Document text
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
3.2.P.8.3. STABILITY DATA - LONG TERM ................................ ................................ ........ 3
LIST OF TABLES
Table 3.2.P.8.3-1. Summary Table of Drug Product L ong Term Stability Studies ................. 4
Table 3.2.P.8.3-2. Stability Data for Drug Product EN6199 Stored at -90 to -60 °C .............. 6
Table 3.2.P.8.3-3. Stability Data for Drug Product EL3249 Stored at -90 to -60 °C............... 7
Table 3.2.P.8.3-4. Stability Data for Drug Product EL9267 Stored at -90 to -60 °C............... 8
Table 3.2.P.8.3-5. Stability Data for Drug Product EL3248 Stored at -90 to -60 °C............. 10
Table 3.2.P.8.3-6. Stability Data for Drug Product EM4965 Stored at - 90 to -60 °C............ 11
Table 3.2.P.8.3-7. Stability Data for Drug Product EL7834 Stored at -90 to -60 °C............. 13
Table 3.2.P.8.3-8. Stability Data for Drug Product EN1195 Stored at -90 to -60 °C ............ 14
Table 3.2.P.8.3-9. Stability Data for Drug Product EK4242 Stored at -90 to -60 °C ............ 15
Table 3.2.P.8.3-10. Stability Data for Drug Product EP2166 Stored at -90 to -60 °C............. 16
Table 3.2.P.8.3-11. Stability Data for Drug Product EL8713 Stored at -90 to -60 °C............. 18
Table 3.2.P.8.3-12. Stability Data for Drug Product EM6950 Stored at - 90 to -60 °C............ 20
Table 3.2.P.8.3-13. Stability Data for Drug Product EL8723 Stored at -90 to -60 °C............. 22
Table 3.2.P.8.3-14. Stability Data for Drug Product EL1491 Stored at -90 to -60 °C............. 24
Table 3.2.P.8.3-15. Stability Data for Drug Product Emergency Supply Lot EH9899
Stored at - 90 to -60 °C................................ ................................ .............. 25
Table 3.2.P.8.3-16. Stability Data for Drug Product Emergency Supply Lot EJ1688
Stored at - 90 to -60 °C................................ ................................ .............. 27
Table 3.2.P.8.3-17. Stability Data for Drug Pr oduct Emergency Supply Lot EK1768
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 28
Table 3.2.P.8.3-18. Stability Data for Drug Product Emergency Supply Lot EJ1686
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 29
Table 3.2.P.8.3-19. Stability Data for Drug Product Emergency Supply Lot EJ168 5
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 31
Table 3.2.P.8.3-20. Stability Data for Drug Product Emergency Supply Lot EJ0553
Stored at -70 °C ( -90 to -60 °C) ................................ ................................ 32
Table 3.2.P.8.3-21. Stability Data for Drug Product Emergency Supply Lot EE8493
Stored at - 70 °C ( -90 to -60 ° C)................................ ................................ 33
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
FDA-CBER-2021-5683-1149172
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.8.3-22. Stability Data for Drug Product Emergency Supply Lot EE8492
Stored at - 70 °C ( -90 to -60 °C) ................................ ................................ 34
Table 3.2.P.8.3-23. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40820 -P Stored at - 70 ± 10 °C ................................ ......................... 35
Table 3.2.P.8.3 -24.Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -P Stored at - 70 ± 10 °C ................................ ......................... 36
Table 3.2.P.8.3-25. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -C Stored at -70 ± 10 °C ................................ ......................... 37
Table 3.2.P.8.3-26. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40720 -A Stored at - 70 ± 10 °C ................................ ......................... 38
Table 3.2.P.8.3-27. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -E Stored at -70 ± 10 °C ................................ ......................... 39
Table 3.2.P.8.3-28. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40620 -A Stored at - 70 ± 10 °C ................................ ......................... 40
Table 3.2.P.8.3-29. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40420 -A Stored at - 70 ± 10 °C ................................ ......................... 41
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 ....................... 42
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
FDA-CBER-2021-5683-1149173
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 33.2.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 Polymun Scientific (with fill and finish at Pfizer, Puurs),
mibe (with fill and finish at Pfizer, Puurs), Pfizer, Puur s and Pfizer , Kalamazoo (
).
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 -2 through
Table 3.2.P.8.3-30. All results, generated to date, met the acceptance criteria at the time of
testing.
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149174
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 4Table 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 Presented Table Location
(BNT162b 2)
EN6199
(Pfizer, Kalamazoo,
Line )Stability, Emergency
Supplya, Process
performance
qualificationFebruary 2021 -90 to -60 °C: 1 month Table 3.2.P.8.3 -2
EL3249
(Pfizer, Kalamazoo,
Line )Stability, Clinical,
Emergency Supplya,
Process performance
qualificationDecember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -3
EL9267
(Pfizer, Kalamazoo,
Line )Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C: 1 month Table 3.2.P.8.3 -4
EL3248
(Pfizer, Kalamazoo,
Line )Stability, Clinical,
Emergency Supplya,
Process performance
qualificationDecember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -5
EM4965
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplya, Process
performance
qualificationFebruary 2021 -90 to -60 °C: 1 month Table 3.2.P.8.3 -6
EL7834
(Polymun
Scientific/Pfizer,
PuursStability, Emergency
Supplya, Process
performance
qualificationDecember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -7
EN1195
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationMarch 2021 -90 to -60 °C: 1 month Table 3.2.P.8.3 -8
EK4242
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationDecember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -9
EP2166
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C: 2 months Table 3.2.P.8.3 -10
EL8713
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C: 2 months Table 3.2.P.8.3 -11
EM6950
(Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 -90 to -60 °C: 2 months Table 3.2.P.8.3 -12
EL8723
(Pfizer, Puurs)Stability, Clinical,
Emergency Supplya,
Process performance
qualificationJanuary 2021 -90 to -60 °C: 2 months Table 3.2.P.8.3 -13
EL1491
(Pfizer, Puurs)Stability, Emergency
Supplya,Clinical,
Process performance
qualificationDecember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -14
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b
)
(b
)
(
b
(
b
FDA-CBER-2021-5683-1149175
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 Presented Table Location
EH9899
Pfizer, Kalamazoo)Stability, Emergency
SupplyaNovember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -15
EJ1688
(mibe/Pfizer, Puurs)Stability, Emergency
SupplyaNovember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -16
EK1768
(Polymun
Scientific/Pfizer,
PuursStability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -17
EJ1686
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C: 3month s Table 3.2.P.8.3 -18
EJ1685
(Polymun
Scientific/ Pfizer,
Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C: 3 months Table 3.2.P.8.3 -19
EJ0553
(Polymun
Scientific/ Pfizer,
Puurs)Stability, Emergency
Supplya, Clinical
inventoryNovember 2020 -90 to -60 °C: 3 months Table 3.2.P.8.3 -20
EE8493
(Polymun
Scientific/ Pfizer,
Puurs)Stability, Emergency
Supplya, Clinical
inventorySeptember 2020 -90 to -60 °C: 6months Table 3.2.P.8.3 -21
EE8492
(Polymun
Scientific/ Pfizer,
Puurs)Stability, Emergency
SupplyaSeptember 2020 -90 to -60 °C: 6months Table 3.2.P.8.3 -22
EE3813c
(Polymun
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: 9months Table 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 w ill 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.
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
FDA-CBER-2021-5683-1149176
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 6Table 3.2.P.8.3 -2.Stability Data for Drug Product EN6199 Stored at -90 to -60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M S S S S S S NS NS NS
3M S S S S S S 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
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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149177
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 7Table 3.2.P.8.3 -3. Stability Data for Drug Product EL3249 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
1M 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
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, LNP = Lipid Nanoparticle; WOFS = White to off -white suspension,
, NGD = No grow th detected
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149178
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 8Table 3.2.P.8.3 -4. Stability Data for Drug Product EL9267 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M S S S S S S NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149179
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 9Table 3.2.P.8.3 -4. Stability Data for Drug Product EL9267 Stored at -90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149180
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 10Table 3.2.P.8.3 -5. Stability Data for Drug Product EL3248 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
1M 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
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,
, No growth detected
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149181
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.8.3 -6.Stability Data for Drug Product EM4965 Stored at - 90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M S S S S S S NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149182
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.8.3 -6.Stability Data for Drug Product EM4965 Stored at - 90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149183
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 13Table 3.2.P.8.3 -7. Stability Data for Drug Product EL7834 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Acceptance
CriteriaaWhite to off -white
suspensi onMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOS Meets
1M WOS Meets NS
3M WOS 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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
1M 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
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.
M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, W OS = White to off -white suspension, , LNP
= Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149184
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 14Table 3.2.P.8.3 -8.Stability Data for Drug Product EN1195 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pending
1M Pending Pending Pending Pending NS NS NS
2M S S S S S S NS NS NS
3M S S S S S S 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
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 of f-white suspension,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149185
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.8.3 -9. Stability Data for Drug Product EK4242 Stored at - 90 to - 60 °C
Time Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Acceptance
CriteriaaWhite to off -white
suspensi onMay contain white
to off -white opaque,
amorphous particles7.4 ± 0.5
0 WOS Meets
1M WOS Meets NS
3M WOS 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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container Closure
Integrity
Acceptance
Criteriaa
0 Pass
1M 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
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.
M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point, W OS = White to off -white suspe nsion, , LNP
= Lipid Nanoparticle ,NGD = No grow th detected
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149186
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.8.3 -10.Stability Data for Drug Product EP2166 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M Pending NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149187
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.8.3 -10.Stability Data for Drug Product EP2166 Stored at -90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149188
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.8.3 -11.Stability D ata for Drug Product EL8713 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering
(DLS)Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M Pending NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149189
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.8.3 -11.Stability D ata for Drug Product EL8713 Stored at -90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149190
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.8.3 -12.Stability Data for Drug Product EM6950 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149191
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.8.3 -12.Stability Data for Drug Product EM6950 Stored at -90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149192
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.8.3 -13.Stability D ata for Drug Product EL8723 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Acceptance
Criteriaa
0 Pass
2W NS NS NS
1M NS NS NS
2M NS NS NS
3M S S S S S S 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149193
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.8.3 -13.Stability D ata for Drug Product EL8723 Stored at -90 to - 60 °C
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,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149194
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.8.3 -14. Stability Data for Drug Product EL1491 Stored at -90 to - 60 °C
Time Appearance pH Subvisible Particles bDynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pass
1M NS NS NS
3M Pending 70 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
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 of f-white suspension,
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (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-2021-5683-1149195
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.8.3 -15.Stability Data for Drug Product Emergency Supply Lot EH9899 Stored at - 90 to - 60 °C
Time Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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 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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pass
1W NS NS NS
2W NS NS NS
1M 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b)
(b)
(b)
(b)
(b)
(4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149196
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 26Table 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. 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, WOFS = White to off -white suspension, ,
LNP = Lipid Nanoparticle, NGD = No Growth Detected
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149197
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.8.3 -16. Stability Data for Drug Product Emergency Supply Lot EJ1688 Stored at - 90 to -60 °C
Time Appearance pH Subvisible Particles b Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance
(Visible)Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Acceptance
CriteriaaWhite to off -white
suspensionMay contain w hite 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 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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin
(LAL)Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Acceptance
Criteriaa
0 Pass
1W NS NS NS
2W NS NS NS
1M 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
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, WOFS = White to off -white suspension, ,
LNP = Lipid Nanoparticle, NGD = No Growth Detected
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(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-2021-5683-1149198
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 28Table 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 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
Criteriab
0 Pass
1W NS NS NS
2W NS NS NS
1M 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
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing . Current specifications applied at the 3 month time point.
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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b)
(b)
(b) (4)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149199
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 29Table 3.2.P.8.3 -18.Stability 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
2W WOFS Meets NS
1M WOFS Meets NS
3M WOFS Meets NS
6M 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 Content ALC -0159 Content DSPC 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 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149200
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.8.3 -18.Stability Data for Drug Product Emergency Supply Lot EJ1686 Stored at - 70 °C ( -90 to -60 °C)
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing . Current specifications applied at the 3 month time point.
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 = Meet s Compendial Requirements, WOFS = White to off- white
suspension
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149201
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 31Table 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 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 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA 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 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
a. Subvisible particles are reported per container.
b. Acceptance criteria in place at time of testing. Current specifications applied at the 3 months time point.
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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149202
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 32Table 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 Polydispersity RNA Encapsulation RNA Content
Timepoint /
Acceptance
Criteriab White 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 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 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure Integrity
Timepoint /
Acceptance
Criteriab
0 Pass
1M NS NS NS
3M Pending NS Pass
6M S S S S S S S NS S
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. Current specifications applied at the 3 month time point.
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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149203
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 33Table 3.2.P.8.3 -21. Stability Data for Drug Product Emergency Supply Lot EE8493 Stored at - 70 °C ( -90 to -60 °C)
Time Appearance pH Subvisible ParticlesaDynamic Ligh t Scattering
(DLS)Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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
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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC
ContentCholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Acceptance Criteriaa
0 Pass
1M NS NS NS
3M NS Pass
6M Pending 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. Acceptance criteria in place at time of testing. Current version of specification applied to 6 month time point.
b. Subvisible particles are reported per container.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; WOFS = W hite to off -white suspension, ; LNP = Lipid
Nanoparticle; HPLC -CAD =high performance liquid chromatography -charged aerosol detector, MCR = Meets Compendial Requirements
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149204
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 34Table 3.2.P.8.3 -22. Stability Data for Drug Product Emergency Supply Lot EE8492 Stored at - 70 °C ( -90 to -60 °C)
Time Appearance pH Subvisible ParticlesbDynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
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 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
Time HPLC -CAD Cell-based Flow
CytometryCapillary Gel
ElectrophoresisEndotoxin Sterility Dye Incursion
ALC -0315
ContentALC -0159
ContentDSPC Content Cholesterol
ContentIn Vitro
ExpressionRNA Integrity Container
Closure
Integrity
Acceptance
Criteriab
0 Pass
1W NS NS
2W NS NS
1M NS NS
2M NS NS
3M NS Pass
6M Pending Pending 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. Acceptance criteria in place at time of testing . Current version of specification applied to 6 month time point.
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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(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-2021-5683-1149205
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 35Table 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149206
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 36Table 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.Accep
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149207
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 37Table 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.Acceptance criteria in place at time of testing.
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149208
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 38Table 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.Acceptance criteria in place at time of testing.
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149209
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 39Table 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149210
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 40Table 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
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149211
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 41Table 3.2.P.8.3 -29. Stability Data for Polymun Scientific Drug Product BNT162b2 Lot BCV40420- A Stored at -70 ± 10 °C
Time
(Month s)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
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 s)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity Sterility
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
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.
b. Method integration parameters w ere changed after the 1 month time point
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149212
BNT162b2
3.2.P.8.3 Stability Data
Long Term
PFIZER CONFIDENTIAL
Page 42Table 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 S ize 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 testing.
W = Week, M = Month, S = S cheduled, LNP = Lipid Nanoparticle
090177e19703f72b\Approved\Approved On: 12-May-2021 12:39 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149213