Document text
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
1 µg
Yo
unger 10015 3.0
, 17 Apr 2020
5.0
, 26
MAY 2020
7.0
, 26 JUN 2020 23
APR2020
10
JUN2020
22
JUL2020 23
APR2020 29
APR2020 20
MAY2020 17
JUN2020
10018 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 23
APR2020
10
JUN2020
21
JUL2020 23
APR2020 29
APR2020 20
MAY2020 17
JUN2020
10023 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 24
APR2020
16
JUN2020
28
JUL2020 24
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10025 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 24
APR2020
16
JUN2020
28
JUL2020 24
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10033 3.0
, 17
Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
16
JUN2020
28
JUL2020 27
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10036 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
04
JUN2020
31
JUL2020 27
APR2020 08
MAY2020 29
MAY2020 25
JUN2020
10040 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 28
APR2020
04
JUN2020 28
APR2020 08
MAY2020 29
MAY2020 25
JUN2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 1 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 1
FDA-CBER-2021-5683-0049453
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
1 µg
Yo
unger 10041 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 28
APR2020
04
JUN2020 28
APR2020 08
MAY2020 29
MAY2020 25
JUN2020
10042 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 28
APR2020
04
JUN2020 28
APR2020 08
MAY2020 29
MAY2020 25
JUN2020
10045 3.0
, 17 Apr 2020
5.0
, 26
MAY 2020
7.0
, 26 JUN 2020 28
APR2020
16
JUN2020
28
JUL2020 28
APR2020 05
MAY2020 26
MAY2020 23
JUN2020
10048 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 28
APR2020
04
JUN2020 28
APR2020 08
MAY2020 29
MAY2020 25
JUN2020
10052 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 05
MAY2020
03
JUN2020 05
MAY2020 08
MAY2020 29
MAY2020 03
JUL2020
3 µg
Yo
unger 10170 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 02
JUL2020
30
JUL2020
07
AUG2020
18
SEP2020 02
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
10194 7.0
, 26 JUN 20
20
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 13
JUL2020
12
AUG2020
14
OCT2020 13
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 2 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 2
FDA-CBER-2021-5683-0049454
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. Sn
apshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
3 µg
Yo
unger 10198 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 15
JUL2020
12
AUG2020
14
OCT2020 15
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
10200 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 15
JUL2020
12
AUG2020
14
OCT2020 15
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
10204 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 15
JUL2020
12
AUG2020 15
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
10209 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
JUL2020
12
AUG2020
14
OCT2020 17
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
10212 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
JUL2020
12
AUG2020
14
OCT2020 17
JUL2020 22
JUL2020 12
AUG2020 08
SEP2020
10221 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
JUL2020
07
AUG2020
18
SEP2020 24
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
10224 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
JUL2020
07
AUG2020
18
SEP2020 24
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 3 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 3
FDA-CBER-2021-5683-0049455
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDT
M data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subj
ects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
3 µg
Yo
unger 10225 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
JUL2020
07
AUG2020
18
SEP2020 24
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
10226 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL
2020 24
JUL2020
07
AUG2020
18
SEP2020 24
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
10227 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
JUL2020
07
AUG2020
18
SEP2020 24
JUL2020 31
JUL2020 21
AUG2020 18
SEP2020
10
µg
Yo
unger 10001 3.0
, 17 Apr 2020
5.0
, 26
MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 22
APR2020
04
JUN2020
17
JUL2020
23
OCT2020 22
APR2020 24
APR2020 15
MAY2020 12
JUN2020 23
OCT2020
10003 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 22
APR2020
09
JUN2020
21
JUL2020 22
APR2020 28
APR2020 19
MAY2020 17
JUN2020
10004 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 22
APR2020
04
JUN2020
23
OCT2020 22
APR2020 24
APR2020 15
MAY2020 12
JUN2020
10005 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 22
APR2020
04
JUN2020 22
APR2020 24
APR2020 15
MAY2020 12
JUN2020 23
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 4 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 4
FDA-CBER-2021-5683-0049456
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of pri
me
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Yo
unger 10006 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 22
APR2020
09
JUN2020
21
JUL2020 22
APR2020 28
APR2020 19
MAY2020 17
JUN2020
10007 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 22
APR2020
04
JUN2020
17
JUL2020
23
OCT2020 22
APR2020 23
APR2020 14
MAY2020 12
JUN2020
10008 3.0
, 17 Apr 2020
5.0
, 26 MA
Y 2020
7.0
, 26 JUN 2020 22
APR2020
09
JUN2020
21
JUL2020 22
APR2020 28
APR2020 19
MAY2020 17
JUN2020
10009 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 22
APR2020
09
JUN2020
21
JUL2020 22
APR2020 28
APR2020 19
MAY2020 17
JUN2020
10010 3.0
, 17 Apr 2020 22
APR2020 22
APR2020 24
APR2020 19
MAY2020 Adv
erse Event
10011 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 22
APR2020
04
JUN2020
17
JUL2020 22
APR2020 24
APR2020 15
MAY2020 12
JUN2020 23
OCT2020
10017 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 23
APR2020
09
JUN2020
21
JUL2020 23
APR2020 28
APR2020 19
MAY2020 17
JUN2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 5 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 5
FDA-CBER-2021-5683-0049457
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col ve
rsions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Yo
unger 10019 3.0
, 17
Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 23
APR2020
09
JUN2020
21
JUL2020 23
APR2020 28
APR2020 19
MAY2020 17
JUN2020
20
µg
Yo
unger 10151 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
JUN2020
16
JUL2020
13
AUG2020
09
OCT2020 17
JUN2020 16
JUL2020 06
AUG2020 03
SEP2020
10171 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020
09
OCT2020 07
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
10172 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 20
20
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020
15
OCT2020 07
JUL2020 16
JUL2020 06
AUG2020 02
SEP2020
10173 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020
09
OCT2020 07
JUL2020 16
JUL2020 06
AUG2020 02
SEP2020
10175 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020
09
OCT2020 07
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
10176 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020 07
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 6 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 6
FDA-CBER-2021-5683-0049458
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20
µg
Yo
unger 10178 5.0
, 26 MAY 2020
7.0
, 26 JUN
2020
8.0
, 21 JUL 2020 07
JUL2020
16
JUL2020
13
AUG2020 07
JUL2020 16
JUL2020 06
AUG2020 09
SEP2020 Oth
er
10179 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 09
JUL2020
16
JUL2020
13
AUG2020
09
OCT2020 09
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
10181 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 09
JUL2020
16
JUL2020
13
AUG2020
14
OCT2020 09
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
10182 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 09
JUL2020
16
JUL2020 09
JUL2020 16
JUL2020 23
JUL2020 Wi
thdrawal By Subject
10183 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 09
JUL2020
16
JUL2020
13
AUG2020
09
OCT2020 09
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
10197 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 13
JUL2020
13
AUG2020
09
OCT2020 13
JUL2020 16
JUL2020 06
AUG2020 03
SEP2020
30
µg
Yo
unger 10016 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 23
APR2020
10
JUN2020
22
JUL2020 23
APR2020 29
APR2020 20
MAY2020 17
JUN2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 7 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 7
FDA-CBER-2021-5683-0049459
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Yo
unger 10020 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 24
APR2020
10
JUN2020
22
JUL2020 24
APR2020 29
APR2020 20
MAY2020 17
JUN2020
10021 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 24
APR2020
16
JUN2020
28
JUL2020 24
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10028 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
04
JUN2020
30
JUL2020 27
APR2020 07
MAY2020 28
MAY2020 25
JUN2020
10031 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 27
APR2020
04
JUN2020 27
APR2020 07
MAY2020 28
MAY2020 27
JUN2020
10032 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
16
JUN2020
28
JUL2020 27
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10034 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
16
JUN2020
28
JUL2020 27
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
10037 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
16
JUN2020
28
JUL2020 27
APR2020 05
MAY2020 26
MAY2020 22
JUN2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 8 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 8
FDA-CBER-2021-5683-0049460
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro Gm
bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Yo
unger 10038 3.0
, 17 Apr 2020
5.0
, 26 MA
Y 2020
7.0
, 26 JUN 2020 27
APR2020
04
JUN2020
24
JUL2020 27
APR2020 07
MAY2020 28
MAY2020 25
JUN2020
10039 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 27
APR2020
04
JUN2020
30
JUL2020 27
APR2020 07
MAY2020 28
MAY2020 25
JUN2020
10043 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 28
APR2020
03
JUN2020
30
JUL2020 28
APR2020 07
MAY2020 28
MAY2020 25
JUN2020
10047 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 28
APR2020
04
JUN2020
30
JUL2020 28
APR2020 07
MAY2020 28
MAY2020 25
JUN2020
50
µg
Yo
unger 10049 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 05
MAY2020
09
JUN2020 05
MAY2020 12
MAY2020 02
JUN2020 30
JUN2020
10050 3.0
, 17 Apr 2020 05
MAY2020 05
MAY2020 15
MAY2020 03
JUN2020 Oth
er
10053 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 05
MAY2020
09
JUN2020 05
MAY2020 12
MAY2020 02
JUN2020 30
JUN2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 9 of 18
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
50
µg
Yo
unger 10055 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 07
MAY2020
03
JUN2020 07
MAY2020 13
MAY2020 03
JUN2020 30
JUN2020
10056 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 07
MAY2020
03
JUN2020 07
MAY2020 13
MAY2020 03
JUN2020 30
JUN2020
10057 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 07
MAY2020
05
JUN2020
11
AUG2020 07
MAY2020 15
MAY2020 05
JUN2020 03
JUL2020
10059 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 07
MAY2020
03
JUN2020 07
MAY2020 13
MAY2020 03
JUN2020 30
JUN2020
10060 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020 07
MAY2020
03
JUN2020 07
MAY2020 13
MAY2020 03
JUN2020 30
JUN2020
10067 3.0
, 17
Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 08
MAY2020
05
JUN2020
07
AUG2020 08
MAY2020 15
MAY2020 05
JUN2020 03
JUL2020
10068 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 08
MAY2020
05
JUN2020
11
AUG2020 08
MAY2020 15
MAY2020 05
JUN2020 03
JUL2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 10 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
50
µg
Yo
unger 10070 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 08
MAY2020
05
JUN2020
07
AUG2020 08
MAY2020 15
MAY2020 05
JUN2020 03
JUL2020
10073 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 11
MAY2020
05
JUN2020
07
AUG2020 11
MAY2020 15
MAY2020 05
JUN2020 03
JUL2020
60
µg
Yo
unger 10066 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 08
MAY2020
09
JUN2020
12
AUG2020 08
MAY2020 19
MAY2020 07
JUL2020
10075 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 11
MAY2020
12
JUN2020
14
AUG2020 11
MAY2020 22
MAY2020 10
JUL2020
10076 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 11
MAY2020
12
JUN2020
14
AUG2020 11
MAY2020 22
MAY2020 10
JUL2020
10078 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 11
MAY2020
12
JUN2020
07
AUG2020 11
MAY2020 22
MAY2020 10
JUL2020
10083 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 12
MAY2020
10
JUN2020
12
AUG2020 12
MAY2020 20
MAY2020 07
JUL2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 11 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
60
µg
Yo
unger 10084 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 12
MAY2020
12
JUN2020
14
AUG2020 12
MAY2020 22
MAY2020 10
JUL2020
10085 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 12
MAY2020
12
JUN2020
14
AUG2020 12
MAY2020 22
MAY2020 10
JUL2020
10089 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL
2020 12
MAY2020
10
JUN2020
12
AUG2020 12
MAY2020 20
MAY2020 07
JUL2020
10093 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 12
MAY2020
10
JUN2020
12
AUG2020 12
MAY2020 20
MAY2020 07
JUL2020
10096 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 12
MAY2020
09
JUN2020
12
AUG2020 12
MAY2020 19
MAY2020 07
JUL2020
10103 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 14
MAY2020
12
JUN2020
14
AUG2020 14
MAY2020 22
MAY2020 10
JUL2020
10104 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
8.0
, 21 JUL 2020 14
MAY2020
10
JUN2020
12
AUG2020 14
MAY2020 20
MAY2020 07
JUL2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 12 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Ol
der 10273 8.0
, 21 JUL 2020
8.0
, 21 JUL
2020 12
AUG2020
17
SEP2020 12
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
10274 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
17
SEP2020 12
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
10282 8.0
, 21 JUL 2020 14
AUG2020 14
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10283 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
17
SEP2020 14
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
10286 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
15
SEP2020 14
AUG2020 25
AUG2020 15
SEP2020
10287 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
15
SEP2020 14
AUG2020 25
AUG2020 15
SEP2020 13
OCT2020
10288 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
15
SEP2020 14
AUG2020 25
AUG2020 15
SEP2020 13
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 13 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of
subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Ol
der 10289 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
17
SEP2020 14
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10291 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
15
SEP2020 14
AUG2020 25
AUG2020 15
SEP2020 13
OCT2020
10292 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
17
SEP2020 14
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
10298 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
AUG2020
17
SEP2020 17
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
10320 8.0
, 21
JUL 2020
8.0
, 21 JUL 2020 24
AUG2020
17
SEP2020 24
AUG2020 27
AUG2020 17
SEP2020 15
OCT2020
20
µg
Ol
der 20207 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 10
AUG2020
15
SEP2020 10
AUG2020 09
SEP2020 30
SEP2020
20211 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 10
AUG2020
15
SEP2020 10
AUG2020 08
SEP2020 30
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 14 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20
µg
Ol
der 20220 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
15
SEP2020 14
AUG2020 08
SEP2020 30
SEP2020
20227 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 19
AUG2020
12
SEP2020 19
AUG2020 11
SEP2020 02
OCT2020
20234 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
AUG2020
15
SEP2020 27
AUG2020 09
SEP2020 30
SEP2020
20236 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
AUG2020
12
SEP2020 27
AUG2020 11
SEP2020 02
OCT2020
20237 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
AUG2020
12
SEP2020 27
AUG2020 11
SEP2020 02
OCT2020
20238 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
AUG2020
12
SEP2020 27
AUG2020 11
SEP2020 02
OCT2020
20239 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 28
AUG2020
12
SEP2020 28
AUG2020 11
SEP2020 02
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 15 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NO
V2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for pr
emature
term
ination
20
µg
Ol
der 20241 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 28
AUG2020
15
SEP2020 28
AUG2020 09
SEP2020 30
SEP2020
20242 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 28
AUG2020
15
SEP2020 28
AUG2020 09
SEP2020
20243 8.0
, 21 JUL 2020
8.0
, 21 JUL 20
20 28
AUG2020
12
SEP2020 28
AUG2020 11
SEP2020 02
OCT2020
30
µg
Ol
der 10350 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10351 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10352 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 22
SEP2020 13
OCT2020
10353 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 22
SEP2020 13
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 16 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30 µg
Ol
der 10358 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 23
SEP2020 14
OCT2020
10360 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 23
SEP2020 14
OCT2020
10361 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10362 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10363 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10364 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 25
SEP2020 16
OCT2020
10365 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 23
SEP2020 14
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 17 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-1:
Listing of subjects disposition - BN
T162b1
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Ol
der 10366 8.0
, 21 JUL 2020 14
SEP2020 14
SEP2020 23
SEP2020 14
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 18 of 18) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
1 µg
Younger 10015 53
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 160 64
.2 25
.1
10018 21
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 169 62 21
.7
10023 33
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 169 71 24
.9
10025 35
.92 Ma
le Not Hi
spanic or Latino Wh
ite 181 97 29
.6
10033 44
.75 Ma
le Not Hi
spanic or Latino Wh
ite 183 93
.4 27
.9
10036 40
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 166 58
.3 21
.2
10040 41
.08 Ma
le Not Hi
spanic or Latino Wh
ite 171 78
.3 26
.8
10041 40
.17 Fem
ale Hisp
anic or Latino Wh
ite 152 50
.1 21
.7
10042 39
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 165 70 25
.7
10045 24
.00 Fem
ale Not Hi
spanic or Latino Wh
ite 166 70
.5 25
.6
10048 28
.75 Ma
le Not Hi
spanic or Latino Wh
ite 179 93
.1 29
.1
10052 55
.75 Ma
le Not Hi
spanic or Latino Wh
ite 173 68 22
.7
3 µg
Younger 10170 53
.92 Ma
le Not Hi
spanic or Latino Wh
ite 178 76
.5 24
.1
10194 33
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 172 62
.8 21
.2
10198 49
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 177 85
.6 27
.3
10200 47
.00 Ma
le Not Hi
spanic or Latino Wh
ite 172 64
.2 21
.7
10204 55
.17 Ma
le Not Hi
spanic or Latino Wh
ite 181 81
.9 25
10209 49
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 172 78
.8 26
.6
10212 50
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 176 87 28
.1
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 1 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 19
FDA-CBER-2021-5683-0049471
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
3 µg
Younger 10221 31
.33 Ma
le Not Hi
spanic or Latino Wh
ite 180 81
.3 25
.1
10224 23
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 170 71
.4 24
.7
10225 43
.00 Ma
le Not Hi
spanic or Latino Wh
ite 194 11
0.2 29
.3
10226 24
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 166 57
.6 20
.9
10227 35
.75 Ma
le Not Hi
spanic or Latino Wh
ite 164 68 25
.3
10
µg Younger 10001 51
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 171 75
.4 25
.8
10003 36
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 155 55
.3 23
10004 55
.00 Ma
le Not Hi
spanic or Latino Wh
ite 193 10
0.5 27
10005 33
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 171 68 23
.3
10006 52
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 171 75 25
.6
10007 29
.67 Ma
le Not Hi
spanic or Latino Bla
ck or African American 177 76
.1 24
.3
10008 25
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 165 57
.8 21
.2
10009 42
.00 Ma
le Not Hi
spanic or Latino Wh
ite 178 91 28
.7
10010 53
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 166 65
.1 23
.6
10011 54
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 168 62
.4 22
.1
10017 36
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 161 54
.5 21
10019 54
.25 Ma
le Not Hi
spanic or Latino Wh
ite 177 77
.7 24
.8
20
µg Younger 10151 52
.08 Ma
le Not Hi
spanic or Latino Wh
ite 187 72
.2 20
.6
10171 30
.50 Ma
le Not Hi
spanic or Latino Wh
ite 179 72
.5 22
.6
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 2 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 20
FDA-CBER-2021-5683-0049472
Bi
oNTech RNA Pha
rmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
20
µg Yo
unger 10172 39
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 159 55
.1 21
.8
10173 36
.33 Ma
le Not Hi
spanic or Latino Wh
ite 192 10
3.7 28
.1
10175 36
.00 Ma
le Not Hi
spanic or Latino Wh
ite 182 78
.6 23
.7
10176 24
.17 Ma
le Not Hi
spanic or Latino Wh
ite 163 60
.2 22
.7
10178 20
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 167 71
.7 25
.7
10179 49
.33 Ma
le Not Hi
spanic or Latino Wh
ite 170 67
.3 23
.3
10181 54
.08 Ma
le Not Hi
spanic or Latino Asi
an 176 75
.5 24
.4
10182 38
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 171 80
.5 27
.5
10183 55
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 171 73 25
10197 35
.83 Ma
le Not Hi
spanic or Latino Wh
ite 165 72
.6 26
.7
30
µg Younger 10016 26
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 170 61
.3 21
.2
10020 42
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 166 79 28
.7
10021 34
.50 Ma
le Not Hi
spanic or Latino Wh
ite 184 97 28
.7
10028 42
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 162 77 29
.3
10031 23
.92 Ma
le Not Hi
spanic or Latino Wh
ite 167 66
.7 23
.9
10032 35
.83 Ma
le Not Hi
spanic or Latino Wh
ite 179 95
.4 29
.8
10034 42
.00 Ma
le Not Hi
spanic or Latino Wh
ite 189 96
.8 27
.1
10037 54
.00 Ma
le Not Hi
spanic or Latino Wh
ite 174 68
.3 22
.6
10038 31
.92 Ma
le Not Hi
spanic or Latino Wh
ite 179 91
.7 28
.6
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 3 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 21
FDA-CBER-2021-5683-0049473
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs
Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
30
µg Younger 10039 32
.00 Ma
le Not Hi
spanic or Latino Wh
ite 185 86
.1 25
.2
10043 36
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 171 59 20
.2
10047 26
.58 Ma
le Not Hi
spanic or Latino Wh
ite 187 79
.8 22
.8
50
µg Younger 10049 46
.42 Ma
le Not Hi
spanic or Latino Wh
ite 172 85
.4 28
.9
10050 21
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 178 76
.6 24
.2
10053 28
.75 Ma
le Not Hi
spanic or Latino Wh
ite 185 67
.1 19
.6
10055 34
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 170 80 27
.7
10056 24
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 175 80 26
.1
10057 47
.75 Ma
le Not Hi
spanic or Latino Wh
ite 180 78
.8 24
.3
10059 26
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 159 59
.1 23
.4
10060 47
.50 Ma
le Not Hi
spanic or Latino Wh
ite 172 84
.9 28
.7
10067 30
.33 Ma
le Not Hi
spanic or Latino Wh
ite 180 97 29
.9
10068 19
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 164 60 22
.3
10070 47
.83 Ma
le Not Hi
spanic or Latino Wh
ite 178 94
.5 29
.8
10073 31
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 164 57
.4 21
.3
60
µg Younger 10066 24
.33 Ma
le Not Hi
spanic or Latino Wh
ite 179 65
.7 20
.5
10075 27
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 179 82
.4 25
.7
10076 50
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 162 62
.2 23
.7
10078 53
.17 Ma
le Not Hi
spanic or Latino Wh
ite 173 78
.9 26
.4
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 4 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 22
FDA-CBER-2021-5683-0049474
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demogr
aphics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
60
µg Younger 10083 42
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 179 76
.8 24
10084 32
.33 Ma
le Not Hi
spanic or Latino Wh
ite 177 93
.5 29
.8
10085 24
.67 Ma
le Not Hi
spanic or Latino Wh
ite 190 71
.5 19
.8
10089 52
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 165 66
.3 24
.4
10093 48
.75 Ma
le Not Hi
spanic or Latino Wh
ite 192 10
5.6 28
.6
10096 20
.92 Ma
le Hisp
anic or Latino Wh
ite 175 77
.5 25
.3
10103 25
.33 Fem
ale Not Hi
spanic or Latino Asi
an 163 66
.5 25
10104 27
.58 Ma
le Not Hi
spanic or Latino Wh
ite 183 97
.5 29
.1
10
µg Older 10273 71
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 162 55
.6 21
.2
10274 67
.33 Ma
le Not Hi
spanic or Latino Wh
ite 173 80
.2 26
.8
10282 73
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 164 67
.9 25
.2
10283 61
.42 Ma
le Not Hi
spanic or Latino Wh
ite 190 81
.3 22
.5
10286 56
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 169 75
.7 26
.5
10287 65
.08 Ma
le Not Hi
spanic or Latino Wh
ite 170 63
.3 21
.9
10288 61
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 156 62
.9 25
.8
10289 69
.00 Ma
le Not Hi
spanic or Latino Wh
ite 169 76
.4 26
.7
10291 63
.25 Ma
le Not Hi
spanic or Latino Wh
ite 172 74
.1 25
10292 56
.08 Ma
le Not Hi
spanic or Latino Wh
ite 183 91
.7 27
.4
10298 57
.33 Ma
le Not Hi
spanic or Latino Wh
ite 170 78 27
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 5 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 23
FDA-CBER-2021-5683-0049475
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on cl
ean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
10
µg Older 10320 68
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 164 55
.7 20
.7
20
µg Older 20207 66
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 164 76 28
.3
20211 67
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 153 58
.2 24
.9
20220 70
.75 Fem
ale Not Hi
spanic or Latino Wh
ite 157 68
.1 27
.6
20227 67
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 167 63
.6 22
.8
20234 57
.00 Fem
ale Not Hi
spanic or Latino Wh
ite 175 87
.2 28
.5
20236 58
.92 Ma
le Not Hi
spanic or Latino Wh
ite 178 79
.1 25
20237 67
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 159 57
.6 22
.8
20238 58
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 169 81 28
.4
20239 59
.33 Ma
le Not Hi
spanic or Latino Wh
ite 174 72
.5 23
.9
20241 75
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 165 64
.1 23
.5
20242 70
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 166 67
.5 24
.5
20243 68
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 161 69
.6 26
.9
30
µg Older 10350 57
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 162 60
.3 23
10351 57
.33 Ma
le Not Hi
spanic or Latino Wh
ite 177 73
.6 23
.5
10352 68
.00 Ma
le Not Hi
spanic or Latino Wh
ite 173 67
.2 22
.5
10353 67
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 162 67
.2 25
.6
10358 73
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 159 72
.4 28
.6
10360 59
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 159 60
.5 23
.9
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 6 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 24
FDA-CBER-2021-5683-0049476
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs
Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-1:
Listing of subjects demographics - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg
/m2]
30
µg Older 10361 72
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 167 67
.7 24
.3
10362 76
.75 Ma
le Not Hi
spanic or Latino Wh
ite 179 82
.3 25
.7
10363 63
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 155 63
.4 26
.4
10364 66
.75 Ma
le Not Hi
spanic or Latino Wh
ite 175 87
.1 28
.4
10365 73
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 156 69
.5 28
.6
10366 69
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 159 68
.5 27
.1
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 7 of 7)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 25
FDA-CBER-2021-5683-0049477
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-1:
Listing of medi
cal history - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
1 µg
Yo
unger 10041 1 Mi
graine Mi
graine Nerv o
us system disorders 28
APR2020 Ye
s
10
µg
Yo
unger 10011 1 Ge
nital herpes intermittent Ge
nital herpes Infe
ctions and infestations Ye
s
10017 1 Gl
aucoma Gl
aucoma Eye
disorders 2017 Ye
s
20
µg
Yo
unger 10172 1 End
ometriosis End
ometriosis Repro
ductive system and
bre
ast disorders DEC 2
017 DEC 2
017
30
µg
Yo
unger 10047 1 Head
ache, periodic Head
ache Nerv o
us system disorders 2013 Ye
s
50
µg
Yo
unger 10049 1 Herp e
s labialis intermittent Ora
l herpes Infe
ctions and infestations Ye
s
10
µg Older 10289 1 Sli
ght stenosis of the internal
ca
rotid artery left si
te Caro ti
d artery stenosis Nerv o
us system disorders 2017 Ye
s
20
µg Older 20207 1 Hys
terectomy Hys
terectomy Surg
ical and medical
pro
cedures 1991 1991
2 Me
nopause Me
nopause Soc
ial circumstances 1991 1991
20211 1 me
nopause Me
nopause Soc
ial ci
rcumstances 2005 2005
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 1 of 2)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 26
FDA-CBER-2021-5683-0049478
Bi
oNTech RNA Pharmaceuticals Gm
bH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b1
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-1:
Listing of medical history - BN
T162b1
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
20
µg Older 20220 1 me
nopause Me
nopause Soc
ial circumstances 1999 1999
20234 1 Hys
terectomy Hys
terectomy Surg
ical and medical
pro
cedures 2000 2000
20237 1 hy
sterectomy Hys
terectomy Surg
ical and medical
pro
cedures 1999 1999
2 me
nopause Me
nopause Soc
ial circumstances 1999 1999
20238 1 me
nopause Me
nopause Soc
ial circumstances 2015 2015
20241 1 Me
nopause Me
nopause Soc
ial circumstances 1999 1999
20242 1 Me
nopause Me
nopause Soc
ial circumstances 2004 2004
20243 1 Me
nopause Me
nopause Soc
ial circumstances 1999 1999
30
µg Older 10358 1 Inte
rmittent muscle cramps Mu
scle spasms Mu
sculoskeletal and
co
nnective tissue disorders 1987 Ye
s
10365 1 Pol
yarthrosis -> p
ain
(an
kles, knees, spinal chord) Os
teoarthritis Mu
sculoskeletal and
co
nnective tissue disorders 1980 Ye
s
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 2 of 2)
090177e196971658\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 27
FDA-CBER-2021-5683-0049479
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
1 µg
Yo
unger 20153 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL
2020
8.0
, 21 JUL 2020 12
JUN2020
20
JUL2020
11
AUG2020
21
SEP2020 12
JUN2020 29
JUN2020 20
JUL2020 18
AUG2020
20154 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
JUN2020
20
JUL2020
11
AUG2020
21
SEP2020 12
JUN2020 29
JUN2020 20
JUL2020 18
AUG2020
20157 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
JUN2020
20
JUL2020
11
AUG2020
21
SEP2020 12
JUN2020 29
JUN2020 20
JUL2020 18
AUG2020
20158 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 15
JUN2020
13
JUL2020
07
AUG2020
06
OCT2020 15
JUN2020 13
JUL2020 03
AUG2020 31
AUG2020
20160 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 15
JUN2020
20
JUL2020 15
JUN2020 29
JUN2020 30
JUL2020 Wi
thdrawal By Subject
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 1 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 28
FDA-CBER-2021-5683-0049480
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs
Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
1 µg
Yo
unger 20163 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 15
JUN2020
20
JUL2020
12
AUG2020
21
SEP2020 15
JUN2020 29
JUN2020 20
JUL2020 18
AUG2020
20164 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 19
JUN2020
13
JUL2020
10
AUG2020
05
OCT2020 19
JUN2020 13
JUL2020 03
AUG2020 04
SEP2020
20166 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 20
20 19
JUN2020
20
JUL2020
11
AUG2020
18
SEP2020 19
JUN2020 29
JUN2020 20
JUL2020 18
AUG2020
20171 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUN2020
13
JUL2020
11
AUG2020
05
OCT2020 22
JUN2020 13
JUL2020 03
AUG2020 31
AUG2020
20181 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
27
JUL2020
18
AUG2020
15
SEP2020 03
JUL2020 28
JUL2020 18
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 2 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
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oNTech RNA Pharmaceuticals GmbH / Lis
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napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects di
sposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
1 µg
Yo
unger 20188 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 16
JUL2020
18
AUG2020
15
SEP2020 16
JUL2020 28
JUL2020 18
AUG2020
20189 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 16
JUL2020
18
AUG2020
15
SEP2020 16
JUL2020 28
JUL2020 18
AUG2020 15
SEP2020
3 µg
Yo
unger 20176 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
20
JUL2020
18
AUG2020
16
SEP2020 03
JUL2020 29
JUL2020 18
AUG2020 16
SEP2020
20185 7.0
, 26 JUN 20
20
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 13
JUL2020
18
AUG2020
16
SEP2020 13
JUL2020 29
JUL2020 18
AUG2020 16
SEP2020
20191 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
07
AUG2020
17
SEP2020 22
JUL2020 06
AUG2020 26
AUG2020 24
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 3 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
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napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
3 µg
Yo
unger 20192 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
11
AUG2020
15
SEP2020 22
JUL2020 28
JUL2020 18
AUG2020 15
SEP2020
20193 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
18
AUG2020
16
SEP2020 22
JUL2020 29
JUL2020 18
AUG2020 16
SEP2020
20194 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
18
AUG2020
16
SEP2020 22
JUL2020 29
JUL2020 18
AUG2020 16
SEP2020
20195 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
07
AUG2020
18
SEP2020 22
JUL2020 31
JUL2020 19
AUG2020
20197 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUL2020
18
AUG2020
15
SEP2020 22
JUL2020 28
JUL2020 18
AUG2020 15
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 4 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
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oNTech RNA Pharmaceuticals GmbH / Lis
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napshot Al
l TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
3 µg
Yo
unger 20200 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
JUL2020
07
AUG2020
18
SEP2020 27
JUL2020 30
JUL2020 19
AUG2020 18
SEP2020
20201 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
JUL2020
07
AUG2020
17
SEP2020 27
JUL2020 06
AUG2020 26
AUG2020 24
SEP2020
20203 7.0
, 26 JUN
2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
JUL2020
07
AUG2020
18
SEP2020 27
JUL2020 31
JUL2020 21
AUG2020
20204 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 28
JUL2020
07
AUG2020
18
SEP2020 28
JUL2020 31
JUL2020 19
AUG2020
10
µg
Yo
unger 20101 3.0
, 17
Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 18
MAY2020
15
JUN2020
14
JUL2020
08
SEP2020 18
MAY2020 16
JUN2020 07
JUL2020 04
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 5 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NO
V2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects di
sposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Yo
unger 20102 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 18
MAY2020
15
JUN2020
14
JUL2020
08
SEP2020 18
MAY2020 16
JUN2020 07
JUL2020 04
AUG2020
20103 3.0
, 17 Apr 2020
5.0
, 26 MA
Y 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 18
MAY2020
15
JUN2020
13
JUL2020
07
SEP2020 18
MAY2020 15
JUN2020 06
JUL2020 03
AUG2020
20104 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 18
MAY2020
15
JUN2020
14
JUL2020
14
SEP2020 18
MAY2020 16
JUN2020 07
JUL2020 04
AUG2020
20105 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 18
MAY2020
15
JUN2020
14
JUL2020
08
SEP2020 18
MAY2020 16
JUN2020 06
JUL2020 04
AUG2020
20110 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21
JUL 2020 19
MAY2020
15
JUN2020
14
JUL2020
07
AUG2020 19
MAY2020 16
JUN2020 07
JUL2020 07
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 6 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Bas
ed on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10 µg
Yo
unger 20111 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 19
MAY2020
15
JUN2020
15
JUL2020
04
SEP2020 19
MAY2020 18
JUN2020 15
JUL2020 06
AUG2020
20114 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 19
MAY2020
15
JUN2020
16
JUL2020
07
AUG2020 19
MAY2020 18
JUN2020 09
JUL2020 07
AUG2020
20116 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020 20
MAY2020
17
JUN2020
16
JUL2020 20
MAY2020 18
JUN2020 16
JUL2020 Adv
erse Event
20117 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26
JUN 2020
8.0
, 21 JUL 2020 20
MAY2020
17
JUN2020
13
JUL2020
10
SEP2020 20
MAY2020 18
JUN2020 09
JUL2020 06
AUG2020
20118 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 20
MAY2020
17
JUN2020
16
JUL2020
10
SEP2020 20
MAY2020 18
JUN2020 09
JUL2020 06
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 7 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Yo
unger 20121 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 20
20
8.0
, 21 JUL 2020 20
MAY2020
17
JUN2020
16
JUL2020
10
SEP2020 20
MAY2020 18
JUN2020 09
JUL2020 06
AUG2020
20
µg
Yo
unger 20156 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
JUN2020
23
JUL2020
13
AUG2020
24
SEP2020 12
JUN2020 02
JUL2020 23
JUL2020 20
AUG2020
20159 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 15
JUN2020
22
JUL2020
07
AUG2020
23
SEP2020 15
JUN2020 01
JUL2020 22
JUL2020 19
AUG2020
20168 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 20
20 19
JUN2020
22
JUL2020
12
AUG2020
23
SEP2020 19
JUN2020 01
JUL2020 22
JUL2020 19
AUG2020
20172 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 22
JUN2020
23
JUL2020
13
AUG2020
24
SEP2020 22
JUN2020 02
JUL2020 23
JUL2020 20
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 8 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20
µg
Yo
unger 20173 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 30
JUN2020
14
JUL2020
13
AUG2020
24
SEP2020 30
JUN2020 02
JUL2020 23
JUL2020 20
AUG2020
20174 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
13
JUL2020
17
AUG2020
28
SEP2020 03
JUL2020 06
JUL2020 27
JUL2020 24
AUG2020
20175 5.0
, 26
MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
13
JUL2020
17
AUG2020
28
SEP2020 03
JUL2020 06
JUL2020 27
JUL2020 24
AUG2020
20177 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
14
JUL2020
18
AUG2020
28
SEP2020 03
JUL2020 06
JUL2020 27
JUL2020 24
AUG2020
20178 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
13
JUL2020
17
AUG2020
28
SEP2020 03
JUL2020 06
JUL2020 27
JUL2020 24
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 9 of 20
) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20
µg
Yo
unger 20179 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
13
JUL2020
17
AUG2020
28
SEP2020 03
JUL2020 06
JUL2020 29
JUL2020 24
AUG2020
20180 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 03
JUL2020
13
JUL2020
10
AUG2020
05
OCT2020 03
JUL2020 13
JUL2020 03
AUG2020 31
AUG2020
20183 5.0
, 26
MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 08
JUL2020
13
JUL2020
10
AUG2020
05
OCT2020 08
JUL2020 13
JUL2020 03
AUG2020 03
SEP2020 05
OCT2020 Wi
thdrawal By Subject
30
µg
Yo
unger 20127 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL
2020
8.0
, 21 JUL 2020 25
MAY2020
21
JUN2020
14
JUL2020
10
AUG2020
14
SEP2020 25
MAY2020 22
JUN2020 14
JUL2020 10
AUG2020
20128 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 26
MAY2020
22
JUN2020
14
JUL2020
11
AUG2020
15
SEP2020 26
MAY2020 23
JUN2020 14
JUL2020 11
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 10 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Yo
unger 20134 3.0
, 17 Apr 2020
5.0
, 26 MA
Y 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 27
MAY2020
21
JUN2020
15
JUL2020
07
AUG2020
21
SEP2020 27
MAY2020 25
JUN2020 15
JUL2020 13
AUG2020
20137 3.0
, 17 Apr 2020
5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 28
MAY2020
22
JUN2020
14
JUL2020
11
AUG2020
15
SEP2020 28
MAY2020 23
JUN2020 14
JUL2020 11
AUG2020
20138 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 08
JUN2020
15
JUL2020
07
AUG2020
17
SEP2020 08
JUN2020 25
JUN2020 15
JUL2020 14
AUG2020
20142 5.0
, 26
MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 08
JUN2020
15
JUL2020
12
AUG2020
17
SEP2020 08
JUN2020 25
JUN2020 15
JUL2020 12
AUG2020
20143 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 08
JUN2020
15
JUL2020
13
AUG2020
17
SEP2020 08
JUN2020 25
JUN2020 15
JUL2020 13
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 11 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 38
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Yo
unger 20144 5.0
, 26 MAY 2020
7.0
, 26 JUN
2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 08
JUN2020
15
JUL2020
13
AUG2020
17
SEP2020 08
JUN2020 25
JUN2020 15
JUL2020 13
AUG2020
20145 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 09
JUN2020
15
JUL2020
13
AUG2020
17
SEP2020 09
JUN2020 25
JUN2020 15
JUL2020 13
AUG2020
20149 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 09
JUN2020
14
JUL2020
12
AUG2020
16
SEP2020 09
JUN2020 22
JUN2020 14
JUL2020 12
AUG2020
20150 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21
JUL 2020 09
JUN2020
14
JUL2020
11
AUG2020
21
SEP2020 09
JUN2020 23
JUN2020 14
JUL2020 11
AUG2020
20155 5.0
, 26 MAY 2020
7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
JUN2020
14
JUL2020
11
AUG2020
15
SEP2020 12
JUN2020 23
JUN2020 14
JUL2020 11
AUG2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 12 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Ol
der 10261 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 05
AUG2020
13
AUG2020
25
SEP2020 05
AUG2020 14
AUG2020 04
SEP2020 02
OCT2020
10263 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 05
AUG2020
13
AUG2020
25
SEP2020 05
AUG2020 14
AUG2020 04
SEP2020 02
OCT2020
10265 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 05
AUG2020
10
AUG2020
15
SEP2020 05
AUG2020 18
AUG2020 08
SEP2020 06
OCT2020
10267 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020 05
AUG2020
15
SEP2020 05
AUG2020 18
AUG2020 08
SEP2020 06
OCT2020
10268 7.0
, 26 JUN 2020
8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 05
AUG2020
13
AUG2020
15
SEP2020 05
AUG2020 18
AUG2020 08
SEP2020 06
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 13 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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FDA-CBER-2021-5683-0049492
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Ol
der 10269 7.0
, 26 JUN 2020 05
AUG2020 05
AUG2020 18
AUG2020 08
SEP2020 06
OCT2020
10275 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
17
SEP2020 12
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10276 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
17
SEP2020 12
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10277 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
17
SEP2020 12
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10279 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
17
SEP2020 12
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 14 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 41
FDA-CBER-2021-5683-0049493
Bi
oNTech RNA Pha
rmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
10
µg
Ol
der 10299 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
AUG2020
17
SEP2020 17
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
10300 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
AUG2020
17
SEP2020 17
AUG2020 20
AUG2020 10
SEP2020 08
OCT2020
20
µg
Ol
der 20208 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 10
AUG2020
14
SEP2020 10
AUG2020 25
AUG2020 14
SEP2020 13
OCT2020
20214 8.0
, 21
JUL 2020
8.0
, 21 JUL 2020 11
AUG2020
14
SEP2020 11
AUG2020 26
AUG2020 14
SEP2020 14
OCT2020
20215 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 11
AUG2020
22
SEP2020 11
AUG2020 01
SEP2020 22
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 15 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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FDA-CBER-2021-5683-0049494
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NO
V2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20
µg
Ol
der 20216 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 11
AUG2020
14
SEP2020 11
AUG2020 25
AUG2020 14
SEP2020 13
OCT2020
20221 8.0
, 21 JUL 2020
8.0
, 21 JUL
2020 14
AUG2020
22
SEP2020 14
AUG2020 01
SEP2020 22
SEP2020
20222 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
14
SEP2020 14
AUG2020 26
AUG2020 14
SEP2020 14
OCT2020
20223 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
14
SEP2020 14
AUG2020 26
AUG2020 14
SEP2020 14
OCT2020
20224 8.0
, 21 JUL 2020 14
AUG2020 14
AUG2020 01
SEP2020 22
SEP2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 16 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 43
FDA-CBER-2021-5683-0049495
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on cl
ean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
20 µg
Ol
der 20225 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 14
AUG2020
14
SEP2020 14
AUG2020 26
AUG2020 14
SEP2020 14
OCT2020
20226 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 19
AUG2020
22
SEP2020 19
AUG2020 01
SEP2020 22
SEP2020
20229 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 19
AUG2020
22
SEP2020 19
AUG2020 01
SEP2020 22
SEP2020
20233 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 19
AUG2020
22
SEP2020 19
AUG2020 01
SEP2020 22
SEP2020
30
µg
Ol
der 10272 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 12
AUG2020
24
SEP2020 12
AUG2020 04
SEP2020 24
SEP2020 23
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 17 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 44
FDA-CBER-2021-5683-0049496
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of
prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Ol
der 10303 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
AUG2020
24
SEP2020 17
AUG2020 04
SEP2020 24
SEP2020 23
OCT2020
10305 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 17
AUG2020
25
SEP2020 17
AUG2020 04
SEP2020 25
SEP2020 23
OCT2020
10306 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 21
AUG2020
22
SEP2020 21
AUG2020 01
SEP2020 22
SEP2020 20
OCT2020
10308 8.0
, 21
JUL 2020
8.0
, 21 JUL 2020 21
AUG2020
24
SEP2020 21
AUG2020 04
SEP2020 24
SEP2020 23
OCT2020
10309 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 21
AUG2020
23
SEP2020 21
AUG2020 02
SEP2020 23
SEP2020 21
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 18 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 45
FDA-CBER-2021-5683-0049497
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs
Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects disposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Ol
der 10310 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 21
AUG2020
23
SEP2020 21
AUG2020 02
SEP2020 23
SEP2020 21
OCT2020
10314 8.0
, 21 JUL 2020
8.0
, 21 JUL
2020 21
AUG2020
23
SEP2020 21
AUG2020 02
SEP2020 23
SEP2020 21
OCT2020
10316 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 21
AUG2020
22
SEP2020 21
AUG2020 01
SEP2020 22
SEP2020 20
OCT2020
10319 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
AUG2020
24
SEP2020 24
AUG2020 04
SEP2020 24
SEP2020 23
OCT2020
10323 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
AUG2020
24
SEP2020 24
AUG2020 04
SEP2020 24
SEP2020 23
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 19 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
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FDA-CBER-2021-5683-0049498
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -1-3:
Listing of subjects di
sposition - BN
T162b2
Safe
ty set
Dose
gro
up Sub
ject
nu
mber Proto
col versions Date
s of
in
formed
co
nsent Date
of
sc
reening Date
of prime
im
munization Date
of boost
im
munization Date
of trial
co
mpletion Date
of
fol
low-up
co
mpletion Date
of
pre
mature
term
ination Ma
in reason for premature
term
ination
30
µg
Ol
der 10324 8.0
, 21 JUL 2020
8.0
, 21 JUL 2020 24
AUG2020
23
SEP2020 24
AUG2020 02
SEP2020 23
SEP2020 21
OCT2020
Prog
ram: Lb
ase_Disp_1.sas (Pag
e 20 of 20) Note: This trial is clinically ongoing. The “date of trial completion” is therefore the “date of the end of treatment visit”.
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 47
FDA-CBER-2021-5683-0049499
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg
/m2]
1 µg
Younger 20153 47
.75 Fem
ale Not Hi
spanic or Latino Wh
ite 173 67
.9 22
.7
20154 53
.42 Ma
le Not Hi
spanic or Latino Wh
ite 174 89
.4 29
.5
20157 24
.17 Ma
le Not Hi
spanic or Latino Wh
ite 183 91
.3 27
.3
20158 34
.58 Ma
le Not Hi
spanic or Latino Wh
ite 184 98
.6 29
.1
20160 21
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 169 55
.7 19
.5
20163 35
.67 Ma
le Not Hi
spanic or Latino Wh
ite 177 82
.4 26
.3
20164 32
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 172 66
.9 22
.6
20166 22
.67 Ma
le Not Hi
spanic or Latino Wh
ite 204 99
.1 23
.8
20171 41
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 173 69
.1 23
.1
20181 39
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 173 69
.7 23
.3
20188 41
.58 Ma
le Not Hi
spanic or Latino Wh
ite 175 91
.4 29
.8
20189 44
.92 Ma
le Not Hi
spanic or Latino Wh
ite 176 80
.6 26
3 µg
Younger 20176 44
.08 Ma
le Not Hi
spanic or Latino Wh
ite 195 89
.9 23
.6
20185 42
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 155 71
.6 29
.8
20191 26
.58 Ma
le Not Hi
spanic or Latino Wh
ite 177 75
.9 24
.2
20192 24
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 168 70
.5 25
20193 35
.17 Ma
le Not Hi
spanic or Latino Wh
ite 184 98 28
.9
20194 55
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 157 57
.2 23
.2
20195 52
.17 Ma
le Not Hi
spanic or Latino Wh
ite 181 76
.7 23
.4
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 1 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 48
FDA-CBER-2021-5683-0049500
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Fi
nal 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
3 µg
Younger 20197 48
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 172 65 22
20200 39
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 169 82
.9 29
20201 33
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 168 77
.9 27
.6
20203 28
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 176 83
.4 26
.9
20204 45
.50 Ma
le Not Hi
spanic or Latino Wh
ite 184 76 22
.4
10
µg Younger 20101 35
.75 Ma
le Not Hi
spanic or Latino Wh
ite 171 72
.4 24
.8
20102 30
.42 Ma
le Not Hi
spanic or Latino Wh
ite 171 79 27
20103 22
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 191 91
.6 25
.1
20104 45
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 169 63
.7 22
.3
20105 37
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 183 97
.1 29
20110 46
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 165 75
.1 27
.6
20111 29
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 167 67
.8 24
.3
20114 19
.00 Ma
le Not Hi
spanic or Latino Wh
ite 173 74
.2 24
.8
20116 23
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 166 60
.6 22
20117 51
.50 Ma
le Not Hi
spanic or Latino Wh
ite 188 89 25
.2
20118 44
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 165 63
.8 23
.4
20121 36
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 174 79 26
.1
20
µg Younger 20156 45
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 167 73
.4 26
.3
20159 30
.92 Ma
le Not Hi
spanic or Latino Wh
ite 175 85
.9 28
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 2 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 49
FDA-CBER-2021-5683-0049501
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
20
µg Younger 20168 38
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 157 61
.6 25
20172 31
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 169 70
.6 24
.7
20173 49
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 172 62
.6 21
.2
20174 55
.75 Ma
le Not Hi
spanic or Latino Wh
ite 173 86
.7 29
20175 35
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 165 72
.2 26
.5
20177 29
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 160 56
.9 22
.2
20178 53
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 172 78
.4 26
.5
20179 50
.75 Fem
ale Not Hi
spanic or Latino Wh
ite 162 61
.5 23
.4
20180 54
.67 Fem
ale Not Hi
spanic or Latino Wh
ite 181 90
.2 27
.5
20183 38
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 167 69
.4 24
.9
30
µg Younger 20127 55
.67 Ma
le Not Hi
spanic or Latino Wh
ite 189 83
.2 23
.3
20128 39
.17 Ma
le Not Hi
spanic or Latino Wh
ite 179 82
.3 25
.7
20134 35
.75 Ma
le Not Hi
spanic or Latino Wh
ite 179 86 26
.8
20137 54
.92 Ma
le Not Hi
spanic or Latino Wh
ite 172 81
.2 27
.4
20138 43
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 171 73
.6 25
.2
20142 51
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 157 60
.6 24
.6
20143 49
.08 Ma
le Not Hi
spanic or Latino Wh
ite 179 81
.6 25
.5
20144 45
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 175 78 25
.5
20145 45
.75 Ma
le Not Hi
spanic or Latino Wh
ite 186 79 22
.8
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 3 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 50
FDA-CBER-2021-5683-0049502
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
30
µg Younger 20149 54
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 160 61
.5 24
20150 41
.42 Ma
le Not Hi
spanic or Latino Wh
ite 180 82
.8 25
.6
20155 49
.92 Ma
le Not Hi
spanic or Latino Wh
ite 188 83
.6 23
.7
10
µg Ol
der 10261 65
.25 Ma
le Not Hi
spanic or Latino Wh
ite 176 67
.5 21
.8
10263 65
.33 Ma
le Not Hi
spanic or Latino Wh
ite 179 88
.1 27
.5
10265 58
.17 Ma
le Not Hi
spanic or Latino Wh
ite 179 87
.7 27
.4
10267 84
.00 Ma
le Not Hi
spanic or Latino Wh
ite 179 75
.6 23
.6
10268 56
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 178 76
.3 24
.1
10269 73
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 165 72
.2 26
.5
10275 61
.08 Ma
le Not Hi
spanic or Latino Wh
ite 178 78
.8 24
.9
10276 68
.08 Fem
ale Not Hi
spanic or Latino Wh
ite 154 55
.5 23
.4
10277 67
.42 Ma
le Not Hi
spanic or Latino Wh
ite 172 82
.4 27
.9
10279 59
.75 Ma
le Not Hi
spanic or Latino Wh
ite 179 91 28
.4
10299 63
.92 Ma
le Not Hi
spanic or Latino Wh
ite 182 78
.3 23
.6
10300 62
.17 Fem
ale Not Hi
spanic or Latino Wh
ite 176 81 26
.1
20
µg Older 20208 71
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 167 74
.1 26
.6
20214 65
.75 Fem
ale Not Hi
spanic or Latino Wh
ite 172 81
.6 27
.6
20215 80
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 153 57
.7 24
.6
20216 70
.58 Fem
ale Not Hi
spanic or Latino Wh
ite 162 59
.2 22
.6
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 4 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 51
FDA-CBER-2021-5683-0049503
Bi
oNTech RNA Pha
rmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
20
µg Older 20221 62
.83 Ma
le Not Hi
spanic or Latino Wh
ite 170 85
.3 29
.5
20222 56
.75 Ma
le Not Hi
spanic or Latino Wh
ite 177 84
.7 27
20223 61
.67 Ma
le Not Hi
spanic or Latino Wh
ite 180 77
.7 24
20224 68
.33 Fem
ale Not Hi
spanic or Latino Wh
ite 168 64
.2 22
.7
20225 68
.00 Ma
le Not Hi
spanic or Latino Wh
ite 185 84
.1 24
.6
20226 59
.25 Ma
le Not Hi
spanic or Latino Wh
ite 184 78
.1 23
.1
20229 65
.83 Fem
ale Not Hi
spanic or Latino Wh
ite 171 74
.4 25
.4
20233 59
.58 Ma
le Not Hi
spanic or Latino Wh
ite 185 10
1.8 29
.7
30
µg Older 10272 57
.00 Fem
ale Not Hi
spanic or Latino Wh
ite 166 60
.4 21
.9
10303 58
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 175 79
.4 25
.9
10305 61
.50 Ma
le Not Hi
spanic or Latino Wh
ite 180 94
.6 29
.2
10306 57
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 165 80
.1 29
.4
10308 58
.58 Ma
le Not Hi
spanic or Latino Wh
ite 183 84
.5 25
.2
10309 68
.17 Ma
le Not Hi
spanic or Latino Wh
ite 176 77
.6 25
.1
10310 73
.42 Fem
ale Not Hi
spanic or Latino Wh
ite 162 77 29
.3
10314 61
.50 Fem
ale Not Hi
spanic or Latino Wh
ite 158 60
.6 24
.3
10316 66
.42 Ma
le Not Hi
spanic or Latino Wh
ite 179 90
.1 28
.1
10319 67
.92 Fem
ale Not Hi
spanic or Latino Wh
ite 165 61 22
.4
10323 67
.75 Fem
ale Not Hi
spanic or Latino Wh
ite 166 62
.3 22
.6
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 5 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 52
FDA-CBER-2021-5683-0049504
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDT
M data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -5-3:
Listing of subjects demographics - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Age
[years] Ge
nder Ethn
icity Race Heig
ht [cm] We
ight [kg] BM
I [kg/m2]
30
µg Older 10324 68
.25 Fem
ale Not Hi
spanic or Latino Wh
ite 175 82 26
.8
Prog
ram: Lb
ase_Demo_5.sas (Pa
ge 6 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 53
FDA-CBER-2021-5683-0049505
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data rec
eived on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem or
gan class Start
date End
date On
going
1 µg
Yo
unger 20153 1 me
nopause Me
nopause Soc
ial circumstances 2017 2017
20158 1 al
lergy against fur of cat,
mi
ld All
ergy to animal Imm
une system disorders 1995 Ye
s
2 mi
ld seborrheic dermatitis
(sc
alp) Seb
orrhoeic dermatitis Ski
n and subcutaneous
tis
sue disorders 2018 Ye
s
20163 1 ab
rasion both knees from
bi
ke accident Road
traffic accident Inj
ury, poisoning and
pro
cedural complications 09
JUN2020 29
JUN2020
2 ab
rasion both knees from
bi
ke accident Ski
n abrasion Inj
ury, poisoning and
pro
cedural complications 09
JUN2020 29
JUN2020
20164 1 hy
pothyreoidism Hyp
othyroidism End
ocrine disorders 01
JAN2015 01
JUN2019
20166 1 pro
lapsed lumbar disc Inte
rvertebral disc protrusion Mu
sculoskeletal and
co
nnective tissue disorders JAN20
18 JAN20
18
20189 1 mi
ld allergy against pollen
(bi
rch, mogwart) Sea
sonal allergy Imm
une system disorders 2010 Ye
s
3 µg
Yo
unger 20176 1 fun
nel chest Pec
tus excavatum Cong
enital, familial and
ge
netic disorders 1976 Ye
s
10
µg
Yo
unger 20101 1 va
sectomy Vas
ectomy Surg
ical and medical
pro
cedures 01
AUG2016 01
AUG2016
20104 1 dy
smenorrhea Dys
menorrhoea Repro
ductive system and
bre
ast disorders 1989 Ye
s
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 1 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 54
FDA-CBER-2021-5683-0049506
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
10
µg
Yo
unger 20104 2 pe
nicillin intolerance Drug i
ntolerance Ge
neral disorders and
ad
ministration site
co
nditions 01
JAN1995 Ye
s
3 rec
urrent backpain Bac
k pain Mu
sculoskeletal and
co
nnective tissue disorders 2005 Ye
s
4 thy
roid cyst(right) Th
yroid cyst End
ocrine disorders 01
FEB2019 01
MAR2019
20105 1 al
lergy against
di
clofenac(skin reaction) Drug h
ypersensitivity Imm
une system disorders 1998 Ye
s
2 al
lergy against
po
llen(hazelnut,birch,alder) Sea
sonal allergy Imm
une system disorders 1998 Ye
s
20110 1 al
lergy to grass pollen Sea
sonal allergy Imm
une system disorders 1985 Ye
s
2 al
lergy to phenacetin Drug h
ypersensitivity Imm
une system disorders 1994 Ye
s
3 rec
urrent headaches Head
ache Nerv o
us system disorders 1986 Ye
s
4 tin
nitus Ti
nnitus Ear a
nd labyrinth disorders OCT
2011 Ye
s
5 tub
al ligation Fem
ale sterilisation Surg
ical and medical
pro
cedures 2005 2005
20114 1 al
lergy against grass pollen Sea
sonal allergy Imm
une system disorders 2018 Ye
s
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 2 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 55
FDA-CBER-2021-5683-0049507
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
10
µg
Yo
unger 20116 1 co
rrective surgery nasal
se
ptum Nasa
l septal operation Surg
ical and medical
pro
cedures AUG 2
019 AUG 2
019
20117 1 al
lergy against nickel All
ergy to metals Imm
une system di
sorders 2000 Ye
s
2 me
niscus surgery left knee Me
niscus operation Surg
ical and medical
pro
cedures 2016 2016
3 mi
ld lactose intolerance La
ctose intolerance Me
tabolism and nutrition
di
sorders 2000 Ye
s
20
µg
Yo
unger 20159 1 la
ctose intolerance La
ctose intolerance Me
tabolism and nutrition
di
sorders 2013 Ye
s
20168 1 Sli
ght varicosis of the right
leg Vari
cose vein Vas
cular disorders MAR20
18 Ye
s
20178 1 me
nopause Me
nopause Soc
ial circumstances 2015 2015
2 too
th pain after dental root
trea
tment To
othache Ga
strointestinal disorders 02
JUL2020 Ye
s
20179 1 me
nopause Me
nopause Soc
ial circumstances 2019 2019
20180 1 me
nopause Me
nopause Soc
ial circumstances 2018 2018
2 mi
ld knee complaints Arthra
lgia Mu
sculoskeletal and
co
nnective tis
sue disorders 2015 Ye
s
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 3 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 56
FDA-CBER-2021-5683-0049508
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
30
µg
Yo
unger 20128 1 al
lergy against oil of pine
ne
edles Hyp
ersensitivity Imm
une system disorders 1985 Ye
s
20137 1 li
poma (back) Li
poma Neop
lasms benign,
ma
lignant and unspecified
(in
cl cysts and polyps) 2018 Ye
s
20138 1 rem
oval of 2 naevi (upper
ba
ck) Mo
le excision Surg
ical and medical
pro
cedures 2018 2018
20142 1 hy
sterectomy Hys
terectomy Surg
ical and medical
pro
cedures MAR20
07 MAR20
07
2 me
nopause Me
nopause Soc
ial circumstances MAR20
07 MAR20
07
20149 1 Me
nopause Me
nopause Soc
ial circumstances 2013 2013
20150 1 he
artburn Dys
pepsia Ga
strointestinal disorders 2019 Ye
s
20155 1 al
lergy against
no
vaminsulfon cutaneous
sy
mptoms only Drug hy
persensitivity Imm
une system disorders 1984 Ye
s
10
µg Older 10267 1 Shi
ngles Herp e
s zoster Infe
ctions and infestations 2017 2017
10275 1 Hyp
ercholesterinemia Hyp
ercholesterolaemia Me
tabolism and nutrition
di
sorders 2017 Ye
s
20
µg Older 20208 1 Me
nopause Me
nopause Soc
ial circumstances 1999 1999
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 4 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 57
FDA-CBER-2021-5683-0049509
Bi
oNTech RNA Pha
rmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
20
µg Older 20214 1 Hys
terectomy Hys
terectomy Surg
ical and medical
pro
cedures 1995 1995
2 Me
nopause Me
nopause Soc
ial circumstances 1995 1995
20215 1 Me
nopause Me
nopause Soc
ial circumstances 1993 1993
20216 1 Me
nopause Me
nopause Soc
ial circumstances 2005 2005
20223 1 ab
rasion right heel and
an
kle from incident with
bi
cycle Road
traffic accident Inj
ury, poisoning and
pro
cedural co
mplications 01
AUG2020 Ye
s
2 ab
rasion right heel and
an
kle from incident with
bi
cycle Ski
n abrasion Inj
ury, poisoning and
pro
cedural complications 01
AUG2020 Ye
s
20224 1 Me
nopause Me
nopause Soc
ial circumstances 2004 2004
20225 1 ca
theter in
tervention
(ob
turation of ventricular
se
ptum defect) Cath
eterisation cardiac Inv
estigations OCT
2016 OCT
2016
2 co
lon inflammation Coli
tis Ga
strointestinal disorders 2017 2017
3 su
rgery colon (excision of
10
cm) Colo
n operation Surg
ical and medical
pro
cedures 2017 2017
4 ve
ntricular septum defect Ven
tricular septal defect Cong
enital, familial and
ge
netic disorders 02
AUG1952 OCT
2016
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 5 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 58
FDA-CBER-2021-5683-0049510
Bi
oNTech RNA Pharmaceuticals GmbH / Lis
tings - 6. S
napshot All TLFs Final 1.0 BNT
162b2
BNT
162-01 Crea
ted on 20NOV2020
Stab
uro GmbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 2
3OCT2020. Listi
ng 16.2.1 -7-3:
Listing of medical history - BN
T162b2
Safe
ty set
Dose
group Sub
ject
nu
mber Seq
uence
nu
mber Abn
ormality/Disease Prefe
rred term Sys
tem organ class Start
date End
date On
going
30
µg Older 10324 1 Neph
rolithiasis Neph
rolithiasis Rena
l and urinary disorders 2018 2018
Me
dical hi
story is co
ded us
ing Me
dDRA ve
rsion 23
.0.
Prog
ram: Lb
ase_Mh_7.sas (Pag
e 6 of 6)
090177e196971659\Approved\Approved On: 23-Mar-2021 06:32 (GMT)
Page 59
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