Document text
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................1
LIST OF FIGURES ................................ ................................ ................................ ................... 3
3.2.P.8.3. STABILITY DATA - LONG TERM ................................ ................................ ........ 4
LIST OF TABLES
Table 3.2.P.8.3-1. Summary Table of Drug Product L ong Term Stability Studies ................. 5
Table 3.2.P.8.3-2. Stabi lity Data for PPQ Drug Product EN6199 Stored at -90 to -60
°C (Pfizer, Kalamazoo)................................ ................................ .............. 7
Table 3.2.P.8.3-3. Stability Data for PPQ Drug Product EL3249 Upright Vials Stored
at -90 to -60 °C (Pfizer, Kalamazoo)................................ .......................... 9
Table 3.2.P.8.3-4. Stability Data for PPQ Drug Product E L9267 Stored at -90 to -60
°C (Pfizer, Kalamazoo).............................................................................10
Table 3.2.P.8.3-5. Stability Data for PPQ Drug Product EL3248 Upright Vials Stored
at -90 to -60 °C (Pfizer, Kalamazoo)................................ ........................ 12
Table 3.2.P.8.3-6. Stability Data for PPQ Drug Product EM4965 Stored at - 90 to -60
°C (Poly mun/Pfizer, Puurs) ................................ ................................ .....13
Table 3.2.P.8.3-7. Stability Data for PPQ Drug Product EN1195 Stored at -90 to -60
°C (mibe/Pfizer, Puurs) ................................ ................................ ............. 15
Table 3.2.P.8.3-8. Stability Data for PPQ Drug Product EL7834 Upright Vials Stored
at -90 to -60 °C (Poly mun/Pfizer, Puurs) ................................ ................. 17
Table 3.2.P.8.3-9. Stability Data for PPQ Drug Product EK4242 Upright Vials Stored
at -90 to -60 °C (mibe/Pfizer, Puurs) ................................ ........................ 18
Table 3.2.P.8.3-10. Stability Data for PPQ Drug Product EP2166 Stored at -90 to -60
°C (Pfizer, Puurs) ................................ ................................ ...................... 19
Table 3.2.P.8.3-11. Stability Data for PPQ Drug Product EL8713 Stored at - 90 to -60
°C (Pfizer, Puurs) ................................ ................................ ...................... 21
Table 3.2.P.8.3-12. Stability Data for PPQ Drug Product EM6950 Stored at - 90 to -60
°C (Pfizer, Puurs) ................................ ................................ ...................... 23
Table 3.2.P.8.3-13. Stability Data for PPQ Drug Product EL8723 Stored at - 90 to -60
°C (Pfizer, Puurs) ................................ ................................ ...................... 25
Table 3.2.P.8.3-14. Stability Data for PPQ Drug Product EL1491 Upright Vials Stored
at -90 to -60 °C (Pfizer, Puurs) ................................ ................................ .27
Table 3.2.P.8.3-15. Stability Data for Drug Product Emergency Supply Lot EH9899
Stored at - 90 to -60 °C................................ ................................ .............. 28
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FDA-CBER-2021-5683-1149779
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.8.3-16. Stability Data for Drug Product Emergency Supply Lot EJ1688
Stored at - 90 to -60 °C................................ ................................ .............. 30
Table 3.2.P.8.3-17. Stability Data for Drug Product Emergency Supply Lot EK1768
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 31
Table 3.2.P.8.3-18. Stability Data for Drug Product Emergency Supply Lot EJ1686
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 32
Table 3.2.P.8.3-19. Stability Data for Drug Product Emergency Supply Lot EJ1685
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 34
Table 3.2.P.8.3-20. Stability Data for Drug Product Emergency Supply Lot EJ0553
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 35
Table 3.2.P.8.3-21. Stability Data for Drug Product Emergency Supply Lot EE8493
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 36
Table 3.2.P.8.3-22. Stability Data for Drug Product Emergency Supply Lot EE8492
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 37
Table 3.2.P.8.3-23. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40820 -P Stored at - 70 ± 10 °C ................................ ......................... 38
Table 3.2.P.8.3 -24.Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -P Stored at - 70 ± 10 °C ................................ ......................... 39
Table 3.2.P.8.3-25. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -C Stored at -70 ± 10 °C ................................ ......................... 40
Table 3.2.P.8.3-26. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -A Stored at - 70 ± 10 °C ................................ ......................... 41
Table 3.2.P.8.3-27. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -E Stored at -70 ± 10 °C ................................ ......................... 42
Table 3.2.P.8.3-28. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -A Stored at - 70 ± 10 °C ................................ ......................... 43
Table 3.2.P.8.3-29. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40420 -A Stored at - 70 ± 10 °C ................................ ......................... 44
Table 3.2.P.8.3-30. Stability Data for Pol ymun Scientific Drug Product BNT162b2
Non-clinical Lot CoVVAC/270320 Stored at - 70 ± 10 °C ....................... 45
Table 3.2.P.8.3-31. Stability Data for Drug Product Lot EL7834 Stored at -90 to -60 °C
(Inverted Vials) ................................ ................................ ......................... 46
Table 3.2.P.8.3-32. Stability Data for Drug Product Lot EK4242 Stored at -90 to -60 °C
(Inverted Vials) ................................ ................................ ......................... 47
Table 3.2.P.8.3-33. Stability Data for Drug Product Lot EL1491 Stored at -90 to -60 °C
(Inverted Vials) ................................ ................................ ......................... 48
Table 3.2.P.8.3-34. Stability Data for Drug Product Lot EL3249 Stored at -90 to -60 °C
(Inverted Vials) ................................ ................................ ......................... 49
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FDA-CBER-2021-5683-1149780
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 3Table 3.2.P.8.3-35. Stability Data for Drug Product Lot EL3248 Stored at -90 to -60 °C
(Inverted Vials) ................................ ................................ ......................... 50
LIST OF FI GURES
Figure 3.2.P.8.3-1. LNP Poly dispersity Results for Emergency Supply and PPQ Drug
Product L ots Stored at -90 to -60 °C ................................ ........................ 51
Figure 3.2.P.8.3-2. LNP Size Results for Emergency Suppl y and PPQ Drug Product
Lots Stored at - 90 to -60 °C ................................ ................................ ......52
Figure 3.2.P.8.3-3. RNA Content Results for Emergency Suppl y and PPQ Drug
Product L ots Stored at -90 to -60 °C ................................ ........................ 53
Figure 3.2.P.8.3-4. RNA Encapsulation Results for Emergency Supply and PPQ Drug
Product L ots Stored at -90 to -60 °C ................................ ........................ 54
Figure 3.2.P.8.3-5. Lipid Content (ALC -0315) Results for Emergency Supply & PPQ
Drug Product Lots Stored at -90 to -60 °C ................................ ............... 55
Figure 3.2.P.8.3-6. Lipid Content (ALC -0159) Results for Emergency Supply & PPQ
Drug Product Lots Stored at -90 to -60 °C ................................ ............... 56
Figure 3.2.P.8.3-7. Lipid Content (DSPC) Results for Emergency Supply & PPQ Drug
Product L ots Stored at -90 to -60 °C ................................ ........................ 57
Figure 3.2.P.8.3-8. Lipid Content (Cholesterol) Results for Emergency Supply & PPQ
Drug Product Lots Stored -90 to -60 °C ................................ ................... 58
Figure 3.2.P.8.3-9. RNA I ntegrit y Results for Emergency Supply and PPQ Drug
Product L ots Stored at -90 to -60 °C ................................ ........................ 59
Figure 3.2.P.8.3-10. IVE Results for Emergency Suppl y and PPQ Drug Product
Lots Stored at - 90 to -60 °C ................................ ................................ ......60
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BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 43.2.P.8.3. STABILITY DATA - LONG TERM
Data from stability studies on BNT162b2 drug product lot sstored at the long term condition
of -90 to -60 C are presented for emergency supply lots and process performance
qualification lots manufactured b y multiple manufacturing and fill and finish sites .
Data from seven clinical and one non- clinical stability studies on drug product manufactured
by Poly mun Scientific are also being presented at the long term condition of -70 ± 10 C.
All studies are listed in Table 3.2.P.8.3-1 . Results are provided in Table 3.2.P.8.3 -2through
Table 3.2.P.8.3-35 and in Figure 3.2.P.8.3-1 through Figure 3.2.P.8.3-10. All results,
generated to date, met the acceptance cri teria at the time of testing .
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BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 5Table 3.2.P.8.3 -1.Summary Table of Drug Product Long Term Stability Studies
LotNum ber D rug Product Lot
UseStability Study
StartStability Data
PresentedTable Location
(BNT162b 2)
EN6199
(Pfizer, Kalamazoo,
Line )Stability, Emergency
Supplya, Process
performance
qualificationFebruary 2021 -90 to -60 °C:
3 month sTable 3.2.P.8.3 -2
EL3249
(Pfizer, Kalamazoo,
Line )Stability, Clinical,
Emergency Supplya,
Process performance
qualificationDecember 2020 -90 to -60 °C Upright:
6 monthsTable 3.2.P.8.3 -3
-90 to -60 °C Inverted:
6 monthsTable 3.2.P.8.3 -34
EL9267
(Pfizer, Kalamazoo,
Line Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C:
3month sTable 3.2.P.8.3 -4
EL3248
(Pfizer, Kalamazoo,
Line Stability, Clinical,
Emergency Supplya,
Process performance
qualificationDecember 2020 -90 to -60 °C Upright:
6 monthsTable 3.2.P.8.3 -5
-90 to -60 °C Inverted:
6 monthsTable 3.2.P.8.3 -35
EM4965
(Polymun
Scientific/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationFebruary 2021 -90 to -60 °C:
3month sTable 3.2.P.8.3 -6
EL7834
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Process
performance
qualificationDecember 2020 -90 to -60 °C Upright:
6 monthsTable 3.2.P.8.3 -8
-90 to -60 °C Inverted:
6 monthsTable 3.2.P.8.3 -31
EN1195
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationMarch 2021 -90 to -60 °C:
3 month sTable 3.2.P.8.3 -7
EK4242
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationDecember 2020 -90 to -60 °C Upright:
6 monthsTable 3.2.P.8.3 -9
-90 to -60 °C Inverted:
6 monthsTable 3.2.P.8.3 -32
EP2166
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C:
3monthsTable 3.2.P.8.3 -10
EL8713
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C:
3monthsTable 3.2.P.8.3 -11
EM6950
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C:
3monthsTable 3.2.P.8.3 -12
EL8723
(Pfizer, Puurs)Stability, Clinical,
Emergency Supplya,
Process performance
qualificationJanuary 2021 -90 to -60 °C:
3monthsTable 3.2.P.8.3 -13
EL1491
(Pfizer, Puurs)Stability, Emergency
Supplya, Clinical,
Process performance
qualificationDecember 2020 -90 to -60 °C Upright:
6 monthsTable 3.2.P.8.3 -14
-90 to -60 °C Inverted:
6 monthsTable 3.2.P.8.3 -33
0
(b) (4)
(b) (4)
(b) (4
(b) (4
FDA-CBER-2021-5683-1149783
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 6Table 3.2.P.8.3 -1.Summary Table of Drug Product Long Term Stability Studies
LotNum ber D rug Product Lot
UseStability Study
StartStability Data
PresentedTable Location
EH9899
Pfizer, Kalamazoo)Stability, Emergency
SupplyaNovember 2020 -90 to -60 °C:
6month sTable 3.2.P.8.3 -15
EJ1688
(mibe/Pfizer, Puurs)Stability, Emergency
SupplyaNovember 2020 -90 to -60 °C:
6month sTable 3.2.P.8.3 -16
EK1768
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Clin ical
inventoryNovember 2020 -90 to -60 °C:
6month s Table 3.2.P.8.3 -17
EJ1686
(Polymun
Scientific/Pfizer, Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C:
6month s Table 3.2.P.8.3 -18
EJ1685
(Polymun
Scientific/ Pfizer, Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C:
6months Table 3.2.P.8.3 -19
EJ0553
(Polymun
Scientific/ Pfizer, Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C:
6months Table 3.2.P.8.3 -20
EE8493
(Polymun
Scientific/ Pfizer, Puurs)Stability, Emergency
Supplya, Clinical
inventorySeptember 2020 -90 to -60 °C:
9months Table 3.2.P.8.3 -21
EE8492
(Polymun
Scientific/ Pfizer, Puurs)Stability, Emergency
SupplyaSeptember 2020 -90 to -60 °C:
9months Table 3.2.P.8.3 -4
EE3813c
(Polymu n
Scientific/Pfizer, Puurs)Stability, clinical August 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8. 3-23
ED3938d
(Polymun
Scientific/Pfizer, Puurs)Stability, clinical
inventoryAugust 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8.3 -24
BCV40720 -C
(Polymun Scientific)Stability, clinical August 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8.3 -25
BCV40720 -A
(Polymun Scientific)Stability, clinical August 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8.3 -26
BCV40620 -E
(Polymun Scientific)Stability, clinical July 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8.3 -27
BCV40620 -A
(Polymun Scientific)Stability, clinical July 2020 -70 ± 10 °C:
6months
(Complete)Table 3.2.P.8.3 -28
BCV40420 -A
(Polymun Scientific)Stability, c linical May 2020 -70 ± 10 °C:
12monthsTable 3.2.P.8.3 -29
CoVVAC/270320
(Polymun Scientific)Stability, non -clinical
toxicologyMarch 2020 -70 ± 10 °C: 6 months
(Complete)Table 3.2.P.8.3 -30
a. Emergency supply designation applies to US market.
b. A minimum of three PPQ lot will be enrolled in stability programs compliant with ICH Guidelines and further
information on lot numbers, manufacture, stability enrollment and available data will be provided in the future.
c. This lot number is equivalent to BCV40820 -P
d. This lot number is equivalent to BCV40720 -P.
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BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 7Table 3.2.P.8.3 -2.Stability Data for PPQ Drug Product EN6199 Stored at -90 to -60 °C (Pfizer, Kalamazoo)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
Encapsulati
onRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149785
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 8a.Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle; WOFS = White to off -white suspension,
, NGD = No grow th detected
0
(b) (4)
FDA-CBER-2021-5683-1149786
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 9Table 3.2.P.8.3 -3. Stability Data for PPQ Drug Product EL3249 Upright Vials Stored at -90 to -60 °C (Pfizer, Kalamazoo)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S 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,
, NGD = No grow th detected
0
(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-2021-5683-1149787
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 10Table 3.2.P.8.3 -4.Stability Data for PPQ Drug Product EL9267 Stored at -90 to -60 °C (Pfizer, Kalamazoo)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro Expression RNA Integrity Container
Closure Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149788
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.8.3 -4.Stability Data for PPQ Drug Product EL9267 Stored at -90 to -60 °C (Pfizer, Kalamazoo)
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,
0
(b) (4)
FDA-CBER-2021-5683-1149789
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.8.3 -5.Stability Data for PPQ Drug Product EL3248 Upright Vials Stored at - 90 to - 60 °C (Pfizer,
Kalamazoo)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ±
0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S 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,
, No growth detected
0
(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-2021-5683-1149790
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 13Table 3.2.P.8.3 -6.Stability Data for PPQ Drug Product EM4965 Stored at -90 to -60 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149791
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 14Table 3.2.P.8.3 -6.Stability Data for PPQ Drug Product EM4965 Stored at -90 to -60 °C (Polymun/Pfizer, Puurs)
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 of f-white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149792
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.8.3 -7.Stability Data for PPQ Drug Product EN1195 Stored at -90 to -60 °C (mibe/Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 c WOFS Meets
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149793
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.8.3 -7.Stability Data for PPQ Drug Product EN1195 Stored at -90 to -60 °C (mibe/Pfizer, Puurs)
a.Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
c. T=0 testing performed for this lot (release values not utilized)
d. Original result investigated and invalidated. Reference PR 5889739
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, LNP = Lipi d Nanoparticle; WOFS = White to off -white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149794
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.8.3 -8. Stability Data for PPQ Drug Product EL7834 Upright Vials Stored at -90 to -60 °C (Polymun/Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOS Meets
1M WOS Meets NS
3M WOS Meets NS
6M WOS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, W OS = White to off -white suspension, , LNP
= Lipid Nanoparticle
0
(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-2021-5683-1149795
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.8.3 -9. Stability Data for PPQ Drug Product EK4242 Upright Vials Stored at -90 to -60 °C (mibe/Pfizer, Puurs )
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOS Meets
1M WOS Meets NS
3M WOS Meets NS
6M WOS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, W OS = White to off -white suspension, , LNP
= Lipid Nanoparticle
0
(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-2021-5683-1149796
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.8.3 -10.Stability Data for PPQ Drug Product EP2166 Stored at -90 to -60 °C (Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149797
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.8.3 -10.Stability Data for PPQ Drug Product EP2166 Stored at -90 to -60 °C (Pfizer, Puurs)
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 of f-white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149798
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.8.3 -11.Stability Data for PPQ Drug Product EL8713 Stored at -90 to -60 °C (Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering
(DLS)Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro Expression RNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149799
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.8.3 -11.Stability Data for PPQ Drug Product EL8713 Stored at -90 to -60 °C (Pfizer, Puurs)
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 of f-white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149800
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.8.3 -12.Stability Data for PPQ Drug Product EM6950 Stored at -90 to -60 °C (Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance CriteriaaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro Expression RNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149801
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.8.3 -12.Stability Data for PPQ Drug Product EM6950 Stored at -90 to -60 °C (Pfizer, Puurs)
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 of f-white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149802
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.8.3 -13.Stability Data for PPQ Drug Product EL8723 Stored at -90 to -60 °C (Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP Polydispersity RNA
Enca
psula
tionRNA Content
Timepoint /
Acceptance CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
2W WOFS Meets NS
1M WOFS Meets NS
2M WOFS Meets NS
3M WOFS Meets NS
6M S S S S S S S S
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS NS NS
6M S S S S S S NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(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-2021-5683-1149803
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 26Table 3.2.P.8.3 -13.Stability Data for PPQ Drug Product EL8723 Stored at -90 to -60 °C (Pfizer, Puurs)
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 of f-white suspension,
0
(b) (4)
FDA-CBER-2021-5683-1149804
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.8.3 -14.Stability Data for PPQ Drug Product EL1491 Upright Vials Stored at - 90 to - 60 °C (Pfizer, Puurs)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS Meets
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S 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 of f-white suspension,
0
(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-2021-5683-1149805
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 28Table 3.2.P.8.3 -15.Stability Data for Drug Product Emergency Supply Lot EH9899 Stored at - 90 to - 60 °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 c WOFS
1W WOFS NS
2W WOFS NS
1M WOFS NS
3M WOFS NS
6M WOFS
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint/
Acceptance Criteriaa
0 Pass
1W NS NS NS
2W NS NS NS
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
0
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149806
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 29Table 3.2.P.8.3 -15.Stability Data for Drug Product Emergency Supply Lot EH9899 Stored at - 90 to - 60 °C
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, WOFS = White to off -white suspension, ,
LNP = Lipid Nanoparticle, NGD = No Growth Detected
0
(b) (4)
FDA-CBER-2021-5683-1149807
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.8.3 -16. Stability Data for Drug Product Emergency Supply Lot EJ1688 Stored at - 90 to -60 °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 Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance Criteriaa
0 Pass
1W NS NS NS
2W NS NS NS
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S 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, WOFS = White to off -white suspension, ,
LNP = Lipid Nanoparticle, NGD = No Growth Detected
0
(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)
(b) (4)
FDA-CBER-2021-5683-1149808
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 31Table 3.2.P.8.3 -17. Stability Data for Drug Product Emergency Supply Lot EK1768 Stored at - 70 °C ( -90 to -60 °C)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particlesa Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA
Content
Timepoint /
Acceptance
Criteriab White to off -
white suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1W WOFS Meets NS
2W WOFS Meets NS
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance
Criteriab
0 Pass
1W NS NS NS
2W NS NS NS
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing .
W = Week, M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point; NMT = No more than; ; LNP = Lipid Nanoparticle; HPLC -
CAD = high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements, WOFS = White to off -white suspension
0
(b)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149809
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 32Table 3.2.P.8.3 -18.Stab ility Data for Drug Product Emergency Supply Lot EJ1686 Stored at -70 °C ( -90 to -60 °C)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particlesa Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA
Content
Timepoint /
Acceptance
Criteriab White to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0c WOFS
1W WOFS Meets NS
2W WOFS Meets NS
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC Content Cholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance
Criteriab
0c Pass
1W NS NS NS
2W NS NS NS
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing .
c. Initial data (t0) are not from release testing, with the exception of sterility and endotoxin. Analysis for t0 were repea ted for this study.
W = Week, M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point; NMT = No more than; ; LNP = Lipi d
Nanoparticle; HPLC-CAD = high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements, WOFS = White to off- white
suspension
0
(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)
FDA-CBER-2021-5683-1149810
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 33
0
FDA-CBER-2021-5683-1149811
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 34Table 3.2.P.8.3 -19. Stability Data for Drug Product Emergency Supply Lot EJ1685 Stored at - 70 °C ( -90 to -60 °C)
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particlesa Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriab White to off -
white
suspensionMay contain w hite
to off -white opaque,
amorphous particles7.4 ± 0.5
0 White to off -white
suspension
1W WOFS NS
2W WOFS Meets NS
1M WOFS Meets NS
3M WOFS Meets NS
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro Expression RNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance Criteriab
0 Pass
1W NS
2W NS NS NS
1M NS NS NS
3M NS NS NS
6M NS NS NS
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; NMT = No more than; ; LNP = Lipid
Nanoparticle; HPLC -CAD = high performance liquid chromatography -charged aerosol detector, WOFS = White to off -white suspension
0
(b)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149812
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 35Table 3.2.P.8.3 -20. Stability Data for Drug Product Emergency Supply Lot EJ0553 Stored at - 70 °C ( -90 to -60 °C)
Analytical
Procedure/Quality
AttributeAppearance pH Subvisible Particlesa Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visual)Visible Particulates LNP Size LNP
PolydispersityRNA Encapsulation RNA Content
Timepoint /
Acceptance CriteriabWhite to off -
white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 White to off -
white
suspension
1M WOFS NS
3M WOFS Meets
6M WOFS Meets
9M S S S NS 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
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC Content Cholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance Criteriab
0 Pass
1M NS
3M NS Pass
6M NS Pass
9M S S S S S S NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; NMT = No more than; ; LNP = Lipid Nanoparticle; HPLC -
CAD = high performance li quid chromatography -charged aerosol detector, WOFS = White to off -white suspension
0
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149813
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 36Table 3.2.P.8.3 -21. Stability Data for Drug Product Emergency Supply Lot EE8493 Stored at - 70 °C ( -90 to -60 °C)
Analytical
Procedure/Quality
AttributeAppearance pH Subvisible ParticlesaDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance CriteriaWhite to off -white
suspensionMay contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOFS
1M WOFS NS
3M WOFS Meets
6M WOFS Meets
9M WOFS Meets NS
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
ElectrophoresisEndotoxin Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Timepoint /
Acceptance Criteriaa
0 Pass
1M NS NS NS
3M NS Pass
6M NS Pass
9M NS NS NS
12M S S S
18M S S S S S S NS NS NS
24M S S S 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; WOFS = White to off -white suspension, ; LNP = Lipid
Nanoparticle; HPLC -CAD =high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements
0
(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-2021-5683-1149814
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 37Table 3.2.P.8.3 -22. Stability Data for Drug Product Emergency Supply Lot EE8492 Stored at - 70 °C ( -90 to -60 °C)
Analytical
Procedure/Quality
AttributeAppearance pH Subvisible ParticlesbDynamic 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 NS
2W WOFS NS
1M WOFS NS
2M WOFS NS
3M WOFS Meets
6M WOFS Meets
9M WOFS Meets NS
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
ElectrophoresisEndotoxin Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Timepoint /
Acceptance Criteriaa
0 Pass
1W NS NS NS
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M NS Pass
6M NS Pass
9M NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S 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 S cheduled, NS = Not Scheduled at Time Point; WOFS = White to off -white suspension, ; LNP = Lipid
Nanoparticle; HPLC -CAD =high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements
0
(b)
(b)
(b)
(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-2021-5683-1149815
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 38Table 3.2.P.8. 3-23. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40820- P Stored at - 70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Acceptance criteria in place at time of testing.
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149816
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 39Table 3.2.P.8.3 -24. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720- P Stored at - 70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Accepta
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149817
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 40Table 3.2.P.8.3 -25. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720- C Stored at -70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Accep
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149818
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 41Table 3.2.P.8.3 -26. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40720- A Stored at -70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Accepta
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149819
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 42Table 3.2.P.8.3 -27. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40620- E Stored at - 70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Acceptance criteria in place at time of testing.
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149820
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 43Table 3.2.P.8.3 -28. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40620- A Stored at -70 ±10 °C
Time
(Months)Appearance pH Subvisible Particles 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
3 Pass NS NS NS
6 Pass
Time
(Months)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
6 Pass
a.Accep
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149821
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 44Table 3.2.P.8.3 -29. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40420- A Stored at -70 ±10 °C
Analytical
Procedure /Quality
AttributeAppearance pH Subvisible Particles LNP Size LNP
PolydispersityRNA
EncapsulationRNA
Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
1 Pass NS NS NS
3 Pass NS NS NS
4 Pass NS NS NS
6 Pass NS NS NS
9 Pass NS NS NS
12 Pass
18 S NS NS NS S S S S
24 S S S S S S S S
Analytical
Procedure /Quality
AttributeALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentRNA Integrity Sterility
Timepoint/
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results (mg/mL) Report Results
(mg/mL)Sterile
0 Pass
1 NS
3 NS
4 NS
6 NS
9 NS
12 NS
18 S S S S S NS
24 S S S S S S
a.Acceptance criteria in place at time of testing.
b. Method integration parameters w ere changed after the 1 month time point
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, RP = Result Pending
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149822
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 45Table 3.2.P.8.3 -30.Stability Data for Polymun Scientific Drug Product BNT 162b2 Non-clinical Lot CoVVAC/ 270320
Stored at -70 ± 10 °C
Time Appearance LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaReport Results (Visual
Appearance and Visible
Particles)Report Results
(nm)Report Results Report Results
(%)Report Results
(mg/mL)
0 Pass
2W Pass
1M 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
2M
3M
6M
a. Acceptance criteria in place at time of te
W = Week, M = Month, S = S cheduled, LNP = Lipid Nanoparticle
0
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149823
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 46Inverted Vial Stability Studies
Table 3.2.P.8.3 -31. Stability Data for Drug Product Lot EL7834 Stored at -90 to -60 °C (Inverted Vials)
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 WOFS Meets
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
ElectrophoresisEndotoxin
(LAL)Sterility Container
closure
integrity ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
6M NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
Abbreviations: M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, WOFS = White to off -white suspension,
, NGD = No Growth Detected
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149824
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 47Table 3.2.P.8.3 -32.Stability Data for Drug Product Lot EK4242 Stored at - 90 to -60 °C (Inverted Vials)
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 WOFS Meets
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
ElectrophoresisEndotoxin
(LAL)Sterility Container
closure
integrity ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
6M NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
Abbreviations: M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, WOFS = White to off -white suspension,
, NGD = No Growth Detected
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149825
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 48Table 3.2.P.8.3 -33.Stability Data for Drug Product Lot EL1491 Stored at - 90 to -60 °C (Inverted Vials)
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 WOFS Meets
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
ElectrophoresisEndotoxin
(LAL)Sterility Container
closure
integrity ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
6M NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
Abbreviations: M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, WOFS = White to off -white suspension,
NGD = No Growth Detected
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149826
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 49Table 3.2.P.8.3 -34.Stability Data for Drug Product Lot EL3249 Stored at - 90 to -60 °C (Inverted Vials)
Analytical
Procedure /Quality
AttributeAppearance
pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP SizeLNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
6M WOFS Meets
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 -CADCell-based Flow
CytometryCapillary Gel
Electrophoresis Endotoxin
(LAL)SterilityContainer
closure
integrityALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
6M NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
Abbreviations: M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, WOFS = White to off -white suspension,
, NGD = No Growth Detected
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149827
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 50Table 3.2.P.8.3 -35.Stability Data for Drug Product Lot EL3248 Stored at - 90 to -60 °C (Inverted Vials)
Analytical
Procedure /Quality
AttributeAppearance
pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP SizeLNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint/
Acceptance
CriteriaaWhite to off -white
suspensionMay contain white
to off -white opaque,
amorphous
particles7.4 ± 0.5
0 WOFS Meets
6M WOFS Meets
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 -CADCell-based Flow
CytometryCapillary Gel
Electrophoresis Endotoxin
(LAL)SterilityContainer
closure
integrityALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity
Timepoint/
Acceptance
Criteriaa
0 Pass
6M NS NS NS
12M S S S S S S S S S
18M S S S S S S NS NS NS
24M S S S S S S S S S
a. Acceptance criteria in place at time of testing.
b. Subvisible particles are reported per container.
Abbreviations: M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle, WOFS = White to off -white suspension,
, NGD = No Growth Detected
0
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149828
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 51Figure 3.2.P.8.3 -1.LNP Polydispersity Results for Emergency Supply and PPQ Drug Product Lots Stored at -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149829
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 52Figure 3.2.P.8.3 -2.LNP Size Results for Emergency Supply and PPQ Drug Product Lots Stored at -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149830
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 53Figure 3.2.P.8.3 -3. RNA Content Results for Emergency Supply and PPQ Drug Product Lots Stored at - 90 to - 60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149831
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 54Figure 3.2.P.8.3 -4. RNA Encapsulation Results for Emergency Supply and PPQ Drug Product Lots Stored at - 90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149832
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 55Figure 3.2.P.8.3 -5.Lipid Content (ALC -0315) Results for Emergency Supply & PPQ Drug Product Lots Stored at -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149833
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 56Figure 3.2.P.8.3 -6.Lipid Content (ALC -0159) Results for Emergency Supply & PPQ Drug Product Lots Stored at -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149834
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 57Figure 3.2.P.8.3 -7.Lipid Content (DSPC) Results for Emergency Supply & PPQ Drug Product Lots Stored at -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149835
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 58Figure 3.2.P.8.3 -8.Lipid Content (Cholesterol) Results for Emergency Supply & PPQ Drug Product Lots Stored -90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149836
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 59Figure 3.2.P.8.3 -9. RNA Integrity Results for Emergency Supply and PPQ Drug Product Lots Stored at - 90 to - 60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149837
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 60Figure 3.2.P.8.3 -10. IVE Results for Emergency Supply and PPQ Drug Product Lots Stored at - 90 to -60 °C
0
(b) (4)
FDA-CBER-2021-5683-1149838