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EXTERNAL DATA MONITO RING COMMITTEE
PFIZER INTERNAL USE ONLY
The official version of this form is located in the electronic document management system.
CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template
01-Nov-2019
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TMF Doc ID: 64.05 and 713.02
C459
Investigational BNT162 Vaccine Program
PF-07302048
Version : 13
Date : 16-Ju ly-2021
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FDA-CBER-2022-5812-0224657
EXTERNAL DATA MONITO RING COMMITTEE
PFIZER INTERNAL USE ONLY
The official version of this form is located in the electronic document management system.
CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template
01-Nov-2019
Page 2of 38
TMF Doc ID: 64.05 and 713.02
TABLE OF CONTENTS
APPENDI CES ................................ ................................ ................................ ........................... 3
1. INTRODUCTION ................................ ................................ ................................ ................. 5
1.1. Study Design ................................ ................................ ................................ ............. 5
1.2. Purpose of the Committee ................................ ................................ ......................... 5
1.3. Committee Close -Out................................ ................................ ................................ 6
2. COMMI TTEE MEMBERS HIP................................ ................................ ............................. 6
2.1. Conflicts of I nterest ................................ ................................ ................................ ...6
2.2. Confidentiality Agreement/Contract ................................ ................................ ......... 6
2.3. Authorship................................ ................................ ................................ ................. 6
3. ROL ES AND RESPONS IBILIT IES................................ ................................ ..................... 7
3.1. Committee Members ................................ ................................ ................................ .7
3.2. Committ ee Chairperson ................................ ................................ ............................. 7
3.3. Committee L iaison ................................ ................................ ................................ ....7
3.4. Reporting Team ................................ ................................ ................................ ......... 8
3.5. Study Team ................................ ................................ ................................ ............... 9
4. COMMI TTEE MEETING S................................ ................................ ................................ .10
4.1. Meeting Schedule/Frequency ................................ ................................ .................. 10
4.2. Start -up Meeting ................................ ................................ ................................ ......10
4.3. Review Meetings ................................ ................................ ................................ .....11
4.4. Review Meeting Format................................ ................................ .......................... 12
4.4.1. Open Session ................................ ................................ .............................. 12
4.4.2. Closed Session ................................ ................................ ............................ 12
4.5. Voting Procedure ................................ ................................ ................................ .....12
4.6.AD HOC Meetings for Emergent Safet y Data ................................ ........................ 13
4.7. Meeting Minutes ................................ ................................ ................................ .....13
5. DATA PROVIDED TO THE COMMITTEE AND PA RAMETERS TO BE
MONITORED/REVIEWED B Y THE COMMITTEE ................................ ....................... 13
5.1. C4591001 Study Only ................................ ................................ ............................. 13
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EXTERNAL DATA MONITO RING COMMITTEE
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5.1.1. Serious Adverse Events ................................ ................................ .............. 14
5.1.2. Other Safet y................................ ................................ ................................ 14
5.1.3. Surveillance of Events That Could Represent Enhanced COVID -19
Disease ................................ ................................ ................................ ............. 14
5.1.4. I mmunogenicity................................ ................................ .......................... 15
5.1.5. Efficacy ................................ ................................ ................................ .......15
5.2. All Other Stu dies................................ ................................ ................................ .....15
5.2.1. Serious Adverse Events ................................ ................................ .............. 15
5.2.2. Other Safet y................................ ................................ ................................ 16
5.2.3. I mmunogenicity................................ ................................ .......................... 16
5.2.4. Efficacy ................................ ................................ ................................ .......16
5.3. Provision of Study Data to the Committee ................................ .............................. 16
5.3.1. Open Session Data ................................ ................................ ...................... 17
5.3.2. Closed Session Data ................................ ................................ ................... 17
5.4. Database Information ................................ ................................ .............................. 18
6. COMMU NICATION PL AN BETWEE N PFIZER AND THE COM MITTEE .................. 19
6.1. Recommendations ................................ ................................ ................................ ...20
6.2. Communication of Recommendations ................................ ................................ ....20
6.3. External Pfizer Communication ................................ ................................ .............. 20
6.4. Pfizer I nternal Safety Review Committee ................................ ............................... 21
7. WRI TTEN RECORDS ................................ ................................ ................................ ........ 22
7.1. Deliverables to Pfizer ................................ ................................ .............................. 22
7.2. General Project File ................................ ................................ ................................ .22
7.3. Unblinded data in SAS® Datasets ................................ ................................ .......... 23
8. CHARTER HI STORY ................................ ................................ ................................ ......... 23
APPENDICES
Appendix 1. Committee Membership Log ................................ ................................ .............. 25
Appendix 2. Plan to Control Dissemination of Results ................................ ........................... 28
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Appendix 3. Key Contacts ................................ ................................ ................................ .......29
Appendix 4. List of Studies (if committee is to oversee multiple studies) .............................. 37
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EXTERNAL DATA MONITO RING COMMITTEE
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1.INTRODUCTION
This External Data Monitoring Committee ( E-DMC) (hereafter referred to as “the
committee”) is a single, external, independent, expert advisory group established to oversee
safet y and efficacy data from theBNT162 Vaccine Program. The primary rationale for
establishing the committee is to make certain that appropriate external safeguards are in place
to help ensure the safet y of subjects and to maintain scientific rigor and study integrity while
the trial is on -going .
Pfizer is responsible for conducting this study . BioNTechis the regulatory sponsor of this
study .
1.1.Study Design
The COVID -19 program is being developed to address thepandemic crisis which has spread
globall y at high speed. There are currently no vaccines to prevent infection with
SARS -CoV -2 or antiviral drugs to treat COVID -19.
Given the rapid transmission of COVID- 19 and inci dence of disease in the United States and
elsewhere, the rapid development of a safe and effective vaccine is of utmost importance.
Inthe COVID -19 vaccine program, the safety and tolerability of the BNT162 vaccine candidates
will be evaluated by assessing prompted local injection -site reactions and systemic events, as
well as adverse events and serious adverse events. Predefined stopping rules may be used to
ensure safety of study subjects and guide dose escalation and partic ipants may also undergo
hematological and chemistry evaluation as defined per protocol . These procedures are described
in detail in each study protocol where relevant. The background of the COVID -19 vaccine
candidates and pre -clinical development is descri bed in the BNT162 COVID -19 Investigator
Brochure (IB). The updated IB will be provided to the committee when available.
Please refer to the current study protocol sfor details of the study design.
1.2.Purpose of the Committee
The committee will review accumula ting safet y data across all studies , as well as efficacy
data in the Phase 2/3portion of the C4591001 study . The committee will advise Pfizer
regarding the safet y of current participants and those yet to be recruited, as well as the
continuing scientific validity of the trial . In addition to safet y review b y the committee ,
qualified Pfizer personnel will review safet ydata as specified in the safet y surveillance
review plan and will inform the committee of significant findings. Efficacy data from the
C4591001 study will be available to the committee when there is a planned interim analy sis
of efficacy or if this is considered necessary to conduct a risk-benefit assessment.
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1.3.Committee Close -Out
The committee will have completed its work and been dissolved when it has reviewed final
safety data from the last study within the scope of this charter.
2.COMMITTEE MEMBERSHIP
The committee consists of a chairperson and 2-4additional members, as indicated in the list
ofmembers in Appendix 1Committee Membership Log including at least one with medical
qualifications and at least one other who is a statistician.
During the conduct of the study ,membership of the committee may change based on
expertise needed , availability , and new conflicts of interest that warrant a change . A dated
log must be mainta ined in Appendix 1reflecting any changes in membership . Committee
membership is to be for the duration specified in each member’s contract . If any member
leave sthe committee, Pfizer will promptly appoint areplacement in consultation with the
committee chairperson ,if needed.
2.1.Conflicts of Interest
The committee members will complete a CT22 -GSOP -RF01 Independent Oversight
Committee Member Conflict of Interest Fo rm. Committee members should be free of
apparent significant conflicts of interest . Any potential conflict of interest that develops
during a member’s tenure on the committee must be disclosed by the c ommittee member.
Pfizer will determine if any potent ial conflict requires termination of committee membership.
Each time the committee meets, the study team will ask the committee members to consider
whether or not an y changes in thei r conflict of interest status have emerged. Status must be
recorded in the committee open meeting minutes and any potential conflicts must be reported
using CT22 -GSOP -RF01 .
2.2.Confidential ity Agreement/ Contract
A written agreement (i.e., contract, including confidentiality agreement) must be in place for
each external committee member before an y services are rendered. No communication ,
either written or verbal, concerning the deliberations or recommendations of the committee
will be made outside of the committee without approval of Pfizer , except as p rovided for in
this charter (refer to Section 6Communication Plan Between Pfizer and the Committee ).
2.3.Authorship
A committee member must not be an author of a publication emanating from any study on
the BNT162 vaccine program for which they are a member.
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3.ROLES AND RESPONSIBI LITIES
3.1.Committee Members
The primary responsibilities of the committee members are:
Review, endors e,andimplement the charter.
Assess the safet y data from the study on a regular basis ( refer to Section 4.1
Meeting/Schedule Frequency ) throughout the duration of the trial.
Assess efficacy data for efficacy and/or futility during Phase 2/3.
Provid ean informed risk- benefit assessment and advis e Pfizer regarding the continuation
of the trial based on the reviewed data .
Provid e guidance , where appropriate, on additional questions presented by the study team
prior to review meetings.
Adhere to agreements related to potential conflicts of interest.
3.2.Committee Chairperson
The primary responsibilities of the committee chairperson are:
Review and approve the charter on behalf of the committee members.
Facilitate discussion by integrating differing points of view and moving the committee
towards recommendations to be provided to Pfizer in a timely fashion.
Prepare closed session meeting minutes (or via a designee).
Complete CT22 -GSOP -RF11Brief Recommendation Form and submit to the study team ,
according to the communication plan (refer to Section 6Communication Plan Between
Pfizer and the Committee ).
Communicate with thestudy team according to the communication plan on behalf of the
committee (refer to Section 6Communication Plan Between Pfizer and the Committee ).
Provide all written records to the study team for archiving .
3.3.Committee Liaison
The committee liaison is not a member of the study team for an y stud y being reviewed b y the
committee . The committee liaison is designated by Pfizer and will maintain independence
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from the study team for the duration of the trial. The primary responsibilities of the
committee liaison are:
Serve as the primary liaison between the committee and Pfizer management.
Receive and distribute, according to the communication plan, the committee
recommendations from the committee chairperson.
Ensure the committee has access to timel y information abou t the study .
Handle and maintain a record of communications between the committee and Pfizer .
Manage written records (e.g., closed session meeting minutes and CT22 -GSOP -RF11)
between the committee and Pfizer throughout study conduct.
3.4.Reporting Team
The r eporting team is design ated by Pfizer and is comprised of a reporting s tatistician and
reporting p rogrammer(s) . For the P hase 2/3 portion of C4591001 study a medical monitor
and clinical scientist is also part of the reporting team. The reporting team are not members
of the study team for any of the studies being reviewed b y the committee and who will
maintain independence from the study team for the duration of the trial . The primary
responsibilities of the reporting team are:
Compile and provide unblinde d output to the committee for review .
Write the closed committee report, including a textual summary of unblinded findings .
Coordinat e appropriate operational support activities from a dedicated team, including a
reporting p rogrammer (s).
Maintain copies of the review meeting materials for each meeting in a secure area with
restricted access .
Serve as the primary contact for all data -related issues . If the committee requires
additional data, the request and supporting rationale will be made via email to the
reporting statistician (who may elect to consult with the designated Pfizer m anagement ).
Once the request is agreed, the reporting statistician will provide the data /output to the
committee .
During the Phase 2/3portion of the C4591001 study the unblinded medical monitor will
conduct ongoing review of COVID -19 illness cases .
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3.5.Study Team
The study team includes clinician, clinical lead, study statistician , and safety risk lead, and
other team members as appropriate . The primary responsibilities of the study team are:
Ensure qualified study team personnel are available to review blinded (ifapplicable)
safet y data per the safet y surveillance review plan for the duration of the trial in order to
complement the committee ’s safet y role and fulfill Pfizer ’s obligation to monitor patient
safet y.
Select the committee chairperson and members.
Ensure app ropriate study conduct and preservation of the study blind ( if applicable) to
ensure overall study integrit y is maintained.
Document in a written agree ment (e.g., contract) the terms of each committee member’s
participation and indemnify ingall committee members.
Appoint the committee liaison.
Appoint the reporting team (including statistician ,reporting p rogrammer[s] and medic al
monitor )not associated with the study team .
Prepare open session meeting minutes.
Ensure that all written records are filed appropriately in the Trial Master File (TMF) .
Prepare and implement the committee charter .
Provid eto the committee the study protocol (and any subsequent protocol amendments) .
Notify the committee of any significant new safety information (e.g .,toxicology
information, potential safety signal, and data from other clinical trials) .
Implement the committee recommendations once en dorsed b y Pfizer management .
Promptly review and respond to all committee recommendations and provide the
committee with a summary of actions taken in response to its recommendations (as
described in Section 6.2Communication of Recommendations ).
Maintain committee records other than closed session meeting minutes and CT22 -GSOP -
RF11throughout study conduct .
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Archive allrecords at the end of the study .
Submit the committee charter to the Food and Drug Administration ( FDA )and other
regulatory authorities (RA) when appropriate .
Organize and facilitate committee meetings, including logistical support such as
identify ing meeting dates and locations and provid ing assistance with travel
arrangements.
4.COMMITTEE MEETINGS
4.1.Meeting Schedule/Frequency
A start-upmeeting (refer to Section 4.2Start -up Meeting) will be scheduled with the
committee and members of the study team .
The first committee meeting to review study data will be scheduled no later than within the
first month of the first participant dosed with BNT162 vaccine candidates andsooner if
needed.
Thereafter, the committee will meet in person or via teleconference as required by the
protocol to review cumulative safet y data , effic acy data at the time of interim analy sesand to
make risk- benefit assessments until the study in the program is complete or at intervals
determined based on availability of key study data. It is anticipated that regular scheduled
meetings wi lloccur approximately monthly . The frequency of DMC meetings may decrease
(with agreement between Pfizer and the DMC) as the COVID vaccine program matures
however no fewer than two meetings per y ear will be scheduled .
During Phase 2/3 portion of the C4591001 stud y, the meeting frequency for cumulative data
review will be determined based onavailability of key study data . DMC meetings may occur
weekl y and DMC members will be expected to convene at short notice due to the accelerated
pace and critical need of the s tudy if required . The chairperson and Pfizer have the discretion
to change the meeting frequency (e.g. ifenrollment is slow) or request addit ional ad hoc
meetings with the rationale documented appropriately .
4.2.Start -up Meeting
As soon as possible after the committee is formed the committee members, the reporting
statistician, and members of the study team will meet to discuss the operational details of the
committee and the C4591001 protocol . The committee will review and provid e input on
Pfizer’s proposals for data to be monitored, frequency of reviews, methods for review, and
criteria for making recommendations to Pfizer.
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The committee members , the reporting team , and members of the s tudy team will meet
initially to agree on:
Dataand frequency of data outputs to be provided to committee members outside of
planned meetings
Study conduct issues of interest during review meetings,
Data elements and statistical methods to be included in safet y and efficacy review(s),
List of tables, l istings , and figures and mock -ups,
Procedural issues such as meeting frequency and format, timing of data receipt and
format (including table layouts), definition of a “quorum” (comprising of the Chair,
Statistician and one Clinician) and handling of meeting documentation, and
Criteria and process for unblinding the data and maintaining confidentiality of
unblinded results (in the case of a blinded trial or an open -label trial in which the
dissemination of such information is restricted).
For E -DMCs established for safety monitoring, the charter must be approved before first
subject first visit ( FSFV ). (It is permissible to meet this requirement with approval of a
preliminary version of the charter ; in this situation, t he subsequent version of the c harter
must be approved before the first scheduled time the committee views unblinded data from
the trial.)
For all other E- DMCs t he charter will be finalized and approved prior to the first review
meeting.
4.3.Review Meetings
The committee will convene to review study conduct and safety data at determined intervals
after the start -up and initial safet y review meetings . The frequency of meetings will be
dependent upon availability and nature of data to be reviewed and will be agreed between
Pfizer and the Chair. Additionally , the committee will convene to review data on an as -
needed basis (e.g ., a stop ping rule is met, to review reports of COVID -19-like illnesses,
unexpected potential safety signal or study conduct concerns) . Data listings and summaries
will be supplied to c ommittee members b y the reporting statistician via secure e lectronic
means at least 24 hours prior to the meeting but may be up to 5 day s prior if possible .The
study team will present relevant information on new studies prior to the delivery of the first
dataset for these studies.
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4.4.Review Meeting Format
Each review meeting will consist of an open and a closed session (when needed). The
committee and study team will be unblinded during Phase 1 of the C459100 1study (to
identify preferred vaccine candidate(s), dose level(s), number of doses and schedule of
administration) but not during Phase 2/3 (expanded cohort and efficacy part).No separate
open and closed sessions will be requ ired until the study reaches Phase 2/ 3 (expanded coh ort
and efficacy part)including other studies in the program .
These sessions will correspond with the type of briefing materials the committee will receive .
4.4.1. Open Session
The open session provides an opportunity for the committee to interact with members of the
study team as applicable, for example to review study status, to discuss dose -escalation
decisions made b y the IRC, and to discuss AEs thatmet the stopping rule cri teria as
applicable. In addition, issues relating to the conduct of the study /studies, potential impact of
external data on the study /studies, or other topics defined in the open session of the briefing
materials can be discussed.
4.4.2. Closed Session
The clos ed session is the portion of the meeting where the committee discusses any
unblinded results, deliberates over an y issues ,and votes on recommendations to Pfizer . Only
committee members attend the closed -session meeting; however, the reporting statistician
and/or the committee liaison may attend all or part of the closed- session meetings with
concurrence of the committee chairperson .
Debriefing session
Following the closed session, the committee will meet again with Pfizer representatives to
relay comments made by the committee .
4.5.Voting Procedure
All committee members are voting members and are expected to participate in all meetings
and voting forums. Every effort should be made in scheduling meetings to ensure that all
members can participate . Ifall members are unable to participate in a meeting, the chairperson
and at least one additional clinician must participate in voting. Discussions and decisions
requiring expert statistical interpretation of study data require that every effort be made to include
the committee statistician. Discussions and decisions regarding pause or termination of study
vaccination require that every effort be made to include all committee members. In the event of a
split vote, the chairperson will make the final decision concerning the committee ’s
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recommendation . If the chair cannot participate, he /shewill delegate his /herrole to another
member of the committee .
At each meeting, the committee members will vote and provide one of the recommendations
listed in Section 6.1Recommendations.
The recommendations regarding the primary endpoint should be in accordance with the
guidance provided in this charter, the protocol , or the SAP (or other document, as
appropriate, e.g., interim anal ysis plan) .
4.6.AD HOC Meetings for Emergent Safety Data
In the event that the committee is convened for an ad hoc meeting to evaluate emergent data,
processes other than those outlined in this charter may be undertaken on the recommendation
of and/or with the express consent of the committee c hairperson in order to ensure patient
safet y within the trial . Any alterna tive processes will be documented and justified in the
committee meeting minutes. In some instances, when not all committee members are able to
attend at short notice, it is expected that a minimum of 3 members will meet. At each
meeting, the committee me mbers will vote and provide one of the recommendations listed in
Section 6.1 Recommendations .
4.7.Meeting Minutes
The committee chair is accountable for closed session meeting minutes and may delegate the
act of recording minutes during the meeting. Committee members will review and agree to
the minutes before th ey are finalized. At a minimum the minutes should record the following
information:
Who attended the meeting;
Action items created during the meeting including who is responsible for the action;
Any resolution of action items from a previous meeting;
Any issues or concerns identified during the review of the data with brief rationale for the
concern .
5.DATA PROVIDED TO THE COMMITTEE AND PARAM ETERS TO BE
MONITORED/REVIEWED B Y THE COMMITTEE
5.1.C4591001 Study Only
The commit teewill review all data on a regular basis (see Section 4.1and below) and during
Phase 1 will also review data from the BioNTech German study as it becomes available.
Committ eereviews will allow earl y detection of signs of efficacy or disease enhancement
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with corresponding earl y expansion of testing of vaccine candidates, doses, or regimens to
larger numbers of subject or, conversel y, curtailment of testing for other candidates, doses, or
regimens. Immunogenicity data may also be reviewed. Thecommittee chairperson will
communicate an y required action according to the communication plan (refer to Section 6
Communication Plan Between Pfizer and the Committee ).
5.1.1. S erious Adverse Events
All SAEs deemed unexpected and related to BNT162 SARS -CoV -2 RNA vaccines , either by
the investigator or Pfize r (also known as SUSARs [s uspected unexpected serious adverse
reactions ]), willbe forwarded to the committee at the same time as they are report ed to the
RAs, investigators, and institutional review boards (I RBs)/ethics committees (ECs). The
term “unexpected” refers to an event that is either not listed in the I nvestigator ’sBrochure
(IB) Reference Safety Information section or is of greater severity or specificity than that
listed in the IBReference Safety Information section.
All SAEs collected through 6 months after the vaccination schedule is completed will be
reviewed contemporaneously . Additionally , SAE data from the ongoing BioNTech clinical
trial (BNT162 -01) will be provided to the commit teefor information during the Phase 1
portion of the C4591001 study as it becomes available to ensure a comprehensive overview
of information of the BNT 162vaccines is available .
5.1.2. Other Safety
Cumulative data of reactogenicity events and unsolicited adverse events (including that from
the ongoing BioNTech clinical trial as it becomes available in Phase 1) will be reviewed on a
regular basis during scheduled commi tteemeetings. Contemporaneous review of related AEs
up to 1 month after completion of the vaccination schedule will be performed . In addition,
during Phase 2/3 the committee will review all AEs on a weekl y basis until safet y data
through 7 day s after dose 2 from the first 360 participants has been submitted to regulatory
authorities. The committee will schedule an adhoc meeting if deemed necessary .
The committee will meet as soon as possible to review all available relevant data when an y
stopping rule is met . Please refer to sections 8.2.3 and 10.7 of the C4591001 protocol for
stopping rules.
5.1.3. Surveillance of Events That Could Represent Enhanced COVID -19 Disease
Because within the course of COVID -19, the illness caused by SARS -CoV -2 infection, the
onset of an exaggerated adaptive immune response and containment of viral replication in
some instances is associated with a “cy tokine storm” that accompanies clinical d eterioration,
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patient profiles of all nucleic acid amplification test(NAAT )-confirmed cases will be
reviewed contemporaneously by the commi tteeduring Phase 1 of the study .
In Phase 2/3 , there will be planned reviews of the vaccine/placebo split of protocol -defined
severe COVID -19cases at thetime of efficacy /futility anal yses. The DMC will review this
data and make recommendations base don the guidance outlined in Section 10.7 of the
protocol: S topping and alert rules for severe dise ase defined.
Additionally , in Phase 2/3, the unblinded team supporting the DMC, including an unblinded
medical monitor, will review cases of severe COVID -19 as they are received and will review
AEs at least weekly for additional potential cases of severe COVID -19. At a ny point, the
unblinded team may discuss with the DMC chair whether the DMC should review cases for
an adverse imbalance of cases of COVID -19 and/or severe COVID -19 between the vaccine
and placebo groups. If so, t he DMC will then meet to review available severe COVID -19
cases to determine whether the observed imbalance should result in modifications to the
study .Please refer to section 8.2.4 of the protocol for details.
In addition to the above , data regarding COVID- 19 confirmed illnesses reported in the
BioNTech study will be reviewed by the committee when information is available.
The purpose of these reviews will be to identify whether any features of each case appear
unusual, greater inseverity , compared to available information at the time of review.
Indicators of severit y may include accelerated deterioration, need for hospitalization, need
for ventilation, death. Observed rates of these indicators will be compared with what could be
expected in a similar population to the study participants b ased upon available information at
the time of review (for Phase 1 and 2/3) and to compare cases in active vaccine and placebo
recipients in Phase 2/3 (when Pfizer staff will be blinded).
5.1.4. Immunogenicity
The DMC may review safety and immunogenicity data pri or to expansion into Phase 2/3.
5.1.5. Efficacy
The DMC will assess efficacy data for efficacy and/or futility during the Phase 2/3 portion of
theC4591001 study as defined in the protocol .
5.2.All Other Studies
Please refer to Appendix 4 for details.
5.2.1. Serious Adverse Events
All SAEs deemed unexpected and related to BNT162 SARS- CoV -2 RNA vaccines, either b y
the investigator or Pfizer (also known as SUSARs [suspected unexpected serious adverse
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reactions]), will be forwarded to the committee at the same time as they are reported to the
RAs, investigators, and institutional review boards (I RBs)/ethics committees (ECs). The
term “unexpected” refers to an event that is either not listed in the I nvestigator’s Brochure
(IB) Reference Safety Information section or is of greate r severity or specificity than that
listed in the IB Reference Safety Information section.
All SAEs will be reviewed. Studies in which SAEs are followed for longer timepoints may
also be reviewed b y the committee.
5.2.2. Other Safety
Cumulative data of reactogeni city events, unsolicited adverse events, and clinical laboratory
assessments (if applicable) from other studies in the program will be reviewed on a regular
basis during scheduled committee meetings, as described in Section 5.1.2 . Data may be
blinded or unblinded depending on stud y design.
5.2.3. Immuno genicity
The DMC may review immunogenicit ydata.
5.2.4. Efficacy
The DMC will assess efficacy and/or futil ity for all other studies if appropriate.
5.3. Provision of Study Data to the Committee
The reporting statistician is the primary channel for providing output /reports to the
committee. Approximately 24 hours to up to 5calendar days prior to each review meeting
thereporting statistician will transmit all appropriate study data (as described in Section 5
Data Provided to the Committee and Parameters to b e Monitored/Reviewed by the
Committee )via secure electronic means to the committee members.
Committee members must handle all study data in accordance with the confidentiality
agreement in their contract. Any queries on the data are to be made to repor ting statistician
and an y requests for additional data must be communicated in writing (e.g., meeting minutes)
via secure electronic means to the reporting s tatistician with supporting rationale for such
requests . The reporting s tatistician may consult with the Vaccine Research &Development
Clinical and Statistical Heads (or the IRC if applicable) prior to acting upon the request . If
the study is blinded, the nature and content of the query requests may not be shared with the
study team (s).
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5.3.1. Open Session Data
Prior to each review meeting, the committee will receive the following summary data
combined across or summarized by the vaccine groups , depending on study phase ,regarding
the progress of the trials.
Study conduct issues (e .g., enrollment status, eligibility violations).
Demographic and other baseline characteristics.
Dose -escalation decisions made by the IRC as applicable.
Actions taken b y the IRC in response to events that met the stopping rule criteria as
applicable.
5.3.2. C losed Session Data
Prior to review meetings, the committee will receive the safety data indicated below
summarized/analy zedby vaccine group . Additionally , the committee will receive relevant
subject data l istings. Forblinded studies and or studies with blinded stages /phase s, closed
sessions will be conducted.
Study status .
Demographics .
Reactogenicit y data (up to 7 day s post vaccination) when available .
AEs and SAEs.
AEs associated with withdrawal .
Laboratory data when available .
Significant findings identified by the clinician/clinical lead, who will review blinded
safet y data as specified in the safetysurveillance review plan.
Significant findings identified by the IRC,who will review unbli nded safet y data as
specified in the IRC charter.
Data from interim anal yses of safety , efficacy , and immunogenicit y as defined in the
statistical analy sis plan.
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The DMC may also review safet y signals identified by the JSRT from periodic
reviews of the clinical trial data as specified in JSRT charter.
5.4.Database Information
All data provided to the committee will be from a dy namic database that is continually
updated or revised as new information becomes available. A cop y of the database snapshot
used for the reports will be maintained . Tables , listings, and f igures will be annotated with
the date on which they were generated .
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6.1.Recommendation s
After each meeting, the committee will provide one of the following recommendations (for
each stud y reviewed) to Pfizer via CT22 -GSOP -RF11:
Withhold final recommendation until further information/data is p rovided.
Continue the study or studies as designed.
Modify the study or studies and continue .
Stop the study or studies .
Additionally , the committee may be asked to answer study related questions (e.g., concerning
operational challenges, impact of findings from Pfizer ’s safet y data review or impact of
emerging external information) provided b y the study team . The answers to the questions
will be provided with t he committee recommendation to Pfizer management via the
committee liaison.
The recommendations should be in accordance with the guidance provided in th is charter, th e
protocol ,or the SAP (or other document, as appropriate, e.g., interim analysis plan) .
6.2.Communication of Recommendation s
For each review meeting, o nce a committee recommendation has been finalized the
committee chairperson will convey the recommendation in writing within the timelines listed
on CT22- GSOP -RF11 . The written communication will consist of the CT22 -GSOP -RF11
indicating the committee ’s recommendation and sufficient information to explain the
rationale for an y recommendation will be transmitted by secure electronic means to the
committee liaison.
The final decision to accept or reject the committee’s recommendation resides with Pfizer
management and will be communicated to the committee chairperson in writing. Review of
committee recommendation will be conducted in accordance with CT22 -GSOP -RF11.
6.3.External Pfizer Communication
The committee ’s recommendation, together with Pfizer’s response, will be summarized by
the study team who will be responsible for communicating to all active investigators
participating in the trial and toBioNTech representat ives. The investigators and BioNTech
will be informed about the decision to continue the trial, to stop the trial, or to implement
modifications to trial procedures, on a monthly basis .
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6.4.Pfizer Internal Safety Review Committee
Pfizer has established several ad hoc Internal Safety Review Committees (ISRCs), one for
each BU/RU . The ISRC for a BUis properly firewalled from all study teams conducting
trials sponsored b y that unit . The primary objective of an ISRC is to assess specific events
that may constitute a safety concern in an unblinded manner . The assessment could result in
expedited reports to regulators as required in FDA Final Rule (2010) and EU CT -3 (2011) .
The assessment may also lead to safet y-related protocol changes . When necessary , an ISRC
could look at the occurrence of the specific events across multiple studies in a development
program .
The activities of an ISRC are intended to be complementary and supplemental to existing
Pfizer safet y and risk management processes, including th is committee . There is a charter for
the ISRC describing in detail the purpose, composition ,and operations of an I SRC. The
charter is available upon request
.
There may be several interactions between an I SRC and this committee , including :
When the I SRC accepts a request from the signal management lead to review specific
event s, the ISRC c hair will notify the committee chairperson that a request has been
made and that a review is to be conducted with a target date (t ypicall y within 30 calendar
days ofthe request).
The committee liaison will supply the ISRC chair a copy of the current committee
charter, open meeting minutes and correspondences from the committee regarding issues
for which the ISRCis currentl y being consulted.
ISRC c hair will communicate review findings with the committee chairperson .
If no safety concern is identified, the ISRC will communicate this conclusion to the
signal management lead with a cop y to th e committee .
If a safet y concern is identified, the I SRC chair will communicate its findings to the
committee chairperson by an appropriatel y secure means . The written communication
contains the I SRC’s rationale and final assessment . (As the findings are ty pically based
on unblinded data, they must not be shared with the study team at this stage.)
The committee chairperson is requested to acknowledge receipt of the ISRC
communication as soon as possible . The committee considers the findings identified by
the ISRC but is not obligated to act on them.
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Where disagreement exists between the recommendations of the I SRC and the
committee , the two committees attempt to reach consensus through additional
communication.
The final decision to accept or reject the committee’s and/or ISRC’s recommendation
resides with Pfizer management .
The safet y data (tables, listings, and reports, etc.) received by the I SRC for review are
kept confidential and will be disclosed to the committee upon request from the
committee chairperson .
7.WRITTEN RECORDS
The committee liaison will maintain written records of all closed session meeting minutes,
CT22 -GSOP -RF11,and material sreviewed by the committee, and communications between
the committee and Pfizer . These documents are considered proprietary and confidential and
must be available for inspection upon request from RAs. Upon completion of the
committee’s responsibilities, the study team will obtain all written records for archiving.
7.1.Deliverables to Pf izer
The following are the deliverables from the committee chairperson to the committee liaison .
After each committee review meeting:
CT22 -GSOP -RF11.
Closed session meeting minutes .
7.2.General Project File
The study team will compile and maintain the following document sandcorrespondence
throughout stud y conduct .
Any relevant correspondence between the committee and Pfizer .
Committee c harter and any amendments.
Current IB.
Protocol and protocol amendments.
Curriculum vitae for each committee member .
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CT22 -GSOP -RF01 for each committee member .
Minutes from each open session meeting .
7.3.Unblinded data in SAS ® Datasets
The treatment assignment blind will not be broken in the project database for Phase 2/ 3 of
the study . The unblinded treatment assignment info rmation will be merged
programmaticall y with the study datasets using SAS ®. Unblinded SAS® datasets and
program files will be stored and managed in an area that is separate from the general project
area and inaccessible except to members of the reporting t eam.
8.CHARTER HISTORY
Version Date
(dd-Mmm -yyyy)Summary of Changes
1 29 -Apr-2020 N/A
2 10 -Jul-2020 Updated to reflect Protocol Amendment 4 (C4591001 *)
3 17 -Aug-2020 Updated to reflect Protocol Amendment 5 (C4591001 *)
4 22 -Oct-2020 Updated to include C4591005 Japan Study
5 0 4-Nov-2020 Updated to include 3 additional Programmers and an
unblinded Clinical Scientist to the Reporting Team
6 25 -Jan-2021 Updated to include C4591007, C4591015, C45 91017 and
C4591020
7 05 -Feb-2021 Updated to reflect change in Reporting Team personnel
8 17 -Mar-2021 Updated to include OBGYN DMC Consultants, Dr Robert
Heine and Dr Heather Lipkind.
Added C4591018 and C4591024
9 31 -Mar-2021 Updated to remove C4591018, amend the study title for
C4591024, and add study C45 91028
10 05 -May-2021 Updated to reflect change sin Reporting Team and Study
Team personnel
11 17 -May-2021 Updated to include B7471026 , move dstudy details from
Section 5.2to Appendix 4 and updated stud y team
personnel details.
Removed C4591028 due to study halt.
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12 11 -Jun-2021 Added study C45910 31
13 1 6-Jul-2021 Updated stud y team personnel changes
* Protocol Amendment s 1,2, 3, 6 -11did not result in changes to the Charter, however were
shared with the DMC for information.
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Appendix 1.Committee Membership Log
The following outlines the key selection criteria for membership into the E -DMC:
Relevant clinical, reg ion an d/or drug development expertise
Expert in the field of Infectious Diseases and/or Statistics
Experience serving on a DMC
Required time commitment based on the scope of responsibilities
The committee consists of the following members (past and present) .
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Member Affiliation/Address Role * Dates of
MembershipBiography
Jonathan
Zenilman,
MDInfectious Diseases
Division
Johns Hopkins Bay view
Medical Center
Baltimore, MD, US
Tel: +1 410 440 9729Chair 03-April -2020 Infectious
Diseases
Kathry n
Edwards ,
MDVanderbilt Universit y
School of Medicine 1300
Falkirk Court, Nashville,
TN 37221
Tel: +1 615-429-3226E-DMC
member07-April -2020 Pediatric
infectious
Diseases
Robert
Belshe ,
MDDivision of I nfectious
Diseases & Immunology
Saint L ouis Universit y
Medical Center
714 Schiele Ave,
San Jose, CA 95126
Tel: +1 314 496 1033E-DMC
member03-April -2020 Infectious
Diseases and
Immunology
Lawrence
Stanberry ,
MDColumbia University
456 Riverside Drive, Apt
8A, New York, NY, 10027
Tel: +1 646-330-8329E-DMC
member07-April -2020 Pediatric
Infectious
Diseases
Steve Self,
PhDFred Hutchinson Cancer
Research Center
Vaccine and Infectious
Disease Division
1100 Fairview Avenue
North, M2- C200, Seattle,
WA 98109, USA
Tel: +1 206-915-9617E-DMC
Biostatistician02-April -2020 Professor
Emeritus,
Biostatistics
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Robert
Philips
Heine, MDWake Forest Baptist Health
2555 Bitting Road
Winston -Salem, NC 27104
Tel: +1 919-602-3066E-DMC
member18-February
2021Obstetrics,
Maternal
Fetal
Medicine
Heather S
Lipkind ,
MD, MSDepartment of Obstetrics,
Gynecology , and
Reproductive Sciences
Yale Universit y, New
Haven, CT
Tel: +1 203-643-6992E-DMC
member18-February -
2021Associate
Professor :
Maternal
Fetal
Medicine,
Department
of Obstetrics,
Gynecology ,
&
Reproductive
Sciences
*Initial date of membership is the date the effective date of the contract signed b y the
committee member .
Note: Curriculum vitae are on -file at Pfizer and may be accessed by contacting the Study
Team .
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Appendix 2.Plan to Control Dissemination of Results
For studies that require such a plan, this will be documented in a stud y-level document that
will be filed in the TMF.
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Tel: +1 905-818-6801
[email protected]
Sridhar Guduru Senior Statistical Programming Lead
Manager
Pfizer, I nc
500 Arcola Road
Collegeville PA 19426
USA
[email protected]
Programming
Chris Webber
MDSenior Director
Vaccine Clinical Research and Development
Horizon Building
Honey Lane
Hurley
SL6 6RJ
United Kingdom
Tel:+44 7879 800869
chris [email protected] Medical
Monitor
Lisa Mo yer** Senior Manager
Pfizer, I nc
500 Arcola Road
Collegeville PA 19426
USA
Tel: + 1 (484) 8658348
Lisa.L.Mo [email protected] Clinical
Scientist
* The Reporting Team comprises of a number of supporting/back-up Statistical Programmers
across the C459 program. Full details of supporting staff can be located in a separate staffing
document.
** The unblinded Clinical Scientist (CS) will assist with responding to subject level queries
using relevant data s ystems during DMC closed sessions, w hilstthe unblinded medical
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401 N Middletown Rd
Pearl River, NY 10965
USA
Tel:+1 845-602- 2842 Cell 201-290-0489
Fax:+1 845 474 3219
[email protected]
Susan Mather,
MDSenior Director, S afety Surveillance and Risk
Management
500 Arcola Road
Collegeville, PA 19426
USA
Tel: +1 (484) 8652514
[email protected] Risk Lead
Ruth Bailey Director, Clinical Scientist
Horizon Building
Honey Lane
Hurley
SL6 6RJ
United Kingdom
Tel: +44 1628 515654
ruth.bailey @pfizer.comLead Clinical
Scientist
Harpreet Seehra Senior Manager, Clinical Scientist
Horizon Building
Honey Lane
Hurley
SL6 6RJ
United Kingdom
Tel: +44 7901788821
harpreet [email protected] Responsible
Clinical Scientist
Xia Xu Senior Director
Pfizer, I nc
500 Arcola Road
Collegeville PA 19426Xia Xu (Program
Biostatistician
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USA
Tel: +1 484-865-7762
[email protected]
James Baber
MBChB, MPHDirector, Clinician, Global Medical Monitor
Level 15- 18, 151 Clarence St
Sydney
NSW 2 000
Australia
Tel: +61 419410413
[email protected] Clinician
C4591005 Study
Charulata
Sabharwal,
MD, MPHDirector
Pfizer Vaccine Clinical Research and
Development
401 N Middletown Rd
Pearl River, NY 10965
USA
Tel: +1 (201) 294-8147
[email protected] Clinician
C4591007 Study
Judith Absalon
MD, MPH,
FIDSASenior Director
Pfizer Vaccine Clinical Research and
Development
401 N Middletown Rd
Pearl River, NY 10965
USA
Tel: +1 (845) 6021685
[email protected] Clinician
C4591015 Study
Juleen Gay ed,
MDDirector, Clinician
Horizon Building
Honey Lane
Hurley
SL6 6RJ
United KingdomStudy Clinician
C45910 17
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juleen.gay [email protected]
Sohil Patel,
MDAssociate Director, Clinician
Horizon Building
Honey Lane
Hurley
SL6 6RJ
United Kingdom
[email protected] Clinician
C4591020
Bisrat Abraham,
MDAssociate Director
Pfizer Vaccine Clinical Research and
Development
401 N Middletown Rd
Pearl River, NY 10965
USA
Tel:+1 (646) 9880017
[email protected] Clinician
C4591024
Samuel Dy chter,
MDSenior Director
Pfizer Vaccine Clinical Research and
Development
Pfizer I nc, La Jolla
CA
Tel: +1 (858) 5264987
Samuel.Dy [email protected] Clinician
C4591031
Wendy Watson,
MDExecutive Director
Pfizer, I nc
500 Arcola Road
Collegeville PA 19426
USA
Tel: + +1 (484) 8659247
Wendy [email protected] Clinical
Program Lead
20vPnC
Mariano Young,
MDSenior Director
Pfizer, I nc
500 Arcola RoadStudy Clinician
B7471026
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CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template
01-Nov-2019
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TMF Doc ID: 64.05 and 713.02
Collegeville PA 19426
USA
Mariano.Young [email protected]
090177e1979a5738\Approved\Approved On: 22-Jul-2021 12:54 (GMT)
FDA-CBER-2022-5812-0224692
EXTERNAL DATA MONITO RING COMMITTEE
PFIZER INTERNAL USE ONLY
The official version of this form is located in the electronic document management system.
CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template
01-Nov-2019
Page 37of 38
TMF Doc ID: 64.05 and 713.02
Appendix 4.List of Studies (if committee is to oversee multiple studies)
Study Date Added
(dd-Mmm -yyyy)
C4591001: A Phase 1/2/3, P lacebo -Controlled, R andomized ,
Observer-B lind, Dose-Finding S tudy To E valuate The S afety,
Tolerability , Immunogenicity , And E fficacy OfSARS- COV -2
RNA V accine Candidates Against COVID -19 In Health y
Individuals29-Apr-2020
C4591005: A Phase 1/2, Placebo -controlled, Randomized, and
Observer -blind Study to Evaluate the Safet y, Tolerability, and
Immunogenicit y of a SARS -COV -2 RNA Vaccine Candidate
Against COVID -19 in Healthy Japanese Adults22-Oct-2020
C4591007: A Phase 1 OpenLabel Dose-Finding Study To
Evaluate Safety , Tolerability And Immunogenicit y And Phase
2/3 P lacebo -Controlled, Observer B linded Safety, Tolerability ,
And I mmunogenicity Study of aSARS -COV -2 RNA V accine
Candidate Against COVID -19 In Healthy Children <12 Years
of Age18-Jan 2021
C45910 15: A Phase 2/3, P lacebo -Controlled, R andomized ,
Observer-B lindStudy To E valuate TheSafety, Tolerability ,
And Immunogenicity Of a SARS -COV -2 RNA V accine
Candidate (BNT162b2) A gainst COVID -19 In Healthy Pregnant
Women 18 Y earsOf A geAnd O lder18-Jan 2021
C45910 17: A Phase 3, Randomized, Observer -Blind Study To
Evaluate The Safet y, Tolerability, And Immunogenicity Of
Multiple Production L ots And Dose Levels Of The Vaccine
Candidate BNT162b2 Against COVID -19 In Healthy
Participants 12 Through 50 Years Of Age18-Jan-2021
C45910 20: A Phase 3, Randomized, Observer -Blind Study To
Evaluate The Safet y, Tolerability, And Immunogenicity Of a
Lyophilized Formulation Of The Vaccine Candidate BNT162b2
Against COVID 19 In Healthy Adults 18 Through 55 Years Of
Age18-Jan 2021
C45910 24:A Phase 2B, O penLabel Study To E valuate Safety,
Tolerability AndImmunogenicity OfVaccine Candidate17-Mar-2021
090177e1979a5738\Approved\Approved On: 22-Jul-2021 12:54 (GMT)
FDA-CBER-2022-5812-0224693
EXTERNAL DATA MONITO RING COMMITTEE
PFIZER INTERNAL USE ONLY
The official version of this form is located in the electronic document management system.
CT22- GSOP -RF02 6 .0External Data Monitoring Committee and Internal Review Committee Charter Template
01-Nov-2019
Page 38of 38
TMF Doc ID: 64.05 and 713.02
BNT162B2 I n Immunocompromised Participants ≥2 YearsOf
Age
B7471026: A Phase 3, Randomized , Double BlindTrialTo
Describe TheSafety And Immunogenicity Of 20 V alent
Pneumococcal Conjugate V accine WhenCoadministered With
A Booster DoseOfBNT162b2 I nAdults 65 Years Of A geAnd
Older17-May-2021
C4591031: A Phase 3 Master protocol to Evaluate A dditional
Dose(s) O f BNT162b2 in Health y Individuals Previously
Vaccinated with BNT162b211-June-2021
Please refer to the current C4591001, C4591005, C4591007, C4591015, C4591017,
C4591020, C4591024, B7471026 and C4591031 protocol sfor details of the study designs.
090177e1979a5738\Approved\Approved On: 22-Jul-2021 12:54 (GMT)
FDA-CBER-2022-5812-0224694