125742 S2 M3 32p8 stability data accelerated

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
Download PDF ↗ Live URL (may be dead)
Document text

BNT162b2
3.2.P.8.3. Stability Data
Accelerated
TABLE OF CON TENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
3.2.P.8.3. STABILITY DATA – ACCEL ERATED ................................ ................................ ..4
LIST OF TABLES
Table 3.2.P.8.3-1. Summary  Table of Drug Product Accelerated Stability  Studies ................ 5
Table 3.2.P.8.3-2. Stability  Data for Drug Product EN6199 Stored at -60 to -30 °C .............. 8
Table 3.2.P.8.3-3. Stability  Data for Drug Product EL9267 Stored at -60 to -30 °C............... 9
Table 3.2.P.8.3-4. Stability  Data for Drug Product EM4965 Stored at - 60 to -30 °C............ 10
Table 3.2.P.8.3-5. Stability  Data for Drug Product EM6950 Stored at - 60 to -30 °C............ 11
Table 3.2.P.8.3-6. Stability  Data for Drug Product EL8723 Stored at -60 to -30 °C............. 12
Table 3.2.P.8.3-7. Stability  Data for Drug Product Emergency  Supply  Batch EJ1685 
Stored at - 60 to -30 °C................................ ................................ .............. 13
Table 3.2.P.8.3-8. Stability  Data for Drug Product Emergency  Supply  Batc h EJ0553 
Stored at - 60 to -30 °C................................ ................................ .............. 14
Table 3.2.P.8.3-9. Stability  Data for Drug Product EE8493 Stored at -60 to -30 °C............. 15
Table 3.2.P.8.3-10. Stability  Data for Drug Product EN6199 Stored at -20 ± 5 °C ................ 16
Table 3.2.P.8.3-11. Stability  Data for Drug Product EL3249 Stored at -20 ± 5 °C ................. 17
Table 3.2.P.8.3-12. Stability  Data for Drug Product EL9267 Stored at -20 ± 5 °C ................. 18
Table 3.2.P.8.3-13. Stability Data for Drug Product EL3248 Stored at -20 ± 5 °C ................. 19
Table 3.2.P.8.3-14. Stability  Data for Drug Product EM4965 Stored at -20 ± 5 °C................20
Table 3.2.P.8.3-15. Stability  Data for Drug Product EL7834 Stored at -20 ± 5 °C ................. 21
Table 3.2.P.8.3-16. Stability  Data for Drug Product EN1195 Stored at -20 ± 5 °C ................ 22
Table 3.2.P.8.3-17. Stability  Data for Drug Product EK4242 Stored at -20 ± 5 °C ................ 23
Table 3.2.P.8.3-18. Stability  Data for Drug Product EP2166 Stored at -20 ± 5 °C ................. 24
Table3.2.P.8.3-19. Stability  Data for Drug Product EL8713 Stored at -20 ± 5 °C ................. 25
Table 3.2.P.8.3-20. Stability  Data for Drug Product EM 6950 Stored at - 20 ± 5 °C ................ 26
Table 3.2.P.8.3-21. Stability  Data for Drug Product EL8723 Stored at -20 ± 5 °C ................. 27
Table 3.2.P.8.3-22. Stability  Data for Drug Product EL1491 Stored at -20 ± 5 °C ................. 28
Table 3.2.P.8.3-23. Stability  Data for Drug Product Emergency  Supply  Lot EH9899 
Stored at - 20 ± 5 °C ................................ ................................ .................. 29
Table 3.2.P.8.3-24. Stability  Data for Drug Product Emergency  Supply  Lot EJ1688 
Stored at - 20 ± 5 °C ................................ ................................ .................. 30
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149105
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3-25. Stability  Data for Drug Product Emergency  Supply  Lot EK1768 
Stored at - 20 ± 5 °C ................................ ................................ .................. 31
Table 3.2.P.8.3-26. Stability  Data for Drug Product Emergency  Supply  Lot EJ1686 
Stored at - 20 ± 5 °C ................................ ................................ .................. 32
Table 3.2.P.8.3-27. Stability  Data for Drug Product Emergency  Supply  Lot EJ1685 
Stored at - 20 ± 5 °C ................................ ................................ .................. 33
Table 3.2.P.8.3-28. Stability  Data for Drug Product Emergency Supply  Lot EJ0553 
Stored at - 20 ± 5 °C ................................ ................................ .................. 34
Table 3.2.P.8.3-29. Stability  Data for Drug Product Emergency  Supply  LotEE8493 
Stored at - 20 ± 5 °C ................................ ................................ .................. 35
Table 3.2.P.8.3-30. Stability  Data for Drug Product Emergency  Supply  Lot EE8492 
Stored at - 20 ± 5 °C ................................ ................................ .................. 36
Table 3.2.P.8.3-31. Stability  Data for Drug Product EN6199 Stored at 2 -8 °C....................... 37
Table 3.2.P.8.3-32. Stability  Data for Drug Product EL3249 Stored at 2 -8 °C ....................... 38
Table 3.2.P.8.3-33. Stability  Data for Drug Product EL9267 Stored at 2 -8 °C ....................... 39
Table 3.2.P.8.3-34. Stability  Data for Drug Product EL3248 Stored at 2-8 °C .......................40
Table 3.2.P.8.3-35. Stability  Data for Drug Product EM4965 Stored at 2-8 °C......................41
Table 3.2.P.8.3-36. Stability  Data for Drug Product EL7834 Stored at 2 to 8 °C ................... 42
Table 3.2.P.8.3-37. Stability  Data for Drug Product EN1195 Stored at 2 -8 °C....................... 43
Table 3.2.P.8.3-38. Stability  Data for Drug Product EK4242 Stored at 2 to 8 °C ................... 44
Table 3.2.P.8.3-39. Stability  Data for D rug Product EP2166 Stored at 2 -8 °C ....................... 45
Table 3.2.P.8.3-40. Stability  Data for Drug Product EL8713 Stored at 2 -8 °C ....................... 46
Table 3.2.P.8.3-41. Stability  Data for Drug Product EM6950 Stored at 2-8 °C......................47
Table 3.2.P.8.3-42. Stability  Data for Drug Product EL8723 Stored at 2 -8 °C ....................... 48
Table 3.2.P.8.3-43. Stability  Data for Drug Product EL1491 Stored at 2 -8 °C ....................... 49
Table 3.2.P.8.3-44. Stability  Data for Drug Product Emergency  Supply  Lot EH9899 
Stored at 2-8 °C ........................................................................................50
Table 3.2.P.8.3-45. Stability  Data for Drug Product Emergency  Supply Lot EJ1688 
Stored at 2 to 8 °C................................ ................................ ..................... 51
Table 3.2.P.8.3-46. Stability  Data for Drug Product Emergency  Supply  Lot EK1768 
Stored at 2-8 °C ........................................................................................52
Table 3.2.P.8.3-47. Stability  Data for Drug Product Emergency  Supply  Lot EJ1686 
Stored at 2-8 °C ........................................................................................53
Table 3.2.P.8.3-48. Stability  Data for Drug Product Emergency  Supply  Lot EJ1685 
Stored at 2-8 °C ........................................................................................54
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149106
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
Table 3.2.P.8.3-49. Stability  Data for Drug Product Emergency  Supply  Lot EJ0553 
Stored at 2-8 °C ........................................................................................55
Table 3.2.P.8.3-50. Stability  Data for Drug Product Emergency  Supply  Lot EE8493 
Stored at 2-8 °C ........................................................................................56
Table3.2.P.8.3-51. Stability  Data for Drug Product Emergency  Supply  Lot EE8492 
Stored at 2-8 °C ........................................................................................57
Table 3.2.P.8.3-52. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40820 -P Stored at 2 -8 °C................................ ................................ ..58
Table 3.2.P.8.3-53. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40720 -P Stored at 2 -8 °C................................ ................................ ..59
Table 3.2.P.8.3-54. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40720 -C Stored at 2-8 °C ................................ ................................ .60
Table 3.2.P.8.3-55. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV4 0720 -A Stored at 2-8 °C.................................................................61
Table 3.2.P.8.3-56. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40620 -E Stored at 2 -8 °C ................................ ................................ .62
Table 3.2.P.8.3-57. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40620 -A Stored at 2-8 °C.................................................................63
Table 3.2.P.8.3-58. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40420 -A Stored at - 40 ± 5 °C ................................ ........................... 64
Table 3.2.P.8.3-59. Stability  Data for Pol ymun Scientific Drug Product BNT162b2 Lot 
BCV40420 -A Stored at 2-8 °C.................................................................65
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 ......................... 66
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...............................67
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149107
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
3.2.P.8.3. 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), -20 ± 5 °Cand/or5 ± 3 °C are presented for
emergency  supply  and process performance qualification lotsmanufactured by Pfizer, 
Kalamazoo, mibe (with fill and finish at Pfizer Puurs ), Poly mun (with fill and finish at 
Pfizer, Puurs ) and Pfizer, Puurs.
All studies are listed in Table 3.2.P.8.3-1 . Available d ata isshown in T able 3.2.P.8.3-2
through Table 3.2.P.8.3-61.
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149108
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 
PresentedData 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: 1 month Table 3.2.P.8.3 -10
5 °C: 1 month Table 3.2.P.8.3 -31
EL3249 (Pfizer 
Kalamazoo, Line 
)Stability, Emergency 
Supplyb, Process 
performance 
qualificationDecember 2020 -20 °C: 3month s Table 3.2.P.8.3 -11
5 °C: 3month s Table 3.2.P.8.3 -32
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: 1 month Table 3.2.P.8.3 -12
5 °C: 1 month Table 3.2.P.8.3 -33
EL3248 (Pfizer, 
Kalamazoo, Line 
)Stability, Emergency 
Supplyb,Process 
performance 
qualificationDecember 2020
-20 °C: 3month sTable 3.2.P.8.3 -13
5 °C: 3month s Table 3.2.P.8.3 -34
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: 1 month Table 3.2.P.8.3 -14
5 °C: 1 month Table 3.2.P.8.3 -35
EL7834
(Polymun 
Scientific/Pfizer, 
PuursStability, Emergency 
Supplyb, Process 
performance 
qualificationDecember 2020 -20 °C: 3month s Table 3.2.P.8.3 -15
5 °C: 3month s Table 3.2.P.8.3 -36
EN1195 
(mibe/Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Process 
performance 
qualificationMarch 2021 -20 °C: 1 month Table 3.2.P.8.3 -16
5 °C: 1 month Table 3.2.P.8.3 -37
EK4242
(mibe/Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Process 
performance 
qualificationDecember 2020 -20 °C: 3month s Table 3.2.P.8.3 -17
5 °C: 3month s Table 3.2.P.8.3 -38
EP2166 (Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Process 
performance 
qualificationJanuary 2021 -20 °C: 2 months Table 3.2.P.8.3 -18
5 °C: 2 months Table 3.2.P.8.3 -39
EL8713 (Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Process 
performance 
qualificationJanuary 2021 -20 °C: 2month s Table 3.2.P.8.3 -19
5 °C: 2month s 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: 2 months Table 3.2.P.8.3 -20
5 °C: 2 months 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: 2month s Table 3.2.P.8.3 -21
5 °C: 2month s Table 3.2.P.8.3 -42
EL1491 (Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Process 
performance 
qualificationDecember 2020 -20 °C: 3month s Table 3.2.P.8.3 -22
5 °C: 3month s Table 3.2.P.8.3 -43
November 2020 -20 °C: 3month s Table 3.2.P.8.3 -23
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b
) 
(b
) 
(
b
 
(
b
 
FDA-CBER-2021-5683-1149109
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 
PresentedData Table 
Location
EH9899 (Pfizer, 
Kalamazoo)Stability, Emergency 
Supplyb5 °C: 3 months 
(complete)  Table 3.2.P.8.3 -44
EJ1688 (Polymun 
Scientific/Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Clinical 
inventoryNovember 2020 -20 °C: 3month s 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: 3month s 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: 3month s Table 3.2.P.8.3 -26
5 °C: 3month s 
(complete)  Table 3.2.P.8.3 -47
EJ1685
(Polymun 
Scientific/Pfizer, 
Puurs)Stability, Emergency 
Supplyb, Clinical 
inventoryNovember 2020 -60 to -30 °C: 3month sTable 3.2.P.8.3 -7
-20 °C: 3month s 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: 3month sTable 3.2.P.8.3 -8
-20 °C: 3months 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 sTable 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: 6month s
(complete)Table 3.2.P.8.3 -30
5 °C: 3month s
(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
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149110
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 
PresentedData Table 
Location
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: 9months 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149111
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 8Table 3.2.P.8.3 -2.Stability Data for Drug Product EN6199 Stored at -60 to -30 °C
Analytical 
Procedure/ 
Quality AttributeAppearance 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 
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149112
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 9Table 3.2.P.8.3 -3.Stability Data for Drug Product EL9267 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 
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 , WOFS = White 
to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149113
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 10Table 3.2.P.8.3 -4.Stability Data for Drug Product EM4965 Stored at - 60 to -30 °C
Analytical 
Procedure/ 
Quality AttributeAppearance pH Subvisible ParticlesbDynamic 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
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149114
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.8.3 -5. Stability Data for Drug Product EM6950 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 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149115
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.8.3 -6. Stability Data for Drug Product EL8723 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
0c 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 Pending Pending Pending Pending Pending
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.
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.
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149116
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 13Table 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 S cattering (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
1M WOFS Meets 
3M WOFS Meets 
6M 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
1M
3M Pending Pending Pending Pending
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149117
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 14Table 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 
CriteriaaWhite to off -white 
suspensionMay contain white to off-
white opaque, amorphous 
particles7.4 ± 0.5
0 WOFS
1M WOFS
3M WOFS Meets 
6M 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
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications implemented at the 3 month time point.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPL C-CAD 
=high performance liquid chromatography -charged aerosol detector , WOFS = White to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149118
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.8.3 -9.Stability Data for Drug Product 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.  Current specification applied at the 6 month time point.
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, WOFS = White to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149119
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.8.3 -10.Stability Data for Drug Product EN6199 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 
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 S S S NS S S S S
3M S S S NS S S S S
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 S S S S S S
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(4)
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149120
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.8.3 -11. Stability Data for Drug Product EL3249 Stored at -20 ± 5 °C 
Analyt ical 
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 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
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.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOF S = White 
to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149121
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.8.3 -12. Stability Data for Drug Product EL9267 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
0 WOFS  (Meets)
2W WOFS  (Meets) NS
1M WOFS  (Meets) NS
2M S S S NS S S S S
3M S S S NS S S S S
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 S S S S S S
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149122
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.8.3 -13.Stability Data for Drug Product EL3248 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
0 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
0
1M
3M
6M
a.  Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149123
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.8.3 -14. Stability Data for Drug Product EM4965 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
0 WOFS  (Meets)
2W WOFS  (Meets) NS
1M WOFS  (Meets) NS
2M S S S NS S S S S
3M S S S NS S S S S
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
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149124
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.8.3 -15. Stability Data for Drug Product EL7834 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 
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 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
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149125
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.8.3 -16.Stability Data for Drug Product EN1195 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 Pending Pending Pending NS Pending Pending
2M S S S NS S S S S
3M S S S NS S S S S
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 Pending Pending Pending Pending
2M S S S S S S
3M S S S S S S
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).
W = Week, M = Month, S = To be Scheduled NS = Not Scheduled at Time Point, ,LNP = Lipid Nanoparticle, WOFS = White to 
off-white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149126
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.8.3 -17. Stability Data for Drug Product EK4242 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 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
0
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149127
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.8.3 -18.Stability Data for Drug Product EP2166 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
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M Pending Pending NS Pending Pending
3M S S S NS S S S S
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 Pending
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149128
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.8.3 -19. Stability Data for Drug Product EL8713 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
0 WOFS Meets 
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M S S S NS S S S S
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 S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149129
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 26Table 3.2.P.8.3 -20. Stability Data for Drug Product EM6950 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
0 WOFS Meets 
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M S S S NS S S S S
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 Pending Pending
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149130
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.8.3 -21. Stability Data for Drug Product EL8723 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
0 WOFS Meets 
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M S S S NS S S S S
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
Acceptance 
Criteriaa
0
2W
1M
2M Pending
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149131
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 28Table 3.2.P.8.3 -22. Stability Data for Drug Product EL1491 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
0 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
0
1M
3M Pending
6M S S S S S S
a.  Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point..
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149132
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 29Table 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 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
0c
1M
2M
3M
6M S S S S S S
a.  Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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 suspens ion
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149133
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.8.3 -24. Stability 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 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
1M
2M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149134
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 31Table 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 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
1M
3M 
6M S S S S S S
a. Acceptance criteria in place at time of testing.  Current effective acceptance criteria established at the 3 month time point.
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 suspe nsion
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149135
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 32Table 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 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
0b
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149136
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 33Table 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 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
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing . Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) 
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149137
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 34Table 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 
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 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
1M
3M
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications implemented at the 3 month time point.
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, MCR = Meets Compendial Requirements, WOFS = White to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149138
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 35Table 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 Pending
a.  Acceptance criteria in place at time of testing. Current version of specification effective at 6 month time point
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(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-2021-5683-1149139
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 36Table 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 
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 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 Pending
a.  Acceptance criteria in place at time of testing. Current version of specification effective at 6 month time point.
b.  Subvisible particles are reported per container.
c.   Original result investigated and inva lidated. No result reported as next time point was available for testing at the time 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149140
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 37Table 3.2.P.8.3 -31.Stability Data for Drug Product EN6199 Stored at 2 -8 °C 
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 S S S NS S S S S
3M S S S NS S S S S
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 S S S S
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(4)
(b) 
(b) 
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149141
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 38Table 3.2.P.8.3 -32. Stability Data for Drug Product EL3249 Stored at 2 -8 °C 
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 Pending Pending
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
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.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOF S = White 
to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149142
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 39Table 3.2.P.8.3 -33.Stability Data for Drug Product EL 9267 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)
2W WOFS  (Meets) NS
1M WOFS  (Meets) NS
2M S S S NS S S S S
3M S S S NS S S S S
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 Pending Pending Pending Pending
2M S S S S S S
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149143
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 40Table 3.2.P.8.3 -34. Stability Data for Drug Product EL3248 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)
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
0
1M
3M Pending
6M S S S S S S
a.  Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
b.  Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled,NS = Not Scheduled at Time Point,  , LNP = Lipid Nanoparticle
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149144
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 41Table 3.2.P.8.3 -35.Stability Data for Drug Product EM4965 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  (Meets)
2W WOFS  (Meets) NS
1M WOFS  (Meets) NS
2M S S S NS S S S S
3M S S S NS S S S S
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 S S S S S S
3M S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149145
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 42Table 3.2.P.8.3 -36.Stability Data for Drug Product EL7834 Stored at 2 to 8 °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 
CriteriaaWhite to off -
white su spensionMay contain white to 
off-white opaque, 
amorphous particles7.4 ± 0.5
0  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
0
1M
3M Pending
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149146
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 43Table 3.2.P.8.3 -37.Stability Data for Drug Product EN1195 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
0c WOFS Meets 
1M Pending Pending Pending NS Pending Pending
3M S S S NS S S S S
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 Pending Pending Pending Pending
3M S S S S S S
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).
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, , LNP = Lipid Nanoparticle, WOFS = White 
to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149147
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 44Table 3.2.P.8.3 -38.Stability Data for Drug Product EK4242 Stored at 2 to 8 °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 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
0
1M
3M Pending
6M S S S S S S
a. Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149148
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 45Table 3.2.P.8.3 -39.Stability Data for Drug Product EP2166 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 
2W WOFS Meets 
1M WOFS Meets NS
2M Pending Pending NS Pending Pending
3M S S S NS S S S S
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 Pending Pending Pending Pending Pending
3M S S S S S S
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 -whtie suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149149
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 46Table 3.2.P.8.3 -40. Stability Data for Drug Product EL8713 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 
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M S S S NS S S S S
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 S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149150
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 47Table 3.2.P.8.3 -41. Stability Data for Drug Product EM6950 Stored at 2- 8 °C 
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 S S S NS S S S S
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 S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149151
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 48Table 3.2.P.8.3 -42. Stability Data for Drug Product EL8723 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 
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M S S S NS S S S S
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 S S S S S S
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149152
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 49Table 3.2.P.8.3 -43. Stability Data for Drug Product EL1491 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 
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
0
1M
3M Pending
6M S S S S S S
a.  Acceptance criteria in place at time of testing. Current specifications applied at the 3 month time point..
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149153
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 50Table 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 RNA RNA 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 criter
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 T ime Point, , LNP = Lipid Nanoparticle, WOFS = White 
to off -white suspension
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (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-2021-5683-1149154
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 51Table 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. Current specifications implemented at the 3 months time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149155
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 52Table 3.2.P.8.3 -46.Stability Data for Drug Product Emergency Supply Lot EK1768 Stored at 2 -8 °C 
Analytical 
Proc edure/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. Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149156
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 53Table 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 . Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149157
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 54Table 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 in place at time of testing. Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149158
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 55Table 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. Current specifications implemented at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149159
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 56Table 3.2.P.8.3 -50.Stability Data 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.   Current specification applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149160
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 57Table 3.2.P.8.3 -51.Stability Data for Drug Product Emergency Supply Lot EE8492 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
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. Current specification applied at the 3 month time point.
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) 
(b) 
(b) 
(b) 
(b) 
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149161
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 58Table 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 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149162
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 59Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149163
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 60Table 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
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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149164
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 61Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149165
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 62Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149166
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 63Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149167
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 64Table 3.2.P.8.3 -58. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40420-A Stored at -40 ± 5 °C
Time 
(Month)Appearance Sub-Visible Particles pH Dynamic Light Scattering (DLS) Fluorescence Assay
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
4 Pass NS NS NS
6 Pass NS NS NS
9 Pass NS NS NS
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)HPLC -CAD Capillary Gel 
ElectrophoresisSterility
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)Sterile
0 Pass
1 NS
2 NS
3 NS
4 NS
6 NS
9 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 S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149168
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 65Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149169
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 66Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149170
BNT162b2
3.2.P.8.3. Stability Data
Accelerated
PFIZER CONFIDENTIAL
Page 67Table 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
090177e19703fd82\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149171
Related across Profoundd

Oregon Climate Docs

Medford — Transportation System Plan 2018-2038 p.10
LIST OF TABLES Num ber Description Page 1-1 Summary of City of Medfo rd 20-year Revenu e Estimates ........................................... 1-28 2-1 Adop ted Elemen ts of The Oreg on Tran sportation P…
Medford — Transportation System Plan 2018-2038 p.12
LIST OF TABLES Cont inued Number Description Page G-2 HCM Level of Service Designations for Unsignalized Intersections ....................... G-4 G-3 2023 PM Peak Hour Level s of Service: Downtown Medford…
Medford — Transportation System Plan 2018-2038 p.7
TABLE OF CONTENTS Continued Chapter Page 10 NON-MOTORIZED TRANSPORTATION PLAN Continued Strategies...........................................................................................................…
WEF Publications

Nature Positive Role of the Technology Sector 2025 p.66
Data centres – key metrics for existing and emerging hubs232TABLE A3Data centre archetypes Data centre archetypes, illustrated in Figure 12, were developed based on 15 global data centre hubs, made up of the 10 largest …
Making Rare Diseases Count 2026 p.33
21. Implementation of ORPHAcodes can take different forms: Germany uses Alpha-ID-SE (a combined ICD-10/Orpha coding system); several other European countries have adopted approaches through the EU RD-CODE project; Canad…
From Minerals to Megawatts 2025 p.10
Data centre component breakdown by mineral (kgs per MW) FIGURE 4 Total minerals and metals mass per MW: ~60-75 metric tons Value chain contribution to global demand of minerals and metals (2035) Ga 6.0%Ge 2.4%Sn 1.2%Cu…
Epstein Files

EFTA01382272 — Amendment No. 3 to Form S-I
Amendment No. 3 to Form S-I Table of Contents Fuel prices and availability may adversely affect our results of operations. We currently operate 378 fuel centers that are adjacent to many of our store locations. As a resu…
EFTA01382338 — Amendment No. 3 to Form S-1
Amendment No. 3 to Form S-1 Table of Contents Our Industry We operate in the $584 billion U.S. food and drug retail industry, a highly fragmented sector with a large number of companies competing locally and a limited nu…
EFTA00798769 — Project Submittal
CAT Project Submittal For LSJE, LLC - ST. THOMAS Two (2) Caterpillar Model D125 - 8 Engine Driven Generator Set Warren Cat ID No.: M0114821, M0114822 Warren Cat EA No.: CE36505, CE36506 CATERPILLAR EFTA00798769 LSJE, LLC…
Federal Writers' Project

[W. G. Leonard]
Spokane, Washington January 20, 1937 Personal Narrative W. G. Leonard. A personal narrative by W. G. Leonard, Carlyle Hotel, Spokane, based on his experience and that of his father the late Frederick Charles Leonard (185…
[Mr. Obe Adams]
ca -r) ITOLKLORE-WHITE PIONEER, Miss. Effie Cowan,P.W. IcLennan County, Texas, District p. NO. of.Words :Pile NO.240. Page NO.1. REFERENCE. "Interview with 1,ir Obe Adams, Mart, Texas. I was born in 1857 in Grimes County…
[Human Kindness]
9 lear_tet,Ywn, C. Dairy timer Ante V. ;;teens, writer Douglas arter, Reviser 'ITY. rrne4 By four oteloek la the rornini, lights flicker through the windows of the lretan farmhouses arah araham calls to Dale, "asks up so…
Recent News

"Sesame oil exhibits synergistic effect with anti-diabetic medication in patients with type 2 diabetes mellitus."- GreenMedInfo Summary
This is a member's only feature. Please join or upgrade Sesame oil exhibits synergistic effect with anti-diabetic medication in patients with type 2 diabetes mellitus. Clin Nutr. 2011 Jun ;30(3):351-8. Epub 2010 Dec 16. …
Apple’s twice as fast new MacBook Pro laptop and 24-inch iMac all-in-one desktop are here
Kurt "CyberGuy" Knutsson explains the new smart camper. Apple fans got a surprise on Oct. 30 when the company held a short but spooky online event titled "Scary Fast" to announce its latest products powered by its own si…
If Vaccines Injure Pregnant Women or Their Unborn Babies, What Will the Vaccine Court Do?
This is a member's only feature. Please join or upgrade Originally published on www.nvic.org National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Inj…