125742 S44 M1 response 10aug2021

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COVID -19 Vaccine (BNT162, PF -07302048)
BLA 125742/0
Response to 10 Aug 2021 FDA IR – Testing Related
PFIZER CONFIDENTIAL
Page 1QUERY 1
Please provide the established  and poly dispersity  index limits 
for the control lot of PF -07302048 -DP-RM for the test of “Size and poly dispersity  Index
Measurement in mRNA LNP Samples b y Dynam ic Light Scattering” for drug product.
RESPONSE 1
Table 1provides the established  and maximum poly dispers ity index 
(PDI) for control lot PF -07302048 -DP-RM.
Table 1. Established Acceptable  and PDI Ranges for 
PF-07302048 -DP-RM (Lot # EE8493)
Control Criterion Upper Limit Lower Limit
Literature References
None
SUPPORTING DOCUMENTATION
New or Replaced Supporting Documentation
None
Previously submitted supporting documentation
None
090177e197c95a16\Approved\Approved On: 11-Aug-2021 15:59 (GMT)
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FDA-CBER-2021-5683-1149574