125742 S15 M3 32r comirnaty lot release 16jul2021

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

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Page 1 of 1Date: 
Food and Drug Administration
Center for Biologics Evaluation and Research
Sample Custodian
10903 New Hampshire Avenue
W075 -G707
Silver Spring, MD 20993 -0002
cc: 125742 _0/ 0003 /FC
Please consider this as an official request for batch release for the following product:
License Name of Product :
Type of Container:
Storage Conditions:
Marketing Authorisation 
Holder:
Batch Number:
Date of Filling:
Expiry Date:
Total Quantity:
Site of Manufacture:
Electronic Protocol 
Filename :
Please find enclosed the lot release protocol and genealogy diagram for this batch. Pfizer hereby 
submits the following lot as an electronic submission by Electronic Submissions Gateway ( ESG). 
All tests conducted on this lot are reported and pass specifications as required.
Sample Status
Sample Not Required due to COVID -19 Pandemic 
Sample Submitted with Protocol
Sample Previously Submitted (include date)
Prepared By: Approved By: 
090177e19799c049\Approved\Approved On: 20-Jul-2021 14:44 (GMT)
FDA-CBER-2021-5683-1149341
Page 1of 4REASON FOR SUBMISSION:
For Release
cc: 125742 _0/0003/FC
LotNum ber: 
Licen seNam eofProduct:
Marketing Authori sation Holder Name and Address: 
Manufacturing Site :
Date of Manufacture: Date of Expiry:
Date of Fill:
Product Inform ation : 
COMPONENTS
Component DescriptionBatch 
NumberDate of 
Manuf.Manufacture Site QuantityTarget 
Concentration
BNT162b2 
Drug Substance
Form ulated Bulk Batch N/A
FILL INFORMATION
Container Type: Volum e per container:
Approved Storage Period: Storage Temperature:
Num berofcontainers manufactured :
Num berof Doses per
container:
Num berofcontainers for release:
Volum eof single human dose:Start Date of period of
Validity:
All lot release tests conducted on this lot, as per the product license are reported and pass specifications as 
required. 
Prepared By: Approved By: 
090177e19799c049\Approved\Approved On: 20-Jul-2021 14:44 (GMT)
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FDA-CBER-2021-5683-1149342
Page 2of 4cc: 125742 _0/0003/FC
LotNum ber: 
Licen seNameofProduct: 
Table 1. Filled Vaccine Quality Control Tests
Test Test Method Specification Date of Tes t Result
Appearance Appearance (Visual)White to off -white 
suspension
Appearance (Visible 
Particulates)Appearance (Particles)May contain white to off -
white opaque amorphous 
particles
Subvisible ParticlesSubvisible Particulate 
Matter
pH 6.9 -7.9
Osmolality Osmometry
LNP SizeDynamic Light 
Scattering (DLS)
LNP PolydispersityDynamic Light 
Scattering (DLS)
RNA Encapsulation Fluorescence assay
RNA content Fluorescence assay
ALC -0315 content HPLC -CAD
ALC -0159 content HPLC -CAD
DSPC content HPLC -CAD
Cholesterol content HPLC -CAD
Vial content Container Content
Lipid identities HPLC -CADRetention times 
consistent with 
references (ALC -0315, 
ALC -0159, Cholesterol, 
DSPC)
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Page 3of 4cc: 125742 _0/0003/FC
LotNum ber: 
Licen seNameofProduct: 
Table 1 (Continued) Filled Vaccine Quality Control Tests
Test Test Method Specification Date of Test Result
Identity of encoded 
RNA sequenceRT-PCR Identity confirmed
In Vitro ExpressionCell-based Flow  
Cytometry
RNA IntegrityCapillary Gel 
Electrophoresis
Bacterial Endotoxin Endotoxin (LAL)
Abbreviations:   LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT -PCR = reverse transcription 
polymerase chain reaction;  
 LAL = Limulus amebocyte lysate; EU = endotoxin unit
Filled Vaccine Quality Control Tests (cont.)
Sterility
Method: Type: Final Container
Container :Sterility -
Date OnTest Medium /Temperature Date OffTest Specification Test Result
Nogrowth observed
Nogrowth observed
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Page 4of 4cc: 125742 _0/0003/FC
LotNum ber: 
License NameofProduct: 
BNT162b2 Drug Substance
Lot Number: Manufacturing Site :
Date of Manufacture: Date of Expiry:
Storage Tem perature: Approved Storage Period :
Consumed Quantity:
Table 1. Drug Substance Quality Control Tests
Test Test Method Specification Date of Test Result
Clarity Appearance (Clarity)
ColorationAppearance 
(Coloration)
pH
Content (RNA 
Concentration)UV Spectroscopy
Identity of Encoded 
RNA SequenceRT-PCR
RNA IntegrityCapillary Gel 
Electrophoresis
5’-Cap RP-HPLC
Poly(A) Tail ddPCR
Residual DNA Template qPCR
Residual dsRNA Immunoblot
Bacterial Endotoxin Endotoxin (LAL)
Bioburden Bioburden
Abbreviations:   NTU = Nephelometric Turbidity Units; B = brown; RT -PCR = reverse transcription polymerase 
chain reaction; ddPCR = droplet digital PCR; qPCR = quantitative PCR; dsRNA = double stranded RNA; 
LAL = Limulus amebocyte lysate; EU = endotoxin unit; CFU = colony for ming unit
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Genealogy Flowchart
Page 1of 1Prepared By: Approved By: 
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FDA-CBER-2021-5683-1149346