Document text
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV
2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ incl
usion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
1 µg Y
ounger 10015 Yes Yes Yes Yes Yes Yes Yes Yes
10018 Yes Yes Yes Yes Yes Yes Yes Yes
10023 Yes Yes Yes Yes Yes Yes Yes Yes
10025 Yes Yes Yes Yes Yes Yes Yes Yes
10033 Yes Yes Yes Yes Yes Yes Yes Yes
10036 Yes Yes Yes Yes Yes Yes Yes Yes
10040 Yes Yes Yes Yes Yes Yes Yes Yes
10041 Yes Yes Yes Yes Yes Yes Yes Yes
10042 Yes Yes Yes Yes Yes Yes Yes Yes
10045 Yes Yes Yes Yes Yes Yes Yes Yes
10048 Yes Yes Yes Yes Yes Yes Yes Yes
10052 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
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FDA-CBER-2021-5683-0049512
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
3 µg Y
ounger 10170 Yes Yes Yes Yes Yes Yes Yes Yes
10194 Yes Yes Yes Yes Yes Yes Yes Yes
10198 Yes Yes Yes Yes Yes Yes Yes Yes
10200 Yes Yes Yes Yes Yes Yes Yes Yes
10204 Yes Yes Yes Yes Yes Yes Yes Yes
10209 Yes Yes Yes Yes Yes Yes Yes Yes
10212 Yes Yes Yes Yes Yes Yes Yes Yes
10221 Yes Yes Yes Yes Yes Yes Yes Yes
10224 Yes Yes Yes Yes Yes Yes Yes Yes
10225 Yes Yes Yes Yes Yes Yes Yes Yes
10226 Yes Yes Yes Yes Yes Yes Yes Yes
10227 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 2 of 10)
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FDA-CBER-2021-5683-0049513
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boo
st set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
10 µg
You
nger 10001 Yes Yes Yes Yes Yes Yes Yes Yes
10003 Yes Yes Yes Yes Yes Yes Yes Yes
10004 Yes Yes Yes Yes Yes Yes Yes Yes
10005 Yes Yes Yes Yes Yes Yes Yes Yes
10006 Yes Yes Yes Yes Yes Yes Yes Yes
10007 Yes Yes Yes Yes Yes Yes Yes Yes
10008 Yes Yes Yes Yes Yes Yes Yes Yes
10009 Yes Yes Yes Yes Yes Yes Yes Yes
10010 Yes No Yes Yes No No No No
10011 Yes Yes Yes Yes Yes Yes Yes Yes
10017 Yes Yes Yes Yes Yes Yes Yes Yes
10019 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 3 of 10)
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FDA-CBER-2021-5683-0049514
Bio
NTech RNA Phar
maceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
20 µg
You
nger 10151 Yes Yes Yes Yes Yes Yes Yes Yes
10171 Yes Yes Yes Yes Yes Yes Yes Yes
10172 Yes Yes Yes Yes Yes Yes Yes Yes
10173 Yes Yes Yes Yes Yes Yes Yes Yes
10175 Yes Yes Yes Yes Yes Yes Yes Yes
10176 Yes Yes Yes Yes Yes Yes Yes Yes
10178 Yes Yes Yes Yes Yes Yes Yes Yes
10179 Yes Yes Yes Yes Yes Yes Yes Yes
10181 Yes Yes Yes Yes Yes Yes Yes Yes
10182 Yes No Yes No No No No No
10183 Yes Yes Yes Yes Yes Yes Yes Yes
10197 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 4 of 10)
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Page 4
FDA-CBER-2021-5683-0049515
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Snap
shot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boos
t
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
30 µg
You
nger 10016 Yes Yes Yes Yes Yes Yes Yes Yes
10020 Yes Yes Yes Yes Yes Yes Yes Yes
10021 Yes Yes Yes Yes Yes Yes Yes Yes
10028 Yes Yes Yes Yes Yes Yes Yes Yes
10031 Yes Yes Yes Yes Yes Yes Yes Yes
10032 Yes Yes Yes Yes Yes Yes Yes Yes
10034 Yes Yes Yes Yes Yes Yes Yes Yes
10037 Yes Yes Yes Yes Yes Yes Yes Yes
10038 Yes Yes Yes Yes Yes Yes Yes Yes
10039 Yes Yes Yes Yes Yes Yes Yes Yes
10043 Yes Yes Yes Yes Yes Yes Yes Yes
10047 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 5 of 10)
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FDA-CBER-2021-5683-0049516
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV
2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjec
ts´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Day
s
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
50 µg
You
nger 10049 Yes Yes Yes Yes Yes Yes Yes Yes
10050 Yes No Yes Yes No No No No
10053 Yes Yes Yes Yes Yes Yes Yes Yes
10055 Yes Yes Yes Yes Yes Yes Yes Yes
10056 Yes Yes Yes Yes Yes Yes Yes Yes
10057 Yes Yes Yes Yes Yes Yes Yes Yes
10059 Yes Yes Yes Yes Yes Yes Yes Yes
10060 Yes Yes Yes Yes Yes Yes Yes Yes
10067 Yes Yes Yes Yes Yes Yes Yes Yes
10068 Yes Yes Yes Yes Yes Yes Yes Yes
10070 Yes Yes Yes Yes Yes Yes Yes Yes
10073 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 6 of 10)
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FDA-CBER-2021-5683-0049517
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
60 µg
You
nger 10066 Yes No Yes Yes Yes No No Yes
10075 Yes No Yes Yes Yes No No Yes
10076 Yes No Yes Yes Yes No No Yes
10078 Yes No Yes Yes Yes No No Yes
10083 Yes No Yes Yes Yes No No Yes
10084 Yes No Yes Yes Yes No No Yes
10085 Yes No Yes Yes Yes No No Yes
10089 Yes No Yes Yes Yes No No Yes
10093 Yes No Yes Yes Yes No No Yes
10096 Yes No Yes Yes Yes No No Yes
10103 Yes No Yes Yes Yes No No Yes
10104 Yes No Yes Yes Yes No No Yes
Progra
m: Lba
se_Disp_4_1.sas (Page 7 of 10)
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Page 7
FDA-CBER-2021-5683-0049518
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
10 µg
Older 10273 Yes Yes Yes Yes Yes Yes Yes Yes
10274 Yes Yes Yes Yes Yes Yes Yes Yes
10282 Yes Yes Yes Yes Yes Yes Yes Yes
10283 Yes Yes Yes Yes Yes Yes Yes Yes
10286 Yes Yes Yes Yes Yes Yes Yes Yes
10287 Yes Yes Yes Yes Yes Yes Yes Yes
10288 Yes Yes Yes Yes Yes Yes Yes Yes
10289 Yes Yes Yes Yes Yes Yes Yes Yes
10291 Yes Yes Yes Yes Yes Yes Yes Yes
10292 Yes Yes Yes Yes Yes Yes Yes Yes
10298 Yes Yes Yes Yes Yes Yes Yes Yes
10320 Yes Yes Yes Yes Yes Yes Yes Yes
Progra
m: Lba
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FDA-CBER-2021-5683-0049519
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in analysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boos
t
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
20 µg
Older 20207 Yes Yes Yes Yes Yes Yes No No
20211 Yes Yes Yes Yes Yes Yes No No
20220 Yes Yes Yes Yes Yes Yes No No
20227 Yes Yes Yes Yes Yes Yes No No
20234 Yes Yes Yes Yes Yes Yes No No
20236 Yes Yes Yes Yes Yes Yes No No
20237 Yes Yes Yes Yes Yes Yes No No
20238 Yes Yes Yes Yes Yes Yes No No
20239 Yes Yes Yes Yes Yes Yes No No
20241 Yes Yes Yes Yes Yes Yes No No
20242 Yes No Yes Yes Yes No No Yes
20243 Yes Yes Yes Yes Yes Yes No No
Progra
m: Lba
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FDA-CBER-2021-5683-0049520
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -4.1-1: Lis
ting of subjects´ inclusion in anal
ysis sets - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Safety
set
(SAF) Safety
boost set
(SAFB) Immu
nogenicity
set
(IMM) Prime
+ 7 Days
com
pleters set
(CP7) Prime
to Boost
or Prim
e + 28
Days
com
pleters set
(CPBP28 ) Boos
t + 7 Days
com
pleters set
(CB7) Boos
t + 28
Days
com
pleters set
(CB28 ) Prime
or Boost
+ 28
Days
com
pleters set
(CPB28 )
30 µg
Older 10350 Yes Yes No Yes Yes Yes No No
10351 Yes Yes No Yes Yes Yes No No
10352 Yes Yes No Yes Yes Yes No No
10353 Yes Yes No Yes Yes Yes No No
10358 Yes Yes No Yes Yes Yes No No
10360 Yes Yes No Yes Yes Yes No No
10361 Yes Yes No Yes Yes Yes No No
10362 Yes Yes No Yes Yes Yes No No
10363 Yes Yes No Yes Yes Yes No No
10364 Yes Yes No Yes Yes Yes No No
10365 Yes Yes No Yes Yes Yes No No
10366 Yes Yes No Yes Yes Yes No No
Progra
m: Lba
se_Disp_4_1.sas (Page 10 of 10)
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FDA-CBER-2021-5683-0049521
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Snap
shot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.1-1: Lis
ting of prior medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10041 3 Parac
etamol Parac
etamol Anal
gesics 28APR20
20
8:38 28APR20
20
8:38 Oral 500
mg Onc
e Mig
raine
30 µg
You
nger 10016 1 Lora
ADGC Lora
tadine Antih
istamines
For Sys
temic Use 12APR20
20 12APR20
20 Oral 1 Ta
blet Onc
e Rhini
tis All
ergica
The
rapeutic cla
ss is ATC lev
el 2. Prior med
ications are cod
ed usi
ng WHO Glo
bal (Drug Ins
ight) Marc
h 202
0 B3 sta
ndard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 1 of 1)
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FDA-CBER-2021-5683-0049522
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10015 1 ASS 1 00 Acety
lsalicylic Acid Anal
gesics 20M
AY2020
20:0
0 20M
AY2020
20:0
0 Oral 100
mg Onc
e Heada
che
10018 1 Lev
onance Ethin
ylestradiol;levonorg
estre
l Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2017 Oral 0,03
;
0,15
mg PRN Contrac
eption
10025 1 Hylo
dual Drops Ectoi
ne;hyaluronate
Sodi
um Oph
thalmological
s 28M
AY2020
17:0
0 31M
AY2020
22:0
0 Oph
thal
mic 1 gtt QID Tire
d Irritated Eyes
2 Tea
rs again
Spray Gly
cine Max
Extra
ct;phenoxyethanol;r
etin
ol
Palm
itate;tocopheryl
Aceta
te Oph
thalmological
s 28M
AY2020
17:0
0 28M
AY2020
21:0
0 Oph
thal
mic 1 PUFF QID Tire
d Irritated Eyes
10033 1 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 27M
AY2020
17:0
0 27M
AY2020
22:0
0 Oral 500
mg BID Flue
Like
Symp
toms
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 1 of 52)
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FDA-CBER-2021-5683-0049523
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic cla
ss Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10036 1 Max
ime (R) Dieno
gest;ethinylestradio
l Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m NOV20
19 Oral 1x1
Tab
let PRN Contrac
eption
10040 1 Ibup
rofen Tbl. Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 08J
UN2020
12:0
0 09J
UN2020 Oral 800
mg TID Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
2 Ibup
rofen Tbl. Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 10J
UN2020
9:00 11J
UN2020
6:00 Oral 400
mg TID Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
3 Ibup
rofen Tbl. Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 25J
UN2020
6:00 01J
UL2020
6:00 Oral 400
mg TID Cerv ic
obrachialgia
4 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
12:3
7 29M
AY2020
12:3
7 Oral 500
mg Onc
e Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 2 of 52)
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Page 13
FDA-CBER-2021-5683-0049524
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic cla
ss Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10040 5 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
15:1
0 29M
AY2020
15:1
0 Rectal 1000
mg Onc
e Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
6 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 29M
AY2020
18:0
0 30M
AY2020
0:00 Oral 500
mg QD Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
7 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 30M
AY2020
4:00 30M
AY2020
9:00 Oral 1000
mg BID Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
8 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 31M
AY2020
20:0
0 31M
AY2020
20:0
0 Oral 1000
mg Onc
e Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
9 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 01J
UN2020
4:00 01J
UN2020
4:00 Oral 1000
mg Onc
e Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 3 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 14
FDA-CBER-2021-5683-0049525
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apsh ot Al
l TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic cla
ss Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10040 10 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 02J
UN2020
10:0
0 02J
UN2020
16:0
0 Oral 1000
mg BID Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
11 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 04J
UN2020
6:00 08J
UN2020
12:0
0 Oral 500
mg Q6H Flu L
ike Symptoms
(Hea da
che,
Mya
lgia, Arthralgia,
Nause
a,
Tire
dness)
10041 1 Ibup
rofen Tbl. Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 08J
UN2020
10:0
0 11J
UN2020
14:0
0 Oral 400
mg TID Pain
Injection Arm
4 Parac
etamol Parac
etamol Anal
gesics 28M
AY2020
18:3
0 28M
AY2020
18:3
0 Oral 500
mg Onc
e Heada
che
5 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
9:55 29M
AY2020
9:55 Oral 1000
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 4 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 15
FDA-CBER-2021-5683-0049526
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apsh ot Al
l TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10041 6 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
17:1
5 29M
AY2020
22:0
0 Oral 500
mg BID Flu L
ike Symptoms
7 Parac
etamol Parac
etamol Anal
gesics 30M
AY2020
7:15 30M
AY2020
17:0
0 Oral 1000
mg TID Flu L
ike Symptoms
8 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 04J
UN2020
10:3
0 08J
UN2020
8:00 Oral 500
mg BID Heada
che
10042 4 Leo
na Hexal Ethin
ylestradiol;levonorg
estre
l Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2010 Oral 1x1
Tab
let PRN Contrac
eption
10045 1 Bela
ra
0,03
mg/2mg Chlorm
adinone
Aceta
te;ethinylestradiol Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2011 Oral 1 Ta
blet QD Contrac
eption
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 5 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 16
FDA-CBER-2021-5683-0049527
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
1 µg
You
nger 10052 4 Parac
etamol
500 Parac
etamol Anal
gesics 13M
AY2020
19:1
5 13M
AY2020
19:1
5 Oral 500
mg Onc
e Heada
che
3 µg
You
nger 10198 1 Yas
min Tbl
(3mg
Dros pi
renon,
0.03
mg
Ethin
ylestradiol) Dros pi
renone;ethinylestr
adi
ol Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m APR20 20 Oral 3/0.0
3
mg QD Contrac
eption
10204 1 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 25J
UL2020
20:0
0 25J
UL2020
20:0
0 Oral 500
mg Onc
e Heada
che
(Syste
mic
Reacti
on)
10212 1 Parac
etamol
100
0 mg supp. Parac
etamol Anal
gesics 13AUG
2020
19:0
0 13AUG
2020
19:0
0 Rectal 1000
mg Onc
e Flu L
ike Symptoms
(Syste
mic
Reacti
on)
2 Parac
etamol
500
mg Parac
etamol Anal
gesics 13AUG
2020
6:00 13AUG
2020
6:00 Oral 500
mg Onc
e Heada
che
(Syste
mic
Reacti
on)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 6 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 17
FDA-CBER-2021-5683-0049528
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic cla
ss Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
3 µg
You
nger 10224 1 Kyle
ena
horm
onal IUD Lev
onorgestrel Othe
r
Gyn
ecologicals MAY
2020 Intrau
te
rine 19.5
mg Contin
uous Contrac
eption
10227 1 Parac
etamol
Tbl Parac
etamol Anal
gesics 06AUG
2020
14:1
5 06AUG
2020
14:1
5 Oral 500
mg Onc
e Heada
che
2 Parac
etamol
Tbl Parac
etamol Anal
gesics 21AUG
2020
16:3
5 21AUG
2020
16:3
5 Oral 500
mg Onc
e Heada
che
10 µg
You
nger 10003 1 Mira
nova Ethin
ylestradiol;levonorg
estre
l Sex Horm on
es
And M
odulators
Of T
he Genital
Syste
m MAY
2019 Oral 1 Ta
blet PRN Contrac
eption
2 Parac
etamol
500 Parac
etamol Anal
gesics 28APR20
20
14:3
4 28APR20
20
14:3
4 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 7 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 18
FDA-CBER-2021-5683-0049529
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apsh ot Al
l TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic cla
ss Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
You
nger 10003 3 Parac
etamol
500 Parac
etamol Anal
gesics 29M
AY2020 29M
AY2020 Oral 500
mg Onc
e Heada
che
10004 1 Parac
etamol
500 Parac
etamol Anal
gesics 15M
AY2020
16:0
0 15M
AY2020
16:0
0 Oral 500
mg Onc
e Heada
che
2 Parac
etamol
500 Parac
etamol Anal
gesics 16M
AY2020
14:0
0 16M
AY2020
14:0
0 Oral 500
mg Onc
e Heada
che
10005 1 Parac
etamol Parac
etamol Anal
gesics 12M
AY2020
18:3
0 12M
AY2020
18:3
0 Oral 1000
mg Onc
e Heada
che
2 Parac
etamol Parac
etamol Anal
gesics 13M
AY2020
15:0
0 13M
AY2020
15:0
0 Oral 1000
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 8 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 19
FDA-CBER-2021-5683-0049530
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
You
nger 10005 3 Parac
etamol Parac
etamol Anal
gesics 02J
UN2020
18:0
0 03J
UN2020
9:30 Oral 1500
mg Onc
e Heada
che
4 Parac
etamol
500 Parac
etamol Anal
gesics 15M
AY2020
20:0
0 15M
AY2020
20:0
0 Oral 2x5
00
mg Onc
e Flu L
ike Symptoms
(Chill
s, Malaise,
Mya
lgia, Arthralgia,
Interm
ittent
Heada
che,
Tire
dness)
5 Parac
etamol
500 Parac
etamol Anal
gesics 17M
AY2020
10:0
0 17M
AY2020
10:0
0 Oral 2x5
00
mg Onc
e Flu L
ike Symptoms
(Chill
s, Malaise,
Mya
lgia, Arthralgia,
Interm
ittent
Heada
che,
Tire
dness)
6 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 24APR20
20
15:3
0 24APR20
20
15:3
0 Oral 500
mg Onc
e Heada
che
7 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 24APR20
20
19:3
0 24APR20
20
19:3
0 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 9 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 20
FDA-CBER-2021-5683-0049531
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic clas
s Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
10 µg
Youn
ger 10006 1 Ibupro
fen 400 Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 15MA
Y2020
17:00 16MA
Y2020
16:00 Oral 400
mg QD Ging
ivitis
2 Parace
tamol
500 Parace
tamol Analg
esics 12MA
Y2020
17:00 14MA
Y2020
16:00 Oral 500
mg QD Ging
ivitis
3 Parace
tamol
500 Parace
tamol Analg
esics 20MA
Y2020
4:00 20MA
Y2020
4:00 Oral 500
mg Once Flu-Lke
Symptoms
4 Septan
est
1:100
000 Articai
ne
Hydroc
hloride;epinephrin
e Bitartr
ate Anesth
etics 15MA
Y2020
10:00 15MA
Y2020
10:00 Subcu
ta
neou
s 40/1
mg/mL Once Ging
ivitis (Dental
Treatm
ent Of The
Cause Of
Ging
ivitis)
10007 1 Parace
tamol
500 Parace
tamol Analg
esics 24APR20 2
0
14:00 24APR20 2
0
14:00 Oral 500
mg Once Headac
he
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 10 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 21
FDA-CBER-2021-5683-0049532
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
10 µg
Youn
ger 10007 2 Parace
tamol
500 Parace
tamol Analg
esics 27APR20 2
0
19:00 27APR20 2
0
19:00 Oral 500
mg Once Headac
he
Intermi
ttent
3 Parace
tamol
500 Parace
tamol Analg
esics 13MA
Y2020
16:00 13MA
Y2020
16:00 Oral 500
mg Once Headac
he
4 Parace
tamol
500 Parace
tamol Analg
esics 15MA
Y2020
20:00 15MA
Y2020
20:00 Oral 500
mg Once Flu-Lke
Symptoms
(Incl.
Intermitt.
Headac
he)
5 Parace
tamol
500 Parace
tamol Analg
esics 22MA
Y2020
9:00 22MA
Y2020
9:00 Oral 500
mg Once Headac
he
10008 1 Cetiriz
in Cetiriz
ine Hydrochloride Antihi
stamines
For System
ic Use 27MA
Y2020
11:00 27MA
Y2020
11:00 Oral 10 mg Once Rhinit
is Allergica
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 11 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 22
FDA-CBER-2021-5683-0049533
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
You
nger 10008 2 Cetiri
zin Cetiri
zine Hydrochloride Antih
istamines
For Sys
temic Use 29M
AY2020
12:1
5 29M
AY2020
12:1
5 Oral 10 m
g Onc
e Rhini
tis Allergica
3 Cetiri
zin Cetiri
zine Hydrochloride Antih
istamines
For Sys
temic Use 01J
UN2020
11:0
0 02J
UN2020
10:0
0 Oral 10 m
g QD Rhini
tis All
ergica
4 Cetiri
zin Cetiri
zine Hydrochloride Antih
istamines
For Sys
temic Use 04J
UN2020
9:00 04J
UN2020
9:00 Oral 10 m
g Onc
e Rhini
tis Allergica
5 Cetiri
zin Cetiri
zine Hydrochloride Antih
istamines
For Sys
temic Use 07J
UN2020
9:00 07J
UN2020
9:00 Oral 10 m
g Onc
e Rhini
tis Allergica
8 Cetiri
zin ADGC Cetiri
zine Hydrochloride Antih
istamines
For Sys
temic Use 10J
UN2020
10:0
0 10J
UN2020
10:0
0 Oral 10 m
g Onc
e Poll
en Allergy
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 12 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 23
FDA-CBER-2021-5683-0049534
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
10 µg
Youn
ger 10008 9 Cetiriz
in ADGC Cetiriz
ine Hydrochloride Antihi
stamines
For Syste
mic Use 12JUN
2020
12:00 12JUN
2020
12:00 Oral 10 mg Once Polle
n Allerg
y
10 Cetiriz
in ADGC Cetiriz
ine Hydrochloride Antihi
stamines
For Sys te
mic Use 14JUN
2020
12:00 14JUN
2020
12:00 Oral 10 mg Once Polle
n Allergy
11 Parace
tamol
500 Parace
tamol Analg
esics 19MA
Y2020
21:30 19MA
Y2020
21:30 Oral 2x50
0
mg Once Flu-Lke
Sympto
ms
12 Parace
tamol
500 Parace
tamol Analg
esics 20MA
Y2020
1:40 20MA
Y2020
16:30 Oral 1000
mg TID Flu-Lke
Symptoms
10010 1 Ibupro
fen Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 12MA
Y2020
23:00 12MA
Y2020
23:00 Oral 400
mg Once Intermi
ttent Fever
Up To 3
9,3 Degree
C
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 13 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 24
FDA-CBER-2021-5683-0049535
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snaps
hot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
10 µg
Youn
ger 10010 2 Ibupro
fen Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 13MA
Y2020
9:00 16MA
Y2020
19:00 Oral 400
mg BID Mala
ise / Myalgia
3 Parace
tamol Parace
tamol Analg
esics 25APR20 2
0
11:00 25APR20 2
0
11:00 Oral 500
mg Once Flu-Lke
Symptoms
4 Parace
tamol Parace
tamol Analg
esics 26APR20 2
0 26APR20 2
0 Oral 500
mg Once Flu-Lke
Symptoms
5 Parace
tamol Parace
tamol Analg
esics 02MA
Y2020
18:30 05MA
Y2020
20:00 Oral 500
mg 3X2
TBL. Flu-Lke
Symptoms
6 Scand
icain 1% Mepi
vacaine
Hydroc
hloride Anesth
etics 08MA
Y2020 08MA
Y2020 Subcu
ta
neou
s 30 mg Once Verruca
Operation
In Loc
al
Anesth
esia
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 14 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 25
FDA-CBER-2021-5683-0049536
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
You
nger 10017 1 Brimo
din AL
2mg Brimo
nidine Tartrate Oph
thalmological
s 2018 Conju
nc
tiva
l 1 gtt BID Gla
ucoma
2 Dorz ol
amid AL
Com p.
(20m
g/5mg) Dorz ol
amide
Hydro
chloride;timolol
Mal
eate Oph
thalmological
s 2018 Conju
nc
tiva
l 1 gtt BID Gla
ucoma
3 Lum
igan 0.1 mg Bima
toprost Oph
thalmological
s 2018 Conju
nc
tiva
l 1 gtt QD Gla
ucoma
4 Parac
etamol
500 Parac
etamol Anal
gesics 20M
AY2020
10:3
0 20M
AY2020
19:0
0 Oral 500
mg BID Mus
cle Pain In
Lum
bar Region
10019 1 Parac
etamol
500 Parac
etamol Anal
gesics 20M
AY2020
8:00 20M
AY2020
20:0
0 Oral 1000
mg TID Flu L
ike Symptoms
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 15 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 26
FDA-CBER-2021-5683-0049537
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
You
nger 10019 2 Parac
etamol
500 Parac
etamol Anal
gesics 21M
AY2020
8:00 21M
AY2020
13:0
0 Oral 500
mg BID Interm
ittent
Heada
che
3 Parac
etamol
500 Parac
etamol Anal
gesics 24M
AY2020
7:30 26M
AY2020
19:0
0 Oral 500
mg TID Interm
ittent
Heada
che
20 µg
You
nger 10171 1 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 06AUG
2020
20:2
2 06AUG
2020
20:2
2 Oral 1000
mg Onc
e Feve
r And
Heada
che
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
20:1
5 07AUG
2020
20:1
5 Oral 500
mg Onc
e Feve
r And
Heada
che
10172 1 Parac
etamol
Tbl Parac
etamol Anal
gesics 06AUG
2020
11:3
5 06AUG
2020
11:3
5 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 16 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 27
FDA-CBER-2021-5683-0049538
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
You
nger 10172 2 Parac
etamol
Tbl Parac
etamol Anal
gesics 06AUG
2020
22:1
5 06AUG
2020
22:1
5 Oral 500
mg Onc
e Heada
che
10173 1 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
12:3
0 07AUG
2020
22:0
0 Oral 500
mg TID Feve
r, Headache
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 08AUG
2020
11:0
0 08AUG
2020
22:0
0 Oral 500
mg BID Feve
r, Headache
10176 1 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
1:00 07AUG
2020
1:00 Oral 500
mg Onc
e Feve
r, Headache
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
17:0
0 07AUG
2020
17:0
0 Oral 500 mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 17 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 28
FDA-CBER-2021-5683-0049539
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
You
nger 10179 1 Agom
elatin Agom
elatine Psyc
hoanaleptics 13AUG
2020
20:0
0 Oral 25 m
g OAD Depres
sion;sleepin
g Dis
order
2 Parac
etamol Parac
etamol Anal
gesics 16J
UL2020
15:4
5 16J
UL2020
15:4
5 Oral 1000
mg Onc
e Heada
che
(Syste
mic
Reacti
on)
3 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 06AUG
2020
21:0
0 06AUG
2020
21:0
0 Oral 500
mg Onc
e Heada
che
4 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
21:0
0 07AUG
2020
21:0
0 Oral 500
mg Onc
e Heada
che
5 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 08AUG
2020
13:0
0 08AUG
2020
13:0
0 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 18 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 29
FDA-CBER-2021-5683-0049540
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
You
nger 10182 1 Min
ulet Ethin
ylestradiol;gestoden
e Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2008 Oral 0.07
5 +
0.03
mg QD Contrac
eption
10183 1 Gyn
okadin Estrad
iol Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m SEP2 01
9 Tran
sde
rmal 2.5 g QD Postm
enopausal
Com pl
aints
2 Parac
etamol Parac
etamol Anal
gesics 17J
UL2020
9:58 17J
UL2020
9:58 Oral 1000
mg Onc
e Loc
al And
Syste
mic Reaction
Heada
che;
Inje
ction Site
Reacti
on
3 Parac
etamol Parac
etamol Anal
gesics 17J
UL2020
18:1
5 17J
UL2020
18:1
5 Oral 500
mg Onc
e Syste
mic
Reacti
ons
(Hea da
che, Muscle
Pain
)
4 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 06AUG
2020
22:1
8 06AUG
2020
22:1
8 Oral 500
mg Onc
e Heada
che And
Mya
lgia
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 19 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 30
FDA-CBER-2021-5683-0049541
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
You
nger 10183 5 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020
8:30 07AUG
2020
18:3
0 Oral 500
mg TID Heada
che, Myalgia
10197 1 Parac
etamol Parac
etamol Anal
gesics 16J
UL2020
16:1
4 16J
UL2020
16:1
4 Oral 1000
mg Onc
e Heada
che
(Syste
mic
Reacti
on)
2 Parac
etamol Parac
etamol Anal
gesics 16J
UL2020
20:3
0 17J
UL2020
7:45 Oral 500
mg TID Syste
mic And
Loc
al Reaction
3 Parac
etamol Parac
etamol Anal
gesics 17J
UL2020
14:0
0 18J
UL2020
8:30 Oral 1000
mg BID Gin
giva Pain
Diffus
e; Systemic
Reacti
on (Pain,
Mal
aise, Chills)
4 Parac
etamol Parac
etamol Anal
gesics 18J
UL2020
11:0
0 18J
UL2020
20:3
0 Oral 500
mg TID Gin
giva Pain
Diffus
e; Systemic
Reacti
on (Neck
Pain
, Muscular
Stiffn
ess)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 20 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 31
FDA-CBER-2021-5683-0049542
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
You
nger 10197 5 Parac
etamol Parac
etamol Anal
gesics 18J
UL2020
14:0
0 19J
UL2020
0:00 Rectal 1000
mg BID Gin
giva Pain
Diffus
e; Systemic
Reacti
ons (Neck
Pain
, Muscular
Stiffn
ess)
6 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 06AUG
2020
18:3
0 06AUG
2020 Oral 1000
mg BID Feve
r, Headache
7 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 07AUG
2020 08AUG
2020
1:00 Oral 1000
mg TID Feve
r, Headache
8 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 08AUG
2020
8:00 08AUG
2020
22:0
0 Oral 1000
mg BID Heada
che
9 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 09AUG
2020
8:00 09AUG
2020
8:00 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 21 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 32
FDA-CBER-2021-5683-0049543
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
30 µg
Youn
ger 10016 2 Parace
tamol
500 Parace
tamol Analg
esics 30APR20 2
0
0:45 30APR20 2
0
0:45 Oral 500
mg Once Flu-Lke
Symptoms
3 Parace
tamol
500 Parace
tamol Analg
esics 21MA
Y2020
3:30 21MA
Y2020
3:30 Oral 500
mg Once Flu Li
ke Symptoms
10020 1 Ibupro
fen Tbl.
400m
g Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 13JUN
2020
11:30 13JUN
2020
11:31 Oral 400
mg Once Lumb
algia
2 Sayan
a 104
mg/ 0
,65 ml Medro
xyprogesterone
Acetat
e Sex Horm
ones
And Mo
dulators
Of Th
e Genital
System 1998 Subcu
ta
neou
s 104
mg 1
Time
s
Per 3
Month Contrace
ption
10021 1 Parace
tamol
500 Parace
tamol Analg
esics 26MA
Y2020
16:00 26MA
Y2020
16:00 Oral 500
mg Once Injec
tion Site
Reactio
ns (Pain,
Discom
fort With
Move
ment); Flu -
Like
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 22 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 33
FDA-CBER-2021-5683-0049544
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
30 µg
You
nger 10028 1 Parac
etamol Parac
etamol Anal
gesics 28M
AY2020
22:0
0 28M
AY2020
22:0
0 Oral 500
mg Onc
e Heada
che
2 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
3:00 29M
AY2020
6:30 Oral 500
mg TWICE Flue
Like
Symp
toms
3 Parac
etamol Parac
etamol Anal
gesics 29M
AY2020
15:0
0 29M
AY2020
15:0
0 Oral 500
mg Onc
e Flue
Like
Symp
toms
4 Parac
etamol
500 Parac
etamol Anal
gesics 07M
AY2020
22:0
0 07M
AY2020
22:0
0 Oral 500
mg Onc
e Heada
che
10031 1 Ibup
rofen Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 14J
UN2020
11:0
0 18J
UN2020
15:0
0 Oral 600
mg TID Pain
Right Elbow
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 23 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 34
FDA-CBER-2021-5683-0049545
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
30 µg
Youn
ger 10031 2 Parace
tamol Parace
tamol Analg
esics 28MA
Y2020
22:15 29MA
Y2020
9:30 Oral 500
mg TWICE Flu Li
ke
Sympto
ms;injection
Site Re a
ctions
3 Parace
tamol Parace
tamol Analg
esics 13JUN
2020
20:00 13JUN
2020
20:00 Oral 500
mg Once Pain Ri
ght Elbow
4 Parace
tamol
500 Parace
tamol Analg
esics 07MA
Y2020
21:00 08MA
Y2020
14:00 Oral 500
mg BID Injec
tion Site
Reactio
ns (Pain,
Discom
fort With
Move
ment)
5 Parace
tamol
Suppo
sitorium Parace
tamol Analg
esics 08MA
Y2020
5:45 08MA
Y2020
5:45 Rectal 1000
mg QD Flu-Lke
Symptoms
6 Parace
tamol
supp Parace
tamol Analg
esics 29MA
Y2020
4:30 29MA
Y2020
4:30 Rectal 1000
mg Once Flu Li
ke Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 24 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 35
FDA-CBER-2021-5683-0049546
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
30 µg
Youn
ger 10034 1 Parace
tamol Parace
tamol Analg
esics 05MA
Y2020
23:30 05MA
Y2020
23:30 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Dizzne
ss,
Tired
ness,
Weari
ness,
Shive
ring)
2 Parace
tamol Parace
tamol Analg
esics 26MA
Y2020
19:30 26MA
Y2020
23:00 Oral 500
mg BID Flu-Lke
Symptom
(Myal
gia,
Arthralg
ia, Chills,
Mala
ise, Tiredness,
Pyrexi
a,
Headac
he)
3 Parace
tamol Parace
tamol Analg
esics 27MA
Y2020
10:00 27MA
Y2020
10:00 Oral 500
mg Once Flu-Lke
Symptom
(Myal
gia,
Arthralg
ia, Chills,
Mala
ise, Tiredness,
Pyrexi
a,
Headac
he)
10037 1 Parace
tamol
500 Parace
tamol Analg
esics 26MA
Y2020
18:00 28MA
Y2020
18:00 Oral 500
mg QD Flu-Lke
Symptoms
2 Parace
tamol
500
mg Parace
tamol Analg
esics 17JUN
2020
7:30 17JUN
2020
7:30 Oral 500
mg Once Headac
he
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 25 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 36
FDA-CBER-2021-5683-0049547
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
30 µg
Youn
ger 10039 1 Parace
tamol Parace
tamol Analg
esics 07MA
Y2020
19:00 07MA
Y2020
19:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Eleva
ted Body
Temp
erature)
2 Parace
tamol Parace
tamol Analg
esics 07MA
Y2020
22:00 07MA
Y2020
22:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Eleva
ted Body
Temp
erature)
3 Parace
tamol Parace
tamol Analg
esics 28MA
Y2020
20:00 28MA
Y2020
22:00 Oral 500
mg TID Flu-Lke
Symptoms
(Incl.
Dizziness,
Headac
he)
10047 1 Parace
tamol Parace
tamol Analg
esics 29MA
Y2020
11:00 29MA
Y2020
21:00 Oral 500
mg TWICE Flu-Lke
Symptoms
50 µg
Youn
ger 10049 3 Parace
tamol
500 Parace
tamol Analg
esics 13MA
Y2020
14:00 13MA
Y2020
14:00 Oral 500
mg Once Flu-Lke
Symptoms
(Tired
ness,
Mala
ise, Feeling
Feveri
sh,
Headac
he)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 26 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 37
FDA-CBER-2021-5683-0049548
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10049 4 Parace
tamol
500 Parace
tamol Analg
esics 15MA
Y2020
14:00 15MA
Y2020
14:00 Oral 500
mg Once Neck Pa
in Left
Side
5 Parace
tamol
500 Parace
tamol Analg
esics 02JUN
2020
23:10 02JUN
2020
23:10 Oral 500
mg Once Flu-Lke
Sympto
ms;
Headac
he
6 Parace
tamol
500 Parace
tamol Analg
esics 03JUN
2020
0:30 03JUN
2020
0:30 Oral 500
mg Once Flu-Lke
Sympto
ms;
Headac
he
7 Parace
tamol
500 Parace
tamol Analg
esics 03JUN
2020
7:15 03JUN
2020
20:50 Oral 500
mg TID Flu-Lke
Sympto
ms;
Headac
he
10050 1 Ibupro
fen Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 23MA
Y2020
17:20 23MA
Y2020
17:20 Oral 400
mg Once Mens
trual Pain
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 27 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 38
FDA-CBER-2021-5683-0049549
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
50 µg
You
nger 10050 2 Jay
dess
jen
apharm Lev
onorgestrel Othe
r
Gyn
ecologicals 03J
AN2019 Intrau
te
rine 13,5
mg QD Contrac
eption
3 Parac
etamol
500 Parac
etamol Anal
gesics 15M
AY2020
18:0
0 16M
AY2020
11:3
0 Oral 500
mg PRN
(8X5
00
mg) Heada
che
10053 1 Efforti
l gtt. Etile
frine Hydrochloride Card ia
c Therapy 12M
AY2020
8:25 12M
AY2020
8:25 Oral 10 m
g Onc
e Hypo
tension
During
Blood Draw
For Cm i
10055 1 Benu
ron Supp Parac
etamol Anal
gesics 03J
UN2020
18:0
0 03J
UN2020
18:0
0 Rectal 1000
mg Onc
e Pain
In Joints And
Mus
cles, Lower
Body
Half
2 Parac
etamol
500 Parac
etamol Anal
gesics 13M
AY2020
18:0
0 13M
AY2020
18:0
0 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 28 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 39
FDA-CBER-2021-5683-0049550
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10056 1 Parace
tamol
500 Parace
tamol Analg
esics 14MA
Y2020
1:40 14MA
Y2020
1:40 Oral 500
mg Once Flu-Lke
Symptoms
(Nau sea
,
Headac
he,
Tired
ness, Malaise,
Chills
, Pyrexia
Intermi
tt.,
Arthralg
ia);
Injec
tion Site
Reactio
ns (Pain,
Discom
fort With
Move
ment)
2 Parace
tamol
500 Parace
tamol Analg
esics 14MA
Y2020
10:00 14MA
Y2020
10:00 Oral 500
mg Once Flu-Lke
Symptoms
(Nau sea
,
Headac
he,
Tired
ness, Malaise,
Chills
, Pyrexia
Intermi
tt.,
Arthralg
ia)
3 Parace
tamol
500 T
bl. Parace
tamol Analg
esics 03JUN
2020
18:00 03JUN
2020
18:00 Oral 500
mg Once Flu Li
ke Symptoms
4 Parace
tamol
500 T
bl. Parace
tamol Analg
esics 03JUN
2020
20:00 03JUN
2020
20:00 Oral 500
mg Once Flu Li
ke Symptoms
5 Parace
tamol
500 T
bl. Parace
tamol Analg
esics 04JUN
2020
11:00 04JUN
2020
11:00 Oral 500
mg Once Flu Li
ke Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 29 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 40
FDA-CBER-2021-5683-0049551
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
50 µg
You
nger 10056 6 Parac
etamol
500
Tbl. Parac
etamol Anal
gesics 04J
UN2020
15:0
0 04J
UN2020
15:0
0 Oral 500
mg Onc
e Flu L
ike Symptoms
7 Parac
etamol
500
Tbl. Parac
etamol Anal
gesics 04J
UN2020
22:0
0 04J
UN2020
22:0
0 Oral 500
mg Onc
e Flu L
ike Symptoms
8 Parac
etamol
Supp
. Parac
etamol Anal
gesics 03J
UN2020
23:0
0 03J
UN2020
23:0
0 Rectal 1000
mg Onc
e Flu L
ike Symptoms
9 Parac
etamol
Supp
. Parac
etamol Anal
gesics 04J
UN2020
2:00 04J
UN2020
2:00 Rectal 1000
mg Onc
e Flu L
ike Symptoms
10 Parac
etamol
Supp
. Parac
etamol Anal
gesics 04J
UN2020
9:00 04J
UN2020
9:00 Rectal 1000
mg Onc
e Flu L
ike Symptoms
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 30 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 41
FDA-CBER-2021-5683-0049552
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snaps
hot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10056 11 Parace
tamol
supp
. Parace
tamol Analg
esics 14MA
Y2020
18:00 14MA
Y2020
18:00 Rectal 1000
mg Once Flu-Lke
Symptoms
(Nau sea
,
Headac
he,
Tired
ness, Malaise,
Chills
, Pyrexia
Intermi
tt.,
Arthralg
ia)
12 Solera
Tbl. Chlorma
dinone
Acetat
e;ethinylestradiol Sex Horm
ones
And Mo
dulators
Of Th
e Genital
System FEB2 017 Oral 1 Tab
let QD Contrace
ption
10057 2 Canest
en 1%
Crem e Clotrima
zole Antifun
gals For
Derm atol
ogical
Use 06JUN
2020
20:00 17JUN
2020
20:00 Topi
cal 1 g BID Tine
a Pedis Of
Right F
oot
3 Canest
en 1%
Crem e Clotrima
zole Stomat
ological
Prepara
tions 13JUN
2020
20:00 19JUN
2020
20:00 Topi
cal 1 g BID Ingui
nal Mycosis
4 Parace
tamol Parace
tamol Analg
esics 17MA
Y2020
18:00 17MA
Y2020
18:00 Oral 500
mg Once Flu-Lke
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 31 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 42
FDA-CBER-2021-5683-0049553
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10057 5 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
17:00 05JUN
2020
17:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Arthralgia,
Chills
, Fatigue,
Mala
ise)
6 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
19:00 05JUN
2020
19:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Arthralgia,
Chills
, Fatigue,
Mala
ise)
7 Parace
tamol Parace
tamol Analg
esics 06JUN
2020
10:00 06JUN
2020
10:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Arthralgia,
Chills
, Fatigue,
Mala
ise)
10059 1 Parace
tamol Parace
tamol Analg
esics 03JUN
2020
21:35 03JUN
2020
21:35 Oral 500
mg Once Flu Li
ke Symptoms
2 Parace
tamol
500
mg Parace
tamol Analg
esics 13MA
Y2020
22:30 13MA
Y2020
22:30 Oral 500
mg Once Flu-Lke
Symptoms
(Nau sea
, Chills,
Mala
ise,
Headac
he, Pyrexia
2x, Arthralg
ia)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 32 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 43
FDA-CBER-2021-5683-0049554
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10059 3 Parace
tamol
Supp Parace
tamol Analg
esics 13MA
Y2020
22:45 13MA
Y2020
22:45 Rectal 1000
mg Once Flu-Lke
Symptoms
(Nau sea
, Chills,
Mala
ise,
Headac
he, Pyrexia
2x, Arth
ralgia)
4 Parace
tamol
Supp Parace
tamol Analg
esics 03JUN
2020
20:00 04JUN
2020
17:30 Rectal 1000
mg QID Flu Li
ke Symptoms
10060 1 Novami
nsulfon Metam
izole Sodium Analg
esics 14MA
Y2020
19:10 14MA
Y2020
19:10 Oral 500
mg Once Headac
he
2 Parace
tamol Parace
tamol Analg
esics 04JUN
2020
14:30 04JUN
2020
14:30 Oral 500
mg Once Flu Li
ke Symptoms
10067 1 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
19:00 05JUN
2020
19:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Chills,
Fatigu
e)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 33 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 44
FDA-CBER-2021-5683-0049555
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10067 2 Parace
tamol Parace
tamol Analg
esics 06JUN
2020
8:00 06JUN
2020
17:00 Oral 500
mg BID Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Chills,
Fatigu
e)
3 Parace
tamol
500 Parace
tamol Analg
esics 15MA
Y2020
23:30 15MA
Y2020
23:30 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Fatigu
e,malaise,
Shive
ring)
4 Parace
tamol
500 Parace
tamol Analg
esics 16MA
Y2020
14:00 16MA
Y2020
14:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Fatigu
e,malaise,
Shive
ring)
10068 1 Mini
siston 0,1
mg
Levo
norgestrel,
0,02
mg
Ethiny
lestradiol Ethiny
lestradiol;levonorg
estrel Sex Horm
ones
And Mo
dulators
Of Th
e Genital
System OCT20
19 Oral 1 Tab
let PRN Contrace
ption
2 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
18:30 05JUN
2020
18:30 Oral 500
mg Once Injec
tion Site
Reactio
ns (Pain,
Discom
fort With
Move
ment)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 34 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 45
FDA-CBER-2021-5683-0049556
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10068 3 Parace
tamol Parace
tamol Analg
esics 06JUN
2020
18:30 06JUN
2020
18:30 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he,
Myal
gia, Arthral
gia,
Nausea
, Chills,
Loss
Of Appetite,
Mala
ise, Fatigue)
10070 1 Parace
tamol Parace
tamol Analg
esics 16MA
Y2020
22:00 16MA
Y2020
22:00 Oral 500
mg Once Flu-Lke
Symptoms
(Loss
Of Appetite,
Fatigu
e, Malaise,
Chills
)
2 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
19:30 05JUN
2020
19:30 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he, Chills,
Mala
ise, Fatigue)
10073 1 Dolormi
n Ibupro
fen Antiin
flammatory
And
Antirhe
umatic
Produc
ts 30MA
Y2020
12:15 30MA
Y2020
12:15 Oral 400
mg Once Tens
ion Headache
2 Parace
tamol Parace
tamol Analg
esics 27MA
Y2020
15:05 27MA
Y2020
15:05 Oral 500
mg Once Lowe
r Abdominal
Pain (M
enses)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 35 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 46
FDA-CBER-2021-5683-0049557
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10073 3 Parace
tamol Parace
tamol Analg
esics 30MA
Y2020
7:30 30MA
Y2020
7:30 Oral 500
mg Once Tens
ion Headache
4 Parace
tamol Parace
tamol Analg
esics 05JUN
2020
14:20 05JUN
2020
14:20 Oral 1000
mg Once Flu-Lke
Symptoms
(Hea dac
he, Chills,
Nausea
, Vomiting,
Loss
Of Appetite,
Fatigu
e, Malaise)
5 Parace
tamol Parace
tamol Analg
esics 06JUN
2020
10:00 06JUN
2020
23:00 Oral 500
mg TID Flu-Lke
Symptoms
(Hea dac
he, Chills,
Nausea
, Vomiting,
Loss
Of Appetite,
Fatigu
e, Malaise)
6 Parace
tamol Parace
tamol Analg
esics 15JUN
2020
13:01 15JUN
2020
13:01 Oral 500
mg Once Tens
ion Headache
7 Parace
tamol
500 Parace
tamol Analg
esics 15MA
Y2020
16:30 15MA
Y2020
16:30 Oral 500
mg Once Flu-Lke
Symptoms
(Mala
ise,
Tired
ness, Chills)
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 36 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 47
FDA-CBER-2021-5683-0049558
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
50 µg
Youn
ger 10073 8 Parace
tamol
500 Parace
tamol Analg
esics 16MA
Y2020
7:50 16MA
Y2020
7:50 Oral 500
mg Once Flu-Lke
Symptoms
(Mala
ise,
Tired
ness, Chills
)
9 Parace
tamol
500
mg Parace
tamol Analg
esics 05JUN
2020
19:00 05JUN
2020
19:00 Oral 500
mg Once Flu-Lke
Symptoms
(Hea dac
he, Chills,
Nausea
, Vomiting,
Loss
Of Appetite,
Fatigu
e, Malaise)
60 µg
Youn
ger 10066 1 Parace
tamol Parace
tamol Analg
esics 19MA
Y2020
23:10 19MA
Y2020
23:10 Oral 1000
mg Once Headac
he; Pyrexia
(Highe
st Values
39,2);
Flu-Lke
Sympto
ms
2 Parace
tamol Parace
tamol Analg
esics 20MA
Y2020
13:00 20MA
Y2020
13:00 Oral 500
mg Once Flu-Lke
Symptoms
3 Parace
tamol Parace
tamol Analg
esics 22MA
Y2020
8:00 22MA
Y2020
21:00 Oral 500
mg BID Flu-Lke
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 37 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 48
FDA-CBER-2021-5683-0049559
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
60 µg
You
nger 10066 4 Parac
etamol Parac
etamol Anal
gesics 12J
UN2020
13:3
0 12J
UN2020
13:3
0 Oral 1000
mg Onc
e Heada
che
10075 1 Canes
ten
Crem e Clotrim
azole Antifu
ngals For
Derm ato
logical
Use 12J
UN2020
22:0
0 27J
UN2020
22:0
0 Top
ical 0.5 g QD Tin
ea Pedis Right
Foot
3 Parac
etamol Parac
etamol Anal
gesics 22M
AY2020
22:3
0 22M
AY2020
22:3
0 Oral 500
mg Onc
e Pyrex
ia; Headache
4 Parac
etamol Parac
etamol Anal
gesics 23M
AY2020
4:00 23M
AY2020
4:00 Oral 500
mg Onc
e Pyrex
ia; Headache
5 Parac
etamol Parac
etamol Anal
gesics 23M
AY2020
12:5
0 23M
AY2020
12:5
0 Oral 500
mg Onc
e Pyrex
ia; Headache
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 38 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 49
FDA-CBER-2021-5683-0049560
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot Al
l TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo G m
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
60 µg
Youn
ger 10075 6 Parace
tamol Parace
tamol Analg
esics 23MA
Y2020
22:30 23MA
Y2020
22:30 Rectal 1000
mg Once Pyrexi
a; Headache
7 Parace
tamol
supp
ository Parace
tamol Analg
esics 22MA
Y2020
19:20 22MA
Y2020
19:20 Rectal 1000
mg Once Pyrexi
a; Headache
10084 1 Parace
tamol Parace
tamol Analg
esics 22MA
Y2020
21:00 22MA
Y2020
21:00 Oral 500
mg Once Flu-Lke
Symptoms
10085 1 Parace
tamol Parace
tamol Analg
esics 22MA
Y2020
19:30 22MA
Y2020
19:30 Oral 500
mg Once Flu-Lke
Symptoms
2 Parace
tamol Parace
tamol Analg
esics 22MA
Y2020
23:00 22MA
Y2020
23:00 Oral 500
mg Once Flu-Lke
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 39 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 50
FDA-CBER-2021-5683-0049561
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concom i
tant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
60 µg
Youn
ger 10085 3 Parace
tamol Parace
tamol Analg
esics 23MA
Y2020
11:00 23MA
Y2020
11:00 Oral 1000
mg Once Flu-Lke
Symptoms
10089 1 MCP Sup p Metoc
lopramide
Hydroc
hloride Drug s Fo
r
Funct
ional
Gastro
intestinal
Disorde
rs 20MA
Y2020
19:47 20MA
Y2020
19:47 Rectal 10 mg Once Flu Li
ke Symptoms
(Hea dac
he,
Nausea
);
Intermi
ttend
Vomit
ing
3 ben-u-ron 10
00 Parace
tamol Analg
esics 21MA
Y2020
10:00 21MA
Y2020
10:00 Rectal 1000
mg Once Flu Li
ke Symptoms
(Hea dac
he,
Nausea
)
4 ben-u-ron
1000
mg Parace
tamol Analg
esics 20MA
Y2020
13:01 20MA
Y2020
13:01 Rectal 1000
mg Once Flu Li
ke Symptoms
(Hea dac
he,
Nausea
)
10093 1 Parace
tamol
500 Parace
tamol Analg
esics 21MA
Y2020
14:00 21MA
Y2020
14:00 Oral 500
mg Once Flu-Lke
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 40 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 51
FDA-CBER-2021-5683-0049562
BioNT
ech RNA Pharmaceuticals GmbH / Listing
s - 6. Snap
shot All TLFs Final 1.0 BNT16 2b
1
BNT16 2-01 Created on
20NOV2020
Staburo GmbH. B as
ed on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT
2020. Listing
16.2.1 -6.2-1: List
ing of concomitant medication - BNT16
2b1
Safety s
et
Dose
group Sub-
ject
no. Med.
no. Medi
cation/
Thera
py Preferred
term Thera
peutic class Start da
te
and t
ime End da
te
and t
ime On-
go-
ing Route Dose Fre-
quen -
cy Indic
ation
60 µg
Youn
ger 10096 1 Parace
tamol Parace
tamol Analg
esics 20MA
Y2020
10:00 20MA
Y2020
20:00 Oral 500
mg BID Flu Li
ke Symptoms
(Arth ralg
ia,
Myal
gia, Chills
,
Mala
ise, Elevated
Body T
emperature)
10103 1 Parace
tamol Parace
tamol Analg
esics 23MA
Y2020
1:13 23MA
Y2020
1:13 Oral 500
mg Once Flu-Lke
Symptoms
2 Parace
tamol Parace
tamol Analg
esics 23MA
Y2020
15:18 23MA
Y2020
15:18 Oral 500
mg Once Flu-Lke
Sympto
ms
10104 1 Parace
tamol
500 Parace
tamol Analg
esics 20MA
Y2020
19:22 20MA
Y2020
21:30 Oral 500
mg BID Flu-Lke
Symptoms
2 Parace
tamol
500 Parace
tamol Analg
esics 21MA
Y2020
22:00 21MA
Y2020
22:00 Oral 500
mg Once Flu-Lke
Symptoms
Thera
peutic clas
s is ATC leve
l 2. Concom
itant medi
cations are code
d usin
g WHO Glob
al (Drug Insig
ht) March 2020 B3 stand
ard drug code
s.
BID = twice per day; Med. = medi
cation; no. = numb
er; PRN = as need
ed; Q4D = every 4 days
; QD = dail
y; QID = 4 time
s per day; TID = 3 times per day.
Program
: Lbas
e_PCm_6.sas (Page 41 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 52
FDA-CBER-2021-5683-0049563
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
Old
er 10274 1 Parac
etamol
Tbl Parac
etamol Anal
gesics 17SEP2
020
15:1
0 18SEP2
020
7:50 Oral 500
mg THRIC
E Heada
che
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 27AUG
2020
11:3
0 27AUG
2020
11:3
0 Oral 500
mg Onc
e Heada
che
3 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 27AUG
2020
17:0
0 27AUG
2020
17:0
0 Oral 500
mg Onc
e Heada
che
10282 1 Parac
etamol
Supp Parac
etamol Anal
gesics 21AUG
2020
4:40 21AUG
2020
4:41 Rectal 1000
mg Onc
e Heada
che
2 Parac
etamol
Supp Parac
etamol Anal
gesics 22AUG
2020
3:30 22AUG
2020
3:30 Rectal 1000
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 42 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 53
FDA-CBER-2021-5683-0049564
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
Old
er 10282 3 Parac
etamol
Tab
l. Parac
etamol Anal
gesics 10SEP2
020
16:0
0 11SEP2
020
2:00 Oral 500
mg BID Heada
che
10286 1 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 26AUG
2020
12:1
5 26AUG
2020
12:1
5 Oral 500
mg Onc
e Heada
che
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 04SEP2
020
21:0
0 04SEP2
020
21:0
0 Oral 500
mg Onc
e Mig
raine
3 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 03O
CT2020
23:0
0 03O
CT2020
23:0
0 Oral 500
mg Onc
e Heada
che (Diary)
10288 1 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 26AUG
2020
23:0
0 26AUG
2020
23:0
1 Oral 500
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 43 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 54
FDA-CBER-2021-5683-0049565
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
Old
er 10288 2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 15SEP2
020
21:0
0 15SEP2
020
21:0
1 Oral 500
mg Onc
e Chill
s
3 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 15SEP2
020
22:0
0 15SEP2
020
22:0
1 Oral 500
mg Onc
e Chill
s
4 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 16SEP2
020
10:0
0 16SEP2
020
10:0
1 Oral 500
mg Onc
e Heada
che
5 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 17SEP2
020
15:0
0 17SEP2
020
15:0
1 Oral 1000
mg Onc
e Heada
che
10289 1 ASS 1 00
Tbl. Acety
lsalicylic Acid Antith
rombotic
Agen
ts 2017 Oral 100
mg QD Proph
ylaxis
(Caro tis
stenose)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 44 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 55
FDA-CBER-2021-5683-0049566
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
10 µg
Old
er 10289 2 Ome
ga 3 Kps.
150
0 mg Salm
on Oil Lip
id Modifying
Agen
ts 2017 Oral 1
CAPSU
LE QD Proph
ylaxis
(Caro tis
stenose)
10292 1 Parac
etamol
Tbl Parac
etamol Anal
gesics 17SEP2
020
17:0
0 17SEP2
020
17:0
0 Oral 500
mg Onc
e Heada
che
10298 1 Parac
etamol
Tbl Parac
etamol Anal
gesics 18SEP2
020
10:3
0 18SEP2
020
10:3
0 Oral 500
mg Onc
e Feve
r
20 µg
Old
er 20207 1 Parac
etamol Parac
etamol Anal
gesics 10SEP2
020
13:0
0 10SEP2
020
13:0
0 Oral 500
mg Onc
e Heada
che (See
Diary)
2 Parac
etamol Parac
etamol Anal
gesics 01O
CT2020
2:00 01O
CT2020
2:00 Oral 500
mg Onc
e Heada
che (See
Diary)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 45 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 56
FDA-CBER-2021-5683-0049567
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
Old
er 20211 1 Parac
etamol Parac
etamol Anal
gesics 01O
CT2020
3:00 01O
CT2020
3:00 Oral 500
mg Onc
e Syste
mic Reaction
(Diary
)
20220 1 Parac
etamol Parac
etamol Anal
gesics 09SEP2
020
13:3
0 09SEP2
020
13:3
0 Oral 250
mg Onc
e Incre
ased Body
Tem
perature
2 Parac
etamol Parac
etamol Anal
gesics 09SEP2
020
21:0
0 09SEP2
020
21:0
0 Oral 250
mg Onc
e Incre
ased Body
Tem
perature
20227 1 Parac
etamol Parac
etamol Anal
gesics 12SEP2
020
2:15 12SEP2
020
2:15 Oral 500
mg Onc
e Heada
che (Diary)
2 Parac
etamol Parac
etamol Anal
gesics 03O
CT2020
6:40 03O
CT2020
6:40 Oral 500
mg Onc
e Heada
che,
Mya
lgia, Arthralgia
(Diary
)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 46 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 57
FDA-CBER-2021-5683-0049568
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concomitant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
Old
er 20227 3 Parac
etamol Parac
etamol Anal
gesics 03O
CT2020
15:0
0 03O
CT2020
15:0
0 Oral 500
mg Onc
e Heada
che,
Mya
lgia, Arthralgia
(Diary
)
4 Parac
etamol Parac
etamol Anal
gesics 03O
CT2020
20:0
0 03O
CT2020
20:0
0 Oral 500
mg Onc
e Heada
che,
Arthral
gia, Myalgia
(Diary
)
5 Parac
etamol Parac
etamol Anal
gesics 04O
CT2020
10:2
0 04O
CT2020
10:2
0 Oral 500
mg Onc
e Heada
che (Diary)+
Abdo
minal Pain
(Diary
)
20242 1 Noval
gin Meta
mizole Sodium Anal
gesics 21SEP2
020
2:15 23SEP2
020
8:30 Oral 500
mg QD Pain
Left Costal
Arch An
d Shoulder
2 para
cetamol Parac
etamol Anal
gesics 10SEP2
020
21:4
5 10SEP2
020
21:4
5 Oral 500
mg Onc
e Heada
che, Chills,
Incre
ased
Tem
perature (See
Diary)
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 47 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 58
FDA-CBER-2021-5683-0049569
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
20 µg
Old
er 20242 3 para
cetamol Parac
etamol Anal
gesics 19SEP2
020
20:1
5 19SEP2
020
20:1
5 Oral 500
mg Onc
e Pain
Left Costal
Arch An
d Shoulder
4 para
cetamol Parac
etamol Anal
gesics 20SEP2
020
3:00 20SEP2
020
3:00 Oral 500
mg Onc
e Left
Costal Arch
And Sh
oulder
30 µg
Old
er 10350 1 Parac
etamol Parac
etamol Anal
gesics 26SEP2
020
9:00 26SEP2
020
9:00 Oral 500
mg Onc
e Heada
che
2 Parac
etamol Parac
etamol Anal
gesics 16O
CT2020
20:0
0 17O
CT2020
10:0
0 Oral 500
mg TID Diary Pa
rt 3
Heada
che +
Mus
cle Pain
3 Parac
etamol Parac
etamol Anal
gesics 17O
CT2020
14:3
0 17O
CT2020
14:3
0 Rectal 1000
mg Onc
e Diary Pa
rt 3
Mus
cle Pain
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 48 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
Page 59
FDA-CBER-2021-5683-0049570
Bio
NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
30 µg
Old
er 10352 1 Parac
etamol
500 Parac
etamol Anal
gesics 14O
CT2020
16:3
0 14O
CT2020
16:3
0 Oral 1 Ta
blet QD Syste
mic Reaction
See Di
ary Page
10+1
2
10353 1 Ibup
rofen Tbl. Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 24SEP2
020
12:1
0 24SEP2
020
12:1
0 Oral 400
mg Onc
e Back
pain
2 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 22SEP2
020
16:0
0 24SEP2
020
4:00 Oral 500
mg TID Heada
che;
Back
pain
3 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 13O
CT2020
19:0
0 15O
CT2020
20:0
0 Oral 500
mg PRN Syste
mic
Reacti
ons See
Diary Pa
ge
10358 1 Calci
um Tbl
500
mg Calci
um Min
eral
Supp
lements 2011 Oral 1 Ta
blet QD Proph
ylaxis
Agai
nst
Oste
oporosis
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 49 of 52)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
30 µg
Old
er 10358 2 Mag
nesium
250
mg Tbl Mag
nesium Min
eral
Supp
lements 1987 Oral 1 Ta
blet QD Mus
cle Cramps
3 Panto
prazol
20m
g Panto
prazole Drug s F
or Acid
Relate
d Disorders 07O
CT2020
7:00 07O
CT2020
7:00 Oral 20 m
g QD Heart Bu
rn
4 Panto
prazol
Tab
l. Panto
prazole Drug s F
or Acid
Relate
d Disorders 15O
CT2020
6:00 20O
CT2020
18:3
0 Oral 20 m
g QD Stoma
ch Pain
5 Parac
etamol
500
mg Parac
etamol Anal
gesics 06O
CT2020
15:0
0 06O
CT2020
15:0
0 Oral 500
mg QD Com mo
n Cold
6 Parac
etamol
Tab
l. 500 mg Parac
etamol Anal
gesics 16O
CT2020
11:0
0 20O
CT2020
18:3
0 Oral 500
mg BID Flue
Like
Symp
toms
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 50 of 52)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
30 µg
Old
er 10361 1 Parac
etamol Parac
etamol Anal
gesics 26SEP2
020
6:30 26SEP2
020
11:3
0 Oral 500
mg BID Heada
che
2 Parac
etamol Parac
etamol Anal
gesics 16O
CT2020
17:1
0 17O
CT2020
22:4
0 Oral 500
mg TID Diary Pa
rt 3
Heada
che
10363 1 ASS 1 00 Acety
lsalicylic Acid Antith
rombotic
Agen
ts 2010 Oral 100
mg QD Proph
ylaxis
2 Estram
on TTS
50 Estrad
iol Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2005 Tran
sde
rmal 50 m
g 1 TI
ME
PER
WEEK Horm on
al
Repla
cement
The
rapy
3 Fame
nita 100 Proge
sterone Sex Ho
rmones
And M
odulators
Of T
he Genital
Syste
m 2010 Oral 100
mg QD Horm on
al
Repla
cement
The
rapy
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 51 of 52)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot A
ll TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.1 -6.2-1: Lis
ting of concom
itant medication - BNT
162b1
Safety
set
Dose
grou
p Sub-
jec
t no. Med
.
no. Med
ication/
The
rapy Preferre
d term The
rapeutic class Start d
ate
and
time End d
ate
and
time On-
go-
ing Route Dose Fre-
quen -
cy Indi
cation
30 µg
Old
er 10365 1 Ibup
rofen
600
mg Tbl Ibup
rofen Antii
nflammatory
And
Antirh
eumatic
Produ
cts 2018 Oral 1 Ta
blet PRN Med
ical History:
Interm
ittent Pain
Due To
Poly
arthrosis
2 Parac
etamol
500
mg Parac
etamol Anal
gesics 15O
CT2020
6:00 15O
CT2020
6:00 Oral 1000
mg Onc
e Heada
che (See
Diary Pa
ge 11)
3 Parac
etamol
Tbl Parac
etamol Anal
gesics 03O
CT2020
23:0
0 03O
CT2020
23:0
0 Oral 500
mg Onc
e Ear Pai
n Right
4 Parac
etamol
Tbl Parac
etamol Anal
gesics 04O
CT2020
22:3
0 04O
CT2020
22:3
0 Oral 500
mg Onc
e Ear Pai
n Right
5 Parac
etamol
Tbl
. Parac
etamol Anal
gesics 24SEP2
020
6:30 24SEP2
020
6:30 Oral 1000
mg Onc
e Heada
che
The
rapeutic cla
ss is ATC lev
el 2. Conco
mitant med
ications are cod
ed usi
ng WHO Glo
bal (Drug Insi
ght) Marc
h 202
0 B3 stan
dard drug cod
es.
BID = twic
e per day
; Med
. = med
ication; no. = num
ber; PRN = as nee
ded; Q4D = eve
ry 4 day
s; QD = dai
ly; QID = 4 tim
es per day
; TID = 3 time
s per day
.
Progra
m: Lba
se_PCm_6.sas (Pag
e 52 of 52)
090177e1959f7376\Approved\Approved On: 27-Nov-2020 03:38 (GMT)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10015 0 29APR20
20 23:00 Yes Mod
erate
1 30APR20
20 23:00 No
2 01M
AY2020 20:00 No
3 02M
AY2020 20:00 No
4 03M
AY2020 20:00 No
5 04M
AY2020 20:00 No
6 05M
AY2020 20:00 No
21 0 20M
AY2020 23:00 Yes Mil
d
22 1 21M
AY2020 23:00 No
23 2 22M
AY2020 23:00 No
24 3 23M
AY2020 23:00 No
25 4 24M
AY2020 23:00 No
26 5 25M
AY2020 23:00 No
27 6 26M
AY2020 23:00 No
10018 0 29APR20
20 Yes Mod
erate
1 30APR20
20 20:00 No
2 01M
AY2020 20:00 No
3 02M
AY2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 1 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10018 4 03M
AY2020 21:00 No
5 04M
AY2020 20:00 No
6 05M
AY2020 20:00 No
21 0 20M
AY2020 23:00 Yes Mil
d
22 1 21M
AY2020 23:00 No
23 2 22M
AY2020 23:00 No
24 3 23M
AY2020 22:00 No
25 4 24M
AY2020 22:00 No
26 5 25M
AY2020 23:00 No
27 6 26M
AY2020 22:30 No
10023 0 05M
AY2020 20:00 No
1 06M
AY2020 20:00 No
2 07M
AY2020 20:00 No
3 08M
AY2020 20:00 No
4 09M
AY2020 20:00 No
5 10M
AY2020 20:00 No
6 11M
AY2020 20:00 No
21 0 26M
AY2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 2 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local react
ions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10023 22 1 27M
AY2020 20:00 No
23 2 28M
AY2020 20:00 No
24 3 29M
AY2020 20:00 No
25 4 30M
AY2020 20:00 No
26 5 31M
AY2020 20:00 No
27 6 01J
UN2020 20:00 No
10025 0 05M
AY2020 20:45 No
1 06M
AY2020 21:00 No
2 07M
AY2020 20:55 No
3 08M
AY2020 23:05 No
4 09M
AY2020 22:00 No
5 10M
AY2020 22:00 No
6 11M
AY2020 22:00 No
21 0 26M
AY2020 22:00 Yes Mil
d
22 1 27M
AY2020 22:00 No
23 2 28M
AY2020 21:00 No
24 3 29M
AY2020 22:00 No
25 4 30M
AY2020 22:00 No
Progra
m: Lsa
f_locR_2.sas (Page 3 of 93)
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ngs - 6. Sn
apshot All TLFs Fina
l 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10025 26 5 31M
AY2020 12:00 No
27 6 01J
UN2020 21:30 No
10033 0 05M
AY2020 20:00 Yes Mil
d
1 06M
AY2020 20:00 No
2 07M
AY2020 20:00 No
3 08M
AY2020 20:00 No
4 09M
AY2020 20:00 No
5 10M
AY2020 20:00 No
6 11M
AY2020 20:00 No
21 0 26M
AY2020 21:00 No
22 1 27M
AY2020 20:00 No
23 2 28M
AY2020 20:00 Yes Mil
d
24 3 29M
AY2020 20:30 No
25 4 30M
AY2020 20:00 No
26 5 31M
AY2020 20:00 No
27 6 01J
UN2020 20:00 No
10036 0 08M
AY2020 18:00 No
1 09M
AY2020 18:00 No
Progra
m: Lsa
f_locR_2.sas (Page 4 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance loca
l reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg You
nger 10036 2 10M
AY2020 18:15 No
3 11M
AY2020 18:00 No
4 12M
AY2020 18:20 No
5 13M
AY2020 18:00 No
6 14M
AY2020 18:10 No
7 15M
AY2020 17:05 No
21 0 29M
AY2020 18:05 No
22 1 30M
AY2020 18:00 No
23 2 31M
AY2020 18:00 No
24 3 01J
UN2020 18:00 No
25 4 02J
UN2020 18:00 No
26 5 03J
UN2020 18:00 No
10040 0 08M
AY2020 20:31 Yes Mil
d
1 09M
AY2020 21:20 Yes Mil
d
2 10M
AY2020 21:28 No
3 11M
AY2020 21:15 No
4 12M
AY2020 21:30 No
5 13M
AY2020 21:48 No
Progra
m: Lsa
f_locR_2.sas (Page 5 of 93)
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maceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10040 6 14M
AY2020 21:40 No
21 0 29M
AY2020 22:10 No
22 1 30M
AY2020 21:18 Yes Seve
re
23 2 31M
AY2020 21:04 Yes Seve
re
24 3 01J
UN2020 21:10 Yes Mod
erate
25 4 02J
UN2020 21:00 Yes Seve
re
26 5 03J
UN2020 21:15 Yes Mod
erate
10041 0 08M
AY2020 20:25 Yes Mil
d
1 09M
AY2020 21:20 Yes Mil
d
2 10M
AY2020 21:28 No
3 11M
AY2020 21:15 No
4 12M
AY2020 21:30 No
5 13M
AY2020 21:48 No
6 14M
AY2020 21:40 No
21 0 29M
AY2020 22:10 Yes Seve
re
22 1 30M
AY2020 21:18 Yes Seve
re
23 2 31M
AY2020 21:04 Yes Mod
erate
24 3 01J
UN2020 21:13 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 6 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10041 25 4 02J
UN2020 21:30 No
26 5 03J
UN2020 21:35 No
10042 0 08M
AY2020 22:00 No
1 09M
AY2020 22:00 No
2 10M
AY2020 22:00 No
3 11M
AY2020 22:00 No
4 12M
AY2020 22:00 No
5 13M
AY2020 22:00 No
6 14M
AY2020 22:00 No
21 0 29M
AY2020 22:00 No
22 1 30M
AY2020 22:00 No
23 2 31M
AY2020 22:00 No
24 3 01J
UN2020 22:00 No
25 4 02J
UN2020 22:00 No
26 5 03J
UN2020 22:00 No
10045 0 05M
AY2020 20:30 No
1 06M
AY2020 19:30 No
2 07M
AY2020 20:20 No
Progra
m: Lsa
f_locR_2.sas (Page 7 of 93)
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NTech RNA Phar
maceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect num
ber Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10045 3 08M
AY2020 20:05 No
4 09M
AY2020 20:35 No
5 10M
AY2020 19:45 No
6 11M
AY2020 20:00 No
7 12M
AY2020 19:00 No
22 1 27M
AY2020 20:20 No
23 2 28M
AY2020 20:10 No
24 3 29M
AY2020 20:15 No
25 4 30M
AY2020 20:30 No
26 5 31M
AY2020 20:00 No
27 6 01J
UN2020 20:10 No
10048 0 08M
AY2020 20:06 No
1 09M
AY2020 20:01 No
2 10M
AY2020 20:03 No
3 11M
AY2020 20:11 No
4 12M
AY2020 19:59 No
5 13M
AY2020 20:00 No
6 14M
AY2020 20:04 No
Progra
m: Lsa
f_locR_2.sas (Page 8 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
1 µg Y
ounger 10048 21 0 29M
AY2020 20:00 No
22 1 30M
AY2020 20:11 No
23 2 31M
AY2020 20:03 No
24 3 01J
UN2020 19:57 No
25 4 02J
UN2020 20:00 No
26 5 03J
UN2020 20:01 No
10052 0 08M
AY2020 23:00 Yes Mil
d
1 09M
AY2020 23:10 Yes Mil
d
2 10M
AY2020 23:12 No
3 11M
AY2020 23:00 No
4 12M
AY2020 23:14 No
5 13M
AY2020 23:40 No
6 14M
AY2020 23:25 No
21 0 29M
AY2020 23:58 No
22 1 30M
AY2020 23:44 No
23 2 31M
AY2020 23:55 No
24 3 01J
UN2020 23:40 No
25 4 02J
UN2020 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 9 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10170 0 31J
UL2020 20:00 Yes Mil
d
1 01AUG
2020 20:05 Yes Mil
d
2 02AUG
2020 20:03 No
3 03AUG
2020 20:04 No
4 04AUG
2020 20:02 No
5 05AUG
2020 20:01 No
6 06AUG
2020 20:03 No
7 07AUG
2020 8:30 No
21 0 21AUG
2020 20:04 Yes Mil
d
22 1 22AUG
2020 20:01 No
23 2 23AUG
2020 20:02 No
24 3 24AUG
2020 20:07 No
25 4 25AUG
2020 20:09 No
26 5 26AUG
2020 20:05 No
27 6 27AUG
2020 20:06 No
10194 0 22J
UL2020 21:15 Yes Mil
d
1 23J
UL2020 21:45 Yes Mil
d
2 24J
UL2020 21:30 No
Progra
m: Lsa
f_locR_2.sas (Page 10 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10194 3 25J
UL2020 22:15 No
4 26J
UL2020 21:45 No
5 27J
UL2020 21:45 No
6 28J
UL2020 21:30 No
21 0 12AUG
2020 22:1
5 Yes Mil
d
22 1 13AUG
2020 21:45 Yes Mil
d
23 2 14AUG
2020 22:00 Yes Mil
d
24 3 15AUG
2020 22:15 No
25 4 16AUG
2020 21:30 No
26 5 17AUG
2020 22:00 Yes Mil
d
10198 0 22J
UL2020 21:55 No
1 23J
UL2020 23:10 No
2 24J
UL2020 22:30 No
3 25J
UL2020 23:05 No
4 26J
UL2020 23:10 No
5 27J
UL2020 22:14 No
6 28J
UL2020 23:38 No
20 11AUG
2020 21:48 No
Progra
m: Lsa
f_locR_2.sas (Page 11 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local react
ions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10198 21 0 12AUG
2020 22:30 No
22 1 13AUG
2020 21:05 No
23 2 14AUG
2020 22:10 No
24 3 15AUG
2020 23:05 No
25 4 16AUG
2020 22:32 No
26 5 17AUG
2020 22:45 No
27 6 18AUG
2020 21:45 No
10200 0 22J
UL2020 18:30 No
1 23J
UL2020 22:05 No
2 24J
UL2020 21:00 No
3 25J
UL2020 20:50 No
4 26J
UL2020 21:00 No
5 27J
UL2020 20:55 No
6 28J
UL2020 21:00 No
21 0 12AUG
2020 21:00 No
22 1 13AUG
2020 20:58 No
23 2 14AUG
2020 21:01 No
24 3 15AUG
2020 21:05 No
Progra
m: Lsa
f_locR_2.sas (Page 12 of 93)
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ngs - 6. Sn
apshot All TLFs Fina
l 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10200 25 4 16AUG
2020 21:03 No
26 5 17AUG
2020 21:00 No
10204 0 22J
UL2020 22:05 No
1 23J
UL2020 21:45 No
2 24J
UL2020 21:50 No
3 25J
UL2020 23:15 No
4 26J
UL2020 22:45 No
5 27J
UL2020 21:45 No
6 28J
UL2020 21:55 No
21 0 12AUG
2020 21:45 Yes Mil
d
22 1 13AUG
2020 22:00 Yes Mil
d
23 2 14AUG
2020 22:15 No
24 3 15AUG
2020 22:30 No
25 4 16AUG
2020 21:30 No
26 5 17AUG
2020 21:40 Yes Mil
d
10209 0 22J
UL2020 22:00 No
1 23J
UL2020 22:00 No
2 24J
UL2020 22:15 No
Progra
m: Lsa
f_locR_2.sas (Page 13 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance loca
l reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg You
nger 10209 3 25J
UL2020 21:50 No
4 26J
UL2020 22:00 No
5 27J
UL2020 22:00 No
6 28J
UL2020 21:45 No
21 0 12AUG
2020 22:00 No
22 1 13AUG
2020 21:50 No
23 2 14AUG
2020 22:05 No
24 3 15AUG
2020 22:00 No
25 4 16AUG
2020 21:55 No
26 5 17AUG
2020 22:05 No
10212 0 22J
UL2020 20:30 Yes Mil
d
1 23J
UL2020 21:30 Yes Mil
d
2 24J
UL2020 20:30 Yes Mil
d
3 25J
UL2020 20:45 Yes Mil
d
4 26J
UL2020 20:40 Yes Mil
d
5 27J
UL2020 20:45 Yes Mil
d
6 28J
UL2020 20:35 No
21 0 12AUG
2020 21:30 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 14 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10212 22 1 13AUG
2020 20:00 Yes Mil
d
23 2 14AUG
2020 20:00 Yes Mil
d
24 3 15AUG
2020 22:30 Yes Mil
d
25 4 16AUG
2020 21:00 Yes Mil
d
26 5 17AUG
2020 Yes Mil
d
10221 0 31J
UL2020 20:00 No
1 01AUG
2020 20:00 No
2 02AUG
2020 20:00 No
3 03AUG
2020 20:00 No
4 04AUG
2020 20:00 No
5 05AUG
2020 20:00 No
6 06AUG
2020 20:00 No
7 07AUG
2020 7:34 No
21 0 21AUG
2020 20:00 No
22 1 22AUG
2020 20:00 No
23 2 23AUG
2020 20:00 No
24 3 24AUG
2020 20:00 No
25 4 25AUG
2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 15 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3-1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10221 26 5 26AUG
2020 20:00 No
27 6 27AUG
2020 20:00 No
10224 0 31J
UL2020 18:00 No
1 01AUG
2020 17:00 No
2 02AUG
2020 17:30 No
3 03AUG
2020 17:00 No
4 04AUG
2020 18:00 No
5 05AUG
2020 18:00 No
6 06AUG
2020 19:00 No
7 07AUG
2020 7:47 No
21 0 21AUG
2020 19:30 No
22 1 22AUG
2020 19:30 No
23 2 23AUG
2020 20:00 No
24 3 24AUG
2020 19:00 No
25 4 25AUG
2020 19:00 No
26 5 26AUG
2020 20:00 No
27 6 27AUG
2020 20:30 No
28 7 28AUG
2020 6:00 No
Progra
m: Lsa
f_locR_2.sas (Page 16 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r pri
me
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10225 0 31J
UL2020 20:15 No
1 01AUG
2020 20:08 No
2 02AUG
2020 19:50 No
3 03AUG
2020 20:06 No
4 04AUG
2020 20:01 No
5 05AUG
2020 20:04 No
6 06AUG
2020 19:57 No
7 07AUG
2020 7:57 No
21 0 21AUG
2020 19:45 No
22 1 22AUG
2020 20:00 No
23 2 23AUG
2020 19:50 No
24 3 24AUG
2020 20:00 No
25 4 25AUG
2020 20:05 No
26 5 26AUG
2020 19:55 No
27 6 27AUG
2020 20:00 No
10226 0 31J
UL2020 20:00 Yes Mil
d
1 01AUG
2020 20:00 Yes Mod
erate
2 02AUG
2020 20:00 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 17 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
3 µg Y
ounger 10226 3 03AUG
2020 20:00 Yes Mil
d
4 04AUG
2020 20:00 No
5 05AUG
2020 20:00 No
6 06AUG
2020 20:00 No
7 07AUG
2020 8:11 No
21 0 21AUG
2020 20:00 Yes Mod
erate
22 1 22AUG
2020 20:00 Yes Mod
erate
23 2 23AUG
2020 20:00 Yes Mil
d
24 3 24AUG
2020 20:00 Yes Mil
d
25 4 25AUG
2020 20:00 No
26 5 26AUG
2020 20:00 No
27 6 27AUG
2020 20:00 No
28 7 28AUG
2020 8:00 No
10227 0 31J
UL2020 18:00 Yes Mil
d
1 01AUG
2020 18:00 Yes Mil
d
2 02AUG
2020 18:00 No
3 03AUG
2020 18:00 No
4 04AUG
2020 18:00 No
Progra
m: Lsa
f_locR_2.sas (Page 18 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10001 0 24APR20
20 20:00 No
1 25APR20
20 20:00 No
2 26APR20
20 20:03 No
3 27APR20
20 19:58 No
4 28APR20
20 20:00 No
5 29APR20
20 20:00 No
6 30APR20
20 19:59 No
7 01M
AY2020 20:00 No
3 µg Y
ounger 10227 5 05AUG
2020 18:00 No
6 06AUG
2020 18:00 No
7 07AUG
2020 8:30 No
21 0 21AUG
2020 20:00 No
22 1 22AUG
2020 20:00 No
23 2 23AUG
2020 20:00 No
24 3 24AUG
2020 20:00 No
25 4 25AUG
2020 20:00 No
26 5 26AUG
2020 20:00 No
27 6 27AUG
2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 19 of 93)
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ngs - 6. Sn
apshot All TLFs Fin
al 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10001 8 02M
AY2020 20:00 No
21 0 15M
AY2020 20:00 Yes Mil
d
22 1 16M
AY2020 20:00 No
23 2 17M
AY2020 20:01 No
24 3 18M
AY2020 20:00 No
25 4 19M
AY2020 20:00 No
26 5 20M
AY2020 20:00 No
27 6 21M
AY2020 20:00 No
10003 0 28APR20
20 19:15 No
1 29APR20
20 19:10 Yes Mil
d
2 30APR20
20 19:15 No
3 01M
AY2020 19:15 No
4 02M
AY2020 19:10 No
5 03M
AY2020 19:05 No
6 04M
AY2020 19:00 No
7 05M
AY2020 19:00 No
21 0 19M
AY2020 20:35 Yes Mil
d
22 1 20M
AY2020 20:25 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 20 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compli
ance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10003 23 2 21M
AY2020 20:30 Yes Mil
d
24 3 22M
AY2020 20:15 Yes Mil
d
25 4 23M
AY2020 20:20 Yes Mil
d
26 5 24M
AY2020 20:25 Yes Mil
d
27 6 25M
AY2020 20:10 Yes Mil
d
28 7 26M
AY2020 20:15 Yes Mil
d
10004 0 24APR20
20 22:15 Yes Mil
d
1 25APR20
20 21:00 Yes Mil
d
2 26APR20
20 21:45 No
3 27APR20
20 22:05 No
4 28APR20
20 21:50 No
5 29APR20
20 15:30 No
6 30APR20
20 22:15 No
7 01M
AY2020 21:50 No
8 02M
AY2020 19:50 No
21 0 15M
AY2020 21:30 Yes Mil
d
22 1 16M
AY2020 22:15 Yes Mil
d
23 2 17M
AY2020 23:15 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 21 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10004 24 3 18M
AY2020 23:00 Yes Mil
d
25 4 19M
AY2020 22:45 No
26 5 20M
AY2020 22:50 No
27 6 21M
AY2020 20:42 No
10005 0 24APR20
20 21:00 Yes Mod
erate
1 25APR20
20 19:30 Yes Mod
erate
2 26APR20
20 20:30 No
3 27APR20
20 20:30 No
4 28APR20
20 19:45 No
5 29APR20
20 20:00 No
6 30APR20
20 19:
30 No
7 01M
AY2020 19:30 No
8 02M
AY2020 20:00 No
21 0 15M
AY2020 19:00 Yes Mil
d
22 1 16M
AY2020 19:00 Yes Mil
d
23 2 17M
AY2020 19:00 No
24 3 18M
AY2020 19:00 No
25 4 19M
AY2020 19:00 No
Progra
m: Lsa
f_locR_2.sas (Page 22 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10005 26 5 20M
AY2020 19:00 No
27 6 21M
AY2020 19:00 No
28 7 22M
AY2020 19:00 No
29 8 23M
AY2020 No
10006 0 28APR20
20 22:00 No
1 29APR20
20 22:00 Yes Mil
d
2 30APR20
20 22:00 No
3 01M
AY2020 22:00 No
4 02M
AY2020 22:00 No
5 03M
AY2020 22:05 No
6 04M
AY2020 22:00 No
7 05M
AY2020 22:00 No
8 06M
AY2020 22:00 No
21 0 19M
AY2020 22:00 Yes Mil
d
22 1 20M
AY2020 22:00 Yes Mil
d
23 2 21M
AY2020 22:00 No
24 3 22M
AY2020 22:00 No
25 4 23M
AY2020 22:00 No
Progra
m: Lsa
f_locR_2.sas (Page 23 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local react
ions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10006 26 5 24M
AY2020 22:00 No
27 6 25M
AY2020 22:00 No
28 7 26M
AY2020 22:00 No
10007 0 23APR20
20 20:00 Yes Mil
d
1 24APR20
20 9:10 Yes Mil
d
2 25APR20
20 9:00 Yes Mil
d
3 26APR20
20 20:00 Yes Mil
d
4 27APR20
20 20:00 Yes Mil
d
5 28APR20
20 20:00 Yes Mil
d
6 29APR20
20 20:00 No
21 0 14M
AY2020 Yes Mod
erate
22 1 15M
AY2020 20:00 Yes Mod
erate
23 2 16M
AY2020 20:00 Yes Mil
d
24 3 17M
AY2020 20:00 Yes Mil
d
25 4 18M
AY2020 20:00 Yes Mil
d
26 5 19M
AY2020 20:00 No
27 6 20M
AY2020 21:00 No
28 7 21M
AY2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 24 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r pri
me
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10007 29 8 22M
AY2020 No
10008 0 28APR20
20 22:00 Yes Mod
erate
1 29APR20
20 22:
00 Yes Mil
d
2 30APR20
20 22:00 No
3 01M
AY2020 22:00 No
4 02M
AY2020 22:00 No
5 03M
AY2020 22:00 No
6 04M
AY2020 22:00 No
7 05M
AY2020 0:00 No
21 0 19M
AY2020 22:00 Yes Mil
d
22 1 20M
AY2020 22:00 Yes Mil
d
23 2 21M
AY2020 22:0
0 Yes Mil
d
24 3 22M
AY2020 22:00 No
25 4 23M
AY2020 22:00 No
26 5 24M
AY2020 22:00 No
27 6 25M
AY2020 22:00 No
28 7 26M
AY2020 22:00 No
10009 0 28APR20
20 21:00 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 25 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20
NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10009 1 29APR20
20 20:30 Yes Mil
d
2 30APR20
20 20:00 Yes Mil
d
3 01M
AY2020 20:00 No
4 02M
AY2020 20:00 No
5 03M
AY2020 20:00 No
6 04M
AY2020 20:00 No
7 05M
AY2020 20:00 No
8 06M
AY2020 20:00 No
21 0 19M
AY2020 22:00 Yes Mil
d
22 1 20M
AY2020 19:00 Yes Mil
d
23 2 21M
AY2020 19:00 Yes Mil
d
24 3 22M
AY2020 19:00 No
25 4 23M
AY2020 22:00 No
26 5 24M
AY2020 23:00 No
27 6 25M
AY2020 22:00 No
28 7 26M
AY2020 22:00 No
10010 0 24APR20
20 18:15 No
1 25APR20
20 18:15 Yes Seve
re
Progra
m: Lsa
f_locR_2.sas (Page 26 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10010 2 26APR20
20 18:15 Yes Mod
erate
3 27APR20
20 18:15 Yes Mod
erate
4 28APR20
20 18:30 Yes Mod
erate
5 29APR20
20 18:30 Yes Mod
erate
6 30APR20
20 18:15 Yes Mil
d
7 01M
AY2020 18:45 Yes Mil
d
8 02M
AY2020 19:00 Yes Mil
d
10011 1 25APR20
20 6:30 Yes Mil
d
2 26APR20
20 6:15 Yes Mil
d
3 27APR20
20 6:05 No
4 28APR20
20 6:20 No
5 29APR20
20 6:10 No
6 30APR20
20 6:05 No
7 01M
AY2020 9:00 No
8 02M
AY2020 9:30 No
21 0 15M
AY2020 22:00 Yes Mil
d
22 1 16M
AY2020 22:00 Yes Mil
d
23 2 17M
AY2020 22:15 No
Progra
m: Lsa
f_locR_2.sas (Page 27 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10011 24 3 18M
AY2020 23:00 No
25 4 19M
AY2020 22:30 No
26 5 20M
AY2020 21:45 No
27 6 21M
AY2020 22:10 No
28 7 22M
AY2020 7:15 No
10017 0 28APR20
20 22:00 Yes Mod
erate
1 29APR20
20 20:43 Yes Mod
erate
2 30APR20
20 21:55 No
3 01M
AY2020 22:07 No
4 02M
AY2020 22:43 No
5 03M
AY2020 22:00 No
6 04M
AY2020 22:00 No
7 05M
AY2020 22:00 No
21 0 19M
AY2020 22:00 Yes Mil
d
22 1 20M
AY2020 21:47 No
23 2 21M
AY2020 21:39 No
24 3 22M
AY2020 23:00 No
25 4 23M
AY2020 22:43 No
Progra
m: Lsa
f_locR_2.sas (Page 28 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3-1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10017 26 5 24M
AY2020 22:32 No
27 6 25M
AY2020 22:55 No
28 7 26M
AY2020 21:43 No
10019 0 28APR20
20 20:10 No
1 29APR20
20 20:20 No
2 30APR20
20 20:40 No
3 01M
AY2020 19:50 No
4 02M
AY2020 20:45 No
5 03M
AY2020 19:55 No
6 04M
AY2020 19:10 No
7 05M
AY2020 6:30 No
21 0 19M
AY2020 20:10 No
22 1 20M
AY2020 18:05 No
23 2 21M
AY2020 19:55 No
24 3 22M
AY2020 19:10 No
25 4 23M
AY2020 18:35 No
26 5 24M
AY2020 19:1
5 No
27 6 25M
AY2020 19:50 No
Progra
m: Lsa
f_locR_2.sas (Page 29 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Younger 10019 28 7 26M
AY2020 18:40 No
29 8 27M
AY2020 7:05 No
20 µg
Younger 10151 0 16J
UL2020 18:00 Yes Mil
d
1 17J
UL2020 20:00 Yes Mil
d
2 18J
UL2020 20:00 Yes Mil
d
3 19J
UL2020 20:00 Yes Mil
d
4 20J
UL2020 20:00 No
5 21J
UL2020 20:00 No
6 22J
UL2020 20:00 No
21 0 06AUG
2020 22:00 Yes Mil
d
22 1 07AUG
2020 22:00 Yes Mil
d
23 2 08AUG
2020 22:00 Yes Mil
d
24 3 09AUG
2020 22:00 Yes Mil
d
25 4 10AUG
2020 22:00 Yes Mil
d
26 5 11AUG
2020 22:00 Yes Mil
d
27 6 12AUG
2020 22:00 Yes Mil
d
28 7 13AUG
2020 9:00 No
10171 0 16J
UL2020 17:40 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 30 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10171 1 17J
UL2020 20:28 Yes Mil
d
2 18J
UL2020 20:10 Yes Mil
d
3 19J
UL2020 21:07 Yes Mil
d
4 20J
UL2020 21:51 No
5 21J
UL2020 20:48 No
6 22J
UL2020 21:19 No
21 0 06AUG
2020 20:22 Yes Mod
erate
22 1 07AUG
2020 20:10 Yes Mil
d
23 2 08AUG
2020 20:06 Yes Mil
d
24 3 09AUG
2020 19:40 Yes Mil
d
25 4 10AUG
2020 20:13 Yes Mil
d
26 5 11AUG
2020 20:08 No
27 6 12AUG
2020 20:45 No
10172 0 16J
UL2020 20:15 Yes Mod
erate
1 17J
UL2020 20:22 Yes Mil
d
2 18J
UL2020 20:40 No
3 19J
UL2020 20:15 No
4 20J
UL2020 20:20 No
Progra
m: Lsa
f_locR_2.sas (Page 31 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3-1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10172 5 21J
UL2020 20:15 No
6 22J
UL2020 20:15 No
21 0 06AUG
2020 19:50 Yes Mod
erate
22 1 07AUG
2020 22:00 No
23 2 08AUG
2020 21:50 No
24 3 09AUG
2020 22:30 No
25 4 10AUG
2020 21:20 No
26 5 11AUG
2020 21:10 No
27 6 12AUG
2020 20:50 No
10173 0 16J
UL2020 21:18 No
1 17J
UL2020 16:00 Yes Mil
d
2 18J
UL2020 9:30 No
3 19J
UL2020 22:00 No
4 20J
UL2020 8:40 No
5 21J
UL2020 8:30 No
6 22J
UL2020 21:30 No
21 0 06AUG
2020 22:00 Yes Mod
erate
22 1 07AUG
2020 14:00 No
Progra
m: Lsa
f_locR_2.sas (Page 32 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10173 23 2 08AUG
2020 22:00 Yes Mil
d
24 3 09AUG
2020 13:00 Yes Mil
d
25 4 10AUG
2020 22:00 No
26 5 11AUG
2020 22:05 No
27 6 12AUG
2020 22:20 No
10175 0 16J
UL2020 18:00 No
1 17J
UL2020 17:54 Yes Mil
d
2 18J
UL2020 18:18 No
3 19J
UL2020 18:09 No
4 20J
UL2020 18:31 No
5 21J
UL2020 18:24 No
6 22J
UL2020 18:07 No
7 23J
UL2020 7:39 No
21 0 06AUG
2020 21:00 Yes Mil
d
22 1 07AUG
2020 21:08 Yes Mil
d
23 2 08AUG
2020 21:01 Yes Mil
d
24 3 09AUG
2020 20:21 No
25 4 10AUG
2020 21:00 No
Progra
m: Lsa
f_locR_2.sas (Page 33 of 93)
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ngs - 6. Snap
shot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10175 26 5 11AUG
2020 20:48 No
27 6 12AUG
2020 21:05 No
28 7 13AUG
2020 5:46 No
10176 0 16J
UL2020 21:00 Yes Mil
d
1 17J
UL2020 20:30 Yes Mil
d
2 18J
UL2020 21:00 No
3 19J
UL2020 20:00 No
4 20J
UL2020 19:30 No
5 21J
UL2020 20:00 No
6 22J
UL2020 21:00 No
21 0 06AUG
2020 22:00 Yes Mil
d
22 1 07AUG
2020 22:00 Yes Mil
d
23 2 08AUG
2020 21:00 Yes Mil
d
24 3 09AUG
2020 22:00 Yes Mil
d
25 4 10AUG
2020 19:00 No
26 5 11AUG
2020 20:00 No
27 6 12AUG
2020 20:30 No
10178 0 16J
UL2020 20:15 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 34 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary co
mpliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10178 1 17J
UL2020 20:00 Yes Mil
d
2 18J
UL2020 20:20 Yes Mil
d
3 19J
UL2020 19:40 Yes Mil
d
4 20J
UL2020 20:00 Yes Mil
d
5 21J
UL2020 19:50 No
6 22J
UL2020 20:15 No
21 0 06AUG
2020 19:40 Yes Mil
d
22 1 07AUG
2020 19:0
0 Yes Mil
d
23 2 08AUG
2020 19:30 Yes Mil
d
24 3 09AUG
2020 19:30 No
25 4 10AUG
2020 20:00 No
26 5 11AUG
2020 19:45 No
27 6 12AUG
2020 19:30 No
28 7 13AUG
2020 9:00 No
10179 0 16J
UL2020 21:00 Yes Mil
d
1 17J
UL2020 21:00 No
2 18J
UL2020 21:00 No
3 19J
UL2020 21:00 No
Progra
m: Lsa
f_locR_2.sas (Page 35 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r pri
me
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10179 4 20J
UL2020 21:00 No
5 21J
UL2020 21:00 No
6 22J
UL2020 21:00 No
21 0 06AUG
2020 21:00 Yes Mil
d
22 1 07AUG
2020 21:00 No
23 2 08AUG
2020 21:00 No
24 3 09AUG
2020 21:00 No
25 4 10AUG
2020 21:00 No
26 5 11AUG
2020 21:00 No
27 6 12AUG
2020 21:00 No
28 7 13AUG
2020 10:00 No
10181 0 16J
UL2020 20:15 Yes Mod
erate
1 17J
UL2020 20:45 Yes Mod
erate
2 18J
UL2020 20:45 Yes Mil
d
3 19J
UL2020 20:30 No
4 20J
UL2020 20:40 No
5 21J
UL2020 21:00 No
6 22J
UL2020 20:20 No
Progra
m: Lsa
f_locR_2.sas (Page 36 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10181 21 0 06AUG
2020 20:30 Yes Mil
d
22 1 07AUG
2020 21:10 Yes Mil
d
23 2 08AUG
2020 20:40 Yes Mil
d
24 3 09AUG
2020 20:25 No
25 4 10AUG
2020 20:45 No
26 5 11AUG
2020 21:00 No
27 6 12AUG
2020 20:50 No
10182 0 16J
UL2020 19:31 Yes Mil
d
1 17J
UL2020 20:24 No
2 18J
UL2020 18:37 No
3 19J
UL2020 19:55 No
4 20J
UL2020 20:01 No
5 21J
UL2020 19:40 No
6 22J
UL2020 18:35 No
7 23J
UL2020 9:30 No
10183 0 16J
UL2020 20:30 Yes Seve
re
1 17J
UL2020 0:00 Yes Mod
erate
2 18J
UL2020 7:15 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 37 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo GmbH. B
ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10183 3 19J
UL2020 7:30 No
4 20J
UL2020 7:30 No
5 21J
UL2020 7:30 No
6 22J
UL2020 7:30 No
7 23J
UL2020 10:00 No
21 0 06AUG
2020 18:30 Yes Mil
d
22 1 07AUG
2020 20:10 Yes Mil
d
23 2 08AUG
2020 20:45 Yes Mil
d
24 3 09AUG
2020 21:00 Yes Mil
d
25 4 10AUG
2020 21:05 No
26 5 11AUG
2020 20:50 No
27 6 12AUG
2020 21:15 No
28 7 13AUG
2020 8:30 No
10197 0 16J
UL2020 20:30 Yes Mod
erate
1 17J
UL2020 20:30 Yes Seve
re
2 18J
UL2020 18:30 Yes Mod
erate
3 19J
UL2020 18:20 Yes Mil
d
4 20J
UL2020 18:00 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 38 of 93)
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ngs - 6. Snap
shot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Younger 10197 5 21J
UL2020 16:00 No
6 22J
UL2020 21:00 No
7 23J
UL2020 10:00 No
21 0 06AUG
2020 22:0
0 Yes Mil
d
22 1 07AUG
2020 18:30 Yes Mod
erate
23 2 08AUG
2020 18:30 Yes Mil
d
24 3 09AUG
2020 18:00 Yes Mil
d
25 4 10AUG
2020 17:15 Yes Mil
d
26 5 11AUG
2020 18:00 No
27 6 12AUG
2020 16:00 No
28 7 13AUG
2020 8:15 No
30 µg
Younger 10016 0 29APR20
20 Yes Seve
re
1 30APR20
20 Yes Mil
d
2 01M
AY2020 No
3 02M
AY2020 No
4 03M
AY2020 No
5 04M
AY2020 No
6 05M
AY2020 No
Progra
m: Lsa
f_locR_2.sas (Page 39 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary co
mpliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10016 21 0 20M
AY2020 Yes Mil
d
22 1 21M
AY2020 Yes Mod
erate
23 2 22M
AY2020 No
24 3 23M
AY2020 No
25 4 24M
AY2020 Yes Mil
d
26 5 25M
AY2020 No
27 6 26M
AY2020 No
28 7 27M
AY2020 No
10020 0 29APR20
20 19:50 No
1 30APR20
20 19:46 No
2 01M
AY2020 19:30 No
3 02M
AY2020 19:45 No
4 03M
AY2020 19:47 No
5 04M
AY2020 19:48 No
6 05M
AY2020 19:50 No
21 0 20M
AY2020 19:00 Yes Mil
d
22 1 21M
AY2020 19:05 No
23 2 22M
AY2020 18:55 No
Progra
m: Lsa
f_locR_2.sas (Page 40 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Snap
shot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10020 24 3 23M
AY2020 19:00 No
25 4 24M
AY2020 19:02 No
26 5 25M
AY2020 18:57 No
27 6 26M
AY2020 19:00 No
28 7 27M
AY2020 No
10021 0 05M
AY2020 20:00 Yes Mil
d
1 06M
AY2020 20:00 Yes Mil
d
2 07M
AY2020 20:00 No
3 08M
AY2020 20:00 No
4 09M
AY2020 20:00 No
5 10M
AY2020 20:01 Yes Mil
d
6 11M
AY2020 20:00 No
21 0 26M
AY2020 20:00 Yes Seve
re
22 1 27M
AY2020 20:00 Yes Mod
erate
23 2 28M
AY2020 20:00 Yes Mod
erate
24 3 29M
AY2020 20:00 No
25 4 30M
AY2020 20:00 No
26 5 31M
AY2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 41 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary co
mpliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10021 27 6 01J
UN2020 20:00 No
10028 0 07M
AY2020 21:27 Yes Mil
d
1 08M
AY2020 21:40 Yes Mil
d
2 09M
AY2020 22:00 Yes Mil
d
3 10M
AY2020 22:00 Yes Mil
d
4 11M
AY2020 22:00 No
5 12M
AY2020 22:00 No
6 13M
AY2020 22:0
0 No
7 14M
AY2020
21 0 28M
AY2020 22:00 Yes Mil
d
22 1 29M
AY2020 22:00 Yes Mod
erate
23 2 30M
AY2020 22:00 No
24 3 31M
AY2020 22:00 No
25 4 01J
UN2020 22:00 No
26 5 02J
UN2020 22:00 No
27 6 03J
UN2020 20:00 No
28 7 04J
UN2020 6:00 No
10031 0 07M
AY2020 22:00 Yes Seve
re
Progra
m: Lsa
f_locR_2.sas (Page 42 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r pri
me
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10031 1 08M
AY2020 22:00 Yes Mil
d
2 09M
AY2020 22:00 Yes Mil
d
3 10M
AY2020 21:3
0 No
4 11M
AY2020 22:00 No
5 12M
AY2020 22:00 No
6 13M
AY2020 22:00 No
21 0 28M
AY2020 22:00 Yes Mod
erate
22 1 29M
AY2020 22:00 Yes Mod
erate
23 2 30M
AY2020 22:00 Yes Mil
d
24 3 31M
AY2020 22:00 Yes Mil
d
25 4 01J
UN2020 22:00 Yes Mil
d
26 5 02J
UN2020 22:00 No
27 6 03J
UN2020 22:00 Yes Mil
d
28 7 04J
UN2020 9:11 No
10032 0 05M
AY2020 19:00 Yes Mil
d
1 06M
AY2020 18:33 Yes Mil
d
2 07M
AY2020 19:10 No
3 08M
AY2020 20:02 No
Progra
m: Lsa
f_locR_2.sas (Page 43 of 93)
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maceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10032 4 09M
AY2020 19:10 No
5 10M
AY2020 18:35 No
6 11M
AY2020 19:23 No
21 0 26M
AY2020 19:20 Yes Mil
d
22 1 27M
AY2020 18:35 Yes Mod
erate
23 2 28M
AY2020 18:55 No
24 3 29M
AY2020 19:05 No
25 4 30M
AY2020 19:09 No
26 5 31M
AY2020 20:05 No
27 6 01J
UN2020 18:55 No
10034 0 05M
AY2020 22:05 Yes Mil
d
1 06M
AY2020 20:10 Yes Mod
erate
2 07M
AY2020 20:1
0 Yes Mil
d
3 08M
AY2020 12:15 Yes Mil
d
4 09M
AY2020 20:00 Yes Mod
erate
5 10M
AY2020 20:00 Yes Mod
erate
6 11M
AY2020 20:10 Yes Mil
d
21 0 26M
AY2020 23:00 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 44 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All
TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10034 22 1 27M
AY2020 21:00 Yes Mod
erate
23 2 28M
AY2020 21:00 Yes Mil
d
24 3 29M
AY2020 21:00 No
25 4 30M
AY2020 21:00 No
26 5 31M
AY2020 21:00 No
27 6 01J
UN2020 21:00 No
10037 0 05M
AY2020 21:00 Yes Mil
d
1 06M
AY2020 21:00 Yes Mil
d
2 07M
AY2020 21:00 Yes Mil
d
3 08M
AY2020 21:00 No
4 09M
AY2020 21:00 No
5 10M
AY2020 21:00 No
6 11M
AY2020 21:00 No
21 0 26M
AY2020 21:00 Yes Mod
erate
22 1 27M
AY2020 21:00 Yes Mod
erate
23 2 28M
AY2020 21:00 Yes Mod
erate
24 3 29M
AY2020 21:00 Yes Mil
d
25 4 30M
AY2020 21:00 No
Progra
m: Lsa
f_locR_2.sas (Page 45 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based
on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compli
ance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10037 26 5 31M
AY2020 21:00 No
27 6 01J
UN2020 21:00 No
10038 0 07M
AY2020 21:00 Yes Mod
erate
1 08M
AY2020 21:00 No
2 09M
AY2020 21:00 No
3 10M
AY2020 21:00 No
4 11M
AY2020 21:00 No
5 12M
AY2020 21:00 No
6 13M
AY2020 21:00 No
7 14M
AY2020 21:00 No
21 0 28M
AY2020 21:00 No
22 1 29M
AY2020 21:00 No
23 2 30M
AY2020 21:00 No
24 3 31M
AY2020 21:00 No
25 4 01J
UN2020 21:00 No
26 5 02J
UN2020 21:00 No
27 6 03J
UN2020 21:00 No
28 7 04J
UN2020 8:30 No
Progra
m: Lsa
f_locR_2.sas (Page 46 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10039 No
0 07M
AY2020 22:00 Yes Seve
re
1 08M
AY2020 22:00 Yes Seve
re
2 09M
AY2020 22:00 Yes Mil
d
3 10M
AY2020 22:00 No
4 11M
AY2020 22:00 No
5 12M
AY2020 22:00 No
6 13M
AY2020 22:00 No
7 14M
AY2020 22:00 No
21 0 28M
AY2020 22:00 Yes Seve
re
22 1 29M
AY2020 22:00 Yes Mod
erate
23 2 30M
AY2020 22:00 Yes Mil
d
24 3 31M
AY2020 22:00 No
25 4 01J
UN2020 22:00 No
26 5 02J
UN2020 22:00 No
27 6 03J
UN2020 22:00 No
28 7 04J
UN2020 7:00 No
10043 0 07M
AY2020 20:00 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 47 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3-1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10043 1 08M
AY2020 20:00 Yes Seve
re
2 09M
AY2020 20:00 Yes Mod
erate
3 10M
AY2020 20:00 Yes Mil
d
4 11M
AY2020 20:00 Yes Mil
d
5 12M
AY2020 20:00 Yes Mil
d
6 13M
AY2020 20:00 No
21 0 28M
AY2020 20:00 Yes Mil
d
22 1 29M
AY2020 20:00 Yes Mod
erate
23 2 30M
AY2020 20:00 Yes Mil
d
24 3 31M
AY2020 20:00 Yes Mil
d
25 4 01J
UN2020 20:00 No
26 5 02J
UN2020 20:00 No
10047 0 07M
AY2020 23:00 Yes Mod
erate
1 08M
AY2020 23:45 Yes Mil
d
2 09M
AY2020 23:45 Yes Mil
d
3 10M
AY2020 23:40 Yes Mil
d
4 11M
AY2020 0:30 No
5 12M
AY2020 0:15 No
Progra
m: Lsa
f_locR_2.sas (Page 48 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
30 µg
Younger 10047 6 13M
AY2020 0:30 No
21 0 28M
AY2020 23:55 Yes Mod
erate
22 1 29M
AY2020 21:00 Yes Mod
erate
23 2 30M
AY2020 23:55 Yes Mil
d
24 3 31M
AY2020 22:00 Yes Mil
d
25 4 01J
UN2020 23:55 No
26 5 02J
UN2020 22:30 No
27 6 03J
UN2020 23:45 No
28 7 04J
UN2020 9:50 No
50 µg
Younger 10049 0 12M
AY2020 19:30 Yes Mod
erate
1 13M
AY2020 13:00 Yes Mil
d
2 14M
AY2020 13:45 No
3 15M
AY2020 13:45 No
4 16M
AY2020 14:00 No
5 17M
AY2020 14:00 No
6 18M
AY2020 14:00 No
21 0 02J
UN2020 23:0
0 Yes Mil
d
22 1 03J
UN2020 7:15 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 49 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r pri
me
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10049 23 2 04J
UN2020 9:00 No
24 3 05J
UN2020 9:00 No
25 4 06J
UN2020 11:0
0 No
26 5 07J
UN2020 11:00 No
27 6 08J
UN2020 11:15 No
10050 0 15M
AY2020 19:15 Yes Mod
erate
1 16M
AY2020 19:43 Yes Mod
erate
2 17M
AY2020 20:17 Yes Mod
erate
3 18M
AY2020 20:00 Yes Mil
d
4 19M
AY2020 21:20 Yes Mil
d
5 20M
AY2020 19:2
5 Yes Mil
d
6 21M
AY2020 20:13 Yes Mil
d
10053 0 12M
AY2020 20:00 Yes Mil
d
1 13M
AY2020 20:00 Yes Mod
erate
2 14M
AY2020 20:00 Yes Mil
d
3 15M
AY2020 20:00 Yes Mil
d
4 16M
AY2020 20:00 No
5 17M
AY2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 50 of 93)
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NTech RNA Pharmaceuticals GmbH / Listi
ngs - 6. Sn
apshot All
TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10053 6 18M
AY2020 20:00 No
21 0 02J
UN2020 20:00 Yes Mil
d
22 1 03J
UN2020 20:00 Yes Mil
d
23 2 04J
UN2020 20:00 No
24 3 05J
UN2020 20:00 No
25 4 06J
UN2020 20:00 No
26 5 07J
UN2020 20:00 No
27 6 08J
UN2020 20:00 No
10055 0 13M
AY2020 17:30 No
1 14M
AY2020 21:30 Yes Mil
d
2 15M
AY2020 22:00 Yes Mil
d
3 16M
AY2020 23:40 No
4 17M
AY2020 20:38 No
5 18M
AY2020 22:21 No
6 19M
AY2020 20:08 No
21 0 03J
UN2020 8:30 Yes Mil
d
22 1 04J
UN2020 22:48 Yes Mil
d
23 2 05J
UN2020 23:46 No
Progra
m: Lsa
f_locR_2.sas (Page 51 of 93)
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2b1
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2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compli
ance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10055 24 3 06J
UN2020 23:26 No
25 4 07J
UN2020 22:02 No
26 5 08J
UN2020 23:40 No
10056 0 13M
AY2020 20:30 Yes Mil
d
1 14M
AY2020 20:30 Yes Mil
d
2 15M
AY2020 20:30 No
3 16M
AY2020 20:30 No
4 17M
AY2020 20:30 No
5 18M
AY2020 20:30 No
6 19M
AY2020 No
21 0 03J
UN2020 21:30 Yes Mil
d
22 1 04J
UN2020 21:30 Yes Mod
erate
23 2 05J
UN2020 21:30 Yes Mil
d
24 3 06J
UN2020 21:30 Yes Mil
d
25 4 07J
UN2020 21:30 No
26 5 08J
UN2020 21:30 No
10057 0 15M
AY2020 20:00 Yes Mil
d
1 16M
AY2020 20:00 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 52 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10057 2 17M
AY2020 20:00 No
3 18M
AY2020 20:00 No
4 19M
AY2020 20:00 No
5 20M
AY2020 20:00 No
6 21M
AY2020 20:00 No
21 0 05J
UN2020 20:38 Yes Seve
re
22 1 06J
UN2020 17:30 Yes Mil
d
23 2 07J
UN2020 14:00 Yes Mil
d
24 3 08J
UN2020 14:00 Yes Mil
d
25 4 09J
UN2020 14:00 No
26 5 10J
UN2020 14:0
0 No
27 6 11J
UN2020 14:00 No
10059 0 13M
AY2020 16:50 Yes Mod
erate
1 14M
AY2020 17:00 Yes Mod
erate
2 15M
AY2020 17:50 Yes Mod
erate
3 16M
AY2020 17:30 Yes Mod
erate
4 17M
AY2020 17:15 Yes Mod
erate
5 18M
AY2020 19:00 No
Progra
m: Lsa
f_locR_2.sas (Page 53 of 93)
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2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10059 6 19M
AY2020 22:00 No
21 0 03J
UN2020 11:50 Yes Mod
erate
22 1 04J
UN2020 10:00 Yes Mod
erate
23 2 05J
UN2020 18:00 Yes Mod
erate
24 3 06J
UN2020 17:00 Yes Mod
erate
25 4 07J
UN2020 20:00 Yes Mod
erate
26 5 08J
UN2020 14:20 Yes Mil
d
10060 0 13M
AY2020 11:16 No
1 14M
AY2020 18:00 Yes Seve
re
2 15M
AY2020 18:00 No
3 16M
AY2020 18:00 No
4 17M
AY2020 18:0
0 No
5 18M
AY2020 18:00 No
6 19M
AY2020 18:05 No
21 0 03J
UN2020 10:00 No
22 1 04J
UN2020 6:00 Yes Mil
d
23 2 05J
UN2020 6:00 No
24 3 06J
UN2020 6:00 No
Progra
m: Lsa
f_locR_2.sas (Page 54 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10060 25 4 07J
UN2020 6:00 No
26 5 08J
UN2020 6:00 No
27 6 09J
UN2020 6:03 No
10067 0 15M
AY2020 22:00 Yes Mil
d
1 16M
AY2020 22:00 No
2 17M
AY2020 22:00 No
3 18M
AY2020 22:00 No
4 19M
AY2020 22:00 No
5 20M
AY2020 22:00 No
6 21M
AY2020 22:00 No
21 0 05J
UN2020 22:00 Yes Mil
d
22 1 06J
UN2020 22:00 Yes Mod
erate
23 2 07J
UN2020 22:00 No
24 3 08J
UN2020 22:00 No
25 4 09J
UN2020 22:0
0 No
26 5 10J
UN2020 22:00 No
27 6 11J
UN2020 22:00 No
10068 0 15M
AY2020 22:30 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 55 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV
2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10068 1 16M
AY2020 23:0
0 Yes Mod
erate
2 17M
AY2020 22:30 Yes Mod
erate
3 18M
AY2020 23:00 Yes Mod
erate
4 19M
AY2020 23:00 Yes Mod
erate
5 20M
AY2020 23:30 Yes Mil
d
6 21M
AY2020 23:00 No
21 0 05J
UN2020 22:30 Yes Mod
erate
22 1 06J
UN2020 22:00 Yes Mod
erate
23 2 07J
UN2020 22:30 Yes Mod
erate
24 3 08J
UN2020 23:00 Yes Mod
erate
25 4 09J
UN2020 23:00 Yes Mil
d
26 5 10J
UN2020 23:30 Yes Mil
d
27 6 11J
UN2020 23:00 Yes Mil
d
10070 0 15M
AY2020 19:00 No
1 16M
AY2020 19:00 Yes Seve
re
2 17M
AY2020 19:0
0 Yes Mod
erate
3 18M
AY2020 19:15 Yes Mod
erate
4 19M
AY2020 19:00 Yes Mod
erate
Progra
m: Lsa
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10070 5 20M
AY2020 19:00 No
6 21M
AY2020 19:00 No
21 0 05J
UN2020 19:00 Yes Seve
re
22 1 06J
UN2020 19:00 Yes Mil
d
23 2 07J
UN2020 19:00 Yes Mil
d
24 3 08J
UN2020 19:00 No
25 4 09J
UN2020 19:00 No
26 5 10J
UN2020 19:00 No
27 6 11J
UN2020 19:15 No
10073 0 15M
AY2020 22:1
5 No
1 16M
AY2020 22:00 Yes Mil
d
2 17M
AY2020 22:20 No
3 18M
AY2020 21:37 No
4 19M
AY2020 22:30 No
5 20M
AY2020 22:14 No
6 21M
AY2020 21:53 No
21 0 05J
UN2020 22:23 Yes Seve
re
22 1 06J
UN2020 16:10 Yes Seve
re
Progra
m: Lsa
f_locR_2.sas (Page 57 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
50 µg
Younger 10073 23 2 07J
UN2020 22:46 Yes Seve
re
24 3 08J
UN2020 23:20 Yes Mod
erate
25 4 09J
UN2020 1:04 Yes Mil
d
26 5 10J
UN2020 23:3
7 No
27 6 11J
UN2020 23:06 No
60 µg
Younger 10066 0 19M
AY2020 21:55 Yes Mod
erate
1 20M
AY2020 21:54 Yes Mod
erate
2 21M
AY2020 21:55 Yes Mil
d
3 22M
AY2020 21:55 Yes Mil
d
4 23M
AY2020 21:55 No
5 24M
AY2020 21:55 No
6 25M
AY2020 21:5
5 No
7 26M
AY2020 21:55 No
8 27M
AY2020 21:55 No
10075 0 22M
AY2020 22:05 Yes Seve
re
1 23M
AY2020 22:00 Yes Seve
re
2 24M
AY2020 22:00 Yes Mod
erate
3 25M
AY2020 22:00 Yes Mil
d
Progra
m: Lsa
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created on 20
NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
60 µg
Younger 10075 4 26M
AY2020 22:00 Yes Mil
d
5 27M
AY2020 22:30 Yes Mil
d
6 28M
AY2020 22:00 No
7 29M
AY2020 5:00 No
10076 0 22M
AY2020 22:00 Yes Mil
d
1 23M
AY2020 22:0
0 Yes Mil
d
2 24M
AY2020 21:52 No
3 25M
AY2020 22:07 No
4 26M
AY2020 22:15 No
5 27M
AY2020 22:05 No
6 28M
AY2020 21:58 No
10078 0 22M
AY2020 23:15 Yes Mil
d
1 23M
AY2020 22:45 Yes Mod
erate
2 24M
AY2020 22:40 No
3 25M
AY2020 23:30 No
4 26M
AY2020 23:05 No
5 27M
AY2020 23:15 No
6 28M
AY2020 22:45 No
Progra
m: Lsa
f_locR_2.sas (Page 59 of 93)
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
60 µg
Younger 10078 21 12J
UN2020 22:45 No
22 13J
UN2020 23:05 No
23 14J
UN2020 23:15 No
24 15J
UN2020 22:50 No
25 16J
UN2020 22:55 No
26 17J
UN2020 23:30 No
27 18J
UN2020 22:55 No
10083 0 20M
AY2020 19:21 Yes Mil
d
1 21M
AY2020 18:45 Yes Mil
d
2 22M
AY2020 20:00 Yes Mil
d
3 23M
AY2020 21:05 No
4 24M
AY2020 20:00 No
5 25M
AY2020 22:10 No
6 26M
AY2020 21:20 No
10084 0 22M
AY2020 20:30 Yes Mil
d
1 23M
AY2020 20:30 Yes Mil
d
2 24M
AY2020 20:30 No
3 25M
AY2020 20:30 No
Progra
m: Lsa
f_locR_2.sas (Page 60 of 93)
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apshot All TLFs Fin
al 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
60 µg
Younger 10084 4 26M
AY2020 20:30 No
5 27M
AY2020 20:30 No
6 28M
AY2020 20:30 No
10085 0 22M
AY2020 23:00 Yes Mod
erate
1 23M
AY2020 21:50 Yes Mod
erate
2 24M
AY2020 22:15 Yes Mil
d
3 25M
AY2020 22:00 No
4 26M
AY2020 21:45 No
5 27M
AY2020 20:00 No
6 28M
AY2020 22:00 No
21 12J
UN2020 21:30 No
22 13J
UN2020 20:45 No
23 14J
UN2020 21:00 No
24 15J
UN2020 20:00 No
25 16J
UN2020 20:15 No
26 17J
UN2020 21:00 No
27 18J
UN2020 14:30 No
10089 0 20M
AY2020 22:00 Yes Mod
erate
Progra
m: Lsa
f_locR_2.sas (Page 61 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compli
ance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
60 µg
Younger 10089 1 21M
AY2020 22:00 Yes Mod
erate
2 22M
AY2020 22:00 Yes Mil
d
3 23M
AY2020 22:00 Yes Mil
d
4 24M
AY2020 22:00 No
5 25M
AY2020 22:00 No
6 26M
AY2020 22:00 No
10093 0 20M
AY2020 19:00 Yes Mil
d
1 21M
AY2020 18:4
5 Yes Mil
d
2 22M
AY2020 20:05 No
3 23M
AY2020 21:45 No
4 24M
AY2020 20:20 No
5 25M
AY2020 19:00 No
6 26M
AY2020 21:00 No
10096 0 19M
AY2020 22:49 Yes Mil
d
1 20M
AY2020 19:30 Yes Mil
d
2 21M
AY2020 19:00 No
3 22M
AY2020 20:0
0 No
4 23M
AY2020 23:00 No
Progra
m: Lsa
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
60 µg
Younger 10096 5 24M
AY2020 22:12 No
6 25M
AY2020 21:37 No
7 26M
AY2020 21:30 No
8 27M
AY2020 20:46 No
21 09J
UN2020 23:30 No
22 10J
UN2020 22:05 No
23 11J
UN2020 22:35 No
24 12J
UN2020 23:00 No
25 13J
UN2020 22:40 No
26 14J
UN2020 23:10 No
27 15J
UN2020 23:45 No
28 16J
UN2020 23:30 No
10103 0 22M
AY2020 20:4
8 Yes Mod
erate
1 23M
AY2020 15:18 Yes Mil
d
2 24M
AY2020 21:53 No
3 25M
AY2020 19:50 No
4 26M
AY2020 14:56 No
5 27M
AY2020 19:32 No
Progra
m: Lsa
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apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary
compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st sev
erity/
Inten
sity
10 µg
Older 10273 0 27AUG
2020 18:10 No
1 28AUG
2020 18:10 No
2 29AUG
2020 18:10 No
3 30AUG
2020 18:10 No
4 31AUG
2020 18:10 No
5 01SEP2
020 18:10 No
6 02SEP2
020 18:10 No
21 0 17SEP2
020 18:30 No
22 1 18SEP2
020 18:30 No
23 2 19SEP2
020 18:30 No
60 µg
Younger 10103 6 28M
AY2020 21:03 No
10104 0 20M
AY2020 22:00 Yes Mod
erate
1 21M
AY2020 22:00 Yes Mod
erate
2 22M
AY2020 22:00 Yes Mil
d
3 23M
AY2020 23:00 Yes Mil
d
4 24M
AY2020 22:00 Yes Mil
d
5 25M
AY2020 22:00 No
6 26M
AY2020 22:00 No
Progra
m: Lsa
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10273 24 3 20SEP2
020 18:30 No
25 4 21SEP2
020 18:30 No
26 5 22SEP2
020 18:30 No
27 6 23SEP2
020 18:30 No
10274 0 27AUG
2020 20:45 No
1 28AUG
2020 20:15 No
2 29AUG
2020 20:30 No
3 30AUG
2020 19:30 No
4 31AUG
2020 19:45 No
5 01SEP2
020 19:30 No
6 02SEP2
020 20:45 No
21 0 17SEP2
020 20:30 No
22 1 18SEP2
020 20:00 Yes Mil
d
23 2 19SEP2
020 21:00 Yes Mil
d
24 3 20SEP2
020 19:45 Yes Mil
d
25 4 21SEP2
020 20:15 Yes Mil
d
26 5 22SEP2
020 20:00 Yes Mil
d
27 6 23SEP2
020 19:15 No
Progra
m: Lsa
f_locR_2.sas (Page 65 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10282 0 20AUG
2020 18:50 Yes Mil
d
1 21AUG
2020 19:00 Yes Mil
d
2 22AUG
2020 19:00
3 23AUG
2020 19:00
4 24AUG
2020 19:0
0
5 25AUG
2020 19:00
6 26AUG
2020 19:00
7 27AUG
2020
21 0 10SEP2
020 16:00 Yes Mil
d
22 1 11SEP2
020 18:00 Yes Mil
d
23 2 12SEP2
020 19:00 No
24 3 13SEP2
020 19:00 No
25 4 14SEP2
020 19:00 No
26 5 15SEP2
020 19:00 No
27 6 16SEP2
020 19:00 No
28 7 17SEP2
020 7:00 No
10283 0 27AUG
2020 21:00 Yes Mil
d
1 28AUG
2020 21:30 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 66 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local react
ions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10283 2 29AUG
2020 21:00 No
3 30AUG
2020 21:05 No
4 31AUG
2020 21:00 No
5 01SEP2
020 19:30 No
6 02SEP2
020 21:00 No
7 03SEP2
020 7:00 No
21 0 17SEP2
020 21:00 Yes Mil
d
22 1 18SEP2
020 21:00 Yes Mil
d
23 2 19SEP2
020 21:00 No
24 3 20SEP2
020 21:00 No
25 4 21SEP2
020 21:00 No
26 5 22SEP2
020 21:00 No
27 6 23SEP2
020 21:00 No
10286 0 25AUG
2020 18:30 Yes Mil
d
1 26AUG
2020 18:30 Yes Mil
d
2 27AUG
2020 18:30 No
3 28AUG
2020 18:30 No
4 29AUG
2020 18:30 No
Progra
m: Lsa
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apshot All
TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10286 5 30AUG
2020 18:35 No
6 31AUG
2020 18:20 No
21 0 15SEP2
020 20:00 Yes Mil
d
22 1 16SEP2
020 20:00 No
23 2 17SEP2
020 21:00 No
24 3 18SEP2
020 20:00 No
25 4 19SEP2
020 20:30 No
26 5 20SEP2
020 20:00 No
27 6 21SEP2
020 20:00 No
10287 0 25AUG
2020 21:00 Yes Mil
d
1 26AUG
2020 0:00 Yes Mil
d
2 27AUG
2020 0:00 No
3 28AUG
2020 0:00 No
4 29AUG
2020 0:00 No
5 30AUG
2020 0:00 No
6 31AUG
2020 23:40 No
21 0 15SEP2
020 23:10 Yes Mod
erate
22 1 16SEP2
020 23:00 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 68 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compli
ance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10287 23 2 17SEP2
020 0:00 Yes Mil
d
24 3 18SEP2
020 1:20 Yes Mil
d
25 4 19SEP2
020 1:15 Yes Mil
d
26 5 20SEP2
020 1:05 Yes Mil
d
27 6 21SEP2
020 1:05 No
10288 0 25AUG
2020 21:00 Yes Mil
d
1 26AUG
2020 21:00 Yes Mil
d
2 27AUG
2020 21:00 No
3 28AUG
2020 21:00 No
4 29AUG
2020 21:00 No
5 30AUG
2020 21:00 No
6 31AUG
2020 21:00 No
21 0 15SEP2
020 23:00 Yes Mil
d
22 1 16SEP2
020 23:00 Yes Mil
d
23 2 17SEP2
020 23:00 Yes Mil
d
24 3 18SEP2
020 23:00 Yes Mil
d
25 4 19SEP2
020 23:00 Yes Mil
d
26 5 20SEP2
020 23:00 Yes Mil
d
Progra
m: Lsa
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect num
ber Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10288 27 6 21SEP2
020 23:00 Yes Mil
d
10289 0 20AUG
2020 22:00 No
1 21AUG
2020 22:20 No
2 22AUG
2020 22:20 No
3 23AUG
2020 22:30 No
4 24AUG
2020 22:15 No
5 25AUG
2020 22:15 No
6 26AUG
2020 21:35 No
21 0 10SEP2
020 22:30 No
22 1 11SEP2
020 23:30 No
23 2 12SEP2
020 23:00 No
24 3 13SEP2
020 23:05 No
25 4 14SEP2
020 23:30 No
26 5 15SEP2
020 23:00 No
27 6 16SEP2
020 22:30 No
10291 0 25AUG
2020 22:00 No
1 26AUG
2020 21:00 No
2 27AUG
2020 20:00 No
Progra
m: Lsa
f_locR_2.sas (Page 70 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10291 3 28AUG
2020 20:00 No
4 29AUG
2020 22:00 No
5 30AUG
2020 20:00 No
6 31AUG
2020 20:00 No
21 0 15SEP2
020 20:00 No
22 1 16SEP2
020 20:00 No
23 2 17SEP2
020 21:00 No
24 3 18SEP2
020 21:00 No
25 4 19SEP2
020 20:00 No
26 5 20SEP2
020 20:00 No
27 6 21SEP2
020 21:00 No
10292 0 27AUG
2020 21:05 No
1 28AUG
2020 20:35 No
2 29AUG
2020 20:45 No
3 30AUG
2020 20:45 No
4 31AUG
2020 20:3
0 No
5 01SEP2
020 20:45 No
6 02SEP2
020 20:45 No
Progra
m: Lsa
f_locR_2.sas (Page 71 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10292 21 0 17SEP2
020 20:45 No
22 1 18SEP2
020 21:30 No
23 2 19SEP2
020 20:30 No
24 3 20SEP2
020 21:45 No
25 4 21SEP2
020 20:45 No
26 5 22SEP2
020 20:30 No
27 6 23SEP2
020 21:30 No
10298 0 27AUG
2020 20:15 Yes Mil
d
1 28AUG
2020 20:08 Yes Mil
d
2 29AUG
2020 20:10 Yes Mil
d
3 30AUG
2020 20:16 No
4 31AUG
2020 20:18 No
5 01SEP2
020 20:12 No
6 02SEP2
020 20:20 No
21 0 17SEP2
020 1:00 Yes Mod
erate
22 1 18SEP2
020 10:00 Yes Mod
erate
23 2 19SEP2
020 16:00 Yes Mil
d
24 3 20SEP2
020 20:00 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 72 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
10 µg
Older 10298 25 4 21SEP2
020 20:10 Yes Mil
d
26 5 22SEP2
020 20:05 Yes Mil
d
27 6 23SEP2
020 20:10 Yes Mil
d
10320 0 27AUG
2020 19:00 Yes Mil
d
1 28AUG
2020 19:00 Yes Mil
d
2 29AUG
2020 19:00 No
3 30AUG
2020 19:00 No
4 31AUG
2020 19:00 No
5 01SEP2
020 19:30 No
6 02SEP2
020 19:00 No
21 0 17SEP2
020 Yes Mod
erate
22 1 18SEP2
020 10:00 Yes Mod
erate
23 2 19SEP2
020 10:0
0 Yes Mod
erate
24 3 20SEP2
020 10:00 Yes Mil
d
25 4 21SEP2
020 10:00 Yes Mil
d
26 5 22SEP2
020 10:30 Yes Mil
d
27 6 23SEP2
020 10:00 Yes Mil
d
20 µg
Older 20207 0 09SEP2
020 20:30 Yes Mil
d
Progra
m: Lsa
f_locR_2.sas (Page 73 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the info
rmation in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Older 20207 1 10SEP2
020 20:00 Yes Mil
d
2 11SEP2
020 19:45 No
3 12SEP2
020 21:00 No
4 13SEP2
020 20:00 No
5 14SEP2
020 19:50 No
6 15SEP2
020 9:24 No
21 0 30SEP2
020 19:00 Yes Mil
d
22 1 01O
CT2020 20:00 Yes Mil
d
23 2 02O
CT2020 20:30 Yes Mil
d
24 3 03O
CT2020 19:30 No
25 4 04O
CT2020 20:00 No
26 5 05O
CT2020 19:00 No
27 6 06O
CT2020 20:15 No
28 7 07O
CT2020 7:26 No
20211 0 08SEP2
020 20:3
0 Yes Mil
d
1 09SEP2
020 20:30 Yes Mil
d
2 10SEP2
020 20:30 Yes Mil
d
3 11SEP2
020 20:30 No
Progra
m: Lsa
f_locR_2.sas (Page 74 of 93)
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ngs - 6. Sn
apshot All TLFs Final 1.0 BNT16
2b1
BNT16
2-01 Created
on 20NOV2020
Staburo G
mbH. Based on clean SDTM data rece
ived on 03NOV2020. Data cut -off: 23O
CT2020. Listing
16.2.3 -1.2-1: Lis
ting of diary compliance local reactions - BNT
162b1
Safety
set
Dose g
roup Subj
ect number Num be
r of days
afte
r prime
imm
unization Num be
r of days
afte
r boost
imm
unization Date/t
ime of collection of the information in the diary Any l
ocal
reac
tion Wor
st severity/
Inten
sity
20 µg
Older 202
…[truncated]