Document text
BNT162b2
COVID-19 Case Strain Sequencing Report
CONFIDENTIAL
Page 1COVID-19 Case Strain Sequencing Report
Study C4591001
04 June2021
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Page 2TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 3
ABBREVIAT IONS................................ ................................ ................................ ................... 5
1. BACKGROUND ................................ ................................ ................................ ................... 6
2. PHASE 2/3 COVI D-19 CASE STRAI N SEQUEN CE DATA IN STUDY C45 91001........ 6
2.1. Analy sis Endpoints and Methods ................................ ................................ ..............6
2.1.1. COVID -19 Case Determination and Definitions ................................ ..........6
2.1.2. COVID -19 Case Strain Sequencing ................................ ............................. 8
2.2. COVID -19 Case Analy sis Results ................................ ................................ ..........10
2.2.1.Overall Case Sequence Anal ysis................................ ................................ 10
2.2.2.Country Subgroup Case Sequence Anal ysis................................ ...............12
2.3. Severe COVID -19 Case Anal ysis Results ................................ .............................. 19
2.3.1. Case Sequence Analy sis for Severe COVID -19 per FDA Definition ........19
2.3.2. Case Sequence Analy sis for Severe COVID -19 per CDC Definition ........23
3. CONCL USIONS................................ ................................ ................................ .................. 27
4. ADDITIONAL TABLES, LISTINGS, AND FIGU RES................................ .................... 28
4.1. Listings................................ ................................ ................................ .................... 28
4.2. Tables ................................ ................................ ................................ ...................... 29
4.2.1. COVID -19 Case Analy sis................................ ................................ ...........29
4.2.2. Severe COVID -19 Analysis................................ ................................ .......36
5. REFERENCES ................................ ................................ ................................ .................... 40
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Page 3LIST OF TABLES
Table1.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First COVID -19 Occurrence From 7 Day s After Dose 2 – Blinded
Placebo-Controlled Follow -up Period – Subjects With or Without Evidence
of Infection Prior to 7 Day s After Dose 2 –Evaluable Efficacy (7 Days)
Population ................................ ................................ ................................ .............11
Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First COVID -19 Occurrence From 7 Day s After Dose 2, b y Country –
Blinded Placebo -Controlled Follow- up Period – Subjects With or Without
Evidence of Infection Prior to 7 Day s After Dose 2 –Evaluable Efficacy (7
Days) Population ................................ ................................ ................................ ..13
Table3.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First Severe COVID -19 Occurrence Based on FDA -Definition From 7
Days After Dose 2 – Blinded Placebo -Controlled Follow -up Period –
Subjects With or Without Evidence of Infection Prior to 7 Day s After Dose
2 –Evaluable Efficacy (7 Days) Population ................................ ......................... 20
Table4.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First Severe COVID -19 Occurrence Based on FDA -Definition Af ter
Dose 1 –Blinded Placebo-Controlled Follow- up Period –Dose 1 All -
Available Efficacy Population ................................ ................................ ..............22
Table5.Summary of SARS -CoV-2Variants of Concern or Variants of Interest for
the First Severe COVID -19 Occurrence Based on CDC- Definition From 7
Days After Dose 2 – Blinded Placebo -Controlled Follow -up Period –
Subjects With or Without Evidence of Infection Prior to 7 Day s After Dose
2 –Evaluable Efficacy (7 Days) Population ................................ ......................... 24
Table6.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First Severe COVID -19 Occurrence Based on CDC- Definition After
Dose 1 –Blinded Placebo -Controlled Follow- up Period –Dose 1 All -
Available Efficacy Population ................................ ................................ ..............26
Table7.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence
From 7 Day s After Dose 2 – Blinded Placebo -Controlled Follow- up Period
– Subjects With or Without Evidence of Infection Prior to 7 Day s After
Dose 2 –Evaluable Efficacy (7 Days) Population ................................ ...............29
Table8.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence
From 7 Day s After Dose 2, by Country –Blinded Placebo -Controlled
Follow-up Period – Subjects Wi th or Without Evidence of Infection Prior
to 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population ...................... 32
Table9.Summary of SARS-CoV-2 Variants for the First Severe COVID -19
Occurrence Based on FDA- Definition From 7 Day s After Dose 2 –Blinded
Placebo-Controlled Follow -up Period – Subjects With or Without Evidence
of Infection Prior to 7 Day s After Dose 2 –Evaluable Efficacy (7 Days)
Population ................................ ................................ ................................ .............36
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Page 4Table10.Summary of SARS -CoV-2 Variants for the First Severe COVID -19
Occurrence Based on FDA-Definition After Dose 1 –Blinded Placebo -
Controlled Follow- up Period –Dose 1 All -Available Efficacy Population .........37
Table11.Summary of SARS -CoV-2 Variants for the First Severe COVID -19
Occurrence Based on CDC- Definition From 7 Days After Dose 2 –
Blinded Placebo -Controlled Follow- up Period – Subjects With or Without
Evidence of Infection Prior to 7 Day s After Dose 2 –Evaluable Efficacy (7
Days)Population ................................ ................................ ................................ ..38
Table12.Summary of SARS -CoV-2 Variants for the First Severe COVID -19
Occurrence Based on CDC- Definition After Dose 1 –Blinded Placebo -
Controlled Follow- up Period –Dose 1 All -Available Efficacy Population .........39
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Page 5ABBREVIATIONS
Abbreviation Definition
BLA Biologics License Application
CDC (US) Centers for Disease Control and Prevention
cDNA complimentary DNA
CI confidence interval
CoV coronavirus
Ct cycle threshold
COVID-19 coronavirus d isease 2019
DNA deoxyribonucleic acid
ECMO extracorporeal membrane oxygenation
EUA Emergency Use Authorization
FDA (US) Food and Drug Administration
ICU intensive care unit
INDapplication Investigati onalNew Drug application
NAAT nucleic acid amplification test
PCR polymerase chain reaction
RNA ribonucleic acid
RT-PCR reverse transcription –polymerase chain reaction
SARS severe acute respiratory syndrome
SARS-CoV-2 severe acute respiratory syndrome coronavirus -2; virus causing the disease COVID -19
US United States
VE vaccine efficacy
VOC variant of concern
VOI variant of interest
QNS sample quantity not sufficient sample
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Page 61.BACKGROUND
Reference is made to the Biologics License Application (BLA) 125742 for the COVID-19
vaccine BNT162b2 (BNT162; PF -07302048) , which Pfizer and BioNTech are developing,
and which is currently available in the United States (US) under Emergency Use
Authorization (EUA) 27034 for the prevention of Coronavirus Disease 2019 (COVID-19)in
individuals ≥12years of age. The Investigational New Drug ( IND) application was effective
on 29 April2020and Pfizer initiated the pivotal c linical study (C4591001) in the US on
04May2020.
This report provide ssequencing data for the SARS -CoV-2 lineages identified among the
confirmed COVID -19 cases as of the data cutoff date of 13 March 2021. This same data
cutoff date was applied to updated efficacy data included in the BLA, in clinical modules
submitted on 06 May 2021,which includedthe C4591001 6 -Month Update Interim C linical
Study Report(Module 5.3.5.1), Summary of Clinical Efficacy (Module 2.7.3) , and
ClinicalOverview (Module 2.5). Sequencing data were not available at the time of th e
13March2021 submission data cutoff.
2.PHASE 2 /3COVID-19 CASE STRAIN SEQUENC EDATAINSTUDY C4591001
2.1. Analysis Endpoints and Methods
2.1.1.COVID-19 Case Determination and Definitions
Details of vaccine efficacy (VE) data analyses previously submitted are provided in the
C4591001 protocol and statistical analy sis planand VE results were reported in the
C4591001 6-M onth Update Interim C linical Study ReportSection 11.1.2 .
The previousl y submitted e fficacy analyses used the same data cutoff date (13 March 2021)
as used for the COVID -19 case sequence anal ysis reportedherein.Theefficacy analyses
were conducted on the evaluable and all -available efficacy populations and included
subgroup anal yses for cases reported in each country (corresponding to study site locations).
Efficacy endpoints anal yzed and reported with the data cutoff date of 13 March 2021, for
which corresponding COVID-19 case sequence data are reported herein, include:
COVID-19 incidence per 100 0person-years of follow-upinparticipants with or without
serological or virological evidence of past SARS -CoV-2 infectionbefore and during the
vaccination regimen – cases confirmed ≥7 day s after Dose 2 (evaluable efficacy population)
Severe COVID -19incidence per 100 0person-years of follow -up in participants with or
withoutevidence of past SARS -CoV-2 infection before and during the vaccination
regimen – cases confirmed ≥7 day s after Dose 2 (evaluable efficacy population), or
confirmed after receiving Dose 1 (Dose 1 all -available population)
COVID-19 case determination and definitions, including those for severe disease ,are
provided below for reference. Assays used for case determination were described in the
Summary of Biopharmaceutic Studiesand Associated Anal ytical Methods (Module 2.7.1).
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Page 7Case Determination
Participants who developed an y potential COVID -19 symptoms listed in the protocol were to
contact the site immediately and if confirmed to participate in an in- person or telehealth visit
as soon as possible (optimally within 3 day s of symptom onset, and at the latest 4 day s after
symptom resolution). At the visit (or prior to the visit, if a participant utilized a self -swab as
permitted per protocol), investigators were to collect clinical information and results from
local standard- of-care tests sufficient to confirm a COVID -19 diagnosis.
Investigators were to obtain a nasal swab (mid -turbinate) for testing at a central laboratory
using a validated reverse transcription –polymerase chain reaction (RT -PCR) test (Cepheid;
EUA200047/A001) to detect SARS -CoV-2. If the evaluation was conducted by telehealth,
the participant was to self- collect a nasal swab and ship for assessment at the central
laboratory . Alocal nucleic acid amplification test ( NAAT) result was onl y acceptable if it
met protocol -specified criter ia and if a central laboratory result was not available , in which
case a local NAAT result could be used if obtained using one of the following assay s:
Cepheid Xpert Xpress SARS -CoV-2
Roche cobas SARS -CoV-2 real-time RT-PCR test (EUA200009/A001)
Abbott Mol ecular/RealTime SARS- CoV-2 assay (EUA200023/A001).
PriorSARS-CoV-2infection status was determined by virological testing byNAAT on mid-
turbinate swab andserological testing for SARS -CoV-2 N-bindingantibodies.
Case Definitions
COVID-19 cases(defined byFDA guidance)1were based on SARS -CoV-2 positive test
result per central laboratory or local testing facility (using an acceptable test per protocol and
if no central laboratory result was available) and presence of atleast 1of the following :
Fever
New or increased cough
New or increased shortness of breath
Chills
New or increased muscle pain
New loss of taste or smell
Sore throat
Diarrhea
Vomiting
CDC criteria- defined COVID -19 cases could include the following additional symptoms:
Fatigue
Headache
Nasal congestion or runny nose
Nausea
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Page 8Severe COVID -19cases(defined byFDA)1included presence of at least 1 of the following :
Clinical signs at rest indicative of severe s ystemic illness:
respiratory rate ≥30 breaths per minute
heart rate≥125 beats per minute
SpO2≤93% on room air at sea level or PaO 2/FiO2 <300mm Hg
Respiratory failure:
needing high -flow oxygen
noninvasive ventilation
mechanical ventilation
extracorporeal membrane oxy genation(ECMO)
Evidence of shock:
systolic blood pressure <90 mm Hg
diastolic blood pressure <60 mm Hg
requiring vasopressors
Significant acute renal, hepatic, or neurologic d ysfunction
Admission to an intensive care unit (ICU)
Death
Efficacy analysis for severe COVID -19 cases was also conducted using the CDC definition
of severe COV ID-19 (hospitalization, admission to the I CU, intubation or mechanical
ventilation, or death ).2
2.1.2.COVID-19 Case Strain Sequencing
Sequencing of SARS -CoV-2 viral RNA was performed for confirmed cases of COVID-19
evaluated for efficacy during the Study C4591001 Phase 2/3 blinded placebo -controlled
follow-up period up to a data cutoff date of 13 March 2021 , as described in Section 2.1.1.
Sequencing anal ysesmethods aredescribed in aSARS-CoV-2 Whole Genome Sequencing
Data Collection and Analysis guideline (Module5.3.1.4)and summarized below.
For determination of SARS-CoV-2 lineage, nucleic acid extraction of mid -turbinate nasal
swab specimens was performed using the MagMAX™ Viral/Pathogen Ultra Nucleic Acid
Isolation Kit processed on a KingFisher Flex or KingFisher Presto.
SARS-CoV-2 viral genome sequencing was performed using the Ion Torrent and I llumina
NextSeq platforms. For the Ion Torrent sequencing platform, the Ion AmpliSeq™
SARS-CoV-2 Research Panel was used, which consists of 2 primer pools: one
targetspolymerase chain reaction (PCR) amplicons specific to SARS -CoV-2,and the other
targets amplicons specific to humansassample processing controls. Oligonucleotide primers
based upon available SARS- CoV-2 nucleotide sequences direct the amplification of the viral
genome with amplicon sthatprovide >99% cove rage of the SARS -CoV-2 genome (~30 kb).
To determine the optimal number of target amplification cy cles, SARS- CoV-2 viral RNA
content in the nucleic acid purified from the mid- turbinate specimens was quantified using
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Page 9the TaqMan™ 2019 -nCoV Assay Kit v1, the TaqMan™ 2019- nCoV Control Kit v1, and
TaqPath™ 1- Step RT-qPCR Master Mix, CG. cDNA was s ynthesized with the SuperScript
VILO cDNA s ynthesis kit. L ibraries were prepared using the Ion AmpliSeq™ L ibrary Kit
plus the Ion AmpliSeq™ SARS -CoV-2 Research Panel. L ibraries underwent template
preparation with I on Chef. Prepared templates were loaded onto an Ion 530 chip for
semiconductor sequencing on the Ion GeneStudio™ S5 plus sequencer according to the
manufacturer’s instructions. Raw sequencing reads generated b ythe Ion Torrent sequencer
were quality and adaptor trimmed by Ion Torrent Suite ,and the resulting reads were then
mapped to the complete genome of the SARS -CoV-2 Wuhan- Hu-1 isolate (GenBank
accession number MN908947.3) using TMAP 5.14.0. Variant calling was carried out with
the Torrent Variant Caller using the BAM file from the mapping of the cleaned sequence
reads onto the reference sequence of SARS- CoV-2.
SARS-CoV-2 viral genome sequencing performed with the Illumina NextSeq platform used
the AmpliSeq for Illumina SARS -CoV-2 panel of PCR primers to enrich for SARS- CoV-2 in
the biological specimen. This was a 2 -pool design, onecontaining SARS -CoV-2
amplicon/primer pairs and the otherhuman- specific amplicons as sample processing
controls. Oligonucleotide primers based upon available SARS -CoV-2 nucleotide sequences
directed the amplification of overlapping amplicons that cover >99% of the viral genome.
Nucleic acid extracted from mid-turbinate specimens was digested with DNase (Invitrogen
TURBO DNA -free™Kit, AM1907), and RNA was purified ( Qiagen RNeasy MinElute
Cleanup Kit )before cDNA sy nthesis. S ynthesis of cDNA used random sequence primers ,
after which SARS -CoV-2 amplicons were generated from the cDNA, followed by ligation of
Universal Next Generation Sequencing Adaptors to the ends of the amplicons. Amplicon
libraries were purified with magnetic beads and loaded onto a flow cell for sequence
determination using the Illumina NextSeq instrument. Sequences with coverage
across the entire spike gene were advanced for viral lineage assignment. Single nucleotide
variants were called using the ‘Low Frequency Variant Detection’ function
For specimens that did not meet acceptance criteria on onesequencing platform, the sample
was repeated on the second platform. If the sequence determined using the second platform
met acceptance criteria, a SARS -CoV-2 lineage was assigned. If a lineage could not be
assigned b y either platform (ie, data d idnot meet acceptance criteria for either platform) and
the Cepheid RT -PCR Ct value for that sample was <34 for either the N or E gene target, the
sample was designated ‘indeterminate ’. Those samples that did not meet acceptance criteria
for both platforms and had low SARS- CoV-2 viral RNA content (ie, Ct values for both the N
and E gene targets >34) weredesignated ‘quantity not sufficient ’(QNS).
SARS-CoV-2 lineage assignment was based on Pangolin software, which runs a
multinomial logistic regression model trained against lineage assignments based on isolate
data from GI SAID, a global science initiative established in 2008 that provides open- access
to genomics data forinfluenza and SARS -CoV-2viruses.
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(b) (4)
(b) (4)
(b) (4)
(b) (4)
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Page 102.2.COVID-19 CaseAnalysis Results
This section summarizes sequence anal ysis results for SARS -CoV-2 lineages associated with
confirmed COVID -19 cases (data cutoff date: 13 March 2021). VE is summarized for the
evaluable efficacy population and country subgroups, as was previousl y reported (refer to
Section 2.1.1). Sequence anal ysis for all SARS -CoV-2 lineages associated with confirmed
COVID-19 cases in the BNT162b2 and placebo groups, including an y designated as variants
of concern (VOCs) or variants of interest (VOIs),3,4are presented in Section 2.2.1 , and
reported for each country subgroup in Section 2.2.2.
2.2.1.Overall CaseSequence Analysis
In the evaluable efficacy population of individuals with or without prior evidence of
SARS-CoV-2 infection before andduring the vaccination regimen, evaluation of COVID-19
cases confirme d at least 7 day s after Dose 2 and reported up to the data cutoff date of
13March 2021 yielded an estimated VE of 91.1% (2 -sided 95% CI: 88.8% , 93.0%). Similar
results were observed for participants without prior evidence of infection before andduring
the vaccination regimen.
Whole genome sequence anal ysis of SARS-CoV-2 was performed on nasal swab specimens
from COVID-19 cases confirmed at least 7 days after Dose 2 in the evaluable efficacy
population of study participants with or without prior evidence of SARS -CoV-2 infection
before andduring the vaccination regimen ,andis summarized by lineage. Among the
determinate and quantifiable sequence results , the most frequent ly identified lineagesin total
wereB.1.2 (40.3%)and B.1.1.33 (8.4%)(seeTable7).
Sequence data for any VOCs or VOIs associated with COVI D-19 cases confirmed at least
7days after Dose 2 in the evaluable efficacy population of study participants with or without
prior evidence of SARS- CoV-2 infection before andduring the vaccination regimen are
summarized by lineage in Table1. Variants that are not VOC/VOIs were grouped into the
‘Other’category.
Few VOCs or VOIs were identified in the BNT162b2 group and were overall more
frequently identified in the placebo group than in the BNT162b2 group .Of the VOCs and
VOIs that were identified for COVID -19 cases reported as of 13 March 2021 , P.2 was the
most common lineage : 6/81 cases (7.4%) in the BNT162b2 group and 40/873 cases (4.6%) in
the placebo group (Table1).
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Page 11Table1.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for
the First COVID -19 Occurrence From 7 Days After Dose 2 –Blinded
Placebo-Controlled Follow -up Period –Subjects With or Without Evidence
of Infection Prior to 7 Days After Dose 2 –Evaluable Efficacy (7 Days)
Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=81)Placebo
(Na=873)Total
(Na=954)
SARS-CoV-2 Lineageb
(Location of lineage first identified)nc(%) nc(%) nc(%)
B.1.1.7 (United Kingdom) 0 3 (0.3) 3 (0.3)
B.1.351 (South Africa) 0 9 (1.0) 9 (0.9)
B.1.427/B.1.429 (USA) 1 (1.2) 23 (2.6) 24 (2.5)
B.1.525 (UK and Nigeria) 0 1 (0.1) 1 (0.1)
B.1.526 (USA) 0 1 (0.1) 1 (0.1)
B.1.616 (France) 0 0 0
B.1.617 (India) 0 0 0
B.1.618 (India) 0 0 0
P.1 (Brazil/Japan) 1 (1.2) 1 (0.1) 2 (0.2)
P.2 (Brazil) 6 (7.4) 40 (4.6) 46 (4.8)
P.3 (Philippines) 0 0 0
Other 66 (81.5) 755 (86.5) 821 (86.1)
Unknownd7 (8.6) 33 (3.8) 40 (4.2)
Not sequenced 0 8 (0.9) 8 (0.8)
Abbreviation: SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 0 1JUN2021
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(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2 unblinded/C4591001 BLA Sequence/adxb seq cov 7pd2 eval
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Page 122.2.2.Country Subgroup Case Sequence Analysis
Sequence data were evaluated for all SARS -CoV-2 lineages associated with COVID -19
cases confirmed at least 7 days after Dose 2 in the evaluable efficacy population of study
participants with or without prior evidence of SARS- CoV-2 infection before andduring the
vaccination regimen andsummarized by lineage and bycountry (corresponding to study site
locations). Among the determinate and quantifiable sequence results, a variety of lineages are
represented across country subgroups (see Table8).
As geograph y is an important factor in the circulation of lineages designated as VOCs or
VOIs, sequence data for any VOCs or VOI s associated with COVID -19 cases confirmed at
least 7days after Dose 2 in the evaluable efficacy population of study participants with or
without prior evidence of SARS -CoV-2 infection before andduring the vaccination regimen
aresummarized by lineage for each country. SARS-CoV-2 lineages are summarized in
Table2and described for each country below.Variants that are not VOC/VOI s were grouped
into the ‘Other’ category .
Additionally , for each country , a corresponding summary of estimated VE is provided from
the previously conducted efficacy analyses (refer to Section 2.1.1). The estimated VE was
determined for each country subgroup for the evaluable efficacy population of individuals
with or without prior evidence of SARS -CoV-2 infection before andduring the vaccination
regimen, in which COVID -19 cases were confirmed at least 7 days after Dose 2 and reported
up to the data cutoff date of 13 March 2021. Similar results were observed for participants
without prior evidence of infection before andduring the vaccination regimen.
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Page 13Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the First COVID -19 Occurrence From
7 DaysAfter Dose 2, by Country – Blinded Placebo -Controlled Follow -up Period –Subjects With or Without
Evidence of Infection Prior t o 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 Lineagea
(Location of lineage first identified)Nbnc(%) Nbnc(%) Nbnc(%)
Argentina B.1.1.7 (United Kingdom) 16 0 110 1 (0.9) 126 1 (0.8)
B.1.351 (South Africa) 16 0 110 0 126 0
B.1.427/B.1.429 (USA) 16 0 110 0 126 0
B.1.525 (UK and Nigeria) 16 0 110 0 126 0
B.1.526 (USA) 16 0 110 0 126 0
B.1.616 (France) 16 0 110 0 126 0
B.1.617 (India) 16 0 110 0 126 0
B.1.618 (India) 16 0 110 0 126 0
P.1 (Brazil/Japan) 16 0 110 0 126 0
P.2 (Brazil) 16 1 (6.3) 110 4 (3.6) 126 5 (4.0)
P.3 (Philippines) 16 0 110 0 126 0
Other 16 15 (93.8) 110 102 (92.7) 126 117 (92.9)
Unknownd16 0 110 3 (2.7) 126 3 (2.4)
Not sequenced 16 0 110 0 126 0
Brazil B.1.1.7 (United Kingdom) 14 0 82 0 96 0
B.1.351 (South Africa) 14 0 82 0 96 0
B.1.427/B.1.429 (USA) 14 0 82 0 96 0
B.1.525 (UK and Nigeria) 14 0 82 0 96 0
B.1.526 (USA) 14 0 82 0 96 0
B.1.616 (France) 14 0 82 0 96 0
B.1.617 (India) 14 0 82 0 96 0
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Page 14Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the First COVID -19 Occurrence From
7 DaysAfter Dose 2, by Country – Blinded Placebo -Controlled Follow -up Period –Subjects With or Without
Evidence of Infection Prior t o 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 Lineagea
(Location of lineage first identified)Nbnc(%) Nbnc(%) Nbnc(%)
B.1.618 (India) 14 0 82 0 96 0
P.1 (Brazil/Japan) 14 1 (7.1) 82 1 (1.2) 96 2 (2.1)
P.2 (Brazil) 14 5 (35.7) 82 35 (42.7) 96 40 (41.7)
P.3 (Philippines) 14 0 82 0 96 0
Other 14 6 (42.9) 82 40 (48.8) 96 46 (47.9)
Unknownd14 2 (14.3) 82 6 (7.3) 96 8 (8.3)
Not sequenced 14 0 82 0 96 0
Germany B.1.1.7 (United Kingdom) 0 0 1 0 1 0
B.1.351 (South Africa) 0 0 1 0 1 0
B.1.427/B.1.429 (USA) 0 0 1 0 1 0
B.1.525 (UK and Nigeria) 0 0 1 0 1 0
B.1.526 (USA) 0 0 1 0 1 0
B.1.616 (France) 0 0 1 0 1 0
B.1.617 (India) 0 0 1 0 1 0
B.1.618 (India) 0 0 1 0 1 0
P.1 (Brazil/Japan) 0 0 1 0 1 0
P.2 (Brazil) 0 0 1 0 1 0
P.3 (Philippines) 0 0 1 0 1 0
Other 0 0 1 1 (100.0) 1 1 (100.0)
Unknownd0 0 1 0 1 0
Not sequenced 0 0 1 0 1 0
Turkey B.1.1.7 (United Kingdom) 0 0 6 0 6 0
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Page 15Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the First COVID -19 Occurrence From
7 DaysAfter Dose 2, by Country – Blinded Placebo -Controlled Follow -up Period –Subjects With or Without
Evidence of Infection Prior t o 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 Lineagea
(Location of lineage first identified)Nbnc(%) Nbnc(%) Nbnc(%)
B.1.351 (South Africa) 0 0 6 0 6 0
B.1.427/B.1.429 (USA) 0 0 6 0 6 0
B.1.525 (UK and Nigeria) 0 0 6 0 6 0
B.1.526 (USA) 0 0 6 0 6 0
B.1.616 (France) 0 0 6 0 6 0
B.1.617 (India) 0 0 6 0 6 0
B.1.618 (India) 0 0 6 0 6 0
P.1 (Brazil/Japan) 0 0 6 0 6 0
P.2 (Brazil) 0 0 6 0 6 0
P.3 (Philippines) 0 0 6 0 6 0
Other 0 0 6 6 (100.0) 6 6 (100.0)
Unknownd0 0 6 0 6 0
Not sequenced 0 0 6 0 6 0
USA B.1.1.7 (United Kingdom) 51 0 664 2 (0.3) 715 2 (0.3)
B.1.351 (South Africa) 51 0 664 1 (0.2) 715 1 (0.1)
B.1.427/B.1.429 (USA) 51 1 (2.0) 664 23 (3.5) 715 24 (3.4)
B.1.525 (UK and Nigeria) 51 0 664 1 (0.2) 715 1 (0.1)
B.1.526 (USA) 51 0 664 1 (0.2) 715 1 (0.1)
B.1.616 (France) 51 0 664 0 715 0
B.1.617 (India) 51 0 664 0 715 0
B.1.618 (India) 51 0 664 0 715 0
P.1 (Brazil/Japan) 51 0 664 0 715 0
P.2 (Brazil) 51 0 664 0 715 0
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Page 16Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the First COVID -19 Occurrence From
7 DaysAfter Dose 2, by Country – Blinded Placebo -Controlled Follow -up Period –Subjects With or Without
Evidence of Infection Prior t o 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 Lineagea
(Location of lineage first identified)Nbnc(%) Nbnc(%) Nbnc(%)
P.3 (Philippines) 51 0 664 0 715 0
Other 51 45 (88.2) 664 606 (91.3) 715 651 (91.0)
Unknownd51 5 (9.8) 664 23 (3.5) 715 28 (3.9)
Not sequenced 51 0 664 8 (1.2) 715 8 (1.1)
South Africa B.1.1.7 (United Kingdom) 0 0 10 0 10 0
B.1.351 (South Africa) 0 0 10 8 (80.0) 10 8 (80.0)
B.1.427/B.1.429 (USA) 0 0 10 0 10 0
B.1.525 (UK and Nigeria) 0 0 10 0 10 0
B.1.526 (USA) 0 0 10 0 10 0
B.1.616 (France) 0 0 10 0 10 0
B.1.617 (India) 0 0 10 0 10 0
B.1.618 (India) 0 0 10 0 10 0
P.1 (Brazil/Japan) 0 0 10 0 10 0
P.2 (Brazil) 0 0 10 1 (10.0) 10 1 (10.0)
P.3 (Philippines) 0 0 10 0 10 0
Other 0 0 10 0 10 0
Unknownd0 0 10 1 (10.0) 10 1 (10.0)
Not sequenced 0 0 10 0 10 0
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Page 17Table2.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the First COVID -19 Occurrence From
7 DaysAfter Dose 2, by Country – Blinded Placebo -Controlled Follow -up Period –Subjects With or Without
Evidence of Infection Prior t o 7 Days After Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 Lineagea
(Location of lineage first identified)Nbnc(%) Nbnc(%) Nbnc(%)
Abbreviation: SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.Based on PANGO lineages (cov -lineages.org).
b.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage calculations.
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) sam ples.
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Page 18Note: VOC /VOI lineages by countryarein Table2, with variants that are not VOCs/VOI s
grouped in the ‘Other’ category ; all SARS-CoV-2 lineages b y country are in Table 8.
Argentina
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS- CoV-2 infection in Argentina was
85.7% (2-sided 95% CI: 75.7%, 92.1%), which inc luded 16 cases in the BNT162b2 group and
110 cases in the placebo group. Only a few cases of VOCs or VOIs were identified ( Table2).
Brazil
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS- CoV-2 infection in Brazil was 84.2%
(2-sided 95% CI: 71.9%, 91.7%), which included 14 cases in the BNT162b2 group and 82 cases
in the placebo group.
The P.2 lineage was almost as prevalent as the ‘Other’lineages category (Table2). The P.2
lineage w as identified in 5/14 cases (35.7%) in the BNT162b2 group and 35/82 cases (42.7%) in
the placebo group . ‘Other’lineages were identified in 6/14cases (42.9%) in the BNT162b2
group and 40/82 cases (48.8%) in the placebo group .Thesedata indicate high vaccine
effectiveness against the P2 variant.
Germany
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS- CoV-2 infection in German y was
100.0% (2 -sided 95% CI: -3868.6%, 100.0%), which included 0 cases in the BNT162b2 group
and 1 case in the placebo group .
Turkey
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS -CoV-2 infection in Turkey was 100.0%
(2-sided 95% CI: 22.2% , 100.0%), which included 0 cases in the BNT162b2 group and 6 cases
in the placebo group.
United States
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS- CoV-2 infection in the US was 92.6%
(2-sided 95% CI: 90.2%, 94.6%), which included 51 cases in the BNT162b2 group and
664cases in the placebo group.
SARS-CoV-2 lineages in the US w eremost frequently categorized as ‘Other’ : 45/51cases
(88.2%) in the BNT162b2 group and 606/664cases (91.3 %) in the placebo group (Table2). Of
the VOIor VOC categories, the B.1.427/B.1.429 lineage was the most common ,with 1/51 cases
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Page 19(2.0%) in the BNT162b2 group and 23/664 cases (3.5%) in the placebo group, demonstrating
high vaccine efficacy against this variant.
South Africa
The estimated VE against confirmed COVID -19 occurring at least 7 days after receiving Dose 2
for participants with or without prior evidence of SARS- CoV-2 infection in South Africa was
100.0% (2 -sided 95% CI: 56.6%, 100.0%), which included 0 cases in the BNT162b2 group and
10 cases in the placebo group.
The most frequentl y identified lineage of SARS -CoV-2 in South Africa was the B.1.351 VOC :
8/10cases (80.0%) (Table2). All 8 cases were in the placebo group, demonstrating high efficacy
against this VOC.
2.3.Severe COVID -19 CaseAnalysis Results
This section summarizes sequence anal ysis results for SARS -CoV-2 lineages associated with
confirmed severe COVID -19 cases (data cutoff date : 13 March 2021 ).VE against severe disease
is summarized for evaluable and all -available efficacy populations, as was previously reported
(refer toSection 2.1.1). Sequence anal ysis forallSARS-CoV-2 lineages associated with FDA-
definedsevere cases in the BNT162b2 and placebo groups , including an y designated as VOCs or
VOIs,is presented in Section 2.3.1, and presented for CDC -defined severe cases in Section 2.3.2.
2.3.1.Case Sequence Analysis for Severe COVID -19 per FDA Definition
Evaluable Efficacy Population ( Severe Cases Occurring ≥ 7 Days After Dose 2)
The estimated VE against confirmed severe COVID -19 occurring at least 7 days after receiving
Dose 2 for participants with or without prior evidence of SARS -CoV-2 infection, using the FDA
definition of severit y, was 95 .3%(2-sided 95% CI: 7 0.9%, 99.9 %) which included 1 severe case
in the BNT162b2 group and 21 severe cases in the placebo group. Similar results were observed
for participants without prior evidence of infection.
Sequence data were evaluated for SARS-CoV-2 lineages associated with severe COVID-19
cases (as defined by the FDA) confirmed at least 7 days after Dose 2 in the evaluable efficacy
population of study participants with or without prior evidence of SARS -CoV-2 infection before
and during the vaccination regimen andsummarized by lineage. Among the determinate and
quantifiable sequence results, themost frequent ly identified lineagesin totalwere B.1.2 (31.8%)
and B.1.1.33 (13.6%) (see Table9). Very few VOC or VOI category lineages were found in the
severe cases ( Table3).
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Page 20Table3.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the
First Severe COVID -19 Occurrence Based on FDA -Definition From 7 Days
After Dose 2 –Blinded Placebo- Controlled Follow -up Period –Subjects With
or Without Evidence of Inf ection Prior to 7 Days After Dose 2 –Evaluable
Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=21)Total
(Na=22)
SARS-CoV-2 Lineageb
(Location of lineage first identified)nc(%) nc(%) nc(%)
B.1.1.7 (United Kingdom) 0 0 0
B.1.351 (South Africa) 0 2 (9.5) 2 (9.1)
B.1.427/B.1.429 (USA) 0 0 0
B.1.525 (UK and Nigeria) 0 0 0
B.1.526 (USA) 0 0 0
B.1.616 (France) 0 0 0
B.1.617 (India) 0 0 0
B.1.618 (India) 0 0 0
P.1 (Brazil/Japan) 0 0 0
P.2 (Brazil) 0 0 0
P.3 (Philippines) 0 0 0
Other 1 (100.0) 17 (81.0) 18 (81.8)
Unknownd0 1 (4.8) 1 (4.5)
Not sequenced 0 1 (4.8) 1 (4.5)
Abbreviations: FDA = Food and Drug Administration; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
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Page 21Dose 1 All -Available Efficacy Population (All Severe Cases Occurring after Dose 1)
The estimated VE against confirmed severe COVID -19 occurring after Dose 1, using the FDA
definition of severit y, was 96.7%(2-sided 95% CI: 80.3%, 99.9%) which included 1 severe case
in the BNT162b2 group and 30 severe cases in the placebo group.
Sequence data were evaluated for SARS -CoV-2 lineages associated with severe COVID-19
cases (as defined b y the FDA) in the Dose 1 a ll-available efficacy population who had cases
occurring after Dose 1 andsummarized by lineage. Among the determinate and quantifiable
sequence results, the most frequent ly identified lineages in total were B.1.2 ( 35.5%) and B.1.1.33
(12.9%) (see Table10). Very few VOC or VOI category lineages were found in the severe cases
(Table4).
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Page 22Table4.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the
First Severe COVID -19 Occurrence Based on FDA -Definition After Dose 1 –
Blinded Placebo -Controlled Follow -up Period –Dose 1 All -Available Efficacy
Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=30)Total
(Na=31)
SARS-CoV-2 Lineageb
(Location of lineage first identified)nc(%) nc(%) nc(%)
B.1.1.7 (United Kingdom) 0 0 0
B.1.351 (South Africa) 0 2 (6.7) 2 (6.5)
B.1.427/B.1.429 (USA) 0 0 0
B.1.525 (UK and Nigeria) 0 0 0
B.1.526 (USA) 0 0 0
B.1.616 (France) 0 0 0
B.1.617 (India) 0 0 0
B.1.618 (India) 0 0 0
P.1 (Brazil/Japan) 0 0 0
P.2 (Brazil) 0 0 0
P.3 (Philippines) 0 0 0
Other 1 (100.0) 26 (86.7) 27 (87.1)
Unknownd0 1 (3.3) 1 (3.2)
Not sequenced 0 1 (3.3) 1 (3.2)
Abbreviations: FDA = Food and Drug Administration; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
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Page 232.3.2.Case Sequence Analysis for Severe COVID -19 per CDC Definition
Evaluable Efficacy Population ( Severe Cases Occurring ≥ 7 Days After Dose 2)
The estimated VE against confirmed severe COVID -19 occurring at least 7 days after receiving
Dose 2 for participants with or without prior evidence of SARS -CoV-2 infection, using the CDC
definition of severit y, was 100.0% (2-sided 95% CI : 88.0%, 100.0%)which included 0 severe
cases in the BNT162b2 group and 32 severe cases in the placebo group. Similar results were
observed for participants without prior evidence of infection.
Sequence data were evaluated for all SARS -CoV-2 lineages associated with severe COVID -19
cases (as defined by the CDC) confirmed at least 7 days after Dose 2 in the evaluable efficacy
population of study participants wi th or without prior evidence of SARS- CoV-2 infection before
andduring the vaccination regimen andsummarized by lineage. Among the determinate and
quantifiable sequence results, themost frequent ly identified lineages in total were B.1.2 (25.0%)
and B.1.1 .33 (15.6%) (see Table11).Very few VOC or VOI category lineages were found in the
severe cases ( Table5).
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Page 24Table5.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the
First Severe COVID -19 Occurrence Based on CDC -Definition From 7 Days
After Dose 2 –Blinded Placebo- Controlled Follow -up Period –Subjects With
or Without Evidence of Infection Prior to 7 Days After Dose 2 –Evaluable
Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=0)Placebo
(Na=32)Total
(Na=32)
SARS-CoV-2 Lineageb
(Location of lineage first identified)nc(%) nc(%) nc(%)
B.1.1.7 (United Kingdom) 0 0 0
B.1.351 (South Africa) 0 1 (3.1) 1 (3.1)
B.1.427/B.1.429 (USA) 0 0 0
B.1.525 (UK and Nigeria) 0 0 0
B.1.526 (USA) 0 0 0
B.1.616 (France) 0 0 0
B.1.617 (India) 0 0 0
B.1.618 (India) 0 0 0
P.1 (Brazil/Japan) 0 0 0
P.2(Brazil) 0 1 (3.1) 1 (3.1)
P.3 (Philippines) 0 0 0
Other 0 27 (84.4) 27 (84.4)
Unknownd0 2 (6.3) 2 (6.3)
Not sequenced 0 1 (3.1) 1 (3.1)
Abbreviations: CDC = Centers for Disease Control and Prevention; SARS -CoV-2 = severe acute respiratory sy ndrome
coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
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Page 25Dose 1 All -Available Efficacy Population (All Severe Cases Occurring after Dose 1)
The estimated VE against confirmed severe COVID -19 occurring after Dose 1, using the CDC
definition of severit y, was 97.8 % (2-sided 95% CI: 87.2%, 99.9%) which included 1 severe case
in the BNT162b2 group and 45 severe cases in the placebo group.
Sequence data were evaluated for all SARS -CoV-2 lineages associated with severe COVID -19
cases (as defined by the CDC) in the Dose 1 all -available efficacy population who had cases
occurring after Dose 1 andsummarized by lineage. Among the determinate and quantifiable
sequence results, themost frequent ly identified lineages in total were B.1.2 ( 26.1%) and B.1.1.33
(13.0%) (see Table12).Very few VOC or VOI category lineages were found in the severe cases
(Table6).
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Page 26Table6.Summary of SARS -CoV-2 Variants of Concern or Variants of Interest for the
First Severe COVID -19 Occurrence Based on CDC -Definition After Dose 1 –
Blinded Placebo -Controlled Follow -up Period –Dose 1 All -Available Efficacy
Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=45)Total
(Na=46)
SARS-CoV-2 Lineageb
(Location of lineage first identified)nc(%) nc(%) nc(%)
B.1.1.7 (United Kingdom) 0 0 0
B.1.351 (South Africa) 0 1 (2.2) 1 (2.2)
B.1.427/B.1.429 (USA) 0 0 0
B.1.525 (UK and Nigeria) 0 0 0
B.1.526 (USA) 0 0 0
B.1.616 (France) 0 0 0
B.1.617 (India) 0 0 0
B.1.618 (India) 0 0 0
P.1 (Brazil/Japan) 0 0 0
P.2 (Brazil) 0 1 (2.2) 1 (2.2)
P.3 (Philippines) 0 0 0
Other 1 (100.0) 40 (88.9) 41 (89.1)
Unknownd0 2 (4.4) 2 (4.3)
Not sequenced 0 1 (2.2) 1 (2.2)
Abbreviations: CDC = Centers for Disease Control and Prevention; SARS -CoV-2 = severe acute respiratory syndrome
coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 01JUN2021 (20:13)
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Page 273.CONCLUSIONS
In the Phase 2/3 part of Study C4591001, during blinded placebo- controlled follow -upthrough a
data cutoff date of 13 March 2021,confirmed COVID-19 cases were evaluated in an updated
efficacy analysis encompassing up to 6 months of follow -up after participants received Dose 2 .
Sequence anal ysis indicates thatVOCs and VOIs were circulating during the surveillance period,
and those identified among the confirmed COVID -19 cases in Study C4591001 mostly occurred
in the placebo group withfew occurring in the BNT162b2 group, for cases reported at least
7days after receiving the second dose of BNT162b2 .The distribution of identified VOCs and
VOIs varied by country; however,the estimated V E was high regardless of geograph y.
COVID-19cases considered as severe , defined by eitherFDA or CDC criteria, werecomprised
predominantly of SARS -CoV-2 lineages that are not designated as VOCs or VOIs ,with few
identified VOCs or VOIs in the placebo group and none in BNT162b2 group , for severe cases
reported at least 7 days after receiving the second dose of BNT162b2 . A similar trend was
observed for severe cases ( per FDA or CDC definition) reported fr om Dose 1 onwards.
Thesequence data confirm vaccine efficacy against more prevalent VO Cs/VOIs,such as
B.1.351, P.2,and B.1.427/B.1.429. In summary , there is no apparent SARS -CoV-2 lineage
pattern among vaccine breakthrough cases that would suggest meaningfully reduced BNT162b2
efficacy against any variant.
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Page 284.ADDITIONAL TABLES , LISTINGS, AND FIGURES
4.1.Listings
The following C4591001 BLA Sequence Listingsare located in Module 5.3.5.1:
16.2.8.6 L isting of Subjects and SARS -CoV-2 Variants With First COVI D-19 Occurrence From
7 Days After Dose 2 and With or Without Evidence of Infection Prior to 7 Day s After Dose 2 –
Blinded Placebo -Controlled Follow- up Period –Evaluable Efficacy (7 Days) Population
16.2.8.7 L isting of Subjects and SARS -CoV-2 Variants With Multiple COVID -19 Occurrence
After Dose 1 –Dose 1 All -Available Effica cy Population
16.2.8.8 L isting of Subjects and SARS -CoV-2 Variants With First Severe COVID -19
Occurrence Based on CDC- Defined or FDA -Defined Sy mptoms After Dose 1 – Blinded
Placebo-Controlled Follow -up Period –Dose 1 All -Available Efficacy Population
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Page 294.2.Tables
4.2.1.COVID-19 Case Analysis
Table7.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2 –Blinded Placebo- Controlled Follow -up Period –Subjects
With or Without Evidence of Infection Prior to 7 Days After Dose 2 –
Evaluable Efficacy (7 Day s) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=81)Placebo
(Na=873)Total
(Na=954)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
A.2 0 1 (0.1) 1 (0.1)
A.2.4 1 (1.2) 1 (0.1) 2 (0.2)
B 0 1 (0.1) 1 (0.1)
B.1 3 (3.7) 65 (7.4) 68 (7.1)
B.1.1 1 (1.2) 2 (0.2) 3 (0.3)
B.1.1.1 1 (1.2) 4 (0.5) 5 (0.5)
B.1.1.105 0 1 (0.1) 1 (0.1)
B.1.1.120 0 1 (0.1) 1 (0.1)
B.1.1.122 0 1 (0.1) 1 (0.1)
B.1.1.139 0 1 (0.1) 1 (0.1)
B.1.1.143 3 (3.7) 5 (0.6) 8 (0.8)
B.1.1.152 0 1 (0.1) 1 (0.1)
B.1.1.161 0 1 (0.1) 1 (0.1)
B.1.1.200 0 1 (0.1) 1 (0.1)
B.1.1.207 0 2 (0.2) 2 (0.2)
B.1.1.220 0 3 (0.3) 3 (0.3)
B.1.1.222 3 (3.7) 11 (1.3) 14 (1.5)
B.1.1.231 0 1 (0.1) 1 (0.1)
B.1.1.244 0 3 (0.3) 3 (0.3)
B.1.1.253 0 1 (0.1) 1 (0.1)
B.1.1.28 1 (1.2) 18 (2.1) 19 (2.0)
B.1.1.285 0 1 (0.1) 1 (0.1)
B.1.1.289 0 1 (0.1) 1 (0.1)
B.1.1.29 2 (2.5) 8 (0.9) 10 (1.0)
B.1.1.291 0 1 (0.1) 1 (0.1)
B.1.1.304 0 1 (0.1) 1 (0.1)
B.1.1.33 10 (12.3) 70 (8.0) 80 (8.4)
B.1.1.34 0 4 (0.5) 4 (0.4)
B.1.1.35 1 (1.2) 1 (0.1) 2 (0.2)
B.1.1.4 0 1 (0.1) 1 (0.1)
B.1.1.44 0 1 (0.1) 1 (0.1)
B.1.1.54 0 1 (0.1) 1 (0.1)
B.1.1.63 0 1 (0.1) 1 (0.1)
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Page 30Table7.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2 –Blinded Placebo- Controlled Follow -up Period –Subjects
With or Without Evidence of Infection Prior to 7 Days After Dose 2 –
Evaluable Efficacy (7 Day s) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=81)Placebo
(Na=873)Total
(Na=954)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
B.1.1.7 0 3 (0.3) 3 (0.3)
B.1.1.70 1 (1.2) 0 1 (0.1)
B.1.1.94 1 (1.2) 0 1 (0.1)
B.1.110.3 0 3 (0.3) 3 (0.3)
B.1.119 0 1 (0.1) 1 (0.1)
B.1.139 1 (1.2) 8 (0.9) 9 (0.9)
B.1.142 0 1 (0.1) 1 (0.1)
B.1.177 0 3 (0.3) 3 (0.3)
B.1.182 0 1 (0.1) 1 (0.1)
B.1.189 0 2 (0.2) 2 (0.2)
B.1.2 24 (29.6) 360 (41.2) 384 (40.3)
B.1.210 1 (1.2) 1 (0.1) 2 (0.2)
B.1.215 0 1 (0.1) 1 (0.1)
B.1.232 0 1 (0.1) 1 (0.1)
B.1.234 2 (2.5) 24 (2.7) 26 (2.7)
B.1.235 0 1 (0.1) 1 (0.1)
B.1.239 0 2 (0.2) 2 (0.2)
B.1.240 1 (1.2) 13 (1.5) 14 (1.5)
B.1.241 1 (1.2) 0 1 (0.1)
B.1.243 1 (1.2) 18 (2.1) 19 (2.0)
B.1.265 1 (1.2) 3 (0.3) 4 (0.4)
B.1.280 0 3 (0.3) 3 (0.3)
B.1.302 0 1 (0.1) 1 (0.1)
B.1.306 0 1 (0.1) 1 (0.1)
B.1.311 1 (1.2) 11 (1.3) 12 (1.3)
B.1.324 0 2 (0.2) 2 (0.2)
B.1.349 0 5 (0.6) 5 (0.5)
B.1.351 0 9 (1.0) 9 (0.9)
B.1.361 0 11 (1.3) 11 (1.2)
B.1.366 0 1 (0.1) 1 (0.1)
B.1.369 0 8 (0.9) 8 (0.8)
B.1.375 0 1 (0.1) 1 (0.1)
B.1.395 0 1 (0.1) 1 (0.1)
B.1.396 0 1 (0.1) 1 (0.1)
B.1.399 1 (1.2) 0 1 (0.1)
B.1.400 0 7 (0.8) 7 (0.7)
B.1.403 0 2 (0.2) 2 (0.2)
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
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Page 31Table7.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2 –Blinded Placebo- Controlled Follow -up Period –Subjects
With or Without Evidence of Infection Prior to 7 Days After Dose 2 –
Evaluable Efficacy (7 Day s) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=81)Placebo
(Na=873)Total
(Na=954)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
B.1.404 0 9 (1.0) 9 (0.9)
B.1.405 0 1 (0.1) 1 (0.1)
B.1.409 1 (1.2) 2 (0.2) 3 (0.3)
B.1.413 0 1 (0.1) 1 (0.1)
B.1.427 1 (1.2) 5 (0.6) 6 (0.6)
B.1.428 1 (1.2) 1 (0.1) 2 (0.2)
B.1.429 0 18 (2.1) 18 (1.9)
B.1.438 0 2 (0.2) 2 (0.2)
B.1.443 0 1 (0.1) 1 (0.1)
B.1.499 1 (1.2) 17 (1.9) 18 (1.9)
B.1.509 0 4 (0.5) 4 (0.4)
B.1.511 1 (1.2) 0 1 (0.1)
B.1.517 0 2 (0.2) 2 (0.2)
B.1.525 0 1 (0.1) 1 (0.1)
B.1.526 0 1 (0.1) 1 (0.1)
B.47 0 2 (0.2) 2 (0.2)
N.1 0 1 (0.1) 1 (0.1)
N.3 0 1 (0.1) 1 (0.1)
P.1 1 (1.2) 1 (0.1) 2 (0.2)
P.2 6 (7.4) 40 (4.6) 46 (4.8)
Unknownd7 (8.6) 33 (3.8) 40 (4.2)
Not sequenced 0 8 (0.9) 8 (0.8)
Abbreviation: SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage calculations.
b.Based on PANG O lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 01JUN2021 (18:36)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2 unblinded/C4591001 BLA Sequence/adxb seq var cov 7pd2 eval
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
FDA-CBER-2021-5683-1072407
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Page 32Table8.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2, by Country – Blinded Placebo -Controlled Follow -up
Period– Subjects With or Without Evidence of Infection Prior to 7 Days After
Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 LineageaNbnc(%)Nbnc(%)Nbnc(%)
Argentina B.1 16 1 (6.3) 110 12 (10.9) 126 13 (10.3)
B.1.1.1 16 1 (6.3) 110 3 (2.7) 126 4 (3.2)
B.1.1.200 16 0 110 1 (0.9) 126 1 (0.8)
B.1.1.28 16 0 110 1 (0.9) 126 1 (0.8)
B.1.1.289 16 0 110 1 (0.9) 126 1 (0.8)
B.1.1.291 16 0 110 1 (0.9) 126 1 (0.8)
B.1.1.33 168 (50.0) 110 62 (56.4) 126 70 (55.6)
B.1.1.35 16 1 (6.3) 110 1 (0.9) 126 2 (1.6)
B.1.1.7 16 0 110 1 (0.9) 126 1 (0.8)
B.1.1.70 16 1 (6.3) 110 0 126 1 (0.8)
B.1.2 16 0 110 1 (0.9) 126 1 (0.8)
B.1.302 16 0 110 1 (0.9) 126 1 (0.8)
B.1.428 16 1 (6.3) 110 0 126 1 (0.8)
B.1.499 16 1 (6.3) 110 17 (15.5) 126 18 (14.3)
B.1.511 16 1 (6.3) 110 0 126 1 (0.8)
N.3 16 0 110 1 (0.9) 126 1 (0.8)
P.2 16 1 (6.3) 110 4 (3.6) 126 5 (4.0)
Unknownd16 0 110 3 (2.7) 126 3 (2.4)
Brazil B.1 14 0 82 3 (3.7) 96 3 (3.1)
B.1.1.1 14 0 82 1 (1.2) 96 1 (1.0)
B.1.1.143 142 (14.3) 82 4 (4.9) 96 6 (6.3)
B.1.1.28 14 1 (7.1) 8217 (20.7) 96 18 (18.8)
B.1.1.33 142 (14.3) 82 8 (9.8) 96 10 (10.4)
B.1.1.34 14 0 82 4 (4.9) 96 4 (4.2)
B.1.1.44 14 0 82 1 (1.2) 96 1 (1.0)
B.1.1.94 14 1 (7.1) 82 0 96 1 (1.0)
B.1.182 14 0 82 1 (1.2) 96 1 (1.0)
N.1 14 0 82 1 (1.2) 96 1 (1.0)
P.1 14 1 (7.1) 82 1 (1.2) 96 2 (2.1)
P.2 145 (35.7) 8235 (42.7) 96 40 (41.7)
Unknownd142 (14.3) 82 6 (7.3) 96 8 (8.3)
Germany B.1.177 0 0 11 (100.0) 11 (100.0)
Turkey B.1 0 0 61 (16.7) 6 1 (16.7)
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
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Page 33Table8.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2, by Country – Blinded Placebo -Controlled Follow -up
Period– Subjects With or Without Evidence of Infection Prior to 7 Days After
Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 LineageaNbnc(%)Nbnc(%)Nbnc(%)
B.1.1.105 0 0 61 (16.7) 6 1 (16.7)
B.1.1.120 0 0 61 (16.7) 6 1 (16.7)
B.1.1.29 0 0 61 (16.7) 6 1 (16.7)
B.1.1.54 0 0 61 (16.7) 6 1 (16.7)
B.1.177 0 0 61 (16.7) 6 1 (16.7)
USA A.2 51 0 664 1 (0.2) 715 1 (0.1)
A.2.4 51 1 (2.0) 664 1 (0.2) 715 2 (0.3)
B 51 0 664 1 (0.2) 715 1 (0.1)
B.1 51 2 (3.9) 664 49 (7.4) 715 51 (7.1)
B.1.1 51 1 (2.0) 664 2 (0.3) 715 3 (0.4)
B.1.1.122 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.139 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.143 51 1 (2.0) 664 1 (0.2) 715 2 (0.3)
B.1.1.152 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.161 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.207 51 0 664 2 (0.3) 715 2 (0.3)
B.1.1.220 51 0 664 3 (0.5) 715 3 (0.4)
B.1.1.222 51 3 (5.9) 664 11 (1.7) 715 14 (2.0)
B.1.1.231 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.244 51 0 664 3 (0.5) 715 3 (0.4)
B.1.1.253 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.285 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.29 51 2 (3.9) 664 7 (1.1) 715 9 (1.3)
B.1.1.304 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.4 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.63 51 0 664 1 (0.2) 715 1 (0.1)
B.1.1.7 51 0 664 2 (0.3) 715 2 (0.3)
B.1.110.3 51 0 664 3 (0.5) 715 3 (0.4)
B.1.119 51 0 664 1 (0.2) 715 1 (0.1)
B.1.139 51 1 (2.0) 664 8 (1.2) 715 9 (1.3)
B.1.142 51 0 664 1 (0.2) 715 1 (0.1)
B.1.177 51 0 664 1 (0.2) 715 1 (0.1)
B.1.189 51 0 664 2 (0.3) 715 2 (0.3)
B.1.2 5124 (47.1) 664359 (54.1) 715 383 (53.6)
B.1.210 51 1 (2.0) 664 1 (0.2) 715 2 (0.3)
B.1.215 51 0 664 1 (0.2) 715 1 (0.1)
B.1.232 51 0 664 1 (0.2) 715 1 (0.1)
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
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Page 34Table8.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2, by Country – Blinded Placebo -Controlled Follow -up
Period– Subjects With or Without Evidence of Infection Prior to 7 Days After
Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 LineageaNbnc(%)Nbnc(%)Nbnc(%)
B.1.234 51 2 (3.9) 664 24 (3.6) 715 26 (3.6)
B.1.235 51 0 664 1 (0.2) 715 1 (0.1)
B.1.239 51 0 664 2 (0.3) 715 2 (0.3)
B.1.240 51 1 (2.0) 664 13 (2.0) 715 14 (2.0)
B.1.241 51 1 (2.0) 664 0 715 1 (0.1)
B.1.243 51 1 (2.0) 664 18 (2.7) 715 19 (2.7)
B.1.265 51 1 (2.0) 664 3 (0.5) 715 4 (0.6)
B.1.280 51 0 664 3 (0.5) 715 3 (0.4)
B.1.306 51 0 664 1 (0.2) 715 1 (0.1)
B.1.311 51 1 (2.0) 664 11 (1.7) 715 12 (1.7)
B.1.324 51 0 664 2 (0.3) 715 2 (0.3)
B.1.349 51 0 664 5 (0.8) 715 5 (0.7)
B.1.351 51 0 664 1 (0.2) 715 1 (0.1)
B.1.361 51 0 664 11 (1.7) 715 11 (1.5)
B.1.366 51 0 664 1 (0.2) 715 1 (0.1)
B.1.369 51 0 664 8 (1.2) 715 8 (1.1)
B.1.375 51 0 664 1 (0.2) 715 1 (0.1)
B.1.395 51 0 664 1 (0.2) 715 1 (0.1)
B.1.396 51 0 664 1 (0.2) 715 1 (0.1)
B.1.399 51 1 (2.0) 664 0 715 1 (0.1)
B.1.400 51 0 664 7 (1.1) 715 7 (1.0)
B.1.403 51 0 664 2 (0.3) 715 2 (0.3)
B.1.404 51 0 664 9 (1.4) 715 9 (1.3)
B.1.405 51 0 664 1 (0.2) 715 1 (0.1)
B.1.409 51 1 (2.0) 664 2 (0.3) 715 3 (0.4)
B.1.413 51 0 664 1 (0.2) 715 1 (0.1)
B.1.427 51 1 (2.0) 664 5 (0.8) 715 6 (0.8)
B.1.428 51 0 664 1 (0.2) 715 1 (0.1)
B.1.429 51 0 664 18 (2.7) 715 18 (2.5)
B.1.438 51 0 664 2 (0.3) 715 2 (0.3)
B.1.443 51 0 664 1 (0.2) 715 1 (0.1)
B.1.509 51 0 664 4 (0.6) 715 4 (0.6)
B.1.517 51 0 664 2 (0.3) 715 2 (0.3)
B.1.525 51 0 664 1 (0.2) 715 1 (0.1)
B.1.526 51 0 664 1 (0.2) 715 1 (0.1)
B.47 51 0 664 2 (0.3) 715 2 (0.3)
Unknownd51 5 (9.8) 664 23 (3.5) 715 28 (3.9)
Not sequenced 51 0 664 8 (1.2) 715 8 (1.1)
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
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Page 35Table8.Summary of SARS -CoV-2 Variants for the First COVID -19 Occurrence From
7 Days After Dose 2, by Country – Blinded Placebo -Controlled Follow -up
Period– Subjects With or Without Evidence of Infection Prior to 7 Days After
Dose 2 –Evaluable Efficacy (7 Days) Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg) Placebo Total
Country SARS-CoV-2 LineageaNbnc(%)Nbnc(%)Nbnc(%)
South Africa B.1.351 0 0 10 8 (80.0) 10 8 (80.0)
P.2 0 0 10 1 (10.0) 10 1 (10.0)
Unknownd0 0 10 1 (10.0) 10 1 (10.0)
Abbreviation: SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.Based on PANGO lineages (cov-lineages.org).
b.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage calculations.
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not qu antifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 01JUN2021 (18:36)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2 unblinded/C4591001 BLA Sequence/adxb seq var cov 7p d2 cntry eval
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
FDA-CBER-2021-5683-1072411
BNT162b2
COVID-19 Case Strain Sequencing Report
CONFIDENTIAL
Page 364.2.2.Severe COVID -19 Analysis
Table9.Summary of SARS -CoV-2 Variants for the First Severe COVID-19
Occurrence Based on FDA -Definition From 7 Days After Dose 2 –Blinded
Placebo-Controlled Follow -up Period – Subjects With or Without Evidence of
Infection Prior to 7 Days After Do se 2 –Evaluable Efficacy (7 Days)
Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=21)Total
(Na=22)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
B.1.1.143 0 1 (4.8) 1 (4.5)
B.1.1.291 0 1 (4.8) 1 (4.5)
B.1.1.33 0 3 (14.3) 3 (13.6)
B.1.1.94 1 (100.0) 0 1 (4.5)
B.1.2 0 7 (33.3) 7 (31.8)
B.1.280 0 1 (4.8) 1 (4.5)
B.1.351 0 2 (9.5) 2 (9.1)
B.1.361 0 2 (9.5) 2 (9.1)
B.1.409 0 1 (4.8) 1 (4.5)
B.1.413 0 1 (4.8) 1 (4.5)
Unknownd0 1 (4.8) 1 (4.5)
Not sequenced 0 1 (4.8) 1 (4.5)
Abbreviations: FDA = Food and Drug Administration; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Da ta: adxb Table Generation: 01JUN2021 (21:12)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2 unblinded/C4591001 BLA Sequence/adxb seq var 7pd2 scov eval
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
FDA-CBER-2021-5683-1072412
BNT162b2
COVID-19 Case Strain Sequencing Report
CONFIDENTIAL
Page 37Table10.Summary of SARS -CoV-2 Variants for the First Severe COVID-19
Occurrence Based on FDA -Definition After Dose 1 – Blinded Placebo -
Controlled Follow -up Period – Dose 1 All -Available Efficacy Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=30)Total
(Na=31)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
B.1 0 1 (3.3) 1 (3.2)
B.1.1.143 0 1 (3.3) 1 (3.2)
B.1.1.162 0 1 (3.3) 1 (3.2)
B.1.1.291 0 1 (3.3) 1 (3.2)
B.1.1.33 0 4 (13.3) 4 (12.9)
B.1.1.94 1 (100.0) 0 1 (3.2)
B.1.2 0 11 (36.7) 11 (35.5)
B.1.234 0 1 (3.3) 1 (3.2)
B.1.237 0 1 (3.3) 1 (3.2)
B.1.280 0 1 (3.3) 1 (3.2)
B.1.351 0 2 (6.7) 2 (6.5)
B.1.361 0 2 (6.7) 2 (6.5)
B.1.409 0 1 (3.3) 1 (3.2)
B.1.413 0 1 (3.3) 1 (3.2)
Unknownd0 1 (3.3) 1 (3.2)
Not sequenced 0 1 (3.3) 1 (3.2)
Abbreviations: FDA = Food and Drug Administration; SARS -CoV-2 = severe acute respiratory syndrome coronavirus 2.
a.N = number of subjects with first COVID -19 occurrence. This value is the denominator for the percentage calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN202 1 (17:11) Source Data: adxb Table Generation: 01JUN2021 (21:12)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2 unblinded/C4591001 BLA Sequence/adxb seq var d1 scov aai
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
FDA-CBER-2021-5683-1072413
BNT162b2
COVID-19 Case Strain Sequencing Report
CONFIDENTIAL
Page 38Table11.Summary of SARS -CoV-2 Variants for the First Severe COVID-19
Occurrence Based on CDC -Definition From 7 Days After Dose 2 –Blinded
Placebo-Controlled Follow -up Period – Subjects With or Without Evidence of
Infection Prior to 7 Days After Dose 2 –Evaluable Efficacy (7 Days)
Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=0)Placebo
(Na=32)Total
(Na=32)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
B 0 1 (3.1) 1 (3.1)
B.1 0 4 (12.5) 4 (12.5)
B.1.1.122 0 1 (3.1) 1 (3.1)
B.1.1.200 0 1 (3.1) 1 (3.1)
B.1.1.291 0 1 (3.1) 1 (3.1)
B.1.1.33 0 5 (15.6) 5 (15.6)
B.1.2 0 8 (25.0) 8 (25.0)
B.1.280 0 1 (3.1) 1 (3.1)
B.1.351 0 1 (3.1) 1 (3.1)
B.1.361 0 2 (6.3) 2 (6.3)
B.1.404 0 1 (3.1) 1 (3.1)
B.1.409 0 1 (3.1) 1 (3.1)
B.1.499 0 1 (3.1) 1 (3.1)
P.2 0 1 (3.1) 1 (3.1)
Unknownd0 2 (6.3) 2 (6.3)
Not sequenced 0 1 (3.1) 1 (3.1)
Abbreviations: CDC = Centers for Disease Control and Prevention; SARS -CoV-2 = severe acute respiratory syndrome
coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculations.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include in determinate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 01JUN2021 (18:36)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2_unblinded/C4591001_BLA _Sequence/adxb_seq_var_7pd2_scov_cdc_eval
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Page 39Table12.Summary of SARS -CoV-2 Variants for the First Severe COVID-19
Occurrence Based on CDC -Definition After Dose 1 – Blinded Placebo -
Controlled Follow -up Period – Dose 1 All -Available Efficacy Population
Vaccine Group (as Randomized)
BNT162b2 (30 μg)
(Na=1)Placebo
(Na=45)Total
(Na=46)
SARS-CoV-2 Lineagebnc(%) nc(%) nc(%)
A 0 1 (2.2) 1 (2.2)
B 0 1 (2.2) 1 (2.2)
B.1 0 5 (11.1) 5 (10.9)
B.1.1.122 0 1 (2.2) 1 (2.2)
B.1.1.162 0 1 (2.2) 1 (2.2)
B.1.1.200 0 1 (2.2) 1 (2.2)
B.1.1.291 0 1 (2.2) 1 (2.2)
B.1.1.33 0 6 (13.3) 6 (13.0)
B.1.2 0 12 (26.7) 12 (26.1)
B.1.237 0 1 (2.2) 1 (2.2)
B.1.241 0 1 (2.2) 1 (2.2)
B.1.280 0 1 (2.2) 1 (2.2)
B.1.306 1 (100.0) 0 1 (2.2)
B.1.351 0 1 (2.2) 1 (2.2)
B.1.361 0 2 (4.4) 2 (4.3)
B.1.404 0 1 (2.2) 1 (2.2)
B.1.409 0 1 (2.2) 1 (2.2)
B.1.448 0 1 (2.2) 1 (2.2)
B.1.452 0 1 (2.2) 1 (2.2)
B.1.499 0 1 (2.2) 1 (2.2)
N.3 0 1 (2.2) 1 (2.2)
P.2 0 1 (2.2) 1 (2.2)
Unknownd0 2 (4.4) 2 (4.3)
Not sequenced 0 1 (2.2) 1 (2.2)
Abbreviations: CDC = Centers for Disease Control and Prevention; SARS -CoV-2 = severe acute respiratory syndrome
coronavirus 2.
a.N = number of subjects with first severe COVID -19 occurrence. This value is the denominator for the percentage
calculation s.
b.Based on PANGO lineages (cov -lineages.org).
c.n = Number of subjects with the specified characteristic.
d.Include indeterminate result and not quantifiable (QNS) samples.
PFIZER CONFIDENTIAL SDTM Creation: 01JUN2021 (17:11) Source Data: adxb Table Generation: 01JUN2021 (18:36)
(Cutoff Date: 13MAR2021, Snapshot Date: 28MAY2021) Output File:
./nda2_unblinded/C4591001_BLA_Sequence/adxb_seq_var_d1_scov_cdc_aai
090177e197356daf\Approved\Approved On: 04-Jun-2021 14:56 (GMT)
FDA-CBER-2021-5683-1072415
BNT162b2
COVID-19 Case Strain Sequencing Report
CONFIDENTIAL
Page 405.REFERENCES
1US Food and Drug Administration. Development and L icensure of Vaccines to Prevent
COVID-19. Guidance for Industry . June 2020. Available at:
https://www.fda.gov/media/139638/download.
2Centers for Disease Control and Prevention (CDC). Coronavirus Disease (COVID -19).
Available at: https://www.cdc.gov/coronavirus/2019 -ncov/need -extra-precautions/people-
with-medical-conditions.html. Accessed 09 December 2020.
3Centers for Disease Control and Prevention (CDC). SARS -CoV-2 Variant Classifications
and Definitions. Available at: https://www.cdc.gov/coronavirus/2019 -ncov/variants/variant-
info.html. Accessed 02 June 2021.
4World Health Organization (WHO). Weekly epidemiological update on COVID -19 –
1June2021. Available at: https://www.who.int/publications/m/item/weekly -
epidemiological -update-on-covid-19--- 1-june-2021. Accessed 02 June 2021.
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FDA-CBER-2021-5683-1072416
Document Approval Record
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