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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 12 , 2021; 1: 45 – 2:15 PM EDT
FDA Participants:
Marion Gruber, Ph.D.
Mary Malarkey
Ramachandra Naik, Ph.D.
Applicant Participants:
Neda Aghajani Memar
Donna Boyce Carmel Devlin
Jennifer Huff
Kevin Nepveux
Amit Patel
Paul Rohlfing Nicholas Warne
Summary of discussion:
FDA stated that we understand Pfizer has lots ( doses) of the COVID -19
vaccine under its control that meet BLA standards except labeling requirements as
these lots are currently labeled as EUA material. BLA compliant lots should be
available at time of licensure and therefore, these lots need to be identified as
licensed material. FDA asked
• what cartons the vaccine vials are packaged in.
• how Pfizer will identify the lots as licensed lots .
• what is the smallest package size Pfizer can put the BLA label on, and how
practicably it can be accomplished?
• how Pfizer can relabel vials/cartons without compromising storage conditions?
Pfizer replied that all vials are packaged in vial carton pizza boxes. Pfizer cannot
place sticker on the vials or cartons because they are frozen and relabeling vials and
cartons would compromise storage conditions . Pfizer is shipping “pizza boxes” in a
package and they don’t know if Fact Sheets are included in each carton or in the whole
package.
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FDA-CBER-2021-5683-1024779
STN 125742/0
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Pfizer will submit a proposal on how licensed lots will be identified and draft wording to
be used as well as the logistics of how that identification will accompany the lots ,
shortly
FDA and Pfizer appreciated that availability of both, EUA and licens ed lots in the field
will be confusing, and discussed ways to mitigate this problem, e.g., by potentially
posting the lot numbers of the approved product. Pfizer acknowledged this request and
will provide the lot numbers to FD A. FDA added that Package inser ts will need to
accompany the licensed product that is packaged . This pertains to the lots which are
currently under Pfizer’s control as well as those lots in the field. Pfizer reminded us that
for the EUA material, there is eLabeling, so all doses in the field provide a link to
access. Pfizer also indicated that current vaccine turnover is high, and thus, the lots
may be used up quickly . Also, Pfizer cannot predict at this time how many lots will be
used before the BLA approval. However, Pfizer will get back to FDA with the
information tomorrow or so.
FDA asked if Pfizer would continue to manufacture frozen vaccine formulation. Pfizer
replied that they are manufacturing frozen vaccine formulation.
FDA asked if the lot numbering system for BLA is the same or it is different than the
EUA lot numbering. Pfizer replied that it will likely be the same.
Pfizer committed to provide (1) a proposal on how licensed material will be identified
and draft wording to be used and (2) list of vaccine lots that meet licensure standards in
the field, to FDA soon. Pfizer also stated that they are planning to submit lot release protocols (LRPs) for the lots by Monday, August 16, 2021.
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FDA-CBER-2021-5683-1024780