jul 20 276-01-0203
14. Jul 20 16. Jul 20 276-01-0203 (not dosed), 276-01-0204, 276-01-0200, 276-01-0195
14. Jul 20 16. Jul 20 276-01-0192, 276-01-0197, 276-01-0194, 276-01-0176, 276-01-0193, 276-01-0185
14. Jul 20 16. Jul 20 276-02-0200
14. Jul 20 16. Jul 20 276-01-0225, 276-01-0222, 276-01-0214,
14. Jul 20 16. Jul 20 276-01-0229, 276-01-0215, 276-01-0224
14. Jul 20 16. Jul 20 276-01-0208, 276-01-0216
14. Jul 20 16. Jul 20 276-01-0181, 276-01-0189, 276-01-0188
05. Aug 20 07. Aug 20 276-01-0233, 276-01-0226, 276-01-0221
05. Aug 20 07. Aug 20 276-01-0306
05. Aug 20 07. Aug 20 276-01-0310, 276-01-0309,
05. Aug 20 07. Aug 20 276-01-0268, 276-01-0267, 276-01-0265, 276-01-0269
05. Aug 20 07. Aug 20 276-01-0261, 276-01-0263
090177e195a37cb3\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 14
FDA-CBER-2021-5683-0049347
FDA-CBER-2021-5683-0049348
FDA-CBER-2021-5683-0049349
BioNTech RNA Pharmaceuticals GmbH
ConfidentialInterim Clinical Study Report - BNT162-01
Investigational Product Tracking Table for: BNT162b2Page: 8 of 9
Date: 23 NOV 2020
Packaging
Batch No.
(kit)Medication
No.Sequence
No.
E220195-0018L 20066 10066
E220195-0018L 20067 10067
E220195-0018L 20068 10068
E220195-0018L 20069 10069
E220195-0018L 20070 10070
E220195-0018L 20071 10071
E220195-0018L 20072 10072
E220195-0018L 20073 10073
E220195-0018L 20074 10074
E220195-0018L 20075 10075
E220195-0018L 20076 10076
E220195-0017L 20077 10077
E220195-0017L 20083 10083
E220195-0017L 20088 10088Date of
Shipment
to study
site/pharmacyDate of
Arrival at
study
site/pharmacySubject No.
05. Aug 20 07. Aug 20 276-01-0261
05. Aug 20 07. Aug 20 276-01-0324, 276-01-0314
05. Aug 20 07. Aug 20 276-01-0300, 276-01-0299, 276-01-0279, 276-01-0277, 276-01-0276, 276-01-0275
05. Aug 20 07. Aug 20 276-01-0269, 276-01-0268, 276-01-0267, 276-01-0265
05. Aug 20 07. Aug 20 276-01-0261, 276-01-0263
05. Aug 20 07. Aug 20 276-01-0323, 276-01-0319, 276-01-0308
05. Aug 20 07. Aug 20 276-01-0316
05. Aug 20 07. Aug 20 276-01-0305, 276-01-0303, 276-01-0272
05. Aug 20 07. Aug 20 276-01-0319, 276-01-0308, 276-01-0323
05. Aug 20 07. Aug 20 276-01-0303, 276-01-0272
05. Aug 20 07. Aug 20 276-01-0300, 276-01-0299, 276-01-0279, 276-01-0275, 276-01-0277, 276-01-0276
21. Aug 20 24. Aug 20 276-01-0305
21. Aug 20 24. Aug 20 276-01-0324
21. Aug 20 24. Aug 20 276-01-0314, 276-01-0310, 276-01-0309
090177e195a37cb3\Approved\Approved On: 28-Nov-2020 02:43 (GMT)
Page 17
FDA-CBER-2021-5683-0049350
FDA-CBER-2021-5683-0049351