Document text
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................1
LIST OF FIGURES ................................ ................................ ................................ ................... 5
STABILITY DATA –ACC ELERATED ................................ ................................ .................. 7
LIST OF TABLES
Table 3.2.P.8.3-1. Summary Table of Drug Product Accelerated Stability Studies ................ 8
Table 3.2.P.8.3-2. Stability Data for PPQ Drug Product EN6199 Stored at -60 to -30
°C (Pfizer, Kalamazoo)................................ ................................ ............. 11
Table 3.2.P.8.3-3. Stability Data for PPQ Drug Product EL9267 Stored at - 60 to -30
°C (Pfizer, Kalamazoo).............................................................................12
Table 3.2.P.8.3-4. Stability Data for PPQ Drug Product EM4965 Stored at - 60 to -30
°C (Poly mun/Pfizer, Puurs) ................................ ................................ ......13
Table 3.2.P.8.3-5. Stability Data for PPQ Drug Product EM6950 Stored at - 60 to -30
°C (Pfizer, Puurs) ................................ ................................ ...................... 14
Table 3.2.P.8.3-6. Stability Data for PPQ Drug Product EL8723 Stored at - 60 to -30
°C (Pfizer, Puurs) ................................ ................................ ...................... 15
Table 3.2.P.8.3-7. Stability Data for Drug Product Emergency Supply Batch EJ1685
Stored at - 60 to -30 °C................................ ................................ .............. 16
Table 3.2.P.8.3-8. Stability Data for Drug Product Emergency Supply Batch EJ0553
Stored at - 60 to -30 °C................................ ................................ .............. 17
Table 3.2.P.8.3-9. Stability Data for Drug Product Emergency Supply Lot EE8493
Stored at - 60 to -30 °C................................ ................................ .............. 18
Table 3.2.P.8.3-10. Stability Data for PPQ Drug Product EN6199 Stored at -20 ± 5 °C
(Pfizer, Kalamazoo) ................................ ................................ .................. 19
Table 3.2.P.8.3-11. Stability Data for PPQ Drug Product EL3249 Upright Vials Stored
at -20 ± 5 °C (Pfizer, Kalamazoo) ................................ ............................ 20
Table 3.2.P.8.3-12. Stability Data f or PPQ Drug Product EL9267 Stored at - 20 ± 5 °C
(Pfizer, Kalamazoo) ................................ ................................ .................. 21
Table 3.2.P.8.3-13. Stability Data for Drug Product EL3248 Upr ight Vials Stored at -20
± 5 °C (Pfizer, Kalamazoo) ......................................................................22
Table 3.2.P.8.3-14. Stability Data for PPQ Drug Product EM4965 Stored at -20 ± 5 °C
(Poly mun/Pfizer, Puurs) ................................ ................................ ........... 23
Table 3.2.P.8.3-15. Stability Data for PPQ Drug Product EL7834 Upright Vials Stored
at -20 ± 5 °C (P olymun/Pfizer, Puurs) ................................ ...................... 24
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149640
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3-16. Stability Data for PPQ Drug Product EN1195 Stored at -20 ± 5 °C
(mibe/Pfizer, Puurs) ................................ ................................ .................. 25
Table 3.2.P.8.3-17. Stability Data for PPQ Drug Product EK4242 Upright Vials Stored
at -20 ± 5 °C (mibe/Pfizer, Puurs) ................................ ............................ 26
Table 3.2.P.8.3-18. Stability Data for PPQ Drug Product EP2166 Stored at -20 ± 5 °C
(Pfizer, Puurs)................................ ................................ ........................... 27
Table 3.2.P.8.3-19. Stability Data for PPQ Drug Product EL8713 Stored at - 20 ± 5 °C
(Pfizer, Puurs)................................ ................................ ........................... 28
Table 3.2.P.8.3-20. Stability Data for PPQ Drug Product EM6950 Stored at - 20 ± 5 °C
(Pfizer, Puurs)................................ ................................ ........................... 29
Table 3.2.P.8.3-21. Stability Data for PPQ Drug Product EL8723 Stored at - 20 ± 5 °C
(Pfizer, Puurs)................................ ................................ ........................... 30
Table 3.2.P.8.3-22. Stability Data for PPQ Drug Product EL1491 Upright Vials Stored
at -20 ± 5 °C (Pfizer, Puurs) ................................ ................................ .....31
Table 3.2.P.8.3-23. Stability Data for Drug Product Emergency Supply Lot EH9899
Stored at - 20 ± 5 °C ................................ ................................ .................. 32
Table 3.2.P.8.3-24. Stability Data for Drug Product Emergency Supply Lot EJ1688
Stored at - 20 ± 5 °C ................................ ................................ .................. 33
Table 3.2.P.8.3-25. Stability Data for Dru g Product Emergency Supply Lot EK1768
Stored at - 20 ± 5 °C ................................ ................................ .................. 34
Table 3.2.P.8.3-26. Stability Data for Drug Product Emergency Supply Lot EJ1686
Stored at - 20 ± 5 °C ................................ ................................ .................. 35
Table 3.2.P.8.3-27. Stability Data for Drug Product Emergency Supply Lot EJ1685
Stored at - 20 ± 5 °C ..................................................................................36
Table 3.2.P.8.3-28. Stability Data for Drug Product Emergency Supply Lot EJ0553
Stored at - 20 ± 5 °C ................................ ................................ .................. 37
Table 3.2.P.8.3-29. Stability Data for Drug Product Emergency Supply Lot EE8493
Stored at - 20 ± 5 °C ................................ ................................ .................. 38
Table 3.2.P.8.3-30. Stability Data for Drug Product Emergency Supply Lot EE8492
Stored at - 20 ± 5 °C ................................ ................................ .................. 39
Table 3.2.P.8.3-31. Stability Data for PPQ Drug Product EN6199 Stored at 2 -8 °C
(Pfizer, Kalamazoo) ................................ ................................ .................. 40
Table 3.2.P.8.3-32. Stability Data for PPQ Drug Product EL3249 Upright Vials Stored
at 2-8 °C (Pfizer, Kalamazoo) ................................ ................................ ..41
Table 3.2.P.8.3-33. Stability Data for PPQ Drug Product EL9267 Stored at 2- 8 °C
(Pfizer, Kalamazoo) ................................ ................................ .................. 42
Table 3.2.P.8.3-34. Stability Data for PPQ Drug Product EL3248 Upright Vials Stored
at 2-8 °C (Pfizer, Kalamazoo) ................................ ................................ ..43
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149641
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3-35. Stability Data for PPQ Drug Product EM4965 Stored at 2- 8 °C
(Poly mun/Pfizer, Puurs) ................................ ................................ ........... 44
Table 3.2.P. 8.3-36.Stability Data for PPQ Drug Product EL7834 Upright Vials Stored
at 2 to 8 °C (Poly mun/Pfizer, Puurs) ................................ ........................ 45
Table 3.2.P.8.3-37. Stability Data for PPQ Drug Product EN1195 Stored at 2 -8 °C
(mibe/Pfizer, Puurs) ................................ ................................ .................. 46
Table 3.2.P.8.3-38. Stability Data for PPQ Drug Product EK4242 Upright Vials Stored
at 2 to 8 °C (mibe/Pfizer, Puurs) ................................ .............................. 47
Table 3.2.P.8.3-39. Stability Data for PPQ Drug Product EP 2166 Stored at 2- 8 °C
(Pfizer, Puurs)................................ ................................ ........................... 48
Table 3.2.P.8.3-40. Stability Data for PPQ Drug Product EL8713 Stored at 2- 8 °C
(Pfizer, Puurs) ................................ ................................ ........................... 49
Table 3.2.P.8.3-41. Stability Data for PPQ Drug Product EM6950 Stored at 2- 8 °C
(Pfizer, Puurs)................................ ................................ ........................... 50
Table 3.2.P.8.3-42. Stability Data for PPQ Drug Product EL8723 Stored at 2- 8 °C
(Pfizer, Puurs)................................ ................................ ........................... 51
Table 3.2.P.8.3-43. Stability Data for PPQ Drug Product EL1491 Upright Vials Stored
at 2-8 °C (Pfizer, Puurs) ................................ ................................ ............ 52
Table 3.2.P.8.3-44. Stability Data for Drug Product Emergency Supply Lot EH9899
Stored at 2-8 °C ........................................................................................53
Table 3.2.P.8.3-45. Stability Data for Drug Product Emergency Supply Lot EJ1688
Stored at 2 to 8 °C................................ ................................ ..................... 54
Table 3.2.P.8.3-46. Stability Data for Drug Product Emergency Supply Lot EK1768
Stored at 2-8 °C ........................................................................................55
Table 3.2.P.8.3-47. Stability Data for Drug Product Emergency Supply Lot EJ1686
Stored at 2-8 °C ........................................................................................56
Table 3.2.P.8.3-48. Stability Data for Drug Product Emergency Supply Lot EJ1685
Stored at 2-8 °C ........................................................................................57
Table 3.2.P.8.3-49. Stability Data for Drug Product Emergency Supply Lot EJ0553
Stored at 2-8 °C ........................................................................................58
Table 3.2.P.8.3-50. Stability Data for Drug Product Emergency Supply Lot EE8493
Stored at 2-8 °C ........................................................................................59
Table 3.2.P.8.3-51. Stability Data for Drug Product Emergency Supply Lot EE8492
Stored at 2-8 °C ........................................................................................60
Table 3.2.P.8.3-52. Stability Data for Pol ymun Scientific Drug P roduct BNT162b2 Lot
BCV40820 -P Stored at 2 -8 °C................................ ................................ ..61
Table 3.2.P.8.3-53. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lo t
BCV40720 -P Stored at 2 -8 °C................................ ................................ ..62
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149642
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3-54. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -C Stored at 2 -8 °C ................................ ................................ .63
Table 3.2.P.8.3-55. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -A Stored at 2-8 °C.................................................................64
Table 3.2.P.8.3-56. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -E Stored at 2 -8 °C ................................ ................................ .65
Table 3.2.P.8.3-57. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -A Stored at 2-8 °C.................................................................66
Table 3.2.P.8.3-58. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40420 -A Stored at - 40 ± 5 °C ................................ ........................... 67
Table 3.2.P.8.3-59. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40420 -A Stored at 2-8 °C.................................................................68
Table 3.2.P.8.3-60. Stability Data for Pol ymun Scientific Drug Product BNT162b2
Non-clinical Lot CoVVAC/270320 Stored at - 40 ± 5 °C ......................... 69
Table 3.2.P.8.3-61. Stability Data for Pol ymun Scientific Drug Product BNT162b2
Non-clinical Lot CoVVAC/270320 Stored at 2-8 °C...............................70
Table 3.2.P.8.3-62. Stability Data for PPQ Drug Product EL7834 Inverted Vials Stored
at -20 ± 5 °C (Poly mun/Pfizer, Puurs) ................................ ..................... 71
Table 3.2.P.8.3-63. Stability Data for PPQ Drug Product EK4242 Inverted Vials Stored
at -20 ± 5 °C (mibe/Pfizer, Puurs) ................................ ............................ 72
Table 3.2.P.8.3-64. Stability Data for PPQ Drug Product EL1491 Inverted Vials Stored
at -20 ± 5 °C (Pfizer, Puurs) ................................ ................................ .....73
Table 3.2.P.8.3-65. Stability Data for PPQ Drug Product EL3248 Inverted Vials Stored
at -20 ± 5 °C (Pfizer, Kalamazoo) ................................ ............................ 74
Table 3.2.P.8.3-66. Stability Data for PPQ Drug Product EL3249 Inverted Vials Stored
at -20 ± 5 °C (Pfizer, Kalamazoo) ................................ ........................... 75
Table 3.2.P.8.3-67. Stability Data for PPQ Drug Product EL7834 Inverted Vials Stored
at 2 to 8 °C (Poly munPfizer, Puurs) ................................ ........................ 76
Table 3.2.P.8.3-68. Stability Data for PPQ Drug Product EK4242 Inverted Vials Stored
at 2 to 8 °C (mibe/Pfizer, Puurs) ................................ ............................... 77
Table 3.2.P.8.3-69. Stability Data for PPQ Drug Product EL1491 Inverted Vials Stored
at 2 to 8 °C (Pfizer, Puurs) ................................ ................................ ........ 78
Table 3.2.P.8.3-70. Stability Data for PPQ Drug Product EL3248 Inverted Vials Stored
at 2 to 8 °C (Pfizer, Kalamazoo) ................................ ............................... 79
Table 3.2.P.8.3-71. Stability Data for PPQ Drug Product EL3249 Inverted Vials Stored
at 2 to 8 °C (Pfizer, Kalamazoo) ................................ ............................... 80
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149643
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
LIST OF FIGURES
Figure 3.2.P.8.3-1. LNP Poly dispersity Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated -20 ± 5 °C Conditions ................................ .81
Figure 3.2.P.8.3-2. LNP Poly dispersity Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated -20 ± 5 °C Conditions Expanded View.......82
Figure 3.2.P.8.3-3. LNP Size Results for Emergency Suppl y and PPQ Drug Product
Lots at Accelerated -20 ± 5 °C Conditions ................................ ............... 83
Figure 3.2.P.8.3-4. LNP Size Results for Emergency Suppl y and PPQ Drug Product
Lots at Accelerated -20 ± 5 °C Conditions Expanded View .................... 84
Figure 3.2.P.8.3-5. RNA Content Results for Emergency Suppl y and PPQ Drug
Product L ots at Accelerated - 20 ± 5 °C Conditions ................................ .85
Figure 3.2.P.8.3-6. RNA Encapsulation Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated - 20 ± 5 °C Conditions ................................ .86
Figure 3.2.P.8.3-7. RNA Encapsulation Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated - 20 ± 5 °C Conditions Expanded View .......87
Figure 3.2.P.8.3-8. ALC-0315 Lipid Content Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated -20± 5 °C Conditions ........................ 88
Figure 3.2.P.8.3-9. ALC-0159 Lipid Content Results for Emergency Supply and PPQ
Drug Product Lots at Accelerat ed -20 ± 5 °C Condition .......................... 89
Figure 3.2.P.8.3-10. DSPC L ipid Content Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated -20 ± 5 °C Conditions ........................ 90
Figure 3.2.P.8.3-11. Cholesterol L ipid Content Results for Emergency Supply and
PPQ Drug Product Lots at Accelerated -20 ± 5 °C Conditions ................ 91
Figure 3.2.P.8.3-12. RNA I ntegrit y Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated - 20 ± 5 °C Conditions ................................ .92
Figure 3.2.P.8.3-13. RNA I ntegrit y Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated -20 ± 5 °C Conditions Expanded View....... 93
Figure 3.2.P.8.3-14. IVE Results for Emergency Suppl y and PPQ Drug Product
Lots at Accelerated -20 ± 5 °C Conditions ................................ ............... 94
Figure 3.2.P.8.3-15. LNP Poly dispersity Results for Emergency Supply and PPQ
Drug Produc t Lots at Accelerated 2 to 8 °C Conditions ........................... 95
Figure 3.2.P.8.3-16. LNP Poly dispersity Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated 2 to 8 °C Conditions Expanded
View ................................ ................................ ................................ .......... 96
Figure 3.2.P.8.3-17. LNP Size Results for Emergency Suppl y and PPQ Dru g
Product L ots at Accelerated 2 to 8 °C Conditions ................................ ....97
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149644
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Figure 3.2.P.8.3-18. LNP Size Results for Emergency Suppl y and PPQ Drug
Product L ots at Accelerated 2 to 8 °C Conditions Expanded View ......... 98
Figure 3.2.P.8.3-19. RNA Content Results for Emergency Suppl y and PPQ Drug
Product L ots at Accelerated 2 to 8 °C Conditions ................................ ....99
Figure 3.2.P.8.3-20. RNA Encapsulation Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated 2 to 8 °C Conditions ......................... 100
Figure 3.2.P.8.3-21. RNA Encapsulation Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated 2 to 8 °C Conditions Expanded
View ................................ ................................ ................................ ........ 101
Figure 3.2.P.8.3-22. ALC-0315 Lipid Content Results for Emergency Supply and
PPQ Drug Product Lots at Accelerated 2 to 8 °C Conditions ................ 102
Figure 3.2.P.8.3-23. ALC-0159 Lipid Content Re sults for Emergency Supply and
PPQ Drug Product Lots at Accelerated 2 to 8 °C Conditions ................ 103
Figure 3.2.P.8.3-24. DSPC L ipid Content Results for Emergency Supply and PPQ
Drug Product Lots at Accelerated 2 to 8 °C Conditions ......................... 104
Figure 3.2.P.8.3-25. Cholesterol L ipidContent Results for Emergency Supply and
PPQ Drug Product Lots at Accelerated 2 to 8 °C Conditions ................ 105
Figure 3.2.P.8.3-26. RNA Integrit y Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated 2 to 8 °C Conditions ................................ ..106
Figure 3.2.P.8.3-27. RNA I ntegrity Results for Emergency Supply and PPQ Drug
Product L ots at Accelerated 2 to 8 °C Conditions Expanded View .......107
Figure 3.2.P.8.3-28. IVE Results for Emergency Suppl y and PPQ Drug Product
Lots at Accelerated 2 to 8 °C Conditions ................................ ............... 108
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149645
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
STABILITY DATA – ACCELERATED
Data from stability studies on BNT162b2 drug product lots stored at the accelerated
conditions of - 60 to -30 °C (setpoint -40 °C), -40 ± 5C, -20 ± 5°Cand/or5 ± 3 °C are
presented for emergency supply and process performance qualification lotsmanufactured b y
multiple manufacturing sites .
All studies are listed in Table 3.2.P.8.3-1. Available data is shown in through
Table 3.2.P.8.3-71 and in Figure 3.2.P.8.3-1 through Figure 3.2.P.8.3-28.
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149646
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3 -1.Summary Table of Drug Product Accelerated Stability Studies
Lot Number DP Lot Use Stability
Study StartStability Data Presented Data Table
Location
(BNT162b2)
EN6199 (Pfizer,
Kalamazoo, Line
)Stability, Emergency
SupplybProcess
performance
qualificationFebruary 2021 -60 to -30 °C: Release Table 3.2.P.8.3 -2
-20 °C: 3month s Table 3.2.P.8.3 -10
5 °C: 3month s Table 3.2.P.8.3 -31
EL3249 (Pfizer
Kalamazoo, Line
)Stability, Emergency
Supplyb, Process
performance
qualificationDecember
2020-20 °Cupright vials :
6monthsTable 3.2.P.8.3 -11
-20 °C inverted vials :
6monthsTable 3.2.P.8.3 -66
5 °C upright vials :
6monthsTable 3.2.P.8.3 -32
5 °C inverted vials :
6monthsTable 3.2.P.8.3 -71
EL9267 (Pfizer,
Kalamazoo, Line
)Stability, Clinical,
Commercial, Process
performance
qualificationJanuary 2021 -60 to -30 °C: Release Table 3.2.P.8.3 -3
-20 °C: 3month s Table 3.2.P.8.3 -12
5 °C: 3month Table 3.2.P.8.3 -33
EL3248 (Pfizer,
Kalamazoo, Line
)Stability, Emergency
Supplyb, Process
performance
qualificationDecember
2020-20 °Cupright vials :
6monthsTable 3.2.P.8.3 -13
-20 °C inverted vials :
6monthsTable 3.2.P.8.3 -65
5 °C upright vials :
6monthsTable 3.2.P.8.3 -34
5 °C inverted vials :
6monthsTable 3.2.P.8.3 -70
EM4965
(Polymun
Scientific/Pfizer,
Puurs)Stability, Clinical,
Commercial, Process
performance
qualificationFebruary 2021 -60 to -30 °C: Release Table 3.2.P.8.3 -4
-20 °C: 3month s Table 3.2.P.8.3 -14
5 °C: 3month s Table 3.2.P.8.3 -35
EL7834
(Polymun
Scientific/Pfizer,
PuursStability, Emergency
Supplyb, Process
performance
qualificationDecember
2020-20 °Cupright vials :
6monthsTable 3.2.P.8.3 -15
-20 °C inverted vials :
6monthsTable 3.2.P.8.3 -62
5 °C upright vials :
6monthsTable 3.2.P.8.3 -36
5 °C inverted vials :
6monthsTable 3.2.P.8.3 -67
EN1195
(mibe/Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationMarch 2021 -20 °C: 3month s Table 3.2.P.8.3 -16
5 °C: 3month s Table 3.2.P.8.3 -37
EK4242
(mibe/Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationDecember
2020-20 °Cupright vials :
6monthsTable 3.2.P.8.3 -17
-20 °C inverted vials :
6monthsTable 3.2.P.8.3 -63
5 °C upright vials :
6monthsTable 3.2.P.8.3 -38
5 °C inverted vials :
6monthsTable 3.2.P.8.3 -68
EP2166 (Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationJanuary 2021 -20 °C: 3months Table 3.2.P.8.3 -18
5 °C: 3months Table 3.2.P.8.3 -39
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b
)
(b
)
(
(
FDA-CBER-2021-5683-1149647
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3 -1.Summary Table of Drug Product Accelerated Stability Studies
Lot Number DP Lot Use Stability
Study StartStability Data Presented Data Table
Location
EL8713 (Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationJanuary 2021 -20 °C: 3months Table 3.2.P.8.3 -19
5 °C: 3months Table 3.2.P.8.3 -40
EM6950 (Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationJanuary 2021 -60 to -30 °C: Release Table 3.2.P.8.3 -5
-20 °C: 3months Table 3.2.P.8.3 -20
5 °C: 3months Table 3.2.P.8.3 -41
EL8723 (Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationJanuary 2021 -60 to -30 °C: Release Table 3.2.P.8.3 -6
-20 °C: 3months Table 3.2.P.8.3 -21
5 °C: 3months Table 3.2.P.8.3 -42
EL1491 (Pfizer,
Puurs)Stability, Emergency
Supplyb, Process
performance
qualificationDecember
2020-20 °Cupright vials :
6monthsTable 3.2.P.8.3 -22
-20 °C inverted vials :
6monthsTable 3.2.P.8.3 -64
5 °C upright vials :
6monthsTable 3.2.P.8.3 -43
5 °C inverted vials :
6monthsTable 3.2.P.8.3 -69
EH9899 (Pfizer,
Kalamazoo)Stability, Emergency
SupplybNovember
2020-20 °C: 6month s Table 3.2.P.8.3 -23
5 °C: 3 months (complete) Table 3.2.P.8.3 -44
EJ1688 (Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplyb, Clinical
inventoryNovember
2020-20 °C: 6month s(complete) Table 3.2.P.8.3 -24
5 °C: 3month s (complete) Table 3.2.P.8.3 -45
EK1768
(Polymun
Scientific/Pfizer,
PuursStability, Emergency
Supplyb, Clinical
inventoryNovember
2020-20 °C: 6month s (complete) Table 3.2.P.8.3 -25
5 °C: 3 months (complete) Table 3.2.P.8.3 -46
EJ1686
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplyb, Clinical
inventoryNovember
2020-20 °C: 6month s (complete) Table 3.2.P.8.3 -26
5 °C: 3 months (complete) Table 3.2.P.8.3 -47
EJ1685
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplyb, Clinical
inventoryNovember
2020-60 to -30 °C: 6month s Table 3.2.P.8.3 -7
-20 °C: 6month s (complete) Table 3.2.P.8.3 -27
5 °C: 3month s (complete) Table 3.2.P.8.3 -48
EJ0553
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplyb, Clinical
inventoryNovember
2020 -60 to -30 °C: 6month s
(complete)Table 3.2.P.8.3 -8
-20 °C: 6month s (complete) Table 3.2.P.8.3 -28
5 °C: 3month s (complete) Table 3.2.P.8.3 -49
EE8493
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplyb, Clinical
inventorySeptember
2020-60 to -30 °C: 6month s
(complete)Table 3.2.P.8.3 -9
-20 °C: 6months
(complete)Table 3.2.P.8.3 -29
5 °C: 3month s (complete) Table 3.2.P.8.3 -50
EE8492
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
SupplybSeptember
2020-20 °C: 6months
(complete)Table 3.2.P.8.3 -30
5 °C: 3months (complete) Table 3.2.P.8.3 -51
EE3813c
(Polymun
Scientific/Pfizer,
Puurs)Stability, clinical August 2020 5 °C: 3months
(complete )Table 3.2.P.8.3 -52
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149648
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3 -1.Summary Table of Drug Product Accelerated Stability Studies
Lot Number DP Lot Use Stability
Study StartStability Data Presented Data Table
Location
ED3938d
(Polymun
Scientific/Pfizer,
Puurs)Stability, clinical
inventoryAugust 2020 5 °C: 3months
(complete )Table 3.2.P.8.3 -53
BCV40720 -C
(Polymun
Scientific)Stability, clinical August 2020 5 °C: 3months
(complete )Table 3.2.P.8.3 -54
BCV40720 -A
(Polymun
Scientific)Stability, clinical August 2020 5 °C: 3months
(complete )Table 3.2.P.8.3 -55
BCV40620 -E
(Polymun
Scientific)Stability, clinical July 2020 5 °C: 3 months
(complete)Table 3.2.P.8.3 -56
BCV40620 -A
(Polymun
Scientific)Stability, Clinical July 2020 5 °C: 3 months
(complete)Table 3.2.P.8.3 -57
BCV40420 -A
(Polymun
Scientific)Stability, Clinical May 2020 -40 °C: 12months Table 3.2.P.8.3 -58
5 °C: 6 months
(complete)Table 3.2.P.8.3 -59
CoVVAC/270320
(Polymun
Scientific)Stability, non -clinical
toxicologyMarch 2020a-40 °C: 3 months Table 3.2.P.8.3 -60
5 °C: 6 months
(complete)Table 3.2.P.8.3 -61
a. -40 °C study started in April 2020.
b. Emergency supply designation applies to US market.
c. This lot number is equivalent to BCV40820 -P.
d. This lot number is equivalent to BCV40720- P.
TBD = To Be Determined
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
FDA-CBER-2021-5683-1149649
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.8.3 -2.Stability Data for PPQ Drug Product EN6199 Stored at -60 to -30 °C (Pfizer, Kalamazoo)
Analytical Procedure/
Quality AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible
ParticulatesLNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance Criteria aWhite to
off-white
suspensionMay contain
white to off- white
opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
6M S S S S S S S S
12M S S S S S S S S
18M S S S S S S S S
24M S S S S S S S S
Analytical Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel Electrophoresis
ALC -0315
ContentALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance Criteriaa
0
6M S S S S S S
12M S S S S S S
18M S S S S S S
24M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149650
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.8.3 -3.Stability Data for PPQ Drug Product EL9267 Stored at -60 to -30 °C (Pfizer, Kalamazoo)
Analytical
Procedure/ Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering
(DLS)Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA Encapsulation RNA Content
Timepoint/
Acceptance
Criteria aWhite to
off-white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
6M S S S S S S S S
12M S S S S S S S S
18M S S S S S S S S
24M S S S S S S S S
Analytical
Procedure/ Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteria a
0
6M S S S S S S
12M S S S S S S
18M S S S S S S
24M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, W OFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149651
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 13Table 3.2.P.8.3 -4.Stability Data for PPQ Drug Product EM4965 Stored at -60 to -30 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible ParticlesbDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible
ParticulatesLNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to
off-white
suspensionMay contain white
to off -white
opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets ( )
6M S S S S S S S S
12M S S S S S S S S
18M S S S S S S S S
24M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
6M S S S S S S
12M S S S S S S
18M S S S S S S
24M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149652
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 14Table 3.2.P.8.3 -5.Stability Data for PPQ Drug Product EM6950 Stored at -60 to -30 °C (Pfizer, Puurs)
Analytical
Procedure/ Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
6M S S S S S S S S
12M S S S S S S S S
18M S S S S S S S S
24M S S S S S S S S
Analytical
Procedure/ Quality
Attribute HPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
6M S S S S S S
12M S S S S S S
18M S S S S S S
24M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149653
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.8.3 -6.Stability Data for PPQ Drug Product EL8723 Stored at -60 to -30 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
6M S S S S S S S S
12M S S S S S S S S
18M S S S S S S S S
24M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0c
6M S S S S S S
12M S S S S S S
18M S S S S S S
24M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension.
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149654
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.8.3 -7. Stability Data for Drug Product Emergency Supply Batch EJ1685 Stored at - 60 to -30 °C
Analytical
Procedure/
Quality AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white to off-
white opaque, amorphous
particles7.4 ± 0.5
0 WOFS
1M WOFS Meets
3M WOFS Meets
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149655
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.8.3 -8. Stability Data for Drug Product Emergency Supply Batch EJ0553 Stored at - 60 to -30 °C
Analytical
Procedure/
Quality AttributeAppearance pH Dynamic Light
Scattering (DLS)Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white to off-
white opaque, amorphous
particles7.4 ± 0.5
0 WOFS
1M WOFS
3M WOFS Meets
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance crite
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149656
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.8.3 -9. Stability Data for Drug Product Emergency Supply Lot EE8493 Stored at - 60 to -30 °C
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. No result reported as next time point was available for testing at the tim e the 1 month investigation concluded.
W = Week, M = Month, S = To be Scheduled N S = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, MCR = Meets
Compendial Requirements, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149657
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.8.3 -10.Stability Data for PPQ Drug Product EN6199 Stored at -20 ±5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149658
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.8.3 -11.Stability Data for PPQ Drug Product EL3249 Upright Vials Stored at -20 ± 5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
1M WOFS (Meets) NS
3M WOFS (Meets) NS
6M WOFS (Meets)
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149659
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.8.3 -12.Stability Data for PPQ Drug Product EL9267 Stored at -20 ± 5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality Attribute HPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149660
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.8.3 -13. Stability Data for Drug Product EL3248 Upright Vials Stored at - 20 ± 5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white
opaque,
amorphous
particles7.4 ± 0.5
0 WOFS (Meets)
1M WOFS (Meets) NS
3M WOFS (Meets) NS
6M WOFS (Meets)
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance crite
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149661
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.8.3 -14.Stability Data for PPQ Drug Product EM4965 Stored at -20 ± 5 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering
(DLS )Fluorescence Assay
Appearance
(Visible)Visible
ParticulatesLNP Size LNP
PolydispersityRNA Encapsulation RNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain
white to
off-white
opaque,
amorphous
particles7.4 ±
0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality Attribute HPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149662
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.8.3 -15.Stability Data for PPQ Drug Product EL7834 Upright Vials Stored at - 20 ± 5 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light
Scattering (DLS)Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP
SizeLNP
PolydispersityRNA Encapsulation RNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criter
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WO FS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149663
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.8.3 -16.Stability Data for PPQ Drug Product EN1195 Stored at -20 ± 5 °C (mibe/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0c WOFS Meets
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0c
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. T=0 testing performed for this lot (release values not utilized).
d. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149664
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 26Table 3.2.P.8.3 -17.Stability Data for PPQ Drug Product EK4242 Upright Vials Stored at -20 ± 5 °C (mibe/ Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible
ParticulatesLNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -
white
suspensionMay contain
white to off-
white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149665
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.8.3 -18.Stability Data for PPQ Drug Product EP2166 Stored at -20 ± 5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149666
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 28Table 3.2.P.8.3 -19.Stability Data for PPQ Drug Product EL8713 Stored at -20 ± 5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149667
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 29Table 3.2.P.8.3 -20.Stability Data for PPQ Drug Product EM6950 Stored at -20 ± 5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to
off-white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspensi on
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149668
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.8.3 -21.Stability Data for PPQ Drug Product EL8723 Stored at -20 ± 5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149669
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 31Table 3.2.P.8.3 -22.Stability Data for PPQ Drug Product EL1491 Upright Vials Stored at - 20 ± 5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to
off-white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based
Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criter
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticl e, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149670
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 32Table 3.2.P.8.3 -23. Stability Data for Drug Product Emergency Supply Lot EH9899 Stored at - 20 ± 5 °C
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0c WOFS Meets
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality
Attribute HPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0c
1M
2M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. T=0 testing performed for this lot (release values not utilized).
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149671
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 33Table 3.2.P.8.3 -24.Stab ility Data for Drug Product Emergency Supply Lot EJ1688 Stored at -20 ± 5 °C
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
Criteriaa White to
off-white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
2M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149672
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 34Table 3.2.P.8.3 -25. Stability Data for Drug Product Emergency Supply Lot EK1768 Stored at -20 ±5 °C
Analytical
Procedure/
Quality AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles 7.4 ± 0.5
0 WOFS
1M WOFS Meets
3M WOFS Meets
6M WOFS Meets
Analytical
Procedure /
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149673
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 35Table 3.2.P.8.3 -26. Stability Data for Drug Product Emergency Supply Lot EJ1686 Stored at - 20 ± 5 °C
Analytical
Procedure /
Quality AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles 7.4 ± 0.5
0bWOFS
1M WOFS Meets
3M WOFS Meets
6M WOFS Meets
Analytical
Procedure /
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0b
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. T=0 testing performed for the lot (release values not utilized).
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149674
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 36Table 3.2.P.8.3 -27. Stability Data for Drug Product Emergency Supply Lot EJ1685 Stored at - 20 ± 5 °C
Analytical
Procedure /
Quality AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) May contain white to off-
white opaque, amorphous
particlesLNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
Criteriaa White to off-white
suspension7.4 ± 0.5
0 WOFS
1M WOFS Meets
3M WOFS Meets
6M WOFS Meets
Analytical
Procedure /
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing .
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149675
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 37Table 3.2.P.8.3 -28. Stability Data for Drug Product Emergency Supply Lot EJ0553 Stored at -20 ± 5 °C
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS NS
3M WOFS NS
6M WOFS
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticl e; HPLC -CAD
=high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149676
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 38Table 3.2.P.8.3 -29. Stability Data for Drug Product Emergency Supply Lot EE8493 Stored at -20 ±5 °C
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering
(DLS)Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off w hite opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated with no result being reported.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, MCR = Meets
Compendial Requirements, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149677
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 39Table 3.2.P.8.3 -30. Stability Data for Drug Product Emergency Supply Lot EE8492 Stored at -20 ± 5 °C
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
Polydispersit
yRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1W WOFS NS
2W WOFS NS
1M WOFS NS
2M WOFS NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality Attribute HPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1W
2W
1M
2M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. No result reported as next time point was available for testing at the tim e the 1 month investigation concluded.
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, WOFS = White to off-white suspension, , LNP
= Lipid Nanoparticle, MCR = Meets Compendial Requirements
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149678
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 40Table 3.2.P.8.3 -31.Stability Data for PPQ Drug Product EN6199 Stored at 2- 8 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off w hite opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to off -white
suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(4)
(b)
(b)
(b)
(4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149679
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 41Table 3.2.P.8.3 -32.Stability Data for PPQ Drug Product EL3249 Upright Vials Stored at 2- 8 °C (Pfizer, Kal amazoo)
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
1M WOFS (Meets) NS
3M WOFS (Meets) NS
6M WOFS (Meets)
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149680
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 42Table 3.2.P.8.3 -33.Stability Data for PPQ Drug Product EL9267 Stored at 2 -8 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149681
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 43Table 3.2.P.8.3 -34.Stability Data for PPQ Drug Product EL3248 Upright Vials Stored at 2- 8 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality
Attribute Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
1M WOFS (Meets) NS
3M WOFS (Meets) NS
6M WOFS (Meets)
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149682
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 44Table 3.2.P.8.3 -35.Stability Data for PPQ Drug Product EM4965 Stored at 2 -8 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS (Meets)
2W WOFS (Meets) NS
1M WOFS (Meets) NS
2M WOFS (Meets) NS
3M WOFS (Meets) NS
6M S S S S S S S S
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149683
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 45Table 3.2.P.8.3 -36.Stability Data for PPQ Drug Product EL7834 Upright Vials Stored at 2 to 8 °C (Polymun/Pfizer,
Puurs )
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS (Meets)
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149684
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 46Table 3.2.P.8.3 -37.Stability Data for PPQ Drug Product EN1195 Stored at 2- 8 °C (mibe/Pfizer, Puurs)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0c WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0c
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. T=0 testing performed for this lot (release values not utilized).
d. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled, NS = Not Sc heduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149685
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 47Table 3.2.P.8.3 -38.Stability Data for PPQ Drug Product EK4242 Upright Vials Stored at 2 to 8 °C (mibe/Pfizer, Puurs)
Analytical
Procedure/
Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149686
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 48Table 3.2.P.8.3 -39.Stability Data for PPQ Drug Product EP2166 Stored at 2- 8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality
Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering ( DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149687
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 49Table 3.2.P.8.3 -40.Stability Data for PPQ Drug Product EL8713 Stored at 2 -8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to
off-white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled,NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149688
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 50Table 3.2.P.8.3 -41.Stability Data for PPQ Drug Product EM6950 Stored at 2 -8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particlesb Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled,NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspens ion
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149689
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 51Table 3.2.P.8.3 -42.Stability Data for PPQ Drug Product EL8723 Stored at 2 -8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality
Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
Analytical
Procedure/
Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
2W
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White to
off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149690
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 52Table 3.2.P.8.3 -43.Stability Data for PPQ Drug Product EL1491 Upright Vials Stored at 2- 8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white
to off -white
opaque, amorphous
particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled; NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149691
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 53Table 3.2.P.8.3 -44. Stability Data for Drug Product Emergency Supply Lot EH9899 Stored at 2- 8 °C
Analytical
Procedure/
Quality Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1W WOFS Meets NS
2W WOFS Meets NS
1M WOFS Meets NS
3M WOFS Meets NS
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1W
2W
1M
3M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. T=0 testing performed for this lot (release values not utilized).
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White
to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149692
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 54Table 3.2.P.8.3 -45.Stability Data for Drug Product Emergency Supply LotEJ1688 Stored at 2 to 8 °C
Analytical
Procedure/Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white
to off -white
opaque, amorphous
particles7.4 ± 0.5
0 WOFS
1W WOFS
2W WOFS
1M WOFS Meets
3M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
0
1W
2W
1M
3M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC -CAD
=high performance liquid chromatography -charged aerosol detector , WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149693
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 55Table 3.2.P.8.3 -46.Stability Data for Drug Product Emergency Supply Lot EK1768 Stored at 2- 8 °C
Analytical
Procedure/Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
Criteriaa White to off -white
suspensionMay contain white to off- white
opaque, amorphous particles7.4 ± 0.5
0 WOFS
1W WOFS Meets
2W WOFS Meets
1M WOFS Meets
3M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1W
2W
1M
3M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149694
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 56Table 3.2.P.8.3 -47. Stability Data for Drug Product Emergency Supply Lot EJ1686 Stored at 2- 8 °C
Analytical
Procedure/Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to off- white
opaque, amorphous particles7.4 ± 0.5
0b WOFS
1W WOFS Meets
2W WOFS Meets
1M WOFS Meets
3M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0b
1W
2W
1M
3M
a. Acceptance criteria in place at time of testing .
b. T=0 testing performed for this lot (release values not utilitzed).
W = Week, M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149695
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 57Table 3.2.P.8.3 -48.Stability Data for Drug Product Emergency Supply LotEJ1685 Stored at 2 -8 °C
Analytical
Procedure/Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to off- white
opaque, amorphous particles7.4 ± 0.5
0 WOFS
1W WOFS
2W WOFS Meets
1M WOFS Meets
3M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1W
2W
1M
3M
a. Acceptance criteria i
Nanoparticle; HPLC -CAD =high performance liquid chromatography -charged aerosol detector ,WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149696
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 58Table 3.2.P.8.3 -49.Stability Data for Drug Product Emergency Supply LotEJ0553 Stored at 2-8 °C
Analytical
Procedure/Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA Encapsulation RNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS
3M WOFS Meets
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
3M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector , WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149697
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 59Table 3.2.P.8.3 -50.Stability D ata for Drug Product Emergency Supply Lot EE8493 Stored at 2-8 °C
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS NS
3M WOFS Meets NS
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1M
3M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. No result reported as next time point was available for testing at the tim e the 1 month investigation concluded.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, MCR = Meets
Compendial Requirements
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149698
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 60Table 3.2.P.8.3 -51.Stability Data for Drug Product Emergency Supply Lot EE8492 Stored at 2-8 °C
Analytical
Proced ure/
Quality Attribute Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off-
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1W WOFS NS
2W WOFS NS
1M WOFS NS
2M WOFS NS
3M WOFS Meets S
Analytical
Procedure/
Quality AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint/
Acceptance
Criteriaa
0
1W
2W
1M
2M
3M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. No result reported as next time point was available for testing at the tim e the 1 month investigation concluded.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, WOFS = White to off-white suspension, ,
LNP = Lipid Nanoparticle, MCR = Meets Compendial Requirements
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149699
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 61Table 3.2.P.8.3 -52.Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40 820-PStored at 2- 8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass
2 Pass
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Accepta
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149700
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 62Table 3.2.P.8.3 -53. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720- P Stored at 2 -8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Acceptance criteria in place at time of testing.
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149701
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 63Table 3.2.P.8.3 -54. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720-C Stored at 2 -8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Accepta
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149702
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 64Table 3.2.P.8.3 -55. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720- A Stored at 2 -8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Acceptance criteria in place at time of testing.
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149703
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 65Table 3.2.P.8.3 -56. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40620- E Stored at 2- 8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Acceptance criteria in place at time of testing.
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149704
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 66Table 3.2.P.8.3 -57. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40620- A Stored at 2 -8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Results (mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
a. Acceptance criteria in place at time of testing.
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149705
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 67Table 3.2.P.8.3 -58. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40420- A Stored at -40 ± 5 °C
Analytical
Procedure/
Quality
Attribute Appearance Sub-Visible Particles pH Dynamic Light Scattering (DLS) Fluorescence Assay
LNP Size LNP
PolydispersityRNA
EncapsulationRNA
Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS NS NS
2 Pass NS NS NS
3 Pass NS NS NS
4 Pass NS NS NS
6 Pass NS NS NS
9 Pass NS NS NS
12 Pass
18 S NS NS NS S S S S
24 S S S S S S S S
Analytical
Procedure/
Quality
Attribute HPLC -CAD Capillary Gel
ElectrophoresisSterility
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Timepoint/
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
2 NS
3 NS
4 NS
6 NS
9 NS
12 NS
18 S S S S S NS
24 S S S S S S
a. Acceptance criteria in place at time of testing.
S = To be S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, RP = Result Pending
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149706
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 68Table 3.2.P.8.3 -59.Stability Data for Polymun Scientific Drug Product BNT 162b2 Lot BCV40420 -A Stored at 2-8 °C
Time
(Month)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS
2 Pass NS
3 Pass NS
4 Pass NS
6 Pass
Time
(Month)HPLC -CAD Capillary Gel Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Result s(mg/mL) Report Result (mg/mL) Report Result (mg/mL) Report Result (mg/mL)
0
1
2
3
4
6
a.Acceptance criteria in place at time of testing.
S = S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149707
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 69Table 3.2.P.8.3 -60.Stability Data for Polymun Scientific Drug Product BNT162b2 Non -clinical Lot CoVVAC/ 270320
Stored at -40 ±5 °C
Time
(Month)Appearance Subvisible Particles pH LNP Size LNP
PolydispersityRNA
EncapsulationRNA
Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS NS NS
2 Pass NS NS NS
3 Pass NS NS NS
6 S NS NS NS S S S S
9 S NS NS NS S S S S
12 S S S S S S S S
18 S NS NS NS S S S S
24 S S S S S S S S
Time
(Month)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Bioburden
Acceptance
CriteriaaReport Result s
(mg/mL)Report Result s
(mg/mL)Report Result s(mg/mL) Report Result s
(mg/mL)
0
1 NS
2 NS
3 NS
6 S S S S S NS
9 S S S S S NS
12 S S S S S NS
18 S S S S S NS
24 S S S S S S
a. Acceptance criteria in place at time of testing.
S = To be Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149708
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 70Table 3.2.P.8.3 -61.Stability Data for Polymun Scientific Drug Product BNT162b2 Non -clinical Lot CoVVAC/ 270320
Stored at 2-8 °C
Time Appearance LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaReport Results Report Results (nm) Report Results Report Results (%) Report Results (mg/mL)
0 Pass
2W Pass
1M Pass
6W Pass
2M Pass
3M Pass
6M Pass
Time ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Result s(mg/mL) Report Result s(mg/mL) Report Result s(mg/mL) Report Result s(mg/mL) Report Results (%)
0
2W
1M
6W
2M
3M
6M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149709
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 71Inverted Vial Stability Studies
Table 3.2.P.8.3 -62.Stability Data for PPQ Drug Product EL7834 Inverted Vials Stored at -20 ±5 °C (Polymun/Pfizer,
Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149710
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 72Table 3.2.P.8.3 -63. Stability Data for PPQ Drug Product EK4242 Inverted Vials Stored at -20 ±5 °C (mibe/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WO FS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149711
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 73Table 3.2.P.8.3 -64.Stability Data for PPQ Drug Product EL1491 Inverted Vials Stored at -20 ±5 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149712
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 74Table 3.2.P.8.3 -65.Stability Data for PPQ Drug Product EL3248 Inverted Vials Stored at -20 ±5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149713
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 75Table 3.2.P.8.3 -66.Stability Data for PPQ Drug Product EL3249 Inverted Vials Stored at -20 ±5 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149714
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 76Table 3.2.P.8.3 -67.Stability Data for PPQ Drug Product EL7834 Inverted Vials Stored at 2 to 8 °C (PolymunPfizer,
Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149715
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 77Table 3.2.P.8.3 -68.Stability Data for PPQ Drug Product EK4242 Inverted Vials Stored at 2 to 8 °C (mibe/Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance li quid chromatography -charged aerosol detector, WOFS = White to off -white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149716
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 78Table 3.2.P.8.3 -69. Stability Data for PPQ Drug Product EL1491 Inverted Vials Stored at 2 to 8 °C (Pfizer, Puurs)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off-
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149717
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 79Table 3.2.P.8.3 -70.Stability Data for PPQ Drug Product EL3248 Inverted Vials Stored at 2 to 8 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off-white suspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149718
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 80Table 3.2.P.8.3 -71.Stability Data for PPQ Drug Product EL3249 Inverted Vials Stored at 2 to 8 °C (Pfizer, Kalamazoo)
Analytical
Procedure/
Quality AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
6M WOFS Meets
Analytical
Procedure/Quality
AttributeHPLC -CAD Cell-based Flow
CytometryCapillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint /
Acceptance
Criteriaa
0
1M
6M
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white s uspension
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149719
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 81Figure 3.2.P.8.3 -1. LNP Polydispersity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149720
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 82Figure 3.2.P.8.3 -2.LNP Pol ydispersity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C
Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149721
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 83Figure 3.2.P.8.3 -3.LNP Size Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 ° C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149722
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Page 84Figure 3.2.P.8.3 -4.LNP Size Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 ° C
Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149723
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 85Figure 3.2.P.8.3 -5.RNA Content Results for Emergency Sup ply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149724
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Page 86Figure 3.2.P.8.3 -6. RNA Encapsulation Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5
°C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149725
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 87Figure 3.2.P.8.3 -7.RNA Encapsulation Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5
°C Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149726
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Page 88Figure 3.2.P.8.3 -8.ALC -0315 Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20
± 5 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149727
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 89Figure 3.2.P.8.3 -9.ALC -0159 Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20
± 5 °C Condition
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149728
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 90Figure 3.2.P.8.3 -10. DSPC Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5
°C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149729
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 91Figure 3.2.P.8.3 -11. Cholesterol Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20
± 5 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149730
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 92Figure 3.2.P.8.3 -12. RNA Integrity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149731
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Page 93Figure 3.2.P.8.3 -13.RNA Integrity Re sults for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C
Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149732
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 94Figure 3.2.P.8.3 -14.IVE Results for Emergency Supply and PPQ Drug Product Lots at Accelerated -20 ± 5 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149733
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Page 95Figure 3.2.P.8.3 -15. LNP Polydispersity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 ° C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149734
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 96Figure 3.2.P.8.3 -16.LNP Polydispersity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C
Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149735
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 97Figure 3.2.P.8.3 -17.LNP Size Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149736
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 98Figure 3.2.P.8.3 -18.LNP Size Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C Conditions
Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149737
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 99Figure 3.2.P.8.3 -19.RNA Content Results for Emergenc y Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149738
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 100Figure 3.2.P.8.3 -20. RNA Encapsulation Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 ° C
Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149739
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 101Figure 3.2.P.8.3 -21. RNA Encapsulation Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 ° C
Conditions Expanded View
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149740
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 102Figure 3.2.P.8.3 -22.ALC -0315 Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to
8 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149741
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 103Figure 3.2.P.8.3 -23.ALC -0159 Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to
8 °C Conditions
090177e197d4b87a\Approved\Approved On: 17-Aug-2021 14:37 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149742
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 104Figure 3.2.P.8.3 -24.DSPC Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C
Conditions
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(b) (4)
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BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 105Figure 3.2.P.8.3 -25.Cholesterol Lipid Content Results for Emergency Supply and PPQ Drug Product Lots at Ac celerated 2
to 8°C Conditions
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(b) (4)
FDA-CBER-2021-5683-1149744
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 106Figure 3.2.P.8.3 -26.RNA Integrity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C
Conditions
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(b) (4)
FDA-CBER-2021-5683-1149745
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 107Figure 3.2.P.8.3 -27.RNA Integrity Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C
Conditions Expanded View
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(b) (4)
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BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 108Figure 3.2.P.8.3 -28.IVE Results for Emergency Supply and PPQ Drug Product Lots at Accelerated 2 to 8 °C Condi tions
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(b) (4)
FDA-CBER-2021-5683-1149747