125742 S42 M1 response 04aug2021

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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 04Aug 2021 FDA IR–Lot Release Protocol (LRP) Template
PFIZER CONFIDENTIAL
Page 1The review team has the below comments on the lot release protocol (LRP) template that was 
submitted to BL A 125742/0.14 on July  20, 2021.
QUERY 1
Throughout document
Please correct the cc: line to STN 125742 -0/2229/FC
Page 1 of 6
Please replace with the attached example (Attachment 1 – Electronic Protocol Page 1)
Please make sure that the electronic Protocol Number at the bottom of Page 1 
matches the number on the eLR P Signature letter.
Information after the Date of Manufacturing line and before the Storage Temperature 
is optional.
Note: When submitting LRPs electronicall y, please use a letter formatted per 
Attachment 2 –eLRP Signature letter. Place this letter before the electronic protocol.
Page 2 of 6
Components table
Please add component description for the LNP 
Page 3 of 6
RNA Encapsulation and RNA content
Please use the RNA content template (Attachment 3) to report the results
Lipid analysis
Please provide full  of the lipid components for the sample, 
. Insert the  for 
the reference standard above the sample lines and label all the . The page 
on which the  are provided s hould include a table with test 
date, specifications and results for each lipid content and identity .
Page 4 of 6
Table 1 (Continued) Filled Vaccine Quality Control Tests
Please remove the abbreviations for  
 
.These tests are not performed for the filled vaccine.
Identity of encoded RNA sequence
090177e197c96cc1\Approved\Approved On: 11-Aug-2021 16:39 (GMT)
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FDA-CBER-2021-5683-1149528
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 04Aug 2021 FDA IR–Lot Release Protocol (LRP) Template
PFIZER CONFIDENTIAL
Page 2Please use the identit y test template (Attachment 4) to report the drug product test 
results
In vitro expression
Please use the in vitro expression test template (Attachment 5) to report the drug 
product test results
RNA integrity
Please provide  that are  RNA  
 for each sample replicate and insert the reference standard  
above this line so that the sample lines are not obscured. Please include clear labels 
for product and   that 
were included in the anal ysis of each  Include the name of the test method, the 
specification, date of test and the result on the same page as the .
Bacterial endotoxin
Please use the Limulus Amebocy te Ly sate Test template (Attachment 6) to report the 
drug product endotoxin results. 
Sterility
Method: Please add Method to .
Container: Please change 20 mL  to  
RESPONSE 1
Pfizer/BioNTech agree to correct the cc: line to ST N 125742- 0/2229/FC through outthe 
document.
Pfizer/BioNTech agree to the following requests of the LRP template .  Attachment 1 was 
added to the LRP template.
oReplacement of the provided example (Attachment 1 -Electronic Protocol Page 1)
oThe electronic Protocol Number at the bottom of Page 1 will match the number on 
the eL RP Signature letter
oIt is noted that information after the Date of M anufacturing line and before the 
Storage Temperature is optional
oIt is noted when submitting LRPs electronicall y, touse a letter formatted per 
Attachment 2 –eLRP Signature letter.  This letter is placed before the electronic 
protocol
Pfizer/BioNTech agree to add the component description for the Lipid Nano Particle 
(LNP) to the Components table.
090177e197c96cc1\Approved\Approved On: 11-Aug-2021 16:39 (GMT)
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FDA-CBER-2021-5683-1149529
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 04Aug 2021 FDA IR–Lot Release Protocol (LRP) Template
PFIZER CONFIDENTIAL
Page 3Pfizer/Bi oNTech agree to use the RNA content template (Attachment 3) to report the 
results for RNA Encapsulation and RNA content. Some minor clarifications were made 
to the table to align with the testing performed. Pfizer/BioNTech requests clarification on 
what is required for R2for Standard A and R2for Standard B?
Pfizer/BioNTech acknowledge the request to provide full for L ipid 
analysis. Providing  cannot be achieved through a digital s ystem .In 
addition, the resolution of the  is such that thedata would not provide 
additional value.  Pfizer/BioNTech requests whether specific data from the 
 could be provided in data format in lieu of the ?
Pfizer/BioNTech agree to remove the abbreviation s for  
 
on the Filled Vaccine Quality  Control Tests table. These tests are not 
performed for the filled vaccine .
Pfizer/BioNTech agr ee touse the Identit y test template (Attachment 4) to report the drug 
product test results for the Identity of encoded RNA sequence .
Pfizer/BioNTech agree to use the In vitro expression test template (Attachment 5) to 
report the drug product test results for the In vitro expression assay .Pfizer/BioNTech 
request clarification on what is required for Average Number of Cells Counted for 
Sample and % cell viability .
Pfizer/BioNTech acknowledge the request for for RNA 
Integrity . Providing  cannot be achieved through a digital sy stem . In 
addition ,the resolution of the  is such thatthedata would not provide 
additional value. As a result, Pfizer/BioNTech request whether specific data from the 
 could be provided in data format in lieu of these ?
Pfizer/BioNTech agree to use the L imulus Amebocy te Ly sate Test template 
(Attachment 6) to report the drug product endotoxin results.  As per section 3.2. P.5.3.1 
Verification of Bacterial Endotoxins (Pfizer Global Supply, Puurs, PGS -Puurs), the  
system may  be used as an alternative endotoxin test for the assay . This 
method will impact the data available as per Attachment 6.  Pfizer/BioN Tech will provide 
all available/alternative data in line with Attachment 6 whe nthis method is used.
Pfizer/BioNTech agree to the add the Method to the  
 method.  Additionally , Pfizer/BioNtech will change 20 mL to 
for the container.
Pfizer/BioNTech are currently  working on a  forcompiling the LRP. W hile 
every  effort will be made to maintain the current formatting, there may  be cases where the 
format of the LRP may need to change to support this enhancement. No data will be 
removed from the agreed template without consultation with CBER in advance. Under the 
090177e197c96cc1\Approved\Approved On: 11-Aug-2021 16:39 (GMT)
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FDA-CBER-2021-5683-1149530
COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 04Aug 2021 FDA IR–Lot Release Protocol (LRP) Template
PFIZER CONFIDENTIAL
Page 4current lot release process CBER performs a 48 -hour review. Pfizer /BioNTech respectfull y 
request a continuation of the 48 -hour timeframe to enable rapid release of doses. 
An updated LRP Template is provided.
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
Lot Release Protocol (LRP) Template ,replaced
Previously submitted supporting documentation
None
090177e197c96cc1\Approved\Approved On: 11-Aug-2021 16:39 (GMT)
FDA-CBER-2021-5683-1149531