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TELECONFERENCE SUMMARY
Application number: BLA STN 125742/0
Product name: COVID -19 Vaccine, mRNA (COMIRNATY)
Proposed Indication: Active immunization to prevent COVID -19 caused by
SARS-CoV -2 in individuals 16 years of age and older
Applicant: BioNTech Manufacturing GmbH (in partnership with
Pfizer, Inc.)
Teleconference date & time: August 17 , 2021; 9:00 AM - 9:41 AM
PM EDT
FDA Participants:
Ekaterina Allen
Anissa Cheung, Ph.D.
John Eltermann, R.Ph., M.S.
Debra Emerson Kathleen Jones, Ph.D.
Christian Lynch Ramachandra Naik , Ph.D.
Lori Peters, M.S.
Carolyn Renshaw
Michael Smith, Ph.D.
Applicant Participants:
Paul Rohlfing, GCMC Vaccines Regulatory Affairs, Pfizer Inc.
Adrienne Stafford, GCMC Vaccines Regulatory Affairs, Pfizer Inc.
, GCMC Vaccines Regulatory Affairs, Pfizer Inc.
Andrew Nelson, GCMC Vaccines Regulatory Affairs, Pfizer Inc.
, GCMC Vaccines Regulatory Affairs, Pfizer Inc.
, GCMC Vaccines Regulator y Affairs, Pfizer Inc.
Elisa Harkins Tull , Global Regulatory Affairs Pfizer Inc.
Meg Ruesch, Analytical R&D, Pfizer Inc.
Dave Cirelli , Analytical R&D, Pfizer Inc.
, Analytical R&D, Pfizer Inc.
, Biotherapeutics PharmSci Quality, Pfizer Inc
, Quality Operations, Pfizer Global Supply, Pfizer Inc.
, , Andover, Pfizer Global Supply,
Pfizer Inc.
, Quality Operations, Andover, Pfizer Global Supply, Pfizer Inc.
, Quality Operations, Andover, Pfizer Global Supply, Pfizer
Inc.
, Quality Operations, Andover, Pfizer Global Supply, Pfizer
Inc.
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FDA-CBER-2021-5683-1150416
STN 125742/0 August 16 , 2021
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, Qual ity Operations, Andover, Pfizer Global Supply, Pfizer
Inc.
Amy Lovasko, Andov er Site Lead, Pfizer Global Supply, Pfizer Inc.
, Engineering, Andover, Pfizer Global Supply, Pfizer Inc.
, Engineering, Andover, Pfizer Global Supply, Pfizer Inc.
Background/Purpose of this call:
The purpose of the teleconference between DMPQ and Pfizer was to discuss items 2b,
2c, 6 and 9c from the FDA form 483 for the Andover site.
Teleconference Summary :
Follow -up response to FDA form 483 item 2b :
CBER expressed concern about two issues assoc iated with
Pfizer explained that when the interface is in
m
ode it is and controlled by , but when switch to mode it
is
not controlled by . The ran in the background while in mode. The
data integrity issue was extraneous data seen by the system .
Pfiz
er said in order to avoid this discrepancy they would need to ensure the
software is paused w hen entering mode.
CBER asked if Pfizer would be willing to commit to correcting this before the next inspection. Pfizer committed to investigate this issue and make the required updates
based off of the results.
CBER asked if Pfizer could subm it updated responses as an amendment to the BLA
regarding these follow -up questions. Pfizer said they would do this initially by e-mail
and then submit it as an amendment.
Regarding the extraneous data and data integrity, Pfizer said the ran in the background in the mode. Pfizer also stated that an investigation will be initiated
to determine if pausing the software will eliminate collection of extraneous data
during operations .
Follow -up response to FDA form 483 item 2c:
CBER asked about Pfizer’s response and Pfizer explained that the was a
target, not a control limit and not a critical parameter process at that time . Pfizer
explained this was a retrospective review in of batch records regarding the
less than target.
CBER asked if there were any corrective actions implemented? Pfizer stated that this
was an early batch with limited experience and since there was
Additionally, the is overall controlled by . Pfizer
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FDA-CBER-2021-5683-1150417
STN 125742/0 August 16 , 2021
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has now moved this from a target to a control limit, and will therefore be investigated in
the case of a control limit excursion. There is no impact for this missed target and this
not a critical parameter process .
Pfizer noted that this was originally a , but now it is
an alarm will sound and the shuts off if
that happens.
CBER acknowledged the target vs. control limit information provided in the response;
however, CBER also clarified a more general concern regarding the lack of Quality
oversight during the batch record review process . CBER noted that moving forward
Pfizer should consider ways to enhance their continuou s process verification monitoring
and batch record review process.
Follow -up response to FDA form 483 item 6:
CBER had clarifying questions regarding a couple of discrepancies in Pfizer’s
disinfecting studies in and room .
In study
was on the coupons and shown to be effect ive with a contact time of
However, in another study,
the coupons were and results showed that was not
effective with a contact time of except on .
was effective with a contact time. Pfizer explained that they had
studies where was on the surface of the coupons and
allowed to and another where the coupons were in .
Pfizer explained that with and allowing it to worked
better than .
Pfizer said another study ( ) was performed for where the
was on the coupons and confirmed the effectiveness of
with a contact time of .
CBER asked what were used in the and Pfizer replied it
was
CBER also asked what were used in the study and Pfizer replied
CBER asked how many replicates the study was performed on and Pfizer replied that it
was performed in coupons.
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FDA-CBER-2021-5683-1150418
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CBER noted there was another discrepancy with used at
against against floor and wall surfaces . CBER asked if this was the
same issue and Pfizer replied yes it was.
CBER noted that there was an issue identified in study with
needed a longer contact time and that the evaluation in did not include a
, and said that Pfizer might want to consider adding one of these in the future
depending on the results of EM studies contain .
Follow -up response to FDA form 483 item 9:
Pfizer noted that there was a miscommunication during the inspection and room
, is not a CMC area but ISO room off of CBER asked if the control
room is included in the monitoring and Pfizer replied that is not because it is covered by
a legacy strategy.
Pfizer said the results of the proposed monitoring study will determine if room or
other perimeter rooms will need to be monitored and the frequency and type of
sampling that will be needed.
Pfizer said that they will e -mail a response to CBER today and follow -up with an official
amendment, likely on Wednesday, August 18, 2021. The response will contain
commitment s to 1) investigate how to eliminate data integrity errors when switching to
mode to not have running in the background or provide a signal to show
that it is running and 2) to clarify type of sampling and frequency of testing for item 9c
END
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FDA-CBER-2021-5683-1150419