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BNT162b2
2.3Introduction to Quality Overall Summary –9 Month Expiry Extension
PFIZER CONFIDENTIAL
Page 12.3.INTRODUCTION TO THE QUALITY OVERA LL SUMMARY
This document summarizes updates and changes to the Chemistry , Manufacturing and
Controls (CMC) information for the COVID-19 vaccine for use under BLA 125742
.
Specificall y, this CMC informational amendment covers the following changes.
Introduction of additional stability data to support exten ding the shelf -life of the
undiluted drug product vial from 6 months to 9 months when stored at -90 to -60°C.
Corrections made atypographical error in DSPC result for lot EJ0553 made in a
stability data tables that occurred in a previous submission.
Addition of inverted vial orientation data for various lots at the 5 °C and - 20 °C long
term and accelerated condition s.
Addition of Figures illustrating stabilit y data for LNP polydispersit y, LNP size, RNA
content, RNA encapsulation, lipid content, RNA integrit y, and in vitro expression.
2.3.1. Description of the Amendment
Drug Product Shelf Life
To enhanc e global distribution of and broad enpatient access to the Pfizer/BioNTech
COVID- 19 vaccine, the shelf -life of the undiluted drug product vial isextended from 6
months to 9 months when stored at -90 to -60 °C . The change in shelf -life is supported by
drug product stability data .
2.3.1.1.1. Drug Product Stability and Shelf Life
Drug product stability data are updated in Section 3.2.P.8.1 Stability Summary and
Conclusions , Section 3.2.P.8.3 Long Term , and Section 3.2.P.8.3 Accelerated for clinical
lots, emergency suppl y and PPQ lots. Current available data at the long -term storage
condition of - 90to -60°C include up to 12 months of data from clinical trial material lots
(stored at - 70±10 °C),up to 9months of data from emergency supply lots (stored at -90
to -60°C)and up to 6 months of data from PPQ lots (stored at -90 to -60°C).
Additionally , figures have been added in Section 3.2.P.8.3 L ong Term, and Section 3.2.P.8.3
Accelerated illustrating stability data for LNP poly dispersit y, LNP size, RNA content, RNA
encapsulation, lipid content, RNA integrity , and in vitro expression.
All data generated to date at - 90 to -60 °C are within the specifications in place at the time of
testing for drug product lots and overall, the data generated to date indicate that there have
been no significant changes in terms of quality, purity, or strength for the drug product. The
data provided support sa drug product expiry of 9months when stored at the intended storage
condition of - 90 to -60 °C.
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2.3Introduction to Quality Overall Summary –9 Month Expiry Extension
PFIZER CONFIDENTIAL
Page 2
Drug Product Stability Protocol and Data Corrections
Corrections have been made f or drug product lot EJ0553, in which a typographical error was
corrected in DSPC result at 1 month at -90 to -60 °C from . These changes have
been updated in Section 3.2.P.8.3 L ongTerm .There is no impact to the data assessment
based on these corrections.
Additionally , data tables for upright and inverted vial orientation results are now included for
lotsEK4242, EL 1491, EL3248 and EL3249 at the 5 °Cand - 20 °C condition inSection
3.2.P .8.3 L ong Term as well as in Section 3.2.P.8.3 Accelerated.
For drug product lot EL 8723, revised initial time point results from T=0 testing results to
batch release results, which are more appropriate initial data for this stability stud y. These
changes for - 60 to -30 °C condition have been updated in Section 3.2.P.8.3 Accelerated.
2.3.2. Submission Overview
In addition to updates to the Module 3, the corresponding 2.3.P.8 Stability section has been
updated. Also, the Product Information is updated accordingly.
A summary of the updated CMC information is provided in Table 2.3-1.
Table 2.3-1. Submission Overview – Module 3 References
Module 3
CTD
SectionsDocuments Modifications
modRNA Drug Product
P.8.1 Stability Summary and
ConclusionsUpdated document to provide updated stability summary
information, including additional lots, additional available data,
and conclusions, including support of up to 9 months at - 90 to -
60 °C.
P.8.3 Stability Data –Long Term Updated document to provide additional stability data from
additional lots and additional time points. Added figures
illustrating stability data for LNP polydispersity, LNP size,
RNA content, RNA encapsulation, lipid content, RNA
integrity, and in vitro expression.
Both upright and inverted vial orientation results now included
for lots EK4242 , EL1491 , EL3248 and EL3249 at the 5 °C
and -20 °C condition.
Corrected DSPC results at 1M result for lot EJ0553
(typographical error).
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2.3Introduction to Quality Overall Summary –9 Month Expiry Extension
PFIZER CONFIDENTIAL
Page 3Table 2.3-1.Submission Overview –Module 3 References
Module 3
CTD
SectionsDocuments Modifications
P.8.3 Stability Data –Accelerated Updated document to provide additional stability data
from additional lots, additional stability studies in
additional storage conditions (inverted vials), and
additional time points.
Added figures illustrating stability data for LNP polydispersity,
LNP size, RNA content, RNA encapsulation, lipid content,
RNA integrity, and in vitro expression.
Both upright and inverted vial orientation results now included
for lots EK4242 , EL1491 , EL3248 and EL3249 at the 5 °C
and -20 °C condition.
Updated T=0 results for Lot EL8723 to batch release
results.
Minor editorial updates.
2.3.3. Conclusion
The shelf -life of the undiluted drug product vial is extended from 6 months to 9 months.
Cartons with an expiry date of August 2021 through January 2022 printed on the label may
remain in use for three months bey ond the printed date as long as the approved storage
conditions have been maintained. Table 2.3-2 represents expiry dates for Drug Product lots
that have alread y been dispositioned and their new expiry dates.
Table 2.3-2. Drug Product Expiry Extension for Dispositioned Batches
Printed Date Updated Expiry Date
August 2021 November 2021
September 2021 December 2021
October 2021 January 2022
November 2021 February 2022
December 2021 March 2022
January 2022 April 2022
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