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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 11, 2021; 12: 00 PM - 12:39 PM EDT
FDA Participants:
Anissa Cheung, Ph.D.
Maryna Eichelberger , Ph.D.
John Eltermann, R.Ph., M.S .
Laura Gottschalk , Ph.D.
Marion Gruber , Ph.D.
Phil Krause, M.D., Ph.D .
Robin Levis , Ph.D.
Mary Malarkey
Loris McVittie , Ph.D.
Ramachandra Naik , Ph.D.
Lori Peters , M.S.
Kirk Prutzman , Ph.D.
Carolyn Renshaw
Michael Smith , Ph.D.
Elizabeth Sutkowski , Ph.D.
Jerry Weir, Ph.D.
Applicant Participants:
Neda Aghajani Memar
Donna Boyce
Carmel Devlin
Jennifer Huff
Kevin Nepveux
Amit Patel
Paul Rohlfing
Adrienne Kaye Stafford Nicholas Warne
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Background/Purpose of this call :
To seek clari ty on availability of EUA and BLA product s and plans for distribution after
licensure of COMIRNATY
Teleconference Summary :
FDA stated that the purpose of the call was to get a better idea regarding the post -
licensure availability of the product [the current frozen formulation or Ready -To-Use
(RTU) formulation ] for which Pfizer is seeking licensure.
Pfizer stated that they intend to license and are prepared to launch the frozen
formulation; however, they noted that t hey have a new United States Government
(USG) contract for delivery of RTU formulation, which will be ready in October 2021.
Pfizer is planning to file a BLA supplement for the RTU formulation. They clarified that
they will not be able to provide BLA -labeled frozen formulation product immediately
upon licensure. Some of Pfizer’s EUA -labeled product is fully compliant with the BLA
with the exception of the labeling, but can’t be over -labeled with BLA -labeling because
of the frozen storage conditions.
Pfizer is manufacturing both frozen formulation and RTU formulation DP in Pfizer,
Puurs; they have just started manufacturing the RTU formulation in Pfizer, Kalamazoo. RTU formulation has EUA labels for use in individuals 12 years of age and older, and RTU products also can’t also be over -labeled as these are also stored frozen; this may
present a concern for use of the RTU product once such product is approved via a
future BLA supplement.
With regard to the current original BLA under review, FDA asked how many lots or
millions of doses Pfizer is planning to launch/release after approval. Pfizer replied that they have lots ( million doses) in their control that are compliant with the BL A with
the exception of the labeling. Also, Pfizer can get the inventory of the unused lots of
vaccine distributed to the field for emergency use. Although these lots have EUA label,
some of the lots are BLA -compliant, including being manufactured in fac ilities that will
be licensed as part of the BL A. FDA committed to internally discussing the labelling
issues for all of these lots and getting back to Pfizer on a possible plan forward.
A remaining issue is the need for lot release of lots under BLA. FDA can release these
lots after a lot release protocol (LRP) is established. From now on, Pfizer will
manufacture BLA -compliant product and provide lot release information.
Pfizer stated that they have fulfilled USG contract for frozen formulation. If approval of RTU formulation is delayed, Pfizer has the flexibility to cont inue manufacturing frozen
formulation as it will be licensed and will be under Pfizer’s control , including distribution.
Pfizer is planning to file EUA amendment for RTU formulation (for use in individuals 12 years of age and older) at the end of August 2021. FDA stated that we are prioritizing
review of the BLA for the frozen formulation, and we will review the EUA amendment for the RTU formulation after taking action on the BLA.
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Pfizer is planning to extend the expiration of the EUA product to 9 months per USG
request.
FDA asked regarding the status of the IR for LRP . Pfizer replied that the LRP will be
submitted today, and Pfizer knows how to send samples and submit protocol through gateway. However, Pfizer was concerned about the time CBER may take for testing (30-45 days) , and pointed out that the 48-hour turnaround time for release under the
EUA had been optimal CBER clarified that under EUA, FDA is not releasing the
product. Rather, lot information is submitted to FDA 48 hours prior to distribution. Further FDA replied that we can’t commit to 48- hour turnaround , but we understand the
urgency and need to expedite and agree that 30- 45 days is too long. FDA will work with
Pfizer and can establish concurrent testing, i.e., testing concurrently with Pfizer to
further reduce time to release. Pfizer understood and agreed.
For FDA’s question regarding how Pfizer will supply the BLA -approved product to
physicians, Pf izer replied that it will be achieved by some kind of communication.
Post -Teleconference Note:
An additional teleconfer ence was held at 12:30 PM on Thursday, August 12, 2021,
betw een management from CBER and Pfizer and it was d ecided that Pfizer will
draft a letter for CBER review for inclusion in the cartons for distribution that describes
the product .
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FDA-CBER-2021-5683-1150242