Document text
From: Naik, Ramachandra
Sent: Thursday, January 6, 2022 7:17 AM
To: Smith, Michael (CBER) < [email protected] >; Gottschalk, Laura
<[email protected] >; Sutkowski, Elizabeth M. < [email protected] >;
Wollersheim, Susan < [email protected] >; Lee, Lucia < [email protected] >; Allende,
Maria < [email protected] >; Wang, Xiao < [email protected] >; Cheung, Anissa
<[email protected] >; Peden, Keith < [email protected] >; Yang, Ye
<[email protected] >; Huang, Lei < [email protected] >; Lin, Tsai-Lien < Tsai-
[email protected] >; Thompson, Deborah <[email protected] >; Niu, Manette
<[email protected] >; Yang, Ye < [email protected] >; Forshee, Richard
<[email protected] >; Ravenell, Kanaeko < [email protected] >; Edwards, Char-
Dell < [email protected] >; Cato, Dennis < [email protected] >; Elekwachi, Oluchi
<[email protected] >; Stockbridge, Lisa L < [email protected] >; Baldwin, Brenda
<[email protected] >; McVittie, Loris < [email protected] >; Prutzman, Kirk C
<[email protected] >; Fink, Doran < [email protected] >; Pratt, Douglas R.
<[email protected] >; Reindel, Rebecca < [email protected] >; Levis, Robin
<[email protected] >; Weir, Jerry P. < [email protected] >; Scott, John
<[email protected] >; Lee, Shiowjen < [email protected] >; Nair, Narayan
<[email protected] >; Alimchandani, Meghna < [email protected] >; Mampilly,
Carrie < [email protected] >; Sausville, Robert < [email protected] >
Cc: Yogurtcu, Osman < [email protected] >; Funk, Patrick <[email protected] >;
Marks, Peter < [email protected] >; Walinsky, Sarah <[email protected] >; Farizo,
Karen < [email protected] >; Finn, Theresa <[email protected] >; Izurieta, Hector
<[email protected] >; Hess, Maureen < [email protected] >; Anderson, Steven
([email protected] ) <[email protected] >; Malarkey, Mary
<[email protected]>; Devore, Nicolette < [email protected] >; Cho, David S
(CBER) < [email protected] >; Rouse, David < [email protected] >; Sharma, Nikunj
<[email protected] >; Vujcic, Luba < [email protected] >; MaguireThon, Meghan
<[email protected] >
Subject: STN 125742/45 - Efficacy supplem ent to COMIRNATY BLA for ex tending the indication to
adolescents 12 through 15 years of age: First Committee Meeting
Dear COMIRNATY sBLA re view committee and managers,
Welcome to the Review team for the effi cacy supplement (STN 125742/45) for COVID-
19 Vaccine, mRNA (COMIRNATY) to extend the indication to adolescents 12 through
15 years of age. This efficacy supplement is available in docuBridge and you may use
the Link to Submission in docuBridge to access the submission.
I am the Chair, and I will be working with Mike Smith and Laura Gottschalk as your
review management team. This e-mail se rves as our First Committee Meeting. Mike,
Laura and I would appreciate if the i mmediate review team members (Susan
Wollersheim – Clinical; Ye Yang – Stati stics; Xiao Wang – Serology Assays;
Deborah Thompson – PVP-Epidemiology; Oluchi Elekwachi – APLB; Kanaeko Ravenell – BIMO; and Brenda Baldwin – CDI SC Consult) could confirm receipt of
this e-mail (by replying to us only). If the information regarding your supervisor, or
any other information on the list (attached), is not correct, please let us know. Please Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0014080934, cn=Michael J. Smith -S4 Date: 2022.01.10 16:18:07 -05'00'
FDA-CBER-2022-5812-0500304
include Mike, Laura and me on all e-mails regarding this supplement. Please let
us know of any major review issues that you have uncovered immediately.
This supplement has been designated as a 6- month Priority Review. Therefore, the
action due date for this submission is June 17, 2022 . At this time, we do not anticipate
presenting this application at a VRBPAC me eting. The final decision will be made at the
Filing Meeting or later.
This supplement will be managed through RMS-BLA. Please reach out to the review
management team if you have any questions regarding navigation of RMS-BLA or you
need assistance with completing tasks, such as uploading documents.
The Filing Meeting is scheduled for Monday , January 31, 2022. Thanks to CBER ADRM
excusing us from having to complete the fili ng checklists for this sBLA, the discipline
reviewers do not need to complete the filing checklists. However, please enter your filing
determination in the Sharepoint document by COB January 25, 2022 to help us
determine who else needs to be invited to the Filing Meeting.
We are planning to schedule monthly committee m eetings as well as labeling meetings
soon. Therefore, please keep your calendars updated.Please see the attached Review Committee-Meeting Dates-Milestones document for
more information such as the list of re viewers (and supervisors) on the Review
Committee, Review Timetable, Explanation of Milestones, Explanation of Roles and
Responsibilities, Documentation of revi ew, Communication plan, etc. Please notify
Mike, Laura and me if there are any issues wit h the submission contents or if your role
or supervisor indicated in the attached document is incorrect.
Thank you, Ram
FDA-CBER-2022-5812-0500305
FIRST COMMITTEE MEETING SUMMARY
To: The File
Date: January 6 ,2022
STN #: 125742/45
Submission Type: Efficacy Supplement
Reason for the Submission: To extend the indication to adolescents 12 through 15 years of
age
Applicant: BioNTech Manufacturing GmbH
Product: COVID-19 Vaccine, mRNA (COMIRNATY)
Meeting Chair: Ramachandra Naik, PhD
Table 1: Review Committee
Review responsibilit y Committee Member Team Leader / Supervisor Division Director (and DDD
Chair Ramachandra Naik, PhD BC: Elizabeth Sutkowski, PhDDD: Loris McVittie, PhD
SA: Kirk Prutzman, PhD
Regulatory Project ManagersCAPT Mike Smith, PhD Laura Gottschalk, PhDBC: Elizabeth Sutkowski, PhDDD: Loris McVittie, PhDSA: Kirk Prutzman, PhD
Clinical Susan Wollersheim, MDTL: Lucia Lee, MD
BC: Maria Allende, MDDD: Doran Fink, MD, PhD
Douglas Pratt, MD
SA: Rebecca Reindel, MD
DVP – Serology assays Xiao Wang, PhDS: Keith Peden, PhDAnissa Cheun
g, MScDD: Jerry Weir, PhDDDD: Robin Levis, PhD
Statistics – Clinical (Safety/Efficacy, and Assays,
if needed
)Ye Yang, PhDTL: Lei Huang, PhD
BC: Tsai-Lien Lin, PhDDD: John Scott, PhDDDD: Shiowjen Lee, PhD
Epidemiology/
PharmacovigilanceDeborah Thompson, MD, MSPHBC: Manette Niu, MD DD: Narayan Nair, MDDDD: Meghna
Alimchandani, MD
Benefit-Risk AssessmentHong Yang, PhDCc: Osman Yogurtcu, PhDCc: Patrick Funk, PhDSup: Richard Forshee
BIMOKanaeko RavenellCc: Char-Dell EdwardsBC: Dennis Cato DD: Carrie Mampilly, MPH
APLB Labeling reviewerCAPT Oluchi Elekwachi, PharmD, MPHBC: Lisa Stockbridge, Ph D DD: Robert Sausville
CDISC consult Brenda Baldwin, PhD BC: Elizabeth Sutkowski, PhD DD: Loris McVittie, PhD
Review Timetable (PDUFA Milestones are in blue, * indicates dates that are TBD or to be
scheduled)
Review Milestone Target Due DateSubmitted: 16-DEC-2021
Received: 16-DEC-2021
Committee Assignment: 30-DEC-2021First Committee Meeting: 06-JAN-2022Filing reviews complete: 25-JAN-2022Confirm BIMO (GCP) In spection Sites 30-JAN-2022
FDA-CBER-2022-5812-0500306
First Committee Meeting Summary BLA STN 125742/45
Page 2Filing Meeting: 31-JAN-2022
Filing Action: 12-FEB-2022
Deficiencies Identified: 28-FEB-2022
Primary Draft Reviews & Reviewer Reports Due
(4 days prior to Mid-Cycle meeting): 12-MAR-2022*
Mid-Cycle Meeting (I nternal): 16-MAR-2022*
Determine if Advisory Committe e Meeting is Necessary 16-MAR-2022
PeRC Briefing materials due: 05-APR-2022*
Notify Safety Working Group (SWG) 18-APR-2022
PeRC Meeting: 19-APR-2022*
Labeling Comments to Applicant: 18-MAY-2022
Finalize Discipline Review memo
with supervisory concurrence ( upload not required): 18-MAY-2022
Notify OCOD of pending approval: 18-MAY-2022
Notify Applicant of PMC/PMR: 18-MAY-2022
Obtain Lot Releas e Clearance 18-MAY-2022
Obtain Compliance Check 18-MAY-2022
Final reviews & addenda signed & uploaded: 12-JUN-2022
PDUFA ADD: 17-JUN-2022
Explanation of Milestones:First Committee Meeting: Committee must meet by this date to discuss the review of the
sBLA.
Filing Meeting: Meeti ng at which the review commi ttee determines whether or not
the sBLA can be filed. Review ers must determine whether the
information included in the sBLA is sufficient to allow the reviewer to conduct an adequate review. T he purpose is not to determine
the acceptability of the data but rather to determine whether the
appropriate information was submitted to allow the reviewer to conduct a meaningful review.
Filing Action: Date by which a filing letter (e ither accepting or refusing to file the
sBLA) must be issued.
Deficiencies Identified: Date by which a le tter must be issued in which review issues
identified to date are conveyed to the applicant.
Mid-cycle Meeting: Meeting at which each reviewer is expected to document their
review progress and discuss the rele vant content of the submission
and present an overview. A draft review memorandum identifying
key issues should be completed by t he time of the meeting. First
line supervisors for each review discipline as well as the Director and Deputy Director for DVRPA and OV RR, or their representative,
should be in attendance at the meeting.
Action Due Date: Date by which final action regarding the sBLA must be conveyed to
the applicant (issue Approval or Complete Response letter, depending on review decision). A ll review memos, regardless of
FDA-CBER-2022-5812-0500307
First Committee Meeting Summary BLA STN 125742/45
Page 3the Action being taken, must be signed and uploaded to the EDR
prior to the date of Action.
Explanation of Roles and Responsibili ties (See CBER SOPP 8401 for more detail)
xChair – Manages the administrative processi ng of reviews and ensures the regulatory
and scientific content of submissions and their reviews are appropriate.
xDirector and/or Deputy Director – the Signatory Authority who signs action letters and
is responsible for content of reviews.
xRegulatory Project Manager (RPM) – Manages the review of submissions, including
reviewing assigned portions, performing qua lity control checks, capturing review
committee communications, and ensures that the review and review file is
administratively complete. The RPMs work in tandem with the Chair to ensure that
amendments are disseminated to the appropriate reviewers and that a meaningful
short summary is entered into RMS-BLA. Throughout the review cycle, the RPMs
ensure that all FDA documents are upload ed into the CBER Co nnect as they are
generated and the documentation review memo is maintained in real-time.
xReview Committee – Perform revi ew of all assigned areas of submissions, participate
in review meetings, and perform and documen t a review of the submission that is
scientifically sound and follows Good Review Management Principles. Documentation
of a discipline review may be in the form of a primary review, discipline review letter,
and a review addendum. It is imperative t hat the review committee endeavor to follow
the review timetable and finish reviews in a timely manner to allow for adequate
supervisory review. It is critical that the review committee keeps management,
including senior management, abreast of any significant review issues.
xSupervisors – Ensure the overall content of reviews are appropriate, all administrative processing steps are being completed, including database data entry, and all
deadlines are met. Reviews and approves employees’ review memos and other
submission documents per CBER policies and procedures. Supervisory review is
considered the Secondary Review.
Documentation of ReviewEach discipline reviewer is expected to prepare a written review documenting their review of the file. Timely submissions are imperative to allow time for adequate management review.
The following is recommended:
xIdentify all materials assigned for review and include an executive summary in each
final or complete review memo.
xList and summarize all mate rial reviewed. The summa ry should identify each
amendment reviewed and include a list of t he submission dates, sections and page
numbers etc., as applicable.
xA list of questions communicated to the applic ant, in letter-ready format, along with the
responses received and reviewed should be clearly identified.
xA recommendation for action, approval or CR, based upon the review summary should
be clearly stated.
xDraft reviews should be prepared and discuss ed with the reviewer’s supervisor and a
copy should be given to the Chair by the draft due date(s). Draft reviews should not
be uploaded to the EDR.
xReviewer’s and supervisor’s electronic signatures should be placed on the final PDF version of the review. A Word version should be attached, and the PDF should be
certified and locked to prevent modification. The review should be entered into RMS-
FDA-CBER-2022-5812-0500308
First Committee Meeting Summary BLA STN 125742/45
Page 4BLA using the date of the Reviewer’s approv al stamp as the date of the memo and the
certified PDF should be uploa ded into the CBER Connect.
xIf a Complete Response (CR) Letter is issued, a complete written review is expected
and should reflect all amendments that have been reviewed through the date of the
CR decision. The final signed and certified PDF version of the review should be
uploaded by the date of the CR action.
Communication Plan
We can communicate with the applicant via several methods such as telecon, secure e-mail, and letter. The following is recommended:
xAll communication in regard to requests for information or advice for the applicant will
be coordinated by the RPMs and communicated ei ther via telecon or secure email.
Please contact Ramachandra Naik (Chair), Mike Smith andLaura Gottschalk
(RPMs) if you need to communi cate with the applicant.
xAlthough every effort should be made to include the RPMs and/or Chair when
communicating with the applicant, in rare instances it may be appropriate, with permission from Ramachandra Naik and/or Mike Smith and Laura Gottschalk, to
communicate some requests for information (e.g., so mething that is relatively simple)
to the applicant via a telecon. Please ensur e that all such communication is formally
documented (i.e., write up a telecon memo and send it to the RPMs to include in the
file).
xFormal telecons with the applicant can be scheduled to address issues for which a
direct discussion is helpful. The RPMs will coordinate this if/when it is needed.
xLetters can also be used to communicate revi ew issues to the applicant. Although
both secure e-mail and letters provide the nece ssary documentation for the file, letters
are a more formal process than secure e-mail (letters must go thro ugh more levels of
supervisory review and concurrence) so typically letters are reserved for
communication of policy or serious review issues.
xPlease “Cc” the Chair on significant e-ma il communication and meetings (internal and
external). It is helpful for the Chair to ha ve a general overview of the review status and
review issues in the various disciplines (a llows for more effect ive communication with
internal upper level management and the applicant when necessary).
xSupervisory concurrence will be sought , when appropriate, prior to sending
communications to the applican t (e.g., memos with request fo r information, providing
advice, etc.).
FDA-CBER-2022-5812-0500309