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CMC REVIEW MEMORANDUM
Date: December 22, 2021
To: Biologics License Application (BLA) File STN 125742
From: Xiao Wang, CMC Reviewer, OVRR/DVP
Through: Anissa Cheung, OVRR/DVP Anissa M.
Cheung -S
Dig tally signed by Anissa M. Cheung -S
DN: c=US o=U.S. Government ou=HHS
ou=FDA ou=People
0.9.23 2.19200300.100.1.1=1300155069
cn=Anissa M. Cheung -S
Date: 2021.12.22 11:51: -0500
Applicant: BioNTech Manufacturing GmbH (in partnership with Pfizer Inc.)
Product: COMIRNATY; COVID -19 Vaccine, mRNA (BNT162b2)
Product Type: A Nucleoside -modified Messenger RNA (mRNA) Vaccine Encoding
SARS- CoV-2 Spike Glycoprotein, Formulated with Lipids ALC-0315,
ALC-0159, DSPC, and Cholesterol to form Lipid Nanoparticles
(LNPs)
STN: BLA STN 125742/11
Subject: Product Correspondence;
To Correct the
from to
Action due date : NA
Recommendation: No Further Action
Summary of Product Correspondence
During the review of the original BLA 125742/0 for COMIRNATY, an information request
(IR) regarding the operation was
issued to the applicant on August 17, 2021 (shown below).
In your drug substance (DS) manufacturing process validation studies performed at
both Pfizer and Pfizer the process parameter for the
was validated to be within the range of . However, in
your documents Section 3.2.S.2.2 Manufacturing Process Andover and Section
3.2.S.2.4 Controls of Critical Steps and Intermediates - Manufacturing Process, the
is described as . Please align the acceptance
range of this process control parameter in all the documents based on your validation
study results.
Xiao
Wang -S
(Affiliate) Digitally signed by Xiao
Wang -S (Affiliate)
DN: c=US o=U.S.
Government ou=HHS
ou=FDA ou=People
0.9.23 2.19200300.100.1.1=2
00132 822 cn=X ao Wang -S
(Affi iate)
Date: 2021.12.22 11:33:20
-0500
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FDA-CBER-2021-5683-1150394
On August 18, 2021, the applicant provided relevant supporting information via email
indicating that the was studied as a
experiment with a range of . The study results demonstr ated that the
full range of the gave acceptable results,
Based on the above explanation, CBER emailed the applicant on August 19, 2021 and stated that the PAR of is acceptable. On
August 19, 2021, however, the applicant submitted a change to the
from to in amendment STN 125742/0.62. As the
proposed change was within the approved PAR for , no action was taken at the time.
In the present “Product Correspondence” submission, the applicant is making
corrections to change the from back to the
previously approved in the following three documents:
• 3.2.S.2.2 Description of Manufacturing Process and Process Controls [Andover]
• 3.2.S.2.4 Control of Critical Steps and Intermediates
• 3.2.S.2.6 Manufacturing Process Development – Process Development and
Characterization
Reviewer’s Comment:
The change made for the is considered acceptable. No further
action indicated.
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FDA-CBER-2021-5683-1150395