Document text
BioNTech SE
An der Goldgrube 12
55131 Mainz, Germany
Phone: +49 (0)6131 9084 -0
Telefax: +49 (0)6131 9084 -390
R&D STUDY REPORT No . R-20- 0253
NEUTRALIZIN G ANTIBODY TIT ER AND
SARS-COV-2 S1- AND RBD-SPECIF IC ANTIBODY
CONCENTRATION IN SERUM FROM
PARTICIPANTS I N THE BNT162- 01 TRIAL
Version 02
Date: 28 NOV 2020
Reported by Alexander Muik
Test item: SARS-CoV-2 vaccines BNT162b1 and BNT162b2
Key words: BNT162-01 trial , BNT162b1 , BNT162b2, virus neutralization, antibody
binding
This R&D report consi sts of 52 pages.
Confidentiality Statement: The information contained in this document is the property and copyright of
BioNTech RNA Pharmaceuticals GmbH . Therefore, this document is provided in confidence to the recipient (e.g.,
regulatory authorities, IECs/IRBs, investigators, auditors, inspectors). No information contained herein shall be
published, disclosed, or reproduced without prior written approval of the proprietors.
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TABLE OF CONTENTS
TABLE OF CONTENTS ................................ ................................ ........................ 2
LIST OF FIGURES ................................ ................................ ................................ 3
LIST OF TABLES ................................ ................................ ................................ . 4
LIST OF ABBREVIATION S ................................ ................................ .................. 5
RESPONSIBILITIES ................................ ................................ ............................. 6
1 SUMMARY ................................ ................................ ........................... 7
2 GENERAL INFORMATION ................................ ................................ .. 9
2.1 Spon sor and Test Facilities ................................ ................................ .. 9
2.2 Participating Personnel ................................ ................................ ......... 9
2.3 Study Dates ................................ ................................ ........................ 10
2.4 Guidelines and Regulations ................................ ................................ 10
2.5 Changes and Deviations ................................ ................................ ..... 11
2.6 Documentation and Archive ................................ ................................ 11
3 INTRODUCTION ................................ ................................ ................ 12
3.1 Background ................................ ................................ ........................ 12
3.2 Objectives ................................ ................................ ........................... 12
3.3 Study Design ................................ ................................ ...................... 12
4 MATERIALS AND METHOD S ................................ ........................... 13
4.1 Test Item ................................ ................................ ............................. 13
4.2 Control Item ................................ ................................ ........................ 32
4.3 Test System ................................ ................................ ........................ 33
4.4 Materials ................................ ................................ ............................. 33
4.5 Methods ................................ ................................ .............................. 33
4.6 SARS -CoV-2 S1 and RBD IgG direct Luminex -based immunoassay . 33
4.7 SARS -CoV-2 VNT ................................ ................................ .............. 34
4.8 Statistical Analysis ................................ ................................ .............. 34
5 RESULTS ................................ ................................ ........................... 36
5.1 BNT162b1 study arm ................................ ................................ .......... 36
5.1.1 Secondary endpoint - Functional antibody titer data ........................... 36
5.1.2 Exploratory endpoint - Binding antibody concentrations ..................... 38
5.2 BNT162b2 study arm ................................ ................................ .......... 41
5.2.1 Secondary endpoint - Functional antibody titer data ........................... 41
5.2.2 Exploratory endpoint - Binding antibody concentrations ..................... 43
6 CONCLUSION ................................ ................................ .................... 47
7 DOCUMENT HISTORY ................................ ................................ ...... 49
8 REFERENCES ................................ ................................ ................... 50
9 APPENDIX ................................ ................................ ......................... 51
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LIST OF FIGURES
Figure 1: BNT162b1 – Functional 50% SARS -CoV-2 neutralizing antibody titers
(VN 50) for subjects aged 18 to 55 years ................................ ............... 36
Figure 2: BNT162b1 – Fold increase from baseline in functional 50%
SARS -CoV-2 neutralizing antibody titers (VN 50) for subjects aged 18 to
55 years ................................ ................................ ............................... 37
Figure 3: BNT162b1 – Frequency of subjects aged 18 to 55 years with
SARS -CoV-2 GMT seroconversion ................................ ..................... 38
Figure 4: BNT162b1 – S1-binding antibody concentrations [U/mL] for subjects
aged 18 to 55 years ................................ ................................ ............. 39
Figure 5: BNT162b1 – RBD -binding antibody concentrations [U/mL] for subjects
aged 18 to 55 years ................................ ................................ ............. 39
Figure 6: BNT162b1 – Fold increase from baseline in S1 - and RBD -binding
antibody concentrations for subjects aged 18 to 55 years ................... 40
Figure 7: BNT162b1 – Frequency of subjects aged 18 to 55 years with S1 - and
RBD -binding antibody GMC seroconversion ................................ ....... 40
Figure 8: BNT162b2 – Functional 50% SARS -CoV-2 neutralizing antibody titers
(VN 50) ................................ ................................ ................................ .. 41
Figure 9: BNT162b2 – Fold increase from baseline in functional 50%
SARS -CoV-2 neutralizing antibody titers (VN 50) ................................ .. 42
Figure 10: BNT162b2 – Frequency of subjects with SARS -CoV-2 GMT
seroconversion ................................ ................................ .................... 43
Figure 11: BNT162b2 – S1-binding antibody concentrations [U/mL] .................... 44
Figure 12: BNT162b2 – RBD -binding antibody concentrations [U/mL] ................. 44
Figure 13: BNT162b2 – Fold increase from baseline in S1 - and RBD -binding
antibody concentrations for subjects aged 18 to 55 years ................... 45
Figure 14: BNT162b2 – Fold increase from baseline in S1- and RBD -binding
antibody concentrations for subjects aged 56 to 85 years ................... 45
Figure 15: BNT162b2 – Frequency of subjects aged 18 to 55 years with S1 - and
RBD -binding antibody GMC seroconversion ................................ ....... 46
Figure 16: BNT162b2 – Frequency of subjects aged 56 to 85 years with S1 - and
RBD -binding antibody GMC seroconversion ................................ ....... 46
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LIST OF TABLES
Table 1: BNT162b1 study participant material (younger adults aged 18 to 55
years) ................................ ................................ ................................ ... 13
Table 2: BNT162b2 study participant material (younger adults aged 18 to 55
years) ................................ ................................ ................................ ... 20
Table 3: BNT162b2 study participant material (older adults aged 56 to 85
years) ................................ ................................ ................................ ... 30
Table 4: Material from recovered COVID -19 patients ................................ ........ 32
Table 5: Material and reagents used ................................ ................................ . 33
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LIST OF ABBREVIATIONS
BNT162b1 Investigational SARS -CoV-2 vaccine
BNT162b2 Investigational SARS -CoV-2 vaccine
COVID -19 Coronavirus disease 2019
dLIA Luminex -based direct immunoassay
ELISpot Enzyme -linked immuno sorbent spot assay
GMFI Geometric means fold increase
GMC Geometric mean concentration
GMT Geometric mean titer
HCS Human convalescent sample
ICS Intracellular cytokine staining
IgG Immunoglobulin G
IMP Investigational medicinal product
LOD Limit of detection
MFI Mean fluorescent intensit ies
mNG NT mNeonGreen Microneutralization
N/A Not applicable
QA Quality assurance
QC Quality control
RBD Receptor -binding domain
R&D Research and development
S protein Spike protein
SARS -CoV-2 Severe acute respiratory syndrome coronavirus 2
TDV Titer determining value
VNT Virus neutralization assay
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1 SUMMARY
The clinical trial BNT162 -01 investigates the safety and immunogenicity of four
prophylactic SARS -CoV-2 RNA vaccines against COVID -19 using different dosing
regimens in healthy adults. It is accompanied by an extensive immune monitoring
program to analyze participant s’ immune responses against vaccine -encoded antigens
specific to SARS -CoV-2 spike ( S) protein , S1 fragment , or receptor -binding domain
(RBD ), including Luminex -based direct immunoassay (dLIA) , virus neutralization
assay (VNT), ex vivo enzyme -linked immuno sorbent spot (ELISpot) assay , and
intracellular cytokine staining (ICS) .
The objective of this study was to assess the SARS -CoV-2 virus neutralizing titers
(secondary endpoint ) and the SARS -CoV-2 S1 - and RBD -specific immunoglobulin G
(IgG) concentrations (exploratory endpoint ) at pre-immunization baseline, 7±1, and
21±2 days after the BNT162b1 and BNT162b2 priming immunization (Days 1, 8, and
22), and 7 ±1, 21±2, 28±2, and 63 ±5 days after the booster immunization (Days 29, 43,
50, and 85). At the cut -off date for this report, data was available up until Day 43 for
BNT162b1 -dosed younger participants aged 18 to 55 years dosed with 1, 10, 30, 50,
or 60 µg on Days 1 (all dose levels) and 22 (all dose levels except 60 µg) (n=12 per
group). For BNT162b2 -dosed participants, data was available for younger participants
aged 18 to 55 years dosed with 1, 3, 10, 20, or 30 µg, and older participants aged 56
to 85 years dosed with 20 µg on Days 1 and 22 (n=12 per group). Data for younger
participant dose groups was available up until Day 50 for dose groups 1 µg and 3 µg,
and up until Day 85 for dose groups 10, 20, and 30 µg. For the BNT162b2 -dosed older
participants, data was available up until Day 29
Secondary endpoint - Functional antibody titer da ta
Participants dosed with BNT162b1 showed a strong dose -dependent antibody
response. On Day 22, at 21 days after dose 1 , virus neutralizing antibody geometric
mean titers ( neutralizing GMTs) had increased in a dose -dependent manner for the 1,
10, 30, and 50 µg dose groups. At 7 days after dose 2 (Day 29), virus neutralizing
GMTs showed a strong, dose level dependent booster response. In the 60 µg dose
group, which was only dosed once, neutralizing GMTs remained at a lower level,
indicating that a booster d ose is necessary to increase functional antibody titers. On
Day 43 (21 days after dose 2 ), neutralizing GMTs decreased (with exception of the
1 µg dose level). Day 43 virus neutralizing GMTs were 0.7 -fold (1 µg) to 3.6 -fold
(50 µg) those of a COVID -19 human convalescent serum (HCS) panel.
Participants dosed with BNT162b2 showed a strong IMP -induced antibody response.
Virus neutralizing GMTs were detected at 21 days after dose 1 (Day 22) and had
increased substantially in younger participants (aged 18 to 55 years) immunized with
≥3 µg BNT162b2, and older participants (aged 56 to 85 years) immunized with 20 µg
BNT162b2 by 7 days after dose 2 (Day 29). Day 29 neutralizing GMTs were
comparable between the younger and older adult 20 µg dose level cohorts. After an
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2 GENERAL INFORMATION
2.1 Sponsor and Test Facilities
Sponsor:
BioNTech RNA Pharmaceuticals GmbH
An der Goldgrube 12
55131 Mainz
Germany
Test Facilities:
Pfizer Inc.
Vaccine Research & Development Division
401 North Middletown Rd.
Pearl River, NY 10965
USA
University of Texas Medical Branch (UTMB)
T.G. Blocker Medical Research Building Rm. 5.136 (L15532)
224 11th Street
Galveston, TX 77555
USA
2.2 Participating Personnel
Responsible person:
(as defined in SOP -100-024) Dr. Alexander Muik, Head of Immunomodulators,
BioNTech RNA Pharmaceuticals GmbH
Author: Dr. Alexander Muik, Head of Immunomodulators,
BioNTech RNA Pharmaceuticals GmbH
Experimenter: David Cooper, PhD
Executive Director & Head, High -throughput Clinical
Immunoassays & Diagnostics
Luminex -based direct immunoassay (dLIA) Lead
Pfizer, Inc.
Experimenter: Dr. Pei -Young Shi
Principal Investigator
Virus Neutralization (NT) Assay (VNT) Lead
University of Texas Medical Branch
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2.3 Study Dates
Start of experiments: 28 JUN 2020 (dLIA)
29 JUN 2020 (VNT)
Completion of experiments: 23 OCT 2020 (dLIA)*
23 OCT 2020 (VNT)*
*Completion of experiment dates represent the date
that the assays were completed, and data delivered.
It should be noted that sample workboxes are still
being received and active testing is ongoing.
2.4 Guidelines and Regulatio ns
All experiments are executed in accordance with the existing standard operating
procedures and described processes from BioNTech SE. Applicable documents are
listed below.
BioNTech SE:
SOP -100-003 Archiving of Paper -Based Documents
Pfizer, Inc. for dLIA
VR-TM-10293 – Single -plex Luminex Assay for Quantitation of IgG Antibodies
to SARS -CoV-2S1 Protein in Human Serum
VR-TM-10294 – Single -plex Luminex Assay for Quantitation of IgG Antibodies
to SARS -CoV-2 RBD Protein in Human Serum
VR-SOP -LC-11186 – Standar d Operating Procedure for Running
Method using Robot
VR-SOP -LC-11120 – Data Review Procedures for Direct Luminex
Immunoassays in LIMS v6
UTMB for VNT
SHI-TM-10011 – Manual 96 -well Neutralization Assay for the Detection of
Functional Antibodies to SARS -CoV-2 in Test Serum using Cytation 7 Image
Reader
SHI-TM-10011 -FM01 – MANUAL 96 -WELL SARS -COV -2 NEUTRALIZATION
ASSAY WORKSHEET
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SHI-TM-10011 -FM02 – MANUAL SAMPLE PREPARATION FOR THE 96 -
WELL SARS -COV -2 NEUTRALIZATION ASSAY WORKSHEE T
SHI-SOP -10012 – Neutralization Assay for the Detection of Functional
Antibodies to SARS -CoV-2 in Test Serum Data Analysis using Gen5, Excel, and
Prism
2.5 Changes and Deviations
Not applicable. There is no formal R&D plan available .
2.6 Documentation and Archive
Study plans and reports are stored and archived according to BioNTech’s SOP -100-
003 Archiving of Paper -Based Documents.
For the SARS -CoV-2 S1 and RBD IgG direct Luminex assays (dLIA) at Pfizer, assay
plates are read by the Bio -Plex reader, capturing indiv idual well median fluorescent
intensities (MFI). For each assay plate, a CSV file containing the raw data is generated
from the Bio -Plex reader. These raw data files are stored on the local PC connected
to the Bio -Plex reader(s), and an exact copy of each file is moved to a secured server
where acc ess restrictions are in place. This raw data is additionally parsed into Pfizer’s
VRD LabWare LIMS instance from the secure server, aggregating the raw data into
the LIMS batch (e .g., groupin g of samples tested to gether).
The raw MFI data maintained within LIMS are then analyzed by a custom written SAS
application, using a regression model to calculate antigen -specific antibody
concentrations from MFI data. The final, calculated data , and the corresponding PDF
report from the SAS application are transferred back to VRD LabWare LIMS, where
they are stored.
Finally, for each batch, the executed test method, robotic instrument input and output
files, and final SAS PDF output file are archived per VR -SOP -QU-10517
(Admin istration of the Pfizer Vaccine Research (VRD) Records Management Program)
and VR -SOP -QU-10852 (Management of Records Rooms within Vaccine Research
and Development).
For the SARS -CoV-2 mNeonGreen Microneutralization (mNG NT) assay (VNT) at
UTMB, assay plates are read by a Cytation -7 Cell Imaging Multi -Mode Reader,
capturing fluorescent viral foci for each well. This raw data is used to calculate a sample
titer, the reciprocal serum dilution at 50% and 90% of wh ich the virus was neutralized.
Both the raw data files from the instrument, the intermediate calculated results, and
the final calculated results (in the format per VR -RI-DA-10020) are stored in a Pfizer
SharePoint site with restricted access. The final, calculated data are formatted per VR -
RI-DA-10020 (Research Informatics Data Agreement for External Partners - University
of Texas Medical Branch), and parsed into VRD LabWare LIMS, where they are stored.
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3 INTRODUCTION
3.1 Background
The clinical trial BNT162 -01 investigates the safety and immunogenicity of four
prophylactic SARS -CoV-2 RNA vaccines against COVID -19 using different dosing
regimens in healthy adults. It is accompanied by an extensive immune monitoring
program to analyze participants ’ immune responses against vaccine -encoded antigens
specifi c to SARS -CoV-2 S protein, S1 fragment or RBD, including Luminex -based
direct immunoassay (dLIA), virus neutralization assay (VNT), ex vivo ELISpot , and
ICS.
3.2 Objectives
The objective of this study was to assess the SARS -CoV-2 virus neutralizing titers
(secondary endpoint) and the SARS -CoV-2 S1- and RBD -specific IgG concentrations
(exploratory endpoint) at pre-immunization baseline, 7±1 , and 21±2 days after the
BNT162b1 or BNT162b2 priming immunization ( Days 1, 8, and 22), and 7±1, 21±2 ,
28±2, and 63 ±5 days after the booster immunization (Days 29, 43 , 50, and 85).
3.3 Study Design
Serum prepared from blood of study participant s collected at pre-immunization
baseline, 7±1 , and 21±2 days after the BNT162b1 or BNT162b2 priming immunization
(Days 1, 8, and 22), and 7±1, 21±2 , 28±2, and 63 ±5 days after the booster
immunization (Days 29, 43 , 50, and 85) , was analyzed by Luminex -based dLIA for
SARS -CoV-2 S1- or RBD -specific antibodies , and by VNT for functional antibody titer.
At the cut -off date for this report, data was available up until Day 43 for BNT162b1 -
dosed younger participants aged 18 to 55 years dosed with 1, 10, 30, 50, or 60 µg on
Days 1 (all dose levels) and 22 (all dose levels except 60 µg) (n=12 per group). For
BNT162b2 -dosed participants, d ata was available for younger participants aged 18 to
55 years dosed with 1, 3, 10, 20, or 30 µg, and older participants aged 56 to 85 years
dosed with 20 µg on Days 1 and 22 (n=12 per group). Data for younger participant
dose groups was available up until Day 50 for dose groups 1 µg and 3 µg, and up
until Day 85 for dose groups 10, 20, and 30 µg. For the BNT162b2 -dosed older
participants, data was available up until Day 29
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4 MATERIALS AND METHODS
4.1 Test Item
Serum samples from participant s (n=12 per dose group) in the BNT162 -01 trial
vaccinated with BNT162b1 in younger adult dose group s 1 µg, 10 µg (1 drop -out after
dose 1) , 30 µg, 50 µg (1 drop -out after dose 1 ), and 60 µg (Table 1), or vaccinated with
BNT162b 2 in younger adult dose groups 1 µg (1 drop -out after dose 1 ), 3 µg, and
10 µg (1 drop -out after dose 1; 1 delayed boost er on Day 28), 20 µg, and 30 µg
(Table 2), or in the older adult dose group 20 µg (Table 3).
Table 1: BNT162b1 study participant material (younger adults aged 18 to 55 years)
V1: pre-immunization baseline; V3: 7 ±1 days after primary immunization; V4: 21 ±2 days after primary
immunization (pre -boost er); V5: 29 ±3 days after primary immunization ; V6: 43 ±4 days after primary
immunization ; V7: end of treatment or 50 ±4 days after primary immunization
Participant ID Construct Dose Visit Collection date Comment
276-01-0001 BNT162b1 10 µg Visit 1 (Pre -dose) 24.04.2020 N/A
276-01-0001 BNT162b1 10 µg Visit 3 30.04.2020 N/A
276-01-0001 BNT162b1 10 µg Visit 4 (Pre -dose) 15.05.2020 N/A
276-01-0001 BNT162b1 10 µg Visit 5 22.05.2020 N/A
276-01-0001 BNT162b1 10 µg Visit 6 04.06.2020 N/A
276-01-0003 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0003 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0003 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0003 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0003 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0004 BNT162b1 10 µg Visit 1 (Pre -dose) 24.04.2020 N/A
276-01-0004 BNT162b1 10 µg Visit 3 30.04.2020 N/A
276-01-0004 BNT162b1 10 µg Visit 4 (Pre -dose) 15.05.2020 N/A
276-01-0004 BNT162b1 10 µg Visit 5 22.05.2020 N/A
276-01-0004 BNT162b1 10 µg Visit 6 04.06.2020 N/A
276-01-0005 BNT162b1 10 µg Visit 1 (Pre -dose) 24.04.2020 N/A
276-01-0005 BNT162b1 10 µg Visit 3 30.04.2020 N/A
276-01-0005 BNT162b1 10 µg Visit 4 (Pre -dose) 15.05.2020 N/A
276-01-0005 BNT162b1 10 µg Visit 5 22.05.2020 N/A
276-01-0005 BNT162b1 10 µg Visit 6 04.06.2020 N/A
276-01-0006 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0006 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0006 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0006 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0006 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0007 BNT162b1 10 µg Visit 1 (Pre -dose) 23.04.2020 N/A
276-01-0007 BNT162b1 10 µg Visit 3 30.04.2020 N/A
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Participant ID Construct Dose Visit Collection date Comment
276-01-0007 BNT162b1 10 µg Visit 4 (Pre -dose) 14.05.2020 N/A
276-01-0007 BNT162b1 10 µg Visit 5 25.05.2020 N/A
276-01-0007 BNT162b1 10 µg Visit 6 04.06.2020 N/A
276-01-0008 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0008 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0008 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0008 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0008 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0009 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0009 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0009 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0009 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0009 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0010 BNT162b1 10 µg Visit 1 (Pre -dose) 24.04.2020 N/A
276-01-0010 BNT162b1 10 µg Visit 3 30.04.2020 N/A
276-01-0010 BNT162b1 10 µg Visit 7 (drop -out) 19.05.2020 drop-out after
dose 1
276-01-0011 BNT162b1 10 µg Visit 1 (Pre -dose) 24.04.2020 N/A
276-01-0011 BNT162b1 10 µg Visit 3 30.04.2020 N/A
276-01-0011 BNT162b1 10 µg Visit 4 (Pre -dose) 15.05.2020 N/A
276-01-0011 BNT162b1 10 µg Visit 5 22.05.2020 N/A
276-01-0011 BNT162b1 10 µg Visit 6 04.06.2020 N/A
276-01-0015 BNT162b1 1 µg Visit 1 (Pre -dose) 29.04.2020 N/A
276-01-0015 BNT162b1 1 µg Visit 3 06.05.2020 N/A
276-01-0015 BNT162b1 1 µg Visit 4 (Pre -dose) 20.05.2020 N/A
276-01-0015 BNT162b1 1 µg Visit 5 27.05.2020 N/A
276-01-0015 BNT162b1 1 µg Visit 6 10.06.2020 N/A
276-01-0016 BNT162b1 30 µg Visit 1 (Pre -dose) 29.04.2020 N/A
276-01-0016 BNT162b1 30 µg Visit 3 06.05.2020 N/A
276-01-0016 BNT162b1 30 µg Visit 4 (Pre -dose) 20.05.2020 N/A
276-01-0016 BNT162b1 30 µg Visit 5 27.05.2020 N/A
276-01-0016 BNT162b1 30 µg Visit 6 10.06.2020 N/A
276-01-0017 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0017 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0017 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0017 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0017 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0018 BNT162b1 1 µg Visit 1 (Pre -dose) 29.04.2020 N/A
276-01-0018 BNT162b1 1 µg Visit 3 06.05.2020 N/A
276-01-0018 BNT162b1 1 µg Visit 4 (Pre -dose) 20.05.2020 N/A
276-01-0018 BNT162b1 1 µg Visit 5 27.05.2020 N/A
276-01-0018 BNT162b1 1 µg Visit 6 10.06.2020 N/A
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Participant ID Construct Dose Visit Collection date Comment
276-01-0019 BNT162b1 10 µg Visit 1 (Pre -dose) 28.04.2020 N/A
276-01-0019 BNT162b1 10 µg Visit 4 (Pre -dose) 19.05.2020 N/A
276-01-0019 BNT162b1 10 µg Visit 3 05.05.2020 N/A
276-01-0019 BNT162b1 10 µg Visit 5 27.05.2020 N/A
276-01-0019 BNT162b1 10 µg Visit 6 09.06.2020 N/A
276-01-0020 BNT162b1 30 µg Visit 1 (Pre -dose) 29.04.2020 N/A
276-01-0020 BNT162b1 30 µg Visit 3 06.05.2020 N/A
276-01-0020 BNT162b1 30 µg Visit 4 (Pre -dose) 20.05.2020 N/A
276-01-0020 BNT162b1 30 µg Visit 5 27.05.2020 N/A
276-01-0020 BNT162b1 30 µg Visit 6 10.06.2020 N/A
276-01-0021 BNT162b1 30 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0021 BNT162b1 30 µg Visit 3 12.05.2020 N/A
276-01-0021 BNT162b1 30 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0021 BNT162b1 30 µg Visit 5 02.06.2020 N/A
276-01-0021 BNT162b1 30 µg Visit 6 16.06.2020 N/A
276-01-0023 BNT162b1 1 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0023 BNT162b1 1 µg Visit 3 12.05.2020 N/A
276-01-0023 BNT162b1 1 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0023 BNT162b1 1 µg Visit 5 02.06.2020 N/A
276-01-0023 BNT162b1 1 µg Visit 6 16.06.2020 N/A
276-01-0025 BNT162b1 1 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0025 BNT162b1 1 µg Visit 3 12.05.2020 N/A
276-01-0025 BNT162b1 1 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0025 BNT162b1 1 µg Visit 5 02.06.2020 N/A
276-01-0025 BNT162b1 1 µg Visit 6 16.06.2020 N/A
276-01-0028 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0028 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0028 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0028 BNT162b1 30 µg Visit 5 04.06.2020 N/A
276-01-0028 BNT162b1 30 µg Visit 6 18.06.2020 N/A
276-01-0031 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0031 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0031 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0031 BNT162b1 30 µg Visit 5 04.06.2020 N/A
276-01-0031 BNT162b1 30 µg Visit 6 20.06.2020 N/A
276-01-0032 BNT162b1 30 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0032 BNT162b1 30 µg Visit 3 12.05.2020 N/A
276-01-0032 BNT162b1 30 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0032 BNT162b1 30 µg Visit 5 02.06.2020 N/A
276-01-0032 BNT162b1 30 µg Visit 6 16.06.2020 N/A
276-01-0033 BNT162b1 1 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0033 BNT162b1 1 µg Visit 3 12.05.2020 N/A
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Participant ID Construct Dose Visit Collection date Comment
276-01-0033 BNT162b1 1 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0033 BNT162b1 1 µg Visit 5 02.06.2020 N/A
276-01-0033 BNT162b1 1 µg Visit 6 16.06.2020 N/A
276-01-0034 BNT162b1 30 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0034 BNT162b1 30 µg Visit 3 12.05.2020 N/A
276-01-0034 BNT162b1 30 µg Visit 4 (Pre-dose) 26.05.2020 N/A
276-01-0034 BNT162b1 30 µg Visit 5 02.06.2020 N/A
276-01-0034 BNT162b1 30 µg Visit 6 16.06.2020 N/A
276-01-0036 BNT162b1 1 µg Visit 1 (Pre -dose) 08.05.2020 N/A
276-01-0036 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0036 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0036 BNT162b1 1 µg Visit 5 04.06.2020 N/A
276-01-0036 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0037 BNT162b1 30 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0037 BNT162b1 30 µg Visit 3 12.05.2020 N/A
276-01-0037 BNT162b1 30 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0037 BNT162b1 30 µg Visit 5 02.06.2020 N/A
276-01-0037 BNT162b1 30 µg Visit 6 16.06.2020 N/A
276-01-0038 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0038 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0038 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0038 BNT162b1 30 µg Visit 5 04.06.2020 N/A
276-01-0038 BNT162b1 30 µg Visit 6 18.06.2020 N/A
276-01-0039 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0039 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0039 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0039 BNT162b1 30 µg Visit 5 04.06.2020 N/A
276-01-0039 BNT162b1 30 µg Visit 6 18.06.2020 N/A
276-01-0040 BNT162b1 1 µg Visit 1 (Pre-dose) 08.05.2020 N/A
276-01-0040 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0040 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0040 BNT162b1 1 µg Visit 5 04.06.2020 N/A
276-01-0040 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0041 BNT162b1 1 µg Visit 1 (Pre -dose) 08.05.2020 N/A
276-01-0041 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0041 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0041 BNT162b1 1 µg Visit 5 04.06.2020 N/A
276-01-0041 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0042 BNT162b1 1 µg Visit 1 (Pre -dose) 08.05.2020 N/A
276-01-0042 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0042 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0042 BNT162b1 1 µg Visit 5 04.06.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection date Comment
276-01-0042 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0043 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0043 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0043 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0043 BNT162b1 30 µg Visit 5 03.06.2020 N/A
276-01-0043 BNT162b1 30 µg Visit 6 18.06.2020 N/A
276-01-0045 BNT162b1 1 µg Visit 1 (Pre -dose) 05.05.2020 N/A
276-01-0045 BNT162b1 1 µg Visit 3 13.05.2020 N/A
276-01-0045 BNT162b1 1 µg Visit 4 (Pre -dose) 26.05.2020 N/A
276-01-0045 BNT162b1 1 µg Visit 5 02.06.2020 N/A
276-01-0045 BNT162b1 1 µg Visit 6 16.06.2020 N/A
276-01-0047 BNT162b1 30 µg Visit 1 (Pre -dose) 07.05.2020 N/A
276-01-0047 BNT162b1 30 µg Visit 3 14.05.2020 N/A
276-01-0047 BNT162b1 30 µg Visit 4 (Pre -dose) 28.05.2020 N/A
276-01-0047 BNT162b1 30 µg Visit 5 04.06.2020 N/A
276-01-0047 BNT162b1 30 µg Visit 6 18.06.2020 N/A
276-01-0048 BNT162b1 1 µg Visit 1 (Pre -dose) 08.05.2020 N/A
276-01-0048 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0048 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0048 BNT162b1 1 µg Visit 5 04.06.2020 N/A
276-01-0048 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0049 BNT162b1 50 µg Visit 1 (Pre -dose) 12.05.2020 N/A
276-01-0049 BNT162b1 50 µg Visit 3 19.05.2020 N/A
276-01-0049 BNT162b1 50 µg Visit 4 (Pre-dose) 02.06.2020 N/A
276-01-0049 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0049 BNT162b1 50 µg Visit 6 23.06.2020 N/A
276-01-0050 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0050 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0050 BNT162b1 50 µg Visit 7 (drop -out) 03.06.2020 drop-out after
dose 1
276-01-0052 BNT162b1 1 µg Visit 1 (Pre -dose) 08.05.2020 N/A
276-01-0052 BNT162b1 1 µg Visit 3 15.05.2020 N/A
276-01-0052 BNT162b1 1 µg Visit 4 (Pre -dose) 29.05.2020 N/A
276-01-0052 BNT162b1 1 µg Visit 5 03.06.2020 N/A
276-01-0052 BNT162b1 1 µg Visit 6 19.06.2020 N/A
276-01-0053 BNT162b1 50 µg Visit 1 (Pre -dose) 12.05.2020 N/A
276-01-0053 BNT162b1 50 µg Visit 3 19.05.2020 N/A
276-01-0053 BNT162b1 50 µg Visit 4 (Pre -dose) 02.06.2020 N/A
276-01-0053 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0053 BNT162b1 50 µg Visit 6 23.06.2020 N/A
276-01-0055 BNT162b1 50 µg Visit 1 (Pre -dose) 13.05.2020 N/A
276-01-0055 BNT162b1 50 µg Visit 3 20.05.2020 N/A
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Participant ID Construct Dose Visit Collection date Comment
276-01-0055 BNT162b1 50 µg Visit 4 (Pre -dose) 03.06.2020 N/A
276-01-0055 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0055 BNT162b1 50 µg Visit 6 23.06.2020 N/A
276-01-0056 BNT162b1 50 µg Visit 1 (Pre -dose) 13.05.2020 N/A
276-01-0056 BNT162b1 50 µg Visit 3 20.05.2020 N/A
276-01-0056 BNT162b1 50 µg Visit 4 (Pre -dose) 03.06.2020 N/A
276-01-0056 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0056 BNT162b1 50 µg Visit 6 23.06.2020 N/A
276-01-0057 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0057 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0057 BNT162b1 50 µg Visit 4 (Pre -dose) 05.06.2020 N/A
276-01-0057 BNT162b1 50 µg Visit 5 12.06.2020 N/A
276-01-0057 BNT162b1 50 µg Visit 6 26.06.2020 N/A
276-01-0059 BNT162b1 50 µg Visit 1 (Pre -dose) 13.05.2020 N/A
276-01-0059 BNT162b1 50 µg Visit 3 20.05.2020 N/A
276-01-0059 BNT162b1 50 µg Visit 4 (Pre -dose) 03.06.2020 N/A
276-01-0059 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0059 BNT162b1 50 µg Visit 6 23.06.2020 N/A
276-01-0060 BNT162b1 50 µg Visit 1 (Pre-dose) 13.05.2020 N/A
276-01-0060 BNT162b1 50 µg Visit 3 20.05.2020 N/A
276-01-0060 BNT162b1 50 µg Visit 4 (Pre -dose) 03.06.2020 N/A
276-01-0060 BNT162b1 50 µg Visit 5 09.06.2020 N/A
276-01-0060 BNT162b1 50 µg Visit 6 24.06.2020 N/A
276-01-0066 BNT162b1 60 µg Visit 1 (Pre -dose) 19.05.2020 N/A
276-01-0066 BNT162b1 60 µg Visit 3 26.05.2020 N/A
276-01-0066 BNT162b1 60 µg Visit 4 (Pre -dose) 09.06.2020 N/A
276-01-0066 BNT162b1 60 µg Visit 5 16.06.2020 N/A
276-01-0066 BNT162b1 60 µg Visit 6 30.06.2020 N/A
276-01-0067 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0067 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0067 BNT162b1 50 µg Visit 4 (Pre -dose) 05.06.2020 N/A
276-01-0067 BNT162b1 50 µg Visit 5 12.06.2020 N/A
276-01-0067 BNT162b1 50 µg Visit 6 26.06.2020 N/A
276-01-0068 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0068 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0068 BNT162b1 50 µg Visit 4 (Pre -dose) 05.06.2020 N/A
276-01-0068 BNT162b1 50 µg Visit 5 12.06.2020 N/A
276-01-0068 BNT162b1 50 µg Visit 6 26.06.2020 N/A
276-01-0070 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0070 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0070 BNT162b1 50 µg Visit 4 (Pre -dose) 05.06.2020 N/A
276-01-0070 BNT162b1 50 µg Visit 5 12.06.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection date Comment
276-01-0070 BNT162b1 50 µg Visit 6 26.06.2020 N/A
276-01-0073 BNT162b1 50 µg Visit 1 (Pre -dose) 15.05.2020 N/A
276-01-0073 BNT162b1 50 µg Visit 3 22.05.2020 N/A
276-01-0073 BNT162b1 50 µg Visit 4 (Pre -dose) 05.06.2020 N/A
276-01-0073 BNT162b1 50 µg Visit 5 12.06.2020 N/A
276-01-0073 BNT162b1 50 µg Visit 6 26.06.2020 N/A
276-01-0075 BNT162b1 60 µg Visit 1 (Pre -dose) 22.05.2020 N/A
276-01-0075 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0075 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0075 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0075 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0076 BNT162b1 60 µg Visit 1 (Pre -dose) 22.05.2020 N/A
276-01-0076 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0076 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0076 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0076 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0078 BNT162b1 60 µg Visit 1 (Pre -dose) 22.05.2020 N/A
276-01-0078 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0078 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0078 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0078 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0083 BNT162b1 60 µg Visit 1 (Pre -dose) 20.05.2020 N/A
276-01-0083 BNT162b1 60 µg Visit 3 27.05.2020 N/A
276-01-0083 BNT162b1 60 µg Visit 4 (Pre -dose) 10.06.2020 N/A
276-01-0083 BNT162b1 60 µg Visit 5 16.06.2020 N/A
276-01-0083 BNT162b1 60 µg Visit 6 30.06.2020 N/A
276-01-0084 BNT162b1 60 µg Visit 1 (Pre-dose) 22.05.2020 N/A
276-01-0084 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0084 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0084 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0084 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0085 BNT162b1 60 µg Visit 1 (Pre -dose) 22.05.2020 N/A
276-01-0085 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0085 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0085 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0085 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0089 BNT162b1 60 µg Visit 1 (Pre -dose) 20.05.2020 N/A
276-01-0089 BNT162b1 60 µg Visit 3 27.05.2020 N/A
276-01-0089 BNT162b1 60 µg Visit 4 (Pre -dose) 10.06.2020 N/A
276-01-0089 BNT162b1 60 µg Visit 5 16.06.2020 N/A
276-01-0089 BNT162b1 60 µg Visit 6 30.06.2020 N/A
276-01-0093 BNT162b1 60 µg Visit 1 (Pre -dose) 20.05.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection date Comment
276-01-0093 BNT162b1 60 µg Visit 3 27.05.2020 N/A
276-01-0093 BNT162b1 60 µg Visit 4 (Pre -dose) 10.06.2020 N/A
276-01-0093 BNT162b1 60 µg Visit 5 16.06.2020 N/A
276-01-0093 BNT162b1 60 µg Visit 6 30.06.2020 N/A
276-01-0096 BNT162b1 60 µg Visit 1 (Pre -dose) 19.05.2020 N/A
276-01-0096 BNT162b1 60 µg Visit 3 26.05.2020 N/A
276-01-0096 BNT162b1 60 µg Visit 4 (Pre -dose) 09.06.2020 N/A
276-01-0096 BNT162b1 60 µg Visit 5 17.06.2020 N/A
276-01-0096 BNT162b1 60 µg Visit 6 30.06.2020 N/A
276-01-0103 BNT162b1 60 µg Visit 1 (Pre -dose) 22.05.2020 N/A
276-01-0103 BNT162b1 60 µg Visit 3 29.05.2020 N/A
276-01-0103 BNT162b1 60 µg Visit 4 (Pre -dose) 12.06.2020 N/A
276-01-0103 BNT162b1 60 µg Visit 5 19.06.2020 N/A
276-01-0103 BNT162b1 60 µg Visit 6 03.07.2020 N/A
276-01-0104 BNT162b1 60 µg Visit 1 (Pre -dose) 20.05.2020 N/A
276-01-0104 BNT162b1 60 µg Visit 3 27.05.2020 N/A
276-01-0104 BNT162b1 60 µg Visit 4 (Pre -dose) 10.06.2020 N/A
276-01-0104 BNT162b1 60 µg Visit 5 16.06.2020 N/A
276-01-0104 BNT162b1 60 µg Visit 6 30.06.2020 N/A
Table 2: BNT162b2 study participant material (younger adults aged 18 to 55 years)
V1: pre-immunization baseline; V3: 7 ±1 days after primary immunization; V4: 21 ±2 days after primary
immunization (pre -boost er); V5: 29 ±3 days after primary immunization ; V6: 43 ±4 days after primary
immunization; V7: end of treatment or 50 ±4 days after primary immunization ; V8: follow -up or
85±7 days after primary immunization .
Participant ID Construct Dose Visit Collection Date Comment
276-02-0101 BNT162b2 10 µg Visit 1 (Pre -dose) 16.06.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 3 22.06.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 4 (Pre -dose) 07.07.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 5 14.07.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 6 28.07.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 7 04.08.2020 N/A
276-02-0101 BNT162b2 10 µg Visit 8 08.09.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 1 (Pre -dose) 16.06.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 3 23.06.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 4 (Pre -dose) 07.07.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 5 14.07.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 6 28.07.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 7 04.08.2020 N/A
276-02-0102 BNT162b2 10 µg Visit 8 08.09.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 1 (Pre -dose) 15.06.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 3 22.06.2020 N/A
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0103 BNT162b2 10 µg Visit 4 (Pre -dose) 06.07.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 5 13.07.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 6 27.07.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 7 03.08.2020 N/A
276-02-0103 BNT162b2 10 µg Visit 8 07.09.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 1 (Pre -dose) 16.06.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 3 22.06.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 4 (Pre -dose) 07.07.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 5 14.07.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 6 28.07.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 7 04.08.2020 N/A
276-02-0104 BNT162b2 10 µg Visit 8 14.09.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 1 (Pre -dose) 16.06.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 3 22.06.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 4 (Pre -dose) 06.07.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 5 14.07.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 6 28.07.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 7 04.08.2020 N/A
276-02-0105 BNT162b2 10 µg Visit 8 08.09.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 1 (Pre -dose) 16.06.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 3 22.06.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 4 (Pre -dose) 07.07.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 5 14.07.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 6 24.07.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 7 07.08.2020 N/A
276-02-0110 BNT162b2 10 µg Visit 8 10.09.2020 N/A
276-02-0111 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0111 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0111 BNT162b2 10 µg Unscheduled Visit 09.07.2020 Day 21 after
primary
immunization but
deferred booster
immunization
276-02-0111 BNT162b2 10 µg Visit 4 (Pre -dose) 15.07.2020 Pre-dose sample
at day of booster
immunization
(Day 27)
276-02-0111 BNT162b2 10 µg Visit 5 23.07.2020 N/A
276-02-0111 BNT162b2 10 µg Visit 6 30.07.2020 N/A
276-02-0111 BNT162b2 10 µg Visit 7 06.08.2020 N/A
276-02-0111 BNT162b2 10 µg Visit 8 04.09.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 4 (Pre -dose) 09.07.2020 N/A
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0114 BNT162b2 10 µg Visit 5 16.07.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 6 28.07.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 7 07.08.2020 N/A
276-02-0114 BNT162b2 10 µg Visit 8 10.09.2020 N/A
276-02-0116 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0116 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0116 BNT162b2 10 µg Visit 5 16.07.2020 drop-out after
dose 1
276-02-0116 BNT162b2 10 µg Visit 7 30.07.2020 CAVE: only prime
immunization
276-02-0117 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 4 (Pre -dose) 09.07.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 5 13.07.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 6 30.07.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 7 06.08.2020 N/A
276-02-0117 BNT162b2 10 µg Visit 8 10.09.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 4 (Pre -dose) 09.07.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 5 16.07.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 6 30.07.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 7 06.08.2020 N/A
276-02-0118 BNT162b2 10 µg Visit 8 10.09.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 1 (Pre -dose) 18.06.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 3 24.06.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 4 (Pre -dose) 09.07.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 5 16.07.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 6 30.07.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 7 06.08.2020 N/A
276-02-0121 BNT162b2 10 µg Visit 8 10.09.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 1 (Pre -dose) 22.06.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 3 29.06.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 5 20.07.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 6 03.08.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 7 10.08.2020 N/A
276-02-0127 BNT162b2 30 µg Visit 8 14.09.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 1 (Pre -dose) 23.06.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 3 29.06.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 5 21.07.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 6 04.08.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0128 BNT162b2 30 µg Visit 7 11.08.2020 N/A
276-02-0128 BNT162b2 30 µg Visit 8 15.09.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 3 02.07.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 6 07.08.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 7 13.08.2020 N/A
276-02-0134 BNT162b2 30 µg Visit 8 21.09.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 1 (Pre -dose) 23.06.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 3 30.06.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 5 21.07.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 6 04.08.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 7 11.08.2020 N/A
276-02-0137 BNT162b2 30 µg Visit 8 15.09.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 3 03.07.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 6 07.08.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 7 14.08.2020 N/A
276-02-0138 BNT162b2 30 µg Visit 8 17.09.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 3 02.07.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 6 06.08.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 7 12.08.2020 N/A
276-02-0142 BNT162b2 30 µg Visit 8 17.09.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 3 02.07.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 6 06.08.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 7 13.08.2020 N/A
276-02-0143 BNT162b2 30 µg Visit 8 17.09.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 3 02.07.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 6 06.08.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Strictly Confidential
Participant ID Construct Dose Visit Collection Date Comment
276-02-0144 BNT162b2 30 µg Visit 7 13.08.2020 N/A
276-02-0144 BNT162b2 30 µg Visit 8 17.09.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 1 (Pre -dose) 25.06.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 3 02.07.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 4 (Pre -dose) 15.07.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 5 23.07.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 6 06.08.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 7 13.08.2020 N/A
276-02-0145 BNT162b2 30 µg Visit 8 17.09.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 1 (Pre -dose) 22.06.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 3 29.06.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 5 20.07.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 6 03.08.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 7 12.08.2020 N/A
276-02-0149 BNT162b2 30 µg Visit 8 16.09.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 1 (Pre -dose) 23.06.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 3 30.06.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 5 21.07.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 7 11.08.2020 N/A
276-02-0150 BNT162b2 30 µg Visit 8 21.09.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 5 27.07.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 6 11.08.2020 N/A
276-02-0153 BNT162b2 1 µg Visit 7 18.08.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 5 27.07.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 6 11.08.2020 N/A
276-02-0154 BNT162b2 1 µg Visit 7 18.08.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 1 (Pre -dose) 23.06.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 3 30.06.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 4 (Pre -dose) 14.07.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 5 21.07.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 6 04.08.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 7 11.08.2020 N/A
276-02-0155 BNT162b2 30 µg Visit 8 15.09.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 1 (Pre -dose) 02.07.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Strictly Confidential
Participant ID Construct Dose Visit Collection Date Comment
276-02-0156 BNT162b2 20 µg Visit 3 08.07.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 4 (Pre -dose) 23.07.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 5 30.07.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 6 13.08.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 7 20.08.2020 N/A
276-02-0156 BNT162b2 20 µg Visit 8 24.09.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 5 27.07.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 6 11.08.2020 N/A
276-02-0157 BNT162b2 1 µg Visit 7 18.08.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 1 (Pre -dose) 13.07.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 3 20.07.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 4 (Pre -dose) 03.08.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 5 07.08.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 6 24.08.2020 N/A
276-02-0158 BNT162b2 1 µg Visit 7 31.08.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 1 (Pre -dose) 01.07.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 3 08.07.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 4 (Pre -dose) 22.07.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 5 29.07.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 6 07.08.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 7 19.08.2020 N/A
276-02-0159 BNT162b2 20 µg Visit 8 23.09.2020 N/A
276-02-0160 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0160 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0160 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 drop-out after
dose 1
276-02-0160 BNT162b2 1 µg Visit 5 30.07.2020 CAVE: only prime
immunization
276-02-0163 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0163 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0163 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 N/A
276-02-0163 BNT162b2 1 µg Visit 5 28.07.2020 N/A
276-02-0163 BNT162b2 1 µg Visit 6 12.08.2020 N/A
276-02-0163 BNT162b2 1 µg Visit 7 18.08.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 1 (Pre -dose) 13.07.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 3 20.07.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 4 (Pre -dose) 03.08.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 5 10.08.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 6 24.08.2020 N/A
276-02-0164 BNT162b2 1 µg Visit 7 04.09.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Strictly Confidential
Participant ID Construct Dose Visit Collection Date Comment
276-02-0166 BNT162b2 1 µg Visit 1 (Pre -dose) 29.06.2020 N/A
276-02-0166 BNT162b2 1 µg Visit 3 07.07.2020 N/A
276-02-0166 BNT162b2 1 µg Visit 4 (Pre -dose) 20.07.2020 N/A
276-02-0166 BNT162b2 1 µg Visit 5 27.07.2020 N/A
276-02-0166 BNT162b2 1 µg Visit 6 11.08.2020 N/A
276-02-0166 BNT162b2 1 µg Visit 7 18.08.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 1 (Pre -dose) 01.07.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 3 08.07.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 4 (Pre -dose) 22.07.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 5 29.07.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 6 12.08.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 7 19.08.2020 N/A
276-02-0168 BNT162b2 20 µg Visit 8 23.09.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 1 (Pre -dose) 13.07.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 3 20.07.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 4 (Pre -dose) 03.08.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 5 11.08.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 6 27.08.2020 N/A
276-02-0171 BNT162b2 1 µg Visit 7 31.08.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 1 (Pre -dose) 02.07.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 3 08.07.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 4 (Pre -dose) 23.07.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 5 27.07.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 6 13.08.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 7 20.08.2020 N/A
276-02-0172 BNT162b2 20 µg Visit 8 24.09.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 1 (Pre -dose) 02.07.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 3 08.07.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 4 (Pre -dose) 23.07.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 5 30.07.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 6 13.08.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 7 20.08.2020 N/A
276-02-0173 BNT162b2 20 µg Visit 8 24.09.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 1 (Pre -dose) 06.07.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 3 13.07.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 4 (Pre -dose) 27.07.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 5 06.08.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 6 17.08.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 7 24.08.2020 N/A
276-02-0174 BNT162b2 20 µg Visit 8 28.09.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 1 (Pre -dose) 06.07.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 3 13.07.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0175 BNT162b2 20 µg Visit 4 (Pre -dose) 27.07.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 5 05.08.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 6 17.08.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 7 24.08.2020 N/A
276-02-0175 BNT162b2 20 µg Visit 8 28.09.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 1 (Pre -dose) 29.07.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 3 05.08.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 5 26.08.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 6 09.09.2020 N/A
276-02-0176 BNT162b2 3 µg Visit 7 16.09.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 1 (Pre -dose) 06.07.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 3 14.07.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 4 (Pre -dose) 27.07.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 5 05.08.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 6 18.08.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 7 24.08.2020 N/A
276-02-0177 BNT162b2 20 µg Visit 8 28.09.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 1 (Pre -dose) 06.07.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 3 13.07.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 4 (Pre -dose) 27.07.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 5 05.08.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 6 17.08.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 7 24.08.2020 N/A
276-02-0178 BNT162b2 20 µg Visit 8 28.09.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 1 (Pre -dose) 06.07.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 3 13.07.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 4 (Pre -dose) 29.07.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 5 05.08.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 6 17.08.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 7 24.08.2020 N/A
276-02-0179 BNT162b2 20 µg Visit 8 28.09.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 1 (Pre -dose) 13.07.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 3 20.07.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 4 (Pre -dose) 03.08.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 5 10.08.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 6 24.08.2020 N/A
276-02-0180 BNT162b2 20 µg Visit 7 31.08.2020 N/A
276-02-0181 BNT162b2 1 µg Visit 1 (Pre -dose) 28.07.2020 N/A
276-02-0181 BNT162b2 1 µg Visit 3 04.08.2020 N/A
276-02-0181 BNT162b2 1 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0181 BNT162b2 1 µg Visit 5 26.08.2020 N/A
090177e195a3bc9c\Approved\Approved On: 29-Nov-2020 02:47 (GMT)
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0181 BNT162b2 1 µg Visit 6 08.09.2020 N/A
276-02-0181 BNT162b2 1 µg Visit 7 15.09.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 1 (Pre -dose) 13.07.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 3 20.07.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 4 (Pre -dose) 03.08.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 5 10.08.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 6 24.08.2020 N/A
276-02-0183 BNT162b2 20 µg Visit 7 03.09.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 1 (Pre -dose) 29.07.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 3 05.08.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 5 26.08.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 6 09.09.2020 N/A
276-02-0185 BNT162b2 3 µg Visit 7 16.09.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 1 (Pre -dose) 28.07.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 3 04.08.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 5 25.08.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 6 08.09.2020 N/A
276-02-0188 BNT162b2 1 µg Visit 7 15.09.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 1 (Pre -dose) 28.07.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 3 04.08.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 5 25.08.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 6 08.09.2020 N/A
276-02-0189 BNT162b2 1 µg Visit 7 15.09.2020 N/A
276-02-0191 BNT162b2 3 µg Visit 1 (Pre -dose) 06.08.2020 N/A
276-02-0191 BNT162b2 3 µg Visit 3 13.08.2020 N/A
276-02-0191 BNT162b2 3 µg Visit 4 (Pre -dose) 26.08.2020 N/A
276-02-0191 BNT162b2 3 µg Visit 5 03.09.2020 N/A
276-02-0191 BNT162b2 3 µg Visit 6 17.09.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 1 (Pre -dose) 28.07.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 3 04.08.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 5 25.08.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 6 08.09.2020 N/A
276-02-0192 BNT162b2 3 µg Visit 7 15.09.2020 N/A
276-02-0193 BNT162b2 3 µg Visit 1 (Pre -dose) 29.07.2020 N/A
276-02-0193 BNT162b2 3 µg Visit 3 05.08.2020 N/A
276-02-0193 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0193 BNT162b2 3 µg Visit 5 26.08.2020 N/A
276-02-0193 BNT162b2 3 µg Visit 6 09.09.2020 N/A
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Participant ID Construct Dose Visit Collection Date Comment
276-02-0193 BNT162b2 3 µg Visit 7 16.09.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 1 (Pre -dose) 29.07.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 3 06.08.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 5 24.08.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 6 09.09.2020 N/A
276-02-0194 BNT162b2 3 µg Visit 7 16.09.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 1 (Pre -dose) 31.07.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 3 07.08.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 4 (Pre -dose) 19.08.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 5 28.08.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 6 11.09.2020 N/A
276-02-0195 BNT162b2 3 µg Visit 7 18.09.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 1 (Pre -dose) 28.07.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 3 04.08.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 4 (Pre -dose) 18.08.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 5 25.08.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 6 08.09.2020 N/A
276-02-0197 BNT162b2 3 µg Visit 7 15.09.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 1 (Pre -dose) 30.07.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 3 07.08.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 4 (Pre -dose) 19.08.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 5 28.08.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 6 11.09.2020 N/A
276-02-0200 BNT162b2 3 µg Visit 7 18.09.2020 N/A
276-02-0201 BNT162b2 3 µg Visit 1 (Pre -dose) 06.08.2020 N/A
276-02-0201 BNT162b2 3 µg Visit 3 12.08.2020 N/A
276-02-0201 BNT162b2 3 µg Visit 4 (Pre -dose) 26.08.2020 N/A
276-02-0201 BNT162b2 3 µg Visit 5 03.09.2020 N/A
276-02-0201 BNT162b2 3 µg Visit 6 17.09.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 1 (Pre -dose) 31.07.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 3 07.08.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 4 (Pre -dose) 21.08.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 5 28.08.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 6 11.09.2020 N/A
276-02-0203 BNT162b2 3 µg Visit 7 18.09.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 1 (Pre -dose) 31.07.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 3 07.08.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 4 (Pre -dose) 19.08.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 5 28.08.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 6 11.09.2020 N/A
276-02-0204 BNT162b2 3 µg Visit 7 18.09.2020 N/A
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Table 3: BNT162b2 study participant material (older adults aged 5 6 to 85 years)
V1: pre-immunization baseline; V3: 7 ±1 days after primary immunization; V4: 21 ±2 days after primary
immunization (pre -boost er); V5: 29 ±3 days after primary immunization; V6: 43 ±4 days after primary
immunization; V7: end of treatment or 50 ±4 days after primary immunization ; V8: follow -up or
85±7 days after primary immunization .
Participant ID Construct Dose Visit Collection Date Comment
276-02-0208 BNT162b2 20 µg Visit 1 (Pre -dose) 25.08.2020 N/A
276-02-0208 BNT162b2 20 µg Visit 3 01.09.2020 N/A
276-02-0208 BNT162b2 20 µg Visit 4 (Pre -dose) 14.09.2020 N/A
276-02-0208 BNT162b2 20 µg Visit 5 22.09.2020 N/A
276-02-0214 BNT162b2 20 µg Visit 1 (Pre -dose) 26.08.2020 N/A
276-02-0214 BNT162b2 20 µg Visit 3 02.09.2020 N/A
276-02-0214 BNT162b2 20 µg Visit 4 (Pre -dose) 14.09.2020 N/A
276-02-0214 BNT162b2 20 µg Visit 5 23.09.2020 N/A
276-02-0215 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0215 BNT162b2 20 µg Visit 3 07.09.2020 N/A
276-02-0215 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0215 BNT162b2 20 µg Visit 5 29.09.2020 N/A
276-02-0216 BNT162b2 20 µg Visit 1 (Pre -dose) 25.08.2020 N/A
276-02-0216 BNT162b2 20 µg Visit 3 01.09.2020 N/A
276-02-0216 BNT162b2 20 µg Visit 4 (Pre -dose) 14.09.2020 N/A
276-02-0216 BNT162b2 20 µg Visit 5 22.09.2020 N/A
276-02-0221 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0221 BNT162b2 20 µg Visit 3 07.09.2020 N/A
276-02-0221 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0221 BNT162b2 20 µg Visit 5 29.09.2020 N/A
276-02-0222 BNT162b2 20 µg Visit 1 (Pre -dose) 26.08.2020 N/A
276-02-0222 BNT162b2 20 µg Visit 3 02.09.2020 N/A
276-02-0222 BNT162b2 20 µg Visit 4 (Pre -dose) 14.09.2020 N/A
276-02-0222 BNT162b2 20 µg Visit 5 23.09.2020 N/A
276-02-0223 BNT162b2 20 µg Visit 1 (Pre -dose) 26.08.2020 N/A
276-02-0223 BNT162b2 20 µg Visit 3 02.09.2020 N/A
276-02-0223 BNT162b2 20 µg Visit 4 (Pre-dose) 14.09.2020 N/A
276-02-0223 BNT162b2 20 µg Visit 5 23.09.2020 N/A
276-02-0224 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0224 BNT162b2 20 µg Visit 3 07.09.2020 N/A
276-02-0224 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0224 BNT162b2 20 µg Visit 5 29.09.2020 N/A
276-02-0225 BNT162b2 20 µg Visit 1 (Pre -dose) 26.08.2020 N/A
276-02-0225 BNT162b2 20 µg Visit 4 (Pre -dose) 14.09.2020 N/A
276-02-0225 BNT162b2 20 µg Visit 5 23.09.2020 N/A
276-02-0226 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0226 BNT162b2 20 µg Visit 3 07.09.2020 N/A
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276-02-0226 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0226 BNT162b2 20 µg Visit 5 29.09.2020 N/A
276-02-0229 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0229 BNT162b2 20 µg Visit 3 07.09.2020 N/A
276-02-0229 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0229 BNT162b2 20 µg Visit 5 29.09.2020 N/A
276-02-0233 BNT162b2 20 µg Visit 1 (Pre -dose) 01.09.2020 N/A
276-02-0233 BNT162b2 20 µg Visit 3 07.09.2020 N/A
276-02-0233 BNT162b2 20 µg Visit 4 (Pre -dose) 22.09.2020 N/A
276-02-0233 BNT162b2 20 µg Visit 5 29.09.2020 N/A
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4.2 Control Item
Serum samples from 38 human convalescent COVID-19 patients (HCS sera) were
drawn from individuals aged 18 to 83 years, at least 14 days after confirmed diagnosis,
and at a time when the individuals were asymptomatic. The serum donors
predominantly had symptomatic infections (35 of 38 patients ), and one had been
hospitalized. Serum samples were obtained from Sanguine Biosciences (Sherman
Oaks, CA , USA ), the MT Group (Van Nuys, CA , USA ), and Pfizer Occupational Health
and Wellness (Pearl River, NY , USA ).
Table 4: Material from r ecovered COVID -19 patient s
Participant
number Biosampling ID Clinical score/notes Days after first
diagnosis
(PCR confirmed)
RSP 13049 CV0001 Severely ill, not hospitalized >14 days
RSP 13313 CV0003 Severely ill, not hospitalized >14 days
RSP 13504 CV0005 Severely ill, not hospitalized >14 days
RSP 13513 CV0009 Severely ill, not hospitalized >14 days
SAN 96935 CV0012 Not hospitalized >14 days
SAN 107576 CV0013 Not hospitalized >14 days
SAN 107511 CV0014 Not hospitalized >14 days
SAN 107643 CV0015 Not hospitalized >14 days
SAN 107538 CV0016 Not hospitalized >14 days
SAN 107526 CV0017 Not hospitalized >14 days
SAN 107757 CV0018 Not hospitalized >14 days
SAN 107334 CV0019 Not hospitalized >14 days
SAN 32690 CV0020 Not hospitalized >14 days
SAN 34010 CV0021 Not hospitalized >14 days
SAN 107762 CV0022 Not hospitalized >14 days
SAN 107336 CV0023 Not hospitalized >14 days
MT1560 -002 CV0028 Not hospitalized, cough, sore throat,
diarrhea, body aches >14 days
MT1560 -004 CV0029 Asymptomatic >14 days
MT1560 -008 CV0030 Not hospitalized, fever, cough, nasal
congestion, body aches >14 days
MT1560 -009 CV0031 Not hospitalized, fever, tiredness, cough >14 days
MT1560 -010 CV0032 Not hospitalized, fever, tiredness, cough,
difficulty breathing >14 days
MT1560 -006 CV0033 Not hospitalized, fever, cough, sore
throat, body aches >14 days
MT1560 -003 CV0034 Not hospitalized, fever, cough, sore
throat, body aches >14 days
MT1560 -001 CV0035 Not hospitalized, fever, difficulty breathing >14 days
MT1560 -005 CV0036 Not hospitalized, fever, cough, body
aches >14 days
MT1560 -007 CV0037 Not hospitalized, cough, nasal congestion >14 days
MT1560 -039 CV0038 Hospitalized, ICU, ventilator >14 days
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Participant
number Biosampling ID Clinical score/notes Days after first
diagnosis
(PCR confirmed)
MT1560 -064 CV0039 Not hospitalized, fever, tiredness, nasal
congestion >14 days
MT1560 -065 CV0040 Not hospitalized, diarrhea >14 days
MT1560 -067 CV0041 Not hospitalized, fever, tiredness, cough,
nasal congestion, difficulty breathing >14 days
MT1560 -040 CV0042 Not hospitalized, fever, tiredness, cough,
difficulty breathing >14 days
MT1560 -041 CV0043 Not hospitalized, tiredness, body aches >14 days
MT1560 -042 CV0044 Not hospitalized, fever, tiredness, cough >14 days
MT1560 -043 CV0045 Not hospitalized, fever, tiredness, cough,
difficulty breathing >14 days
MT1560 -044 CV0046 Not hospitalized, fever, tiredness, cough,
nasal congestion, difficulty breathing >14 days
MT1560 -045 CV0047 Not hospitalized, fever, tiredness, body
aches >14 days
MT1560 -046 CV0048 Not hospitalized, fever, diarrhea >14 days
MT1560 -047 CV0049 Not hospitalized, asymptomatic >14 days
4.3 Test System
SARS -CoV-2 S1 and RBD IgG direct Luminex -based assay and SARS -CoV-2 VNT
(mNeonGreen Microneutralization [mNG NT ]).
4.4 Materials
Table 5: Material and reagents used
Experimental step/
Materials Product name Manufacturer/Lot
SARS -CoV-2 S1 and
RBD IgG dLIA Beads (S1) Pfizer Lot 00711492 -0395
Beads (RBD) Pfizer Lot 00711492 -0396
Secondary antibody Jackson Catalog #: 109 -115-098
SARS -CoV-2 mNG NT
assay (VNT) Vero cells ATCC CCL -81
icSARS -CoV-2 mNG virus UTMB
Vero E6 cells ATCC CRL -1586
4.5 Methods
4.6 SARS -CoV-2 S1 and RBD IgG direct Luminex -based
immunoassay
Serum samples were diluted in assay buffer manually or by a qualified liquid -
handling workstation, and each diluted sample was transferred from the
dilution plate to a 96 -well assay plate. Sample preparations on the robot
consisted of dilutions of each sample ). Three
dilutions were used to increase t he likelihood that at least one result for any test sample
would fall within the us able range of the standard curve. S1- or RBD -coated
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(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)(4)
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microspheres were added to the sera in the 96 -well assay plate, with a final
concentration of approximately microspheres in each well. All tests were
performed in duplicate wells. Each assay plate include d an dilution
of reference standard serum, three control ser um samples (QC1, QC2, and QC3),
blank and test sera diluted at dilutions starting at . The assay
plates were incubated, with shaking, for hours at °C. After washing of non -
bound components, anti -human IgG
secondary antibody was added to the microsphere mixture and incubated for
minutes, with shaking, at room temperature. The fluorescent protein coupled to the
secondary antibody allow ed for measurement of the antibody bound to the antigen
coated microspheres by the Bio -Plex reader. Fluorescence was expressed as median
fluorescent intensities (MFI), and the assay results were calculated against a reference
standard curve that was run on each assay plate. The reference standard serum ha d
an arbitrary assigned concentration of 100.00 U/mL of IgG antibodies to the S 1 or RBD
antigen. The magnitude of the fluorescent signal was directly proportional to the
amount of antigen -specific antibodies in the sample. The raw MFI data were analyzed
using a validated custom SAS application, which use d a model to cal culate
antigen -specific antibody concentrations from MFI data. Failed assay plates and
individual tests (based on the pre -specified criteria) could be retested, as required.
4.7 SARS -CoV-2 VNT
The SARS -CoV-2 VNT was a three -day manual 96 -well assay. On Day 0, Vero cells
were seeded into 96 -well tissue -culture treated plates. On Day 1, serial dilutions of test
sera were incubated with SARS -CoV-2 mNG to allow any antigen -specific antibodies
to bind to the virus. The serum -virus mixture was then transferred ont o the Vero cell
monolayer and allowed to incubate overnight to allow for infection by non -neutralized
virus to occur. On Day 2, productive viral infection was enumerated by visualizing
fluorescent viral foci on a Cytation -7 Cell Imaging Multi -Mode Reader. The t otal
number of cells per well was calculated by visualizing Hoech st 33342 stained Vero cell
nuclei, which are blue. An infection ratio was then calculated for each well, whereby
the total number of green (virus infected) cells was divided by the total number of cells
present (blue nuclei). A sample titer was defined as the reciprocal serum dilution at
which a specific percentage of the virus was neutralized: 50% or 90% of the virus
(termed “Titer Determining Value”, TDV).
4.8 Statistical Analysis
There was no formal statistical hypothesis under test and no formal sample size
calculation was performed . The statistical method of aggregation used for the analysis
of antibody concentrations and titers is the geometric mean and the corresponding
95% confidence i nterval. All statistical analyses were performed using GraphPad
Prism software version 8.4.2.
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(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
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Antibody -binding analyses were performed at BioNTech ( Data Science and Biomarker
Analysis Unit) according to the Biomarker SAP .
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5 RESULTS
5.1 BNT162b1 study arm
Between 23 April 2020 and 22 May 2020, 60 participant s aged 18 to 55 years were
vaccinated with BNT162b1 as part of the BNT162 -01 clinical trial . Twelve participant s
per dose level group ( 1, 10, 30, and 50 µg) received a first priming immunization on
Day 1 and a boost er immunization on Day 22 (except for one individual each in the 10
and 50 µg dose -level cohort who discontinued due to reasons not related to the study
drug) . Twelve participant s received a 60 μg prim ing immunization on Day 1 only.
5.1.1 Secondary e ndpoint - Functional antibody titer data
SARS -CoV-2 neutralizing titers were assessed at pre-immunization baseline, 7 , and
21 days after the BNT162b1 priming immunization ( Days 8 and 22), and 7 and 21 days
after the booster immunization ( Days 29 and 43).
Functional antibody titer data for younger adults aged 18 to 55 years are listed in
Appendix Table 1 , summarized in Appendix Table 3 and displayed in Figure 1.
Figure 1: BNT162b1 – Functional 50% SARS -CoV-2 neutralizing antibody titers (VN 50) for subjects
aged 18 to 55 years
VN50 titers with 95% confidence intervals are shown for dose levels 1, 10, 30, 50, and 60 µg BNT162b1. Values
smaller than the limit of detection (LOD) are plotted as 0.5*LOD. Arrowheads indicate pre-immunization baseline
(dose 1, Day 1) and dose 2 ( Day 22). Dose 2 was not performed in the 60 μg dose group. The dotted horizontal
line represents the LOD. VN50 = 50% SARS -CoV-2 neutralizing antibody titers ; HCS = human COVID -19
convalescent serum
Participants dosed with BNT162b1 showed a strong dose -dependent antibody
response. On Day 22, at 21 days after dose 1, virus neutralizing antibody geometric
mean titers ( neutralizing GMTs) had increased in a dose -dependent manner for the 1,
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
HCS101102103104VN50 titer [serum dilution-1]
LOD50 µg
60 µg
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲1 µg
10 µg
30 µg
HCS
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10, 30, and 50 µg dose groups. At 7 days after the dose 2 (Day 29), virus neutralizing
GMTs showed a strong, dose level dependent booster response. In the 60 µg dose
group, whic h was only dosed once, neutralizing GMTs remained at a lower level,
indicating that a booster dose is necessary to increase functional antibody titers.
On Day 43 (21 days after the dose 2 of BNT162b1), neutralizing GMTs decreased
(with exception of the 1 µg dose level). Day 43 virus neutralizing GMTs were 0.7 -fold
(1 µg) to 3.6 -fold (50 µg) those of a COVID -19 HCS panel.
Fold increase from baseline in functional antibody titer data for younger adults aged
18 to 55 years is summarized in Appendix Table 4 and displayed in Figure 2.
Figure 2: BNT162b1 – Fold increase from baseline in functional 50% SARS -CoV-2 neutralizing
antibody titers (VN 50) for subjects aged 18 to 55 years
Geometric means fold increase (GMFI) from baseline in VN 50 titer with 95% confidence intervals are shown for dose
levels 1, 10, 30, 50, and 60 µg BNT162b1. Arrowheads indicate pre-immunization baseline (dose 1 , Day 1) and
dose 2 ( Day 22). Dose 2 was not performed in the 60 μg dose group. The dotted horizontal line represents the
threshold for seroconversion (fold increase ≥4). VN50 = 50% SARS -CoV-2 neutralizing ant body titers.
The frequency of younger adults aged 18 to 55 years with seroconversion is
summarized in Appendix Table 5 and displayed in Figure 3. All participants dosed with
the first dose ≥30 µg BNT162b1 seroconverted by 7 days after the second dose
(Day 29).
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)110100GMFI from baseline in VN50 titer10 µg
30 µg
50 µg
60 µg (no boost)1 µg
Seroconv. 4x
▲ ▲
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Figure 3: BNT162b1 – Frequency of subjects aged 18 to 55 years with SARS -CoV-2 GMT
seroconversion
Seroconversion with regard to 50% SARS -CoV-2 neutralizing antibody titers (VN 50) is shown for dose levels 1, 10,
30, 50, and 60 µg BNT162b1. Seroconversion is defined as a minimum of a 4-fold increase of functional antibody
titers compared to baseline. Arrowheads indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22).
Dose 2 was not performed in the 60 μg dose group.
5.1.2 Exploratory endpoint - Binding antibody concentrations
SARS -CoV-2 S1 - and RBD -binding IgG concentrations were assessed at pre-
immunization baseline, 7 , and 21 days after the BNT162b1 priming immunization
(Days 8 and 22), and 7 and 21 days after the boost er immunization (Days 29 and 43).
Binding antibody conce ntration data for younger adults aged 18 to 55 years are
summarized in Appendix Table 9 and Appendix Table 12 and displayed in Figure 4
(S1-binding IgG) and Figure 5 (RBD -binding IgG) .
Participants dosed with BNT162b1 showed a strong dose -dependent antibody
response against the SARS -CoV-2 S1 subunit and RBD at 21 days after the first dose
(Day 22). At 7 days after the second dose ( Day 29), S1 - and RBD -binding IgG
geometric mean concentrations (GMCs) showed a strong, dose -dependent booster
response. In the 60 µg dose group, which was only dosed once, S1 - and RBD -binding
IgG GMCs remained at a lower level, indicating that a booster dose is necessary to
increase antibody concentrations.
At 21 days after the second BNT162 b1 dose ( Day 43), S1 - and RBD -binding IgG
GMCs decreased (with exception of the 1 µg dose group), but were clearly above those
of a COVID -19 HCS panel for all doses tested.
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)0255075100% subjects with seroconversion
(VN50 titer)10 µg
30 µg
50 µg
60 µg (no boost)1 µg
▲ ▲
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Figure 4: BNT162b1 – S1-binding antibody concentration s [U/mL] for subjects aged 18 to 55 years
S1-binding antibody concentrations with 95% confidence intervals are shown for dose levels 1, 10, 30, 50, and
60 µg BNT162b1. Values smaller than the lower limit of quantification (LLOQ) are plotted as 0.5*LLOQ. Ar rowheads
indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). Dose 2 was not performed in the 60 μg
dose group. The dotted horizontal line represents the LLOQ. HCS = human COVID -19 convalescent serum
Figure 5: BNT162b1 – RBD -binding antibody concentrations [U/mL] for subjects aged 18 to 55 years
RBD -binding antibody concentrations with 95% confidence intervals are shown for dose levels 1, 10, 30, 50, and
60 µg BNT162b1. Values smaller than the lower limit of quantification (LLOQ) are plotted as 0.5*LLOQ. Arrowheads
indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). Dose 2 was not performed in the 60 μg
dose group. The dotted horizontal line represents the LLOQ. HCS = human convalescent COV ID-19 serum
The fold increase from baseline in binding antibody concentrations for younger adults
aged 18 to 55 years is summarized in Appendix Table 10 and Appendix Table 13 and
displayed in Figure 6.
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
HCS10-1100101102103104105106S1-binding IgG concentration [U/m ]LLOQ50 µg
60 µg1 µg
10 µg
30 µg
HCS
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
HCS10-1100101102103104105106RBD-binding IgG concentration [U/ml]LLOQ50 µg
60 µg1 µg
10 µg
30 µg
HCS
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲
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Figure 6: BNT162b1 – Fold increase from baseline in S1 - and RBD -binding antibody concentrations
for subjects aged 18 to 55 years
Geometric means fold increase (GMFI) from baseline in (A) S1- and (B) RBD -binding ant body concentrations with
95% confidence intervals are shown for dose levels 1, 10, 30, 50, and 60 µg BNT162b1. Arrowheads indicate pre-
immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). Dose 2 was not performed in the 60 μg dose group.
The dotted horizontal line represents the threshold for seroconversion (fold increase ≥4).
The frequency of younger adults aged 18 to 55 years with seroconversion is
summarized in Appendix Table 11 and Appendix Table 14 and is displayed in Figure 7.
Figure 7: BNT162b1 – Frequency of subjects aged 18 to 55 years with S1 - and RBD -binding antibody
GMC seroconversion
Seroconversion with regard to ( A) S1- and ( B) RBD -binding antibody GMC is shown for dose levels 1, 10, 30, 50,
and 60 µg BNT162b1. Seroconversion is defined as a minimum of a 4-fold increase of binding antibody
concentrations compared to baseline. Arrowheads indicate pre-immunization baseline (dose 1, Day 1) and dose 2
(Day 22). Dose 2 was not performed in the 60 μg dose group.
Almost all BNT162b1 -immunized participants seroco nverted with regard to the S1 - and
RBD -binding antibody response as early as 21 days after the priming dose ( Day 22).
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)10-1100101102103104105GMFI from baseline
in S1-binding IgG concentrationSeroconv. 4x
▲ ▲1 µg
10 µg
30 µg
50 µg
60 µg (no boost)
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)10-1100101102103104105GMFI from baseline
in RBD-binding IgG concentrationSeroconv. 4x
▲ ▲1 µg
10 µg
30 µg
50 µg
60 µg (no boost)A B
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)0255075100% subjects with seroconversion
(S1-binding IgG concentration)10 µg
30 µg
50 µg
60 µg (no boost)1 µg
▲ ▲
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)0255075100% subjects with seroconversion
(RBD-binding IgG concentration)10 µg
30 µg
60 µg (no boost)1 µg
▲ ▲50 µgA B
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All participants were seropositive at least one time -point after booster immunization
(≥Day 29) with regard to S1 -specific IgG . All partic ipants seroconverted by 7 days after
the booster dose ( Day 29) with regard to RBD -specific IgG .
5.2 BNT162b 2 study arm
Between 15 June 2020 and 01 September 2020, 60 participant s aged 18 to 55 years
and 12 participants aged 5 6 to 85 years (that were evaluable) were vaccinated with
BNT162b 2 as part of the BNT162 -01 clinical trial . Twelve younger adults per 1 µg,
3 µg, 10 μg, 20 μg, and 30 µg dose level group and twelve older adult s per 20 µg dose
level group received a first priming immunization on Day 1 and a b ooster immunization
on Day 22 (except for two participants, who discontinued prior to the booster dose due
to a study drug -unrelated withdrawal [1 µg dose ] and an adverse event [ 10 µg]
[common cold]).
5.2.1 Secondary endpoint - Functional antibody titer data
SARS -CoV-2 neutralizing titers were assessed at pre-immunization baseline, 7 , and
21 days after the BNT162b 2 priming immunization ( Days 8 and 22), and 7 , 21, 28, and
63 days after the booster immunization ( Days 29, 43, 50, and 85). At the cut -off date
for this report, Day 85 data were only available for participants aged 18 to 55 years in
dose groups 10 µg, 20 µg, and 30 µg. For participants aged 5 6 to 85 years in dose
group 20 µg data was available up to Day 29 .
Functional antibody titer data are listed in Appendix Table 2 , summarized in Appendix
Table 6 and displayed in Figure 8.
Figure 8: BNT162b 2 – Functional 50% SARS -CoV-2 neutralizing antibody titers (VN 50)
VN50 titers with 95% confidence intervals are shown for younger adults (aged 18 to 55 years) immunized with 1, 3,
10, 20, or 30 µg BNT162b 2, and older adults (aged 5 6 to 85 years) immunized with 20 µg BNT162b2 . Values
smaller than the limit of detection (LOD) are plotted as 0.5*LOD. Arrowheads indicate pre-immunization baseline
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4)
Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4) Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4) Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
HCS101102103104VN50 titer [serum dilution-1]
LOD
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲1 µg
3 µg
10 µg
20 µg
30 µg
20 µg
▲ ▲ ▲ ▲Younger adults
Older adults
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(dose 1, Day 1) and dose 2 ( Day 22). The dotted horizontal line represents the LOD. VN50 = 50% SARS -CoV-2
neutralizing antibody titers; HCS = human COVID -19 convalescent serum
Participants dosed with BNT162b2 showed a strong IMP -induced antibody response.
Virus neutralizing GMTs were detected at 21 days after dose 1 (Day 22) and had
increased substantially in younger participants (aged 18 to 55 years) immunized with
≥3 µg BNT162b2 , and older participants (aged 5 6 to 85 years) immunized with 20 µg
BNT162b2 by 7 days after dose 2 (Day 29). Day 29 neutralizing GMT s were
comparable between the younger and older adult 20 µg dose level cohorts. The lowest
tested dose of 1 µg BNT162b2 elicited only a minimal neutralizing response in
participants aged 18 to 55 years .
On Day 43 (21 days after the second dose of BNT162b2), virus neutralizing GMTs in
the younger adult cohorts decreased for the 3, 20, and 30 µg dose level s. Thereafter,
GMTs remained stable up to Day 85 (63 days after dose 2 ) for younger adult dose
groups 10, 20 , and 30 µg and were 1.3- to 1.9 -fold those of a COVID -19 HCS panel.
Fold increase from baseline in functional antibody titer data is summarized in Appendix
Table 7 and displayed in Figure 9.
Figure 9: BNT162b2 – Fold increase from baseline in functional 50% SARS -CoV-2 neutralizing
antibody titers (VN 50)
Geometric means fold increase (GMFI) from baseli ne in VN 50 titers with 95% confidence intervals are shown for (A)
younger adults (aged 18 to 55 years) immunized with 1, 3, 10, 20, or 30 µg BNT162b2 , and (B) older adults (aged
56 to 85 years) immunized with 20 µg BNT162b2 . Arrowheads indicate pre-immun ization baseline (dose 1, Day 1)
and dose 2 ( Day 22). The dotted horizontal line represents the threshold for seroconversion (fold increase ≥4).
VN50 = 50% SARS -CoV-2 neutralizing antibody titers.
The frequency of subjects with seroconversion is summarized in Appendix Table 8 and
displayed in Figure 10. All participants immunized with 30 µg BNT162b 2
seroconverted by 21 days after the second dose ( Day 43) and remained seropositive
throughout the follow -up until Day 85.
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)110100GMFI from baseline in VN50 titer
Seroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)110100GMFI from baseline in VN50 titer
Seroconv. 4x
▲ ▲20 µgOlder adultsA B
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Figure 10: BNT162b 2 – Frequency of subjects with SARS -CoV-2 GMT seroconversion
Seroconversion with regard to 50% SARS -CoV-2 neutralizing antibody titers (VN 50) is shown for (A) younger adults
(aged 18 to 55 years) immunized with 1, 3, 10, 20, or 30 µg BNT162b2 , and (B) older adults (aged 5 6 to 85 years)
immunized with 20 µg BNT162b2 . Seroconversion is defined as a minimum of 4 -fold increase of functional antibody
titers as compared to baseline. Arrowheads indicate pre-immunization baseline (dose 1, Day 1) and dose 2
(Day 22).
5.2.2 Exploratory endpoint - Binding antibody concentrations
SARS -CoV-2 S1 - and RBD -binding IgG concentrations were assessed at pre-
immunization baseline, 7 , and 21 days after the BNT162b2 priming immunization
(Days 8 and 22), and 7 and 21 days after the booster immunization ( Days 29 and 43).
Binding antibody concentration data are summarized in Appendix Table 15 and
Appendix Table 18 and displayed in Figure 11 (S1-binding IgG) and Figure 12 (RBD -
binding IgG).
BNT162b2 dosed participants showed a st rong BNT162b2 -induced S1 - and RBD -
binding IgG response at 21 days after the first dose ( Day 22) with evidence of a dose -
dependent response only between the 1 µg and 10 µg dose levels . S1- and RBD -
binding IgG GMCs showed a substantial booster response by 7 days after the second
dose ( Day 29). Day 29 S1 - and RBD -binding IgG GMCs were comparable between
the younger and older adult 20 µg dose level cohorts.
Across all dose -level cohorts , antibody levels decreased over time, but with S1 - and
RBD -binding antibody GMCs well above that observed in a COVID -19 HCS panel at
Day 85 (63 days after the second dose; 10 µg – 30 µg dose level).
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)0255075100% subjects wi h seroconversion
(VN50 titer)
Seroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)0255075100% subjects with seroconversion
(VN50 titer)
Seroconv. 4x
▲ ▲20 µgOlder adultsA B
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Figure 11: BNT162b2 – S1-binding antibody concentrations [U/mL]
S1-binding antibody concentrations with 95% confidence intervals are shown for younger adults (aged 18 to 55
years) immunized with 1, 3, 10, 20, or 30 µg BNT162b2 , and older adults (aged 5 6 to 85 years) immunized with
20 µg BNT162b2 . Values smaller than th e lower limit of quantification (LLOQ) are plotted as 0.5*LLOQ. Arrowheads
indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). The dotted horizontal line represents the
LLOQ. HCS = human COVID -19 convalescent serum
Figure 12: BNT162b2 – RBD -binding antibody concentrations [U/mL]
RBD -binding antibody concentrations with 95% confidence intervals are shown for younger adults (aged 18 to 55
years) immunized with 1, 3, 10, 20, or 30 µg BNT162b2 , and older adults (aged 5 6 to 85 years) immunized with
20 µg BNT162b2 . Values smaller than the lower limit of quantification (LLOQ) are plotted as 0.5*LLOQ. Arrowheads
indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). The dotted horizontal line represe nts the
LLOQ. HCS = human COVID -19 convalescent serum
The fold increase from baseline in binding antibody concentrations is summarized in
Appendix Table 16 and Appendix Table 19 and displayed in Figure 13 and Figure 14.
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3) Day 43 (±4) Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4) Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4)
Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
HCS10-1100101102103104105106S1-binding IgG concentration [U/m ]LLOQ1 µg
3 µg
10 µg
20 µg
30 µg
20 µg
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲Younger adults
Older adults
Baseline
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4) Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3) Day 43 (±4) Day 50 (±4)
Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
Day 43 (±4) Day 50 (±4) Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)
Baseline
Day 8 (±1)
Day 22 (±2) Day 29 (±3)
HCS10-1100101102103104105106RBD-binding IgG concentration [U/ml]LLOQ
▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲1 µg
3 µg
10 µg
20 µg
30 µg
20 µg
▲ ▲ ▲ ▲Younger adults
Older adults
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Figure 13: BNT162b2 – Fold increase from baseline in S1 - and RBD -binding antibody concentrations
for subjects aged 18 to 55 years
Geometric means fold increase (G MFI) from baseline in ( A) S1- and ( B) RBD -binding ant body concentrations with
95% confidence intervals are shown for younger adults (aged 18 to 55 years) immunized with 1, 3, 10, 20, or 30 µg
BNT162b2 . Arrowheads indicate pre-immunization baseline (dose 1, Day 1) and dose 2 ( Day 22). The dotted
horizontal line represents the threshold for seroconversion (fold increase ≥4).
Figure 14: BNT162b2 – Fold increase from baseline in S1 - and RBD -binding antibody concent rations
for subjects aged 56 to 85 years
Geometric means fold increase (GMFI) from baseline in ( A) S1- and ( B) RBD -binding ant body concentrations with
95% confidence intervals are shown for older adults (aged 5 6 to 85 years) immunized with 20 µg BNT162b2 .
Arrowheads indicate pre-immunization baseline (dose 1, Day 1) and dose 2 (Day 22). The dotted horizontal line
represents the threshold for seroconversion (fold increase ≥4).
The frequency of subjects with seroconversion is summarized in Appendix Table 17
and Appendix Table 20 and displayed in Figure 15 and Figure 16.
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)10-1100101102103104105GMFI from baseline
in S1-binding IgG concentrationSeroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)10-1100101102103104105GMFI from baseline
in RBD-binding IgG concentrationSeroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adultsA B
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)10-1100101102103104105GMFI from baseline
in S1-binding IgG concentrationSeroconv. 4x
▲ ▲20 µgOlder adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)10-1100101102103104105GMFI from baseline
in RBD-binding IgG concentrationSeroconv. 4x
▲ ▲20 µgOlder adultsA B
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Figure 15: BNT162b 2 – Frequency of subjects aged 18 to 55 years with S1 - and RBD -binding antibody
GMC seroconversion
Seroconversion with regard to ( A) S1- and ( B) RBD -binding antibody GMC is shown for younger adults (aged 18
to 55 years) immunized with 1, 3, 10, 20, or 30 µg BNT162b2 . Seroconversion is defined as a minimum of a 4-fold
increase of binding antibody concentrations as compared to baseline. Arrowheads indicate pre-immunization
baseline (dose 1, Day 1) and dose 2 ( Day 22).
Figure 16: BNT162b2 – Frequency of subjects aged 5 6 to 85 years with S1 - and RBD -binding antibody
GMC seroconversion
Seroconversion with regard to ( A) S1- and ( B) RBD -binding antibody GMC is shown for older adults (aged 5 6 to 85
years) immunized with 20 µg BNT162b2 . Seroconversion is defined as a minimum of a 4-fold increase of binding
ant body concentrations as compared to baseline. Arrowheads indicate pre-immunization baseline (dose 1, Day 1)
and dose 2 (Day 22).
Independent of age and dose level cohort , all BNT162b 2-immunized participants
seroconverted with regard to the S1 - and RBD -binding antibody response as early as
21 days after the priming dose ( Day 22), except for one subject in the younger adult
10 µg dose group (RBD -binding IgG data). As of Day 29 (7 days after the booster
dose) all participants were seropositive.
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)0255075100% subjects with seroconversion
(S1-binding IgG concentration)Seroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4) Day 85 (±7)0255075100% subjects with seroconversion
(RBD-binding IgG concentration) Seroconv. 4x
▲ ▲1 µg
3 µg
10 µg
20 µg
30 µgYounger adultsA B
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)0255075100% subjects with seroconversion
(S1-binding IgG concentra ion)Seroconv. 4x
▲ ▲20 µgOlder adults
Day 8 (±1)
Day 22 (±2)
Day 29 (±3)
Day 43 (±4)
Day 50 (±4)
Day 85 (±7)0255075100% subjects wi h seroconversion
(RBD-binding IgG concentration) Seroconv. 4x
▲ ▲20 µgOlder adultsA B
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6 CONCLUSION
Both RNA -based SARS -CoV-2 vaccine candidates BNT162b1 and BNT162b2 elicited
robust S1- and RBD -specific IgG responses with neutralizing capacity in live -virus
micro neutralization assay s.
Secondary endpoint - Functional antibody titer data
Participants dosed with BNT162b1 showed a strong dose -dependent antibody
response:
Virus neutralizing GMTs increased in a dos e-dependent manner for the 1, 10,
30, and 50 µg dose groups after the first dose with a further strong, dose level
dependent booster response.
In the 60 µg dose group, which was only dosed once, virus neutralizing GMTs
remained at a lower level, indicating that a booster dose is necessary to
increase functional antibody titers.
Day 43 virus neutralizing GMTs were 0.7 -fold (1 µg) to 3.6 -fold (50 µg) those of
a COVID -19 human convalescent serum (HCS) panel.
Participants dosed with BNT162b2 showed a strong IMP -induced antibody response.
Virus neutralizing GMTs were detected after the first dose and showed a
substantial booster response after the second dose for dose level groups ≥3 µg.
Day 29 virus neutralizing GMTs were comparable between the younger and
older adult 20 µg dose level cohorts .
On Day 43, neutralizing GMTs in the younger adult cohorts decreased for the
3, 20, and 30 µg dose levels. Thereafter, GMTs remained stable up to Day 85
(63 days after dose 2) for younger adult dose groups 10, 20, and 30 µg and
were 1.3 - to 1.9 -fold those of a COVID 19 HCS panel.
All participants dosed with dose 1 at ≥30 µg BNT162b1 or BNT162b2 seroconverted
either by 7 days or 21 days after the second dose ( Day 29 or Day 43). All participants
immunized with 30 µg BNT162b2 remained seropositive throughout the follow -up until
Day 85.
Exploratory endpoint - Binding antibody concentrations
Participants dosed with BNT162b1 showed a strong dose -dependent antibody
response against the SARS -CoV-2 spike (S) protein S1 subunit and receptor -binding
domain (RBD) at 21 days after the first dose ( Day 22).
S1- and RBD -binding IgG GMCs showed a strong, dose -dependent booster
response 7 days after the second dose ( Day 29).
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In the 60 µg dose group, which was only dosed once, S1 - and RBD -binding IgG
GMCs remained at a lower level, indicating that a booster dose is necessary to
increase antibody concentrations.
At 21 days after the second BNT162b1 dose ( Day 43), S1 - and RBD -binding
IgG GMCs decreased (with exception of the 1 µg dose group), bu t were clearly
above those of a COVID -19 HCS panel for all doses tested.
BNT162b2 dosed participants showed a strong BNT162b2 -induced S1 - and RBD -
binding IgG response at 21 days after the first dose ( Day 22) with evidence of a dose -
dependent response only between the 1 µg and 10 µg dose levels .
S1- and RBD -binding IgG GMCs showed a substantial booster response by
7 days after the second dose ( Day 29).
Day 29 S1-binding IgG GMCs were comparable between the younger and older
adult 20 µg dose level cohorts .
Across all dose -level cohorts, antibody levels decreased over time, but with S1 -
and RBD -binding antibody GMCs well above that observed in a COVID -19 HCS
panel at Day 85 (63 days after the second dose; 10 µg – 30 µg dose level).
Independent of age, all participants dosed with the first dose with ≥ 20 µg BNT162b1
or BNT162b2 seroconverted either by 7 days or 21 days after the second dose ( Day 29
or Day 43).
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7 DOCUMENT HISTORY
Second version – minor editorial changes, such as the correction of typing errors , are
not listed.
Reason(s) for change(s) compared to previous version:
Section Version 01 Version 02 Reason for change
1 - Summary updated Update of this report with
available data for younger
and older adult cohorts
vaccinated with BNT162b2
3.2 - Objective updated Inclusion of extended follow -
up time -points
3.3 - Study Design updated Inclusion of additional dose
level group (3 µg) and
extended follow -up time -
points for younger adults
vaccinated with BNT162b2;
Inclusion of older adult
cohort vaccin ated with
BNT162b2
4.1 - Table 2 updated
Table 3 added Inclusion of additional test
items for younger adult and
older adult cohorts
vaccinated with BNT162b2
5.2 - Results and Figures
updated, Figures 9b,
10b, 14, and 16 added Inclusion of additional dose
level group (3 µg) and
extended follow -up data for
younger adult cohort s;
Inclusion of data for older
adult cohort (n=12)
6 - Conclusion updated Update of this report with
available data for younger
and older adult cohorts
vaccinated with BNT162b2
Appendix - Appendices updated Inclusion of additional dose
level group (3 µg) and
extended follow -up data for
younger adult cohorts;
Inclusion of da ta for older
adult cohort
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8 REFERENCES
BNT162 -01 BIOMARKER STATISTICAL ANALYSIS PLAN. BNT162 -01. Protocol
Title: A Multi -site, Phase I/II, 2 -Part, Dose -Escalation Trial Investigating the Safety and
Immunogenicity of four Prophylactic SARS -CoV-2 RNA Vaccines Against
COVID -2019 Using Different Dosing Regimens in Healthy Adults. Date: 25 SEP2020 .
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9 APPENDIX
Appendix Table 1: Listing of functional antibody titer - BNT162b1
Appendix Table 2: Listing of functional antibody titer - BNT162b2
Appendix Table 3: Descriptive statistics of functional antibody titer - BNT162b1
Appendix Table 4: Descriptive statistics of fold increase from baseline in functional antibody titers - BNT162b1
Appendix Table 5: Frequency of subjects with seroconversion - BNT162b1
Appendix Table 6: Descriptive statistics of functional antibody titer - BNT162b2
Appendix Table 7: Descriptive statistics of fold increase from baseline in functional antibody titers - BNT162b2
Appendix Table 8: Frequency of subjects with seroconversion - BNT162b2
Appendix Table 9: Descriptive statistics of S1 antibody concentrations [U/mL] for BNT162b1
Appendix Table 10: Descriptive statistics of fold increase from baseline in S1 antibody concentrations for BNT162b1
Appendix Table 11: Frequency of subjects with seroconversion (S1 antibody response) f or BNT162b1
Appendix Table 12: Descriptive statistics of RBD antibody concentrations [U/mL] for BNT162b1
Appendix Table 13: Descriptive statistics of fold increase from baseline in RBD antibody concentrations for BNT162b1
Appendix Table 14: Frequency of subjects with seroconversion (RBD antibody response) for BNT162b1
Appendix Table 15: Descriptive statistics of S1 antibody concentrations [U/mL] for BNT162b2
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Appendix Table 16: Descriptive statistics of fold increase from baseline in S1 antibody co ncentrations for BNT162b2
Appendix Table 17: Frequency of subjects with seroconversion (S1 antibody response) for BNT162b2
Appendix Table 18: Descriptive statistics of RBD antibody concentrations [U/mL] for BNT162b2
Appendix Table 19: Descriptive statistics of fold increase from baseline in RBD antibody concentrations for BNT162b2
Appendix Table 20: Frequency of subjects with seroconversion (RBD antibody response) for BNT162b2
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10015
1 µg
Younger Day 1 1 29APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 06MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 25.7 2.6
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 52.5 5.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10018
1 µg
Younger Day 1 1 29APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
Program: Limm_tit.sas (Page 1 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10018
1 µg
Younger Day 1 1 29APR2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 06MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 87.4 8.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 44.5 4.5 Yes
Day 43 43 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 151.3 15.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 69.3 6.9 Yes
10023
1 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Program: Limm_tit.sas (Page 2 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10023
1 µg
Younger Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 26.2 2.6
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 161.3 16.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 86.5 8.7 Yes
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 158.7 15.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 77.3 7.7 Yes
10025
1 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 3 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10025
1 µg
Younger Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 39.0 3.9
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10033
1 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 4 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10033
1 µg
Younger Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 88.3 8.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 40.7 4.1 Yes
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 326.0 32.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 163.6 16.4 Yes
10036
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 48.2 4.8 Yes
Program: Limm_tit.sas (Page 5 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10036
1 µg
Younger Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 77.2 7.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 35.7 3.6
Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 58.5 5.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 22.9 2.3
10040
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 6 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10040
1 µg
Younger Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10041
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 122.0 12.2 Yes
Program: Limm_tit.sas (Page 7 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10041
1 µg
Younger Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 53.9 5.4 Yes
Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 136.7 13.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 69.6 7.0 Yes
10042
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 44.8 4.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 23.7 2.4
Program: Limm_tit.sas (Page 8 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10042
1 µg
Younger Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 81.4 8.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 37.4 3.7
10045
1 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 9 13MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 34.7 3.5
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 33.0 3.3
Program: Limm_tit.sas (Page 9 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10045
1 µg
Younger Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10048
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 10 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10001
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
10052
1 µg
Younger Day 1 1 08MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 27 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 98.5 9.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 47.4 4.7 Yes
Program: Limm_tit.sas (Page 11 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10001
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 33.6 3.4
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 42 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10003
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Program: Limm_tit.sas (Page 12 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10003
10 µg
Younger Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 71.8 7.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 33.2 3.3
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 280.1 28.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 161.5 16.2 Yes
Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 280.5 28.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 118.4 11.8 Yes
10004
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 13 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10004
10 µg
Younger Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 43.0 4.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 27.2 2.7
Day 29 29 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 321.6 32.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 176.2 17.6 Yes
Day 43 42 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 283.2 28.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 104.6 10.5 Yes
10005
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 14 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10005
10 µg
Younger Day 22 22 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 192.9 19.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 82.9 8.3 Yes
Day 43 42 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 139.1 13.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 41.2 4.1 Yes
10006
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 35.5 3.6
Program: Limm_tit.sas (Page 15 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10006
10 µg
Younger Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 181.7 18.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 112.4 11.2 Yes
Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 328.1 32.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 151.3 15.1 Yes
10007
10 µg
Younger Day 1 1 23APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 16 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10007
10 µg
Younger Day 29 33 25MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 126.4 12.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 78.1 7.8 Yes
Day 43 43 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 113.6 11.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 42.3 4.2 Yes
10008
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 110.3 11.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 46.1 4.6 Yes
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 513.0 51.3 Yes
Program: Limm_tit.sas (Page 17 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10008
10 µg
Younger Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 299.6 30.0 Yes
Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 555.1 55.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 224.0 22.4 Yes
10009
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 57.5 5.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 28.1 2.8
Program: Limm_tit.sas (Page 18 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10009
10 µg
Younger Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 41.9 4.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10010
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Unsched
uled 1
Day 50 26 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10011
10 µg
Younger Day 1 1 24APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 19 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10011
10 µg
Younger Day 8 7 30APR2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 68.9 6.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 38.1 3.8
Day 43 42 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 43.1 4.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10017
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 20 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10017
10 µg
Younger Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 21.2 2.1
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 354.8 35.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 175.0 17.5 Yes
Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 258.4 25.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 118.6 11.9 Yes
10019
10 µg
Younger Day 1 1 28APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 27.5 2.7
Program: Limm_tit.sas (Page 21 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10016
30 µg
Younger Day 1 1 29APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 06MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 222.0 22.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 123.8 12.4 Yes
10019
10 µg
Younger Day 22 22 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 30 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 154.4 15.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 72.5 7.3 Yes
Day 43 43 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 117.0 11.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 60.2 6.0 Yes
Program: Limm_tit.sas (Page 22 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10016
30 µg
Younger Day 29 29 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 3508.2 350.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 1076.8 107.7 Yes
Day 43 43 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1218.0 121.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 579.9 58.0 Yes
10020
30 µg
Younger Day 1 1 29APR2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 06MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 100.2 10.0 Yes
Program: Limm_tit.sas (Page 23 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10020
30 µg
Younger Day 29 29 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 53.3 5.3 Yes
Day 43 43 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 48.6 4.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 27.2 2.7
10021
30 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 23.5 2.4
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 417.2 41.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 200.2 20.0 Yes
Program: Limm_tit.sas (Page 24 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10021
30 µg
Younger Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 215.5 21.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 100.9 10.1 Yes
10028
30 µg
Younger Day 1 1 07MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 273.6 27.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 156.9 15.7 Yes
Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 128.0 12.8 Yes
Program: Limm_tit.sas (Page 25 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10028
30 µg
Younger Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 47.3 4.7 Yes
10031
30 µg
Younger Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 36.1
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 29 29 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 613.2
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 305.0
Day 43 45 20JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 375.7
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 149.4
10032
30 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Program: Limm_tit.sas (Page 26 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10032
30 µg
Younger Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 60.2 6.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 30.7 3.1
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 651.5 65.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 305.8 30.6 Yes
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 379.4 37.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 154.1 15.4 Yes
10034
30 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 27 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10034
30 µg
Younger Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 66.2 6.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 28.0 2.8
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 97.8 9.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 49.3 4.9 Yes
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 52.2 5.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 26.6 2.7
10037
30 µg
Younger Day 1 1 05MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 28 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10037
30 µg
Younger Day 22 22 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 41.2 4.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 320.9 32.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 182.1 18.2 Yes
Day 43 43 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 243.1 24.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 104.7 10.5 Yes
10038
30 µg
Younger Day 1 1 07MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 30.5 3.0
Program: Limm_tit.sas (Page 29 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10038
30 µg
Younger Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 230.2 23.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 138.2 13.8 Yes
Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 123.2 12.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 66.6 6.7 Yes
10039
30 µg
Younger Day 1 1 07MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 24.3 2.4
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 30 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10039
30 µg
Younger Day 29 29 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 220.0 22.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 105.1 10.5 Yes
Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 114.1 11.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 55.3 5.5 Yes
10043
30 µg
Younger Day 1 1 07MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 162.4 16.2 Yes
Program: Limm_tit.sas (Page 31 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10043
30 µg
Younger Day 29 28 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 103.1 10.3 Yes
Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 71.3 7.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 27.6 2.8
10047
30 µg
Younger Day 1 1 07MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 14MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 28MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 04JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 174.8 17.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 93.7 9.4 Yes
Program: Limm_tit.sas (Page 32 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10047
30 µg
Younger Day 43 43 18JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 76.5 7.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 39.3 3.9
10049
50 µg
Younger Day 1 1 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 50.6 5.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1544.9 154.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 550.1 55.0 Yes
Day 43 43 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 325.1 32.5 Yes
Program: Limm_tit.sas (Page 33 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10049
50 µg
Younger Day 43 43 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 170.0 17.0 Yes
10050
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Unsched
uled 1
Day 50 20 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 40.5 4.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10053
50 µg
Younger Day 1 1 12MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 34 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10053
50 µg
Younger Day 22 22 02JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 307.3 30.7 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 122.9 12.3 Yes
Day 43 43 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 86.0 8.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 38.5 3.8
10055
50 µg
Younger Day 1 1 13MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 37.2 3.7
Program: Limm_tit.sas (Page 35 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10055
50 µg
Younger Day 22 22 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 23.2 2.3
Day 29 28 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 209.3 20.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 109.1 10.9 Yes
Day 43 42 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 249.2 24.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 139.4 13.9 Yes
10056
50 µg
Younger Day 1 1 13MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 36 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10056
50 µg
Younger Day 29 28 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 536.3 53.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 286.4 28.6 Yes
Day 43 42 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 429.0 42.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 218.2 21.8 Yes
10057
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 05JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 37.5 3.8
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 598.8 59.9 Yes
Program: Limm_tit.sas (Page 37 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10057
50 µg
Younger Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 367.7 36.8 Yes
Day 43 43 26JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 250.2 25.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 95.0 9.5 Yes
10059
50 µg
Younger Day 1 1 13MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1229.8 123.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 534.7 53.5 Yes
Program: Limm_tit.sas (Page 38 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10059
50 µg
Younger Day 43 42 23JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1045.5 104.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 493.7 49.4 Yes
10060
50 µg
Younger Day 1 1 13MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 03JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 125.9 12.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 75.8 7.6 Yes
Day 29 28 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 643.9 64.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 307.7 30.8 Yes
Day 43 43 24JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 276.0 27.6 Yes
Program: Limm_tit.sas (Page 39 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10060
50 µg
Younger Day 43 43 24JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 169.3 16.9 Yes
10067
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 05JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 30.1 3.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 403.7 40.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 209.6 21.0 Yes
Day 43 43 26JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 152.6 15.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 75.8 7.6 Yes
Program: Limm_tit.sas (Page 40 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10068
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 05JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 102.8 10.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 38.4 3.8
Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1915.3 191.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 1092.9 109.3 Yes
Day 43 43 26JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 1764.1 176.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 506.7 50.7 Yes
10070
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
Program: Limm_tit.sas (Page 41 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10070
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 05JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 32.5 3.3
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 133.6 13.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 79.8 8.0 Yes
Day 43 43 26JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 109.5 11.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 45.5 4.6 Yes
10073
50 µg
Younger Day 1 1 15MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Program: Limm_tit.sas (Page 42 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10066
60 µg
Younger Day 1 1 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
10073
50 µg
Younger Day 8 8 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 05JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 27.3 2.7
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 914.4 91.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 442.2 44.2 Yes
Day 43 43 26JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 889.7 89.0 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 387.8 38.8 Yes
Program: Limm_tit.sas (Page 43 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10066
60 µg
Younger Day 8 8 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 28.2 2.8
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 28.8 2.9
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10075
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 44 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10075
60 µg
Younger Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10076
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 37.2 3.7
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 37.0 3.7
Program: Limm_tit.sas (Page 45 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10076
60 µg
Younger Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 40.8 4.1 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 23.0 2.3
10078
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 42.7 4.3 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 54.3 5.4 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 26.5 2.7
Program: Limm_tit.sas (Page 46 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10078
60 µg
Younger Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 47.8 4.8 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10083
60 µg
Younger Day 1 1 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 42 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 47 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10083
60 µg
Younger Day 43 42 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10084
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 23.4 2.3
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 27.6 2.8
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 20.5 2.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 48 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10085
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 34.0 3.4
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 37.2 3.7
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 28.2 2.8
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10089
60 µg
Younger Day 1 1 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
Program: Limm_tit.sas (Page 49 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10089
60 µg
Younger Day 1 1 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 42 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10093
60 µg
Younger Day 1 1 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Program: Limm_tit.sas (Page 50 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10093
60 µg
Younger Day 8 8 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 42 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10096
60 µg
Younger Day 1 1 19MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 51 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10096
60 µg
Younger Day 8 8 26MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 09JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 30 17JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10103
60 µg
Younger Day 1 1 22MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 29MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 52 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10103
60 µg
Younger Day 22 22 12JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 32.7 3.3
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 19JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 28.7 2.9
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 43 03JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 20.9 2.1
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
10104
60 µg
Younger Day 1 1 20MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 27MAY2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 23.4 2.3
Program: Limm_tit.sas (Page 53 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b1
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 1 : Listing of functional antibody titer - BNT162b1
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
10104
60 µg
Younger Day 22 22 10JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 28 16JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 26.8 2.7
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 42 30JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 54 of 54)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b2
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 2 : Listing of functional antibody titer - BNT162b2
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
20153
1 µg
Younger Day 1 1 29JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 9 07JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 59.0 5.9 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 24.2 2.4
Day 43 44 11AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 45.6 4.6 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 50 51 18AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 38.4 3.8
Program: Limm_tit.sas (Page 1 of 76)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b2
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 2 : Listing of functional antibody titer - BNT162b2
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
20153
1 µg
Younger Day 50 51 18AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 23.2 2.3
20154
1 µg
Younger Day 1 1 29JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 9 07JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 43 44 11AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Program: Limm_tit.sas (Page 2 of 76)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b2
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 2 : Listing of functional antibody titer - BNT162b2
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
20154
1 µg
Younger Day 50 51 18AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
20157
1 µg
Younger Day 1 1 29JUN2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 9 07JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 20JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 29 29 27JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 154.6 15.5 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 24.8 2.5
Day 43 44 11AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 82.1 8.2 Yes
Program: Limm_tit.sas (Page 3 of 76)
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BioNTech RNA Pharmaceuticals GmbH / Listings - 6. Snapshot All TLFs Final 2.0 BNT162b2
BNT162 -01 Created on 26NOV2020
Staburo GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT2020. Appendix Table 2 : Listing of functional antibody titer - BNT162b2
Immunogenicity set
Subject
number/
Dose
group Visit Study
day Date and time Parameter Value Fold
increase Serocon -
version Not
done? Reason
not done Comment
20157
1 µg
Younger Day 43 44 11AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 27.3 2.7
Day 50 51 18AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 41.6 4.2 Yes
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 26.3 2.6
20158
1 µg
Younger Day 1 1 13JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0
Day 8 8 20JUL2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1.0
SARS -CoV-2 Serum Neutralizing
Titer 90 [NA] 10.0 1.0
Day 22 22 03AUG2020 SARS -CoV-2 Serum Neutralizing
Titer 50 [NA] 10.0 1
…[truncated]