125742 S1 M5 5351 bnt162 01 interim3 lab measurements
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Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:46 -6 Urina lysis Bacte ria [/HPF] +++ Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 0-2 <= 1 Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 10 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 1 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 1 FDA-CBER-2021-5683-0050334 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:46 -6 Urina lysis Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 500 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 21-50 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Progra m: Lfs af_LB_2.sas (Page 2 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 2 FDA-CBER-2021-5683-0050335 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:46 -6 Urina lysis Urob il inogen [µmol/L] norm al Norm al 23APR20 20 7:52 -6 Chemi stry Alan ine Amin otransferase [U/L] 18 <= 34 Norm al Albu min [g/L] 39 35 - 52 Norm al Alka line Phosphatase [U/L] 78 35 - 105 Norm al Amyl ase [U/L] 71 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 15 <= 34 Norm al Bili rubin (Serum) [µmol /L] 6.2 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.4 <= 4.9 Norm al Progra m: Lfs af_LB_2.sas (Page 3 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 3 FDA-CBER-2021-5683-0050336 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:52 -6 Chemi stry Calci um [mmol/L] 2.34 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 82.2 44.2 - 79.6 High No Ferriti n [µg/L] 184 .1 15 - 150 High No Foll icle Stimulating Horm on e [IU/L] 64.2 Mis sing Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.78 <= 5.5 5 High No Lip ase [U/L] 25 13 - 60 Norm al Potas sium [mmol/L] 4.8 3.5 - 5.1 Norm al Progra m: Lfs af_LB_2.sas (Page 4 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 4 FDA-CBER-2021-5683-0050337 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:52 -6 Chemi stry Sodi um [mmol/L] 141 136 - 145 Norm al Urea Nitro gen [mmol/L] 5.50 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.03 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.6 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.08 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 1.6 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.4 4 - 5.2 Norm al Hem ato crit [L/L] 0.41 0.35 - 0.45 Norm al Progra m: Lfs af_LB_2.sas (Page 5 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 5 FDA-CBER-2021-5683-0050338 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:52 -6 Hem ato logy Hem og lobin (Blood) [mmo l/L] 8.4 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 5.0 4 - 10. 4 Norm al Lym phocytes (Blo od) [109/L] 2.17 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 43.3 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.35 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 6.9 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.38 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 47.6 40 - 75 Norm al Progra m: Lfs af_LB_2.sas (Page 6 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 6 FDA-CBER-2021-5683-0050339 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day -30 t o 0 23APR20 20 7:52 -6 Hem ato logy Plate lets [109/L] 246 176 - 391 Norm al Day 1 29APR20 20 7:36 1 Chemi stry Alan ine Amin otransferase [U/L] 16 <= 34 Norm al Albu min [g/L] 40 35 - 52 Norm al Alka line Phosphatase [U/L] 90 35 - 105 Norm al Amyl ase [U/L] 62 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 19 <= 34 Norm al Bili rubin (Serum) [µmol /L] 3.8 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.9 <= 4.9 Norm al Progra m: Lfs af_LB_2.sas (Page 7 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 7 FDA-CBER-2021-5683-0050340 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 1 29APR20 20 7:36 1 Chemi stry Calci um [mmol/L] 2.34 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 76.9 44.2 - 79.6 Norm al Ferriti n [µg/L] 214 .9 15 - 150 High No Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.50 <= 5.5 5 Norm al Lip ase [U/L] 26 13 - 60 Norm al Potas sium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodi um [mmol/L] 135 136 - 145 Low No Progra m: Lfs af_LB_2.sas (Page 8 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 8 FDA-CBER-2021-5683-0050341 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data recei ved on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of labora t ory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10015 Day 1 29APR20 2 0 7:36 1 Chemis try Urea Nitro g en [mmol/L] 4.00 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.04 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 08 02 - 15 Norm al Eosin ophils (Blood) [109/L] 0.07 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 1.4 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Hem atoc rit [L/L] 0.44 0.35 - 0.45 Norm al Hem ogl obin (Blood) [mmol /L] 8.2 7.2 - 9.7 Norm al Program : Lfsa f_LB_2.sas (Page 9 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 9 FDA-CBER-2021-5683-0050342 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 1 29APR20 20 7:36 1 Hem ato logy Leu kocytes (Blood) [109/L] 5.1 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.90 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 37.3 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.27 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 5.3 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.82 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 55.2 40 - 75 Norm al Plate lets [109/L] 253 176 - 391 Norm al Progra m: Lfs af_LB_2.sas (Page 10 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 10 FDA-CBER-2021-5683-0050343 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 1 29APR20 20 7:36 1 Urina lysis Bacte ria [/HPF] not dete ctable Mis sing Bili rubin (Urine) [µmol/L] 17.0 Abno rmal No Casts [/HPF] not dete ctable Mis sing Crysta ls [/HPF] pos itive Abno rmal No Epith elial Cells [/HPF] not dete ctable <= 1 Mis sing Erythro cytes (Urine) [/HPF] not dete ctable <= 1 Mis sing Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 10 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 11 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 11 FDA-CBER-2021-5683-0050344 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 1 29APR20 20 7:36 1 Urina lysis Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 100 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] not dete ctable <= 2 Mis sing Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] not dete ctable Mis sing Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Progra m: Lfs af_LB_2.sas (Page 12 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 12 FDA-CBER-2021-5683-0050345 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 1 29APR20 20 7:36 1 Urina lysis Urob il inogen [µmol/L] norm al Norm al Day 2 30APR20 20 7:35 2 Urina lysis Bacte ria [/HPF] ++ Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 0-2 <= 1 Norm al Glu cose (Urine) neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 13 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 13 FDA-CBER-2021-5683-0050346 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Listi ng of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:35 2 Urina lysis Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 100 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 3-6 <= 2 Abno rmal No Nitrite neg ative Norm al pH 8.0 5 - 7 High No Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 14 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 14 FDA-CBER-2021-5683-0050347 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of l aboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:35 2 Urina lysis Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 30APR20 20 7:55 2 Chemi stry Alan ine Amin otransferase [U/L] 13 <= 34 Norm al Albu min [g/L] 35 35 - 52 Norm al Alka line Pho sphatase [U/L] 77 35 - 105 Norm al Amyl ase [U/L] 69 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 13 <= 34 Norm al Bili rubin (Serum) [µmol /L] 4.6 <= 20 .4 Norm al Progra m: Lfs af_LB_2.sas (Page 15 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 15 FDA-CBER-2021-5683-0050348 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:55 2 Chemi stry C Rea cti ve Protein [mg/L ] 0.7 <= 4.9 Norm al Calci um [mmol/L] 2.29 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 80.4 44.2 - 79.6 High No Ferriti n [µg/L] 190 .3 15 - 150 High No Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.50 <= 5.5 5 Norm al Lip ase [U/L] 30 13 - 60 Norm al Potas sium [mmol/L] 4.9 3.5 - 5.1 Norm al Progra m: Lfs af_LB_2.sas (Page 16 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 16 FDA-CBER-2021-5683-0050349 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:55 2 Chemi stry Sodi um [mmol/L] 139 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.32 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.03 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.6 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.06 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 1.2 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.0 4 - 5.2 Norm al Hem ato crit [L/L] 0.38 0.35 - 0.45 Norm al Progra m: Lfs af_LB_2.sas (Page 17 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 17 FDA-CBER-2021-5683-0050350 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:55 2 Hem ato logy Hem og lobin (Blood) [mmo l/L] 7.8 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 4.8 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.92 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 40.0 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.37 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.7 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.42 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 50.5 40 - 75 Norm al Progra m: Lfs af_LB_2.sas (Page 18 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 18 FDA-CBER-2021-5683-0050351 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 2 30APR20 20 7:55 2 Hem ato logy Plate lets [109/L] 216 176 - 391 Norm al Day 8 06M AY2020 7:28 8 Urina lysis Bacte ria [/HPF] + Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 0-2 <= 1 Norm al Glu cose (Urine) neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 19 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 19 FDA-CBER-2021-5683-0050352 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:28 8 Urina lysis Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 25 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 3-6 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] 0-2 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 20 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 20 FDA-CBER-2021-5683-0050353 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:28 8 Urina lysis Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 06M AY2020 7:57 8 Chemi stry Alan ine Amin otransferase [U/L] 11 <= 34 Norm al Albu min [g/L] 38 35 - 52 Norm al Alka line Phosphatase [U/L] 77 35 - 105 Norm al Amyl ase [U/L] 65 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 12 <= 34 Norm al Bili rubin (Seru m) [µmol /L] 5.5 <= 20 .4 Norm al Progra m: Lfs af_LB_2.sas (Page 21 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 21 FDA-CBER-2021-5683-0050354 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:57 8 Chemi stry C Rea cti ve Protein [mg/L ] 0.4 <= 4.9 Norm al Calci um [mmol/L] 2.27 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 90.2 44.2 - 79.6 High No Ferriti n [µg/L] 185 .6 15 - 150 High No Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.89 <= 5.5 5 High No Lip ase [U/L] 26 13 - 60 Norm al Potas sium [mmol/L] 4.4 3.5 - 5.1 Norm al Progra m: Lfs af_LB_2.sas (Page 22 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 22 FDA-CBER-2021-5683-0050355 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:57 8 Chemi stry Sodi um [mmol/L] 141 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.32 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.03 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.6 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.07 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 1.4 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.1 4 - 5.2 Norm al Hem ato crit [L/L] 0.38 0.35 - 0.45 Norm al Progra m: Lfs af_LB_2.sas (Page 23 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 23 FDA-CBER-2021-5683-0050356 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:57 8 Hem ato logy Hem og lobin (Bloo d) [mmo l/L] 7.9 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 5.1 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.10 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 41.2 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.30 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 5.9 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.60 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 50.9 40 - 75 Norm al Progra m: Lfs af_LB_2.sas (Page 24 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 24 FDA-CBER-2021-5683-0050357 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 8 06M AY2020 7:57 8 Hem ato logy Plate lets [109/L] 239 176 - 391 Norm al Day 29 27M AY2020 8:32 29 Chemi stry Alan ine Amin otransferase [U/L] 14 <= 34 Norm al Albu min [g/L] 40 35 - 52 Norm al Alka line Phosphatase [U/L] 83 35 - 105 Norm al Amyl ase [U/L] 71 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 13 <= 34 Norm al Bili rubin (Serum) [µmol /L] 5.0 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.6 <= 4.9 Norm al Progra m: Lfs af_LB_2.sas (Page 25 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 25 FDA-CBER-2021-5683-0050358 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 29 27M AY2020 8:32 29 Chemi stry Calci um [mmol/L] 2.38 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 93.7 44.2 - 79.6 High No Ferriti n [µg/L] 199 .2 15 - 150 High No Gam ma Glutamyl Tran sferase [U/L] 14 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.45 <= 5.5 5 Norm al Lip ase [U/L] 27 13 - 60 Norm al Potas sium [mmol/L] 4.8 3.5 - 5.1 Norm al Sodi um [mmol/L] 137 136 - 145 Norm al Progra m: Lfs af_LB_2.sas (Page 26 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 26 FDA-CBER-2021-5683-0050359 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10015 Day 29 27MA Y2020 8:32 29 Chemis try Urea Nitro g en [mmol/L] 5.00 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 06 02 - 15 Norm al Eosin ophils (Blood) [109/L] 0.07 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 1.4 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.4 4 - 5.2 Norm al Hem atoc rit [L/L] 0.41 0.35 - 0.45 Norm al Hem ogl obin (Blood) [mmol /L] 8.2 7.2 - 9.7 Norm al Program : Lfsa f_LB_2.sas (Page 27 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 27 FDA-CBER-2021-5683-0050360 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 29 27M AY2020 8:32 29 Hem ato logy Leu kocytes (Bloo d) [109/L] 5.1 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.17 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 42.6 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.33 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 6.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.49 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 48.9 40 - 75 Norm al Plate lets [109/L] 265 176 - 391 Norm al Progra m: Lfs af_LB_2.sas (Page 28 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 28 FDA-CBER-2021-5683-0050361 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 29 27M AY2020 8:50 29 Urina lysis Bacte ria [/HPF] + Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 7-10 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 0-2 <= 1 Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 29 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 29 FDA-CBER-2021-5683-0050362 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 29 27M AY2020 8:50 29 Urina lysis Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 100 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 11-20 <= 2 Abno rmal No Nitrite neg ative Norm al pH 6.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Progra m: Lfs af_LB_2.sas (Page 30 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 30 FDA-CBER-2021-5683-0050363 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clea n SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 29 27M AY2020 8:50 29 Urina lysis Urob il inogen [µmol/L] norm al Norm al Day 50 17J UN2020 7:40 50 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Progra m: Lfs af_LB_2.sas (Page 31 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 31 FDA-CBER-2021-5683-0050364 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [uni t] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 50 17J UN2020 7:40 50 Urina lysis Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.02 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 17J UN2020 7:57 50 Chemi stry Alan ine Amin otransferase [U/L] 10 <= 34 Norm al Albu min [g/L] 36 35 - 52 Norm al Alka line Phosphatase [U/L] 81 35 - 105 Norm al Amyl ase [U/L] 70 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 12 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 32 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 32 FDA-CBER-2021-5683-0050365 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 50 17J UN2020 7:57 50 Chemi stry Bili rubin (Serum) [µmol /L] 3.6 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.4 <= 4.9 Norm al Calci um [mmol/L] 2.36 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 88.4 44.2 - 79.6 High No Ferriti n [µg/L] 189 .1 15 - 150 High No Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.89 <= 5.55 High No Lip ase [U/L] 26 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 33 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 33 FDA-CBER-2021-5683-0050366 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Fin a l 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10015 Day 50 17JUN 2020 7:57 50 Chemis try Potass ium [mmol/L] 5.1 3.5 - 5.1 Norm al Sodiu m [mmol/L] 142 136 - 145 Norm al Urea Nitro g en [mmol/L] 607 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.6 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.10 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.0 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 34 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 34 FDA-CBER-2021-5683-0050367 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 50 17J UN2020 7:57 50 Hem ato logy Hem ato crit [L/L] 0.41 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.1 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 5.0 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.23 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 44.6 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.38 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.27 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 35 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 35 FDA-CBER-2021-5683-0050368 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10015 Day 50 17J UN2020 7:57 50 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 45.3 40 - 75 Norm al Plate lets [109/L] 223 176 - 391 Norm al 10018 Day -30 t o 0 23APR20 20 9:11 -6 Urina lysis Bacte ria [/HPF] (+) Abno rmal No Bili rubin (Urine) [µmol/L] 17.0 Abno rmal No Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 7-10 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 11-20 <= 1 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 36 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 36 FDA-CBER-2021-5683-0050369 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day -30 t o 0 23APR20 20 9:11 -6 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine ) [106/L] 250 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 500 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 21-50 <= 2 Abno rmal No Nitrite neg ative Norm al pH 6.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 37 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 37 FDA-CBER-2021-5683-0050370 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day -30 t o 0 23APR20 20 9:11 -6 Urina lysis Round Epithelial Cells [/HPF] 0-2 Abno rmal No Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 23APR20 20 9:20 -6 Chemi stry Alan ine Amin otransferase [U/L] 20 <= 34 Norm al Albu min [g/L] 46 35 - 52 Norm al Alka line Phosphatase [U/L] 62 35 - 105 Norm al Amyl ase [U/L] 77 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 16 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 38 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 38 FDA-CBER-2021-5683-0050371 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fin al 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day -30 t o 0 23APR20 20 9:20 -6 Chemi stry Bili rubin (Seru m) [µmol /L] 13.2 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.6 <= 4.9 Norm al Calci um [mmol/L] 2.37 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 77.8 44.2 - 79.6 Norm al Ferriti n [µg/L] 54.7 15 - 150 Norm al Gam ma Glu tamyl Tran sferase [U/L] 25 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.06 <= 5.5 5 Norm al Lip ase [U/L] 20 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 39 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 39 FDA-CBER-2021-5683-0050372 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data rec eived on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measu rements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day -30 to 0 23APR20 2 0 9:20 -6 Chemis try Potass ium [mmol/L] 4.2 3.5 - 5.1 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 450 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.3 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.15 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.2 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 40 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 40 FDA-CBER-2021-5683-0050373 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day -30 t o 0 23APR20 20 9:20 -6 Hem ato logy Hem ato crit [L/L] 0.40 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.4 7.2 - 9.7 Norm al Leu kocytes (Bloo d) [109/L] 6.8 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 3.08 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 45.3 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.43 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 6.3 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.12 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 41 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 41 FDA-CBER-2021-5683-0050374 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day -30 t o 0 23APR20 20 9:20 -6 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 45.9 40 - 75 Norm al Plate lets [109/L] 355 176 - 391 Norm al Day 1 29APR20 20 7:40 1 Urina lysis Bacte ria [/HPF] + Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 7-10 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 0-2 <= 1 Norm al Progra m: Lfs af_LB_2.sas (Page 42 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 42 FDA-CBER-2021-5683-0050375 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 1 29APR20 20 7:40 1 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 250 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 500 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 7-10 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 43 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 43 FDA-CBER-2021-5683-0050376 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 1 29APR20 20 7:40 1 Urina lysis Round Epith elial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 29APR20 20 9:04 1 Chemi stry Alan ine Amin otransferase [U/L] 14 <= 34 Norm al Albu min [g/L] 43 35 - 52 Norm al Alka line Phosphatase [U/L] 63 35 - 105 Norm al Amyl ase [U/L] 96 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 17 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 44 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 44 FDA-CBER-2021-5683-0050377 Bio NTech RNA Pha rmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 1 29APR20 20 9:04 1 Chemi stry Bili rubin (Serum) [µmol /L] 8.9 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.4 <= 4.9 Norm al Calci um [mmol/L] 2.36 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 79.6 44.2 - 79.6 Norm al Ferriti n [µg/L] 46.2 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 24 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.73 <= 5.5 5 Norm al Lip ase [U/L] 26 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 45 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 45 FDA-CBER-2021-5683-0050378 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clea n SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 1 29APR20 2 0 9:04 1 Chemis try Potass ium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodiu m [mmol/L] 137 136 - 145 Norm al Urea Nitro g en [mmol/L] 482 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.3 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.14 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.2 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.2 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 46 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 46 FDA-CBER-2021-5683-0050379 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 1 29APR20 20 9:04 1 Hem ato logy Hem ato crit [L/L] 0.43 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.4 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 6.3 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.73 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 43.4 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.37 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 5.9 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.04 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 47 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 47 FDA-CBER-2021-5683-0050380 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 1 29APR20 20 9:04 1 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 48.2 40 - 75 Norm al Plate lets [109/L] 324 176 - 391 Norm al Day 2 30APR20 20 7:40 2 Urina lysis Bacte ria [/HPF] neg ative Norm al Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] pos itive Abno rmal No Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 3-6 <= 1 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 48 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 48 FDA-CBER-2021-5683-0050381 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 2 30APR20 20 7:40 2 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 150 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 25 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 7-10 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 49 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 49 FDA-CBER-2021-5683-0050382 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 2 30APR20 20 7:40 2 Urina lysis Round Epith elial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 30APR20 20 8:15 2 Chemi stry Alan ine Amin otransferase [U/L] 12 <= 34 Norm al Albu min [g/L] 40 35 - 52 Norm al Alka line Phosphatase [U/L] 57 35 - 105 Norm al Amyl ase [U/L] 82 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 12 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 50 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 50 FDA-CBER-2021-5683-0050383 Bio NTech RNA Pha rmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 2 30APR20 20 8:15 2 Chemi stry Bili rubin (Serum) [µmol /L] 13.5 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.0 <= 4.9 Norm al Calci um [mmol/L] 2.23 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 78.7 44.2 - 79.6 Norm al Ferriti n [µg/L] 42.7 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 22 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.61 <= 5.5 5 Norm al Lip ase [U/L] 22 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 51 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 51 FDA-CBER-2021-5683-0050384 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clea n SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 2 30APR20 2 0 8:15 2 Chemis try Potass ium [mmol/L] 4.5 3.5 - 5.1 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 400 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.01 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.1 0.2 - 1.5 Low No Eosin ophils (Blood) [109/L] 0.11 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 1.6 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.2 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 52 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 52 FDA-CBER-2021-5683-0050385 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 2 30APR20 20 8:15 2 Hem ato logy Hem ato crit [L/L] 0.39 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.3 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 6.8 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.93 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 28.4 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.47 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 6.9 4 - 12 Norm al Neutrop hils (Blood) [109/L] 4.28 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 53 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 53 FDA-CBER-2021-5683-0050386 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 2 30APR20 20 8:15 2 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 63.0 40 - 75 Norm al Plate lets [109/L] 298 176 - 391 Norm al Day 8 06M AY2020 7:29 8 Urina lysis Bacte ria [/HPF] + Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] 3-6 <= 1 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 54 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 54 FDA-CBER-2021-5683-0050387 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 8 06M AY2020 7:29 8 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 150 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Leu kocytes (Urine - Mic roscopy) [/HPF] 3-6 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 55 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 55 FDA-CBER-2021-5683-0050388 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 8 06M AY2020 7:29 8 Urina lysis Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 06M AY2020 8:52 8 Chemi stry Alan ine Amin otransferase [U/L] 15 <= 34 Norm al Albu min [g/L ] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 63 35 - 105 Norm al Amyl ase [U/L] 104 28 - 100 High No Aspa rtate Amin otransferase [U/L] 15 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 56 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 56 FDA-CBER-2021-5683-0050389 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 8 06M AY2020 8:52 8 Chemi stry Bili rubin (Serum) [µmol /L] 7.0 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.6 <= 4.9 Norm al Calci um [mmol/L] 2.38 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 87.5 44.2 - 79.6 High No Ferriti n [µg/L] 29.9 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 23 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.28 <= 5.5 5 Norm al Lip ase [U/L] 23 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 57 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 57 FDA-CBER-2021-5683-0050390 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 8 06MA Y2020 8:52 8 Chemis try Potass ium [mmol/L] 4.4 3.5 - 5.1 Norm al Sodiu m [mmol/L] 140 136 - 145 Norm al Urea Nitro g en [mmol/L] 418 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.3 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.11 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 1.6 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.4 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 58 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 58 FDA-CBER-2021-5683-0050391 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 8 06M AY2020 8:52 8 Hem ato logy Hem ato crit [L/L] 0.40 0.35 - 0.45 Norm al Hem og lobin (Bloo d) [mmo l/L] 8.6 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 6.8 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.85 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 41.9 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.38 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 5.6 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.44 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 59 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 59 FDA-CBER-2021-5683-0050392 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 8 06M AY2020 8:52 8 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 50.6 40 - 75 Norm al Plate lets [109/L] 390 176 - 391 Norm al Day 29 27M AY2020 7:39 29 Urina lysis Bacte ria [/HPF] + Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 0-2 <= 1 Norm al Erythro cytes (Urine) [/HPF] 7-10 <= 1 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 60 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 60 FDA-CBER-2021-5683-0050393 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 29 27M AY2020 7:39 29 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 250 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 25 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 3-6 <= 2 Abno rmal No Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 61 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 61 FDA-CBER-2021-5683-0050394 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 29 27M AY2020 7:39 29 Urina lysis Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 27M AY2020 8:58 29 Chemi stry Alan ine Amin otransferase [U/L] 19 <= 34 Norm al Albu min [g/L] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 87 35 - 105 Norm al Amyl ase [U/L] 99 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 19 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 62 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 62 FDA-CBER-2021-5683-0050395 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 29 27M AY2020 8:58 29 Chemi stry Bili rubin (Serum) [µmol /L] 12.3 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.2 <= 4.9 Norm al Calci um [mmol/L] 2.44 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 78.7 44.2 - 79.6 Norm al Ferriti n [µg/L] 57.6 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 30 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.61 <= 5.5 5 Norm al Lip ase [U/L] 21 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 63 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 63 FDA-CBER-2021-5683-0050396 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV 20 20 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 29 27MA Y2020 8:58 29 Chemis try Potass ium [mmol/L] 4.1 3.5 - 5.1 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmo l/L] 486 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.04 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.4 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.53 0.03 - 0.44 High No Eosin ophils/Leukocytes (Blood ) [%] 5.4 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.5 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 64 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 64 FDA-CBER-2021-5683-0050397 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 29 27M AY2020 8:58 29 Hem ato logy Hem ato crit [L/L] 0.42 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.9 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 9.9 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 4.33 1.22 - 3.56 High Yes Lym phocytes/Leukocytes (Bloo d) [%] 43.7 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.46 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 4.6 4 - 12 Norm al Neutrop hils (Blood) [109/L] 4.54 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 65 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 65 FDA-CBER-2021-5683-0050398 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 29 27M AY2020 8:58 29 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 45.9 40 - 75 Norm al Plate lets [109/L] 428 176 - 391 High No Day 50 17J UN2020 7:26 50 Urina lysis Bacte ria [/HPF] ++ Abno rmal No Bili rubin (Urine) [µmol/L] 17.0 Abno rmal No Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 0-2 <= 1 Norm al Erythro cytes (Urine) [/HPF] 3-6 <= 1 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 66 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 66 FDA-CBER-2021-5683-0050399 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data rec eived on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 50 17JUN 2020 7:26 50 Urinal ysis Gluc ose (Urine) nega tive Norm al Hem ogl obin (Urine) [106/L] 250 Abnorm al No Ketone s [mmol/L] 15 Abnorm al No Leuk ocytes (Urine - Dipstic k) [106/L] 25 Abnorm al No Leuk ocytes (Urine - Micro scopy) [/HPF] 3-6 <= 2 Abnorm al No Nitrite nega tive Norm al pH 5.0 5 - 7 Norm al Protein [mg/L] nega tive Norm al Program : Lfsa f_LB_2.sas (Page 67 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 67 FDA-CBER-2021-5683-0050400 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 50 17J UN2020 7:26 50 Urina lysis Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol /L] norm al Norm al 17J UN2020 8:13 50 Chemi stry Alan ine Amin otransferase [U/L] 11 <= 34 Norm al Albu min [g/L] 39 35 - 52 Norm al Alka line Phosphatase [U/L] 65 35 - 105 Norm al Amyl ase [U/L] 81 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 14 <= 34 Norm al Progra m: Lfs af_LB_2.sas (Page 68 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 68 FDA-CBER-2021-5683-0050401 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 50 17J UN2020 8:13 50 Chemi stry Bili rubin (Serum) [µmol /L] 16.4 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.9 <= 4.9 Norm al Calci um [mmol/L] 2.27 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 86.6 44.2 - 79.6 High No Ferriti n [µg/L] 43.1 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 20 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.50 <= 5.5 5 Norm al Lip ase [U/L] 18 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 69 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 69 FDA-CBER-2021-5683-0050402 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snaps hot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10018 Day 50 17JUN 2020 8:13 50 Chemis try Potass ium [mmol/L] 4.2 3.5 - 5.1 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 543 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.5 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.28 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 4.2 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Program : Lfsa f_LB_2.sas (Page 70 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 70 FDA-CBER-2021-5683-0050403 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 50 17J UN2020 8:13 50 Hem ato logy Hem ato crit [L/L] 0.40 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.2 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 6.6 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 2.71 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 41.1 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.36 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 5.4 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.22 1.91 - 7.34 Norm al Progra m: Lfs af_LB_2.sas (Page 71 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 71 FDA-CBER-2021-5683-0050404 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10018 Day 50 17J UN2020 8:13 50 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 48.8 40 - 75 Norm al Plate lets [109/L] 326 176 - 391 Norm al 10023 Day -30 t o 0 24APR20 20 8:45 -11 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 72 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 72 FDA-CBER-2021-5683-0050405 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day -30 to 0 24APR20 2 0 8:45 -11 Urinal ysis pH 6.0 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.015 1.005 - 1038 Norm al Urob ili nogen [µmol/L] norma l Norm al 24APR202 0 8:54 -11 Chemis try Alani ne Amino transferase [U/L] 12 <= 34 Norm al Album in [g/L] 43 35 - 52 Norm al Alkal ine Phos phatase [U/L] 42 35 - 105 Norm al Amyla se [U/L] 69 28 - 100 Norm al Program : Lfsa f_LB_2.sas (Page 73 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 73 FDA-CBER-2021-5683-0050406 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day -30 t o 0 24APR20 20 8:54 -11 Chemi stry Aspa rtate Amin otransferase [U/L] 13 <= 34 Norm al Bili rubin (Serum) [µmol /L] 6.5 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.8 <= 4.9 Norm al Calci um [mmol/L] 2.33 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 69.8 44.2 - 79.6 Norm al Ferriti n [µg/L] 88.2 15 - 150 Norm al Foll icle Stimulating Horm on e [IU/L] 3.4 Mis sing Gam ma Glutamyl Tran sferase [U/L] 16 <= 39 Norm al Progra m: Lfs af_LB_2.sas (Page 74 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 74 FDA-CBER-2021-5683-0050407 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day -30 to 0 24APR20 2 0 8:54 -11 Chemis try Gluc ose (Blood) [mmol /L] 4.34 <= 5.55 Norm al Lipa se [U/L] 73 13 - 60 High No Potass ium [mmol/L] 49 35 - 51 Norm al Sodiu m [mmol/L] 143 136 - 145 Norm al Urea Nitro g en [mmol/L] 4.18 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.04 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.8 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.18 0.03 - 0.44 Norm al Program : Lfsa f_LB_2.sas (Page 75 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 75 FDA-CBER-2021-5683-0050408 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day -30 t o 0 24APR20 20 8:54 -11 Hem ato logy Eosi nophils/Leukocytes (Bloo d) [%] 3.4 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.0 4 - 5.2 Norm al Hem ato crit [L/L] 0.41 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 7.6 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 5.3 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.47 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 27.8 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.24 0.25 - 0.85 Low No Progra m: Lfs af_LB_2.sas (Page 76 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 76 FDA-CBER-2021-5683-0050409 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day -30 t o 0 24APR20 20 8:54 -11 Hem ato logy Mon ocytes/Leukocytes (Bloo d) [%] 4.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.37 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 63.5 40 - 75 Norm al Plate lets [109/L] 239 176 - 391 Norm al Day 1 05M AY2020 8:02 1 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 77 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 77 FDA-CBER-2021-5683-0050410 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 1 05MA Y2020 8:02 1 Urinal ysis Leuk ocytes (Urine - Dipstic k) [106/L] nega tive Norm al Nitrite nega tive Norm al pH 60 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.015 1.005 - 1.038 Norm al Urob ili nogen [µmol/L] norma l Norm al 05MA Y2020 8:49 1 Chemis try Alani ne Amino transferase [U/L] 9 <= 34 Norm al Album in [g/L] 45 35 - 52 Norm al Program : Lfsa f_LB_2.sas (Page 78 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 78 FDA-CBER-2021-5683-0050411 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 1 05M AY2020 8:49 1 Chemi stry Alka line Phosphatase [U/L] 41 35 - 105 Norm al Amyl ase [U/L] 60 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 16 <= 34 Norm al Bili rubin (Serum) [µmol /L] 13.7 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.1 <= 4.9 Norm al Calci um [mmol/L] 2.40 2.15 - 2.55 Norm al Crea tin ine [µmo l/L] 76.9 44.2 - 79.6 Norm al Ferriti n [µg/L] 136 .6 15 - 150 Norm al Progra m: Lfs af_LB_2.sas (Page 79 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 79 FDA-CBER-2021-5683-0050412 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 1 05M AY2020 8:49 1 Chemi stry Gam ma Glutamyl Tran sferase [U/L] 16 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.34 <= 5.5 5 Norm al Lip ase [U/L] 62 13 - 60 High No Potas sium [mmol/L] 5.2 3.5 - 5.1 High No Sodi um [mmol/L] 138 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.00 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.03 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.9 0.2 - 1.5 Norm al Progra m: Lfs af_LB_2.sas (Page 80 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 80 FDA-CBER-2021-5683-0050413 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 1 05M AY2020 8:49 1 Hem ato logy Eosi nophils (Bloo d) [109/L] 0.11 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 3.3 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Hem ato crit [L/L] 0.39 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 8.2 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 3.3 4 - 10. 4 Low No Lym phocytes (Blood) [109/L] 1.13 1.22 - 3.56 Low No Lym phocytes/Leukocytes (Bloo d) [%] 34.1 17 - 47 Norm al Progra m: Lfs af_LB_2.sas (Page 81 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 81 FDA-CBER-2021-5683-0050414 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 1 05M AY2020 8:49 1 Hem ato logy Mon ocytes (Blood) [109/L] 0.28 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 8.4 4 - 12 Norm al Neutrop hils (Blood) [109/L] 1.76 1.91 - 7.34 Low No Neutrop hils/Leukocytes (Bloo d) [%] 53.3 40 - 75 Norm al Plate lets [109/L] 215 176 - 391 Norm al Day 2 06M AY2020 8:19 2 Chemi stry Alan ine Amin otransferase [U/L] 8 <= 34 Norm al Albu min [g/L] 42 35 - 52 Norm al Alka line Pho sphatase [U/L] 43 35 - 105 Norm al Progra m: Lfs af_LB_2.sas (Page 82 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 82 FDA-CBER-2021-5683-0050415 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 2 06M AY2020 8:19 2 Chemi stry Amyl ase [U/L] 63 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 12 <= 34 Norm al Bili rubin (Serum) [µmol /L] 12.3 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.0 <= 4.9 Norm al Calci um [mmol/L] 2.32 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 79.6 44.2 - 79.6 Norm al Ferriti n [µg/L] 115 .8 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 15 <= 39 Norm al Progra m: Lfs af_LB_2.sas (Page 83 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 83 FDA-CBER-2021-5683-0050416 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 2 06MA Y2020 8:19 2 Chemis try Gluc ose (Blood) [mmol /L] 4.89 <= 5.55 Norm al Lipa se [U/L] 70 13 - 60 High No Potass ium [mmol/L] 48 35 - 51 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 3.68 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.7 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.14 0.03 - 0.44 Norm al Program : Lfsa f_LB_2.sas (Page 84 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 84 FDA-CBER-2021-5683-0050417 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 2 06M AY2020 8:19 2 Hem ato logy Eosi nophils/Leukocytes (Bloo d) [%] 3.0 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.0 4 - 5.2 Norm al Hem ato crit [L/L] 0.36 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 7.6 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 4.6 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.26 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 27.3 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.44 0.25 - 0.85 Norm al Progra m: Lfs af_LB_2.sas (Page 85 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 85 FDA-CBER-2021-5683-0050418 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 2 06M AY2020 8:19 2 Hem ato logy Mon ocytes/Leukocytes (Bloo d) [%] 9.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.74 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 59.5 40 - 75 Norm al Plate lets [109/L] 202 176 - 391 Norm al 06M AY2020 8:23 2 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 86 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 86 FDA-CBER-2021-5683-0050419 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 2 06MA Y2020 8:23 2 Urinal ysis Leuk ocytes (Urine - Dipstic k) [106/L] nega tive Norm al Nitrite nega tive Norm al pH 70 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.015 1.005 - 1.038 Norm al Urob ili nogen [µmol/L] norma l Norm al Day 8 12MA Y2020 7:30 8 Urinal ysis Biliru bin (Urine) [µmol /L] nega tive Norm al Gluc ose (Urine) nega tive Norm al Program : Lfsa f_LB_2.sas (Page 87 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 87 FDA-CBER-2021-5683-0050420 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 8 12M AY2020 7:30 8 Urina lysis Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mm ol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 6.5 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al Progra m: Lfs af_LB_2.sas (Page 88 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 88 FDA-CBER-2021-5683-0050421 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 8 12M AY2020 8:10 8 Chemi stry Alan ine Amin otransferase [U/L] 8 <= 34 Norm al Albu min [g/L] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 50 35 - 105 Norm al Amyl ase [U/L] 47 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 19 <= 34 Norm al Bili rubin (Serum) [µmol /L] 8.6 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 1.0 <= 4.9 Norm al Calci um [mmol/L] 2.47 2.15 - 2.55 Norm al Progra m: Lfs af_LB_2.sas (Page 89 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 89 FDA-CBER-2021-5683-0050422 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 8 12M AY2020 8:10 8 Chemi stry Crea tin ine [µmol/L] 93.7 44.2 - 79.6 High No Ferriti n [µg/L] 127 .4 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 14 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.23 <= 5.5 5 Norm al Lip ase [U/L] 51 13 - 60 Norm al Potas sium [mmol/L] 4.4 3.5 - 5.1 Norm al Sodi um [mmol/L] 139 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.18 2.77 - 8.1 Norm al Progra m: Lfs af_LB_2.sas (Page 90 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 90 FDA-CBER-2021-5683-0050423 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snaps hot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 8 12MA Y2020 8:10 8 Hem atol ogy Basop hils (Blood) [109/L] 0.04 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 1.0 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 016 003 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 4.2 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.5 4 - 5.2 Norm al Hem atoc rit [L/L] 0.40 0.35 - 0.45 Norm al Hem ogl obin (Blood) [mmol /L] 8.3 7.2 - 9.7 Norm al Leuk ocytes (Blood) [109/L] 3.8 4 - 10.4 Low No Program : Lfsa f_LB_2.sas (Page 91 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 91 FDA-CBER-2021-5683-0050424 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of labora tory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 8 12M AY2020 8:10 8 Hem ato logy Lym phocytes (Blood) [109/L] 1.26 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 33.2 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.31 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 8.1 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.03 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 53.5 40 - 75 Norm al Plate lets [109/L] 222 176 - 391 Norm al Day 29 02J UN2020 8:03 29 Urina lysis Bacte ria [/HPF] (+) Abno rmal No Progra m: Lfs af_LB_2.sas (Page 92 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 92 FDA-CBER-2021-5683-0050425 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 29 02J UN2020 8:03 29 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 0-2 <= 1 Norm al Erythro cytes (Urine) [/HPF] neg ative <= 1 Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 93 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 93 FDA-CBER-2021-5683-0050426 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 29 02J UN2020 8:03 29 Urina lysis Leu kocytes (Urine - Dipsti ck) [106/L] 25 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 0-2 <= 2 Norm al Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al Progra m: Lfs af_LB_2.sas (Page 94 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 94 FDA-CBER-2021-5683-0050427 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 29 02J UN2020 8:10 29 Chemi stry Alan ine Amin otransferase [U/L] 6 <= 34 Norm al Albu min [g/L] 42 35 - 52 Norm al Alka line Phosphatase [U/L] 41 35 - 105 Norm al Amyl ase [U/L] 63 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 12 <= 34 Norm al Bili rubin (Serum) [µmol /L] 7.7 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.7 <= 4.9 Norm al Calci um [mmol/L] 2.35 2.15 - 2.55 Norm al Progra m: Lfs af_LB_2.sas (Page 95 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 95 FDA-CBER-2021-5683-0050428 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 29 02J UN2020 8:10 29 Chemi stry Crea tin ine [µmol/L] 72.5 44.2 - 79.6 Norm al Ferriti n [µg/L] 73.0 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.67 <= 5.5 5 Norm al Lip ase [U/L] 51 13 - 60 Norm al Potas sium [mmol/L] 5.0 3.5 - 5.1 Norm al Sodi um [mmol/L] 142 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.96 2.77 - 8.1 Norm al Progra m: Lfs af_LB_2.sas (Page 96 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 96 FDA-CBER-2021-5683-0050429 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 29 02JUN 2020 8:10 29 Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.7 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 018 003 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 4.1 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Hem atoc rit [L/L] 0.40 0.35 - 0.45 Norm al Hem ogl obin (Blood) [mmol /L] 8.0 7.2 - 9.7 Norm al Leuk ocytes (Blood) [109/L] 4.4 4 - 10.4 Norm al Program : Lfsa f_LB_2.sas (Page 97 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 97 FDA-CBER-2021-5683-0050430 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 29 02J UN2020 8:10 29 Hem ato logy Lym phocytes (Blood) [109/L] 1.51 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 34.3 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.36 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 8.2 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.32 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 52.7 40 - 75 Norm al Plate lets [109/L] 223 176 - 391 Norm al Day 50 22J UN2020 7:46 49 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 98 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 98 FDA-CBER-2021-5683-0050431 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 50 22J UN2020 7:46 49 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 7.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Progra m: Lfs af_LB_2.sas (Page 99 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 99 FDA-CBER-2021-5683-0050432 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 50 22J UN2020 7:46 49 Urina lysis Urob il inogen [µmol/L] norm al Norm al 22J UN2020 8:05 49 Chemi stry Alan ine Amin otransferase [U/L] 8 <= 34 Norm al Albu min [g/L] 40 35 - 52 Norm al Alka line Phosphatase [U/L] 46 35 - 105 Norm al Amyl ase [U/L] 72 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 15 <= 34 Norm al Bili rubin (Serum) [µmol /L] 3.8 <= 20 .4 Norm al C Reacti ve Protein [mg/L ] 0.8 <= 4.9 Norm al Progra m: Lfs af_LB_2.sas (Page 100 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 100 FDA-CBER-2021-5683-0050433 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 50 22J UN2020 8:05 49 Chemi stry Calci um [mmol/L] 2.31 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 70.7 44.2 - 79.6 Norm al Ferriti n [µg/L] 116 .7 15 - 150 Norm al Gam ma Glutamyl Tran sferase [U/L] 13 <= 39 Norm al Glu cose (Blood) [mmo l/L] 4.84 <= 5.5 5 Norm al Lip ase [U/L] 93 13 - 60 High No Potas sium [mmol/L] 4.9 3.5 - 5.1 Norm al Sodi um [mmol/L] 141 136 - 145 Norm al Progra m: Lfs af_LB_2.sas (Page 101 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 101 FDA-CBER-2021-5683-0050434 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10023 Day 50 22JUN 2020 8:05 49 Chemis try Urea Nitro g en [mmol/L] 5.36 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.03 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 06 02 - 15 Norm al Eosin ophils (Blood) [109/L] 0.19 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 3.9 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 3.9 4 - 5.2 Low No Hem atoc rit [L/L] 0.36 0.35 - 0.45 Norm al Hem ogl obin (Blood) [mmol /L] 7.3 7.2 - 9.7 Norm al Program : Lfsa f_LB_2.sas (Page 102 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 102 FDA-CBER-2021-5683-0050435 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10023 Day 50 22J UN2020 8:05 49 Hem ato logy Leu kocytes (Bloo d) [109/L] 4.9 4 - 10. 4 Norm al Lym phocytes (Blood) [109/L] 1.74 1.22 - 3.56 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 35.6 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.37 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.57 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 52.4 40 - 75 Norm al Plate lets [109/L] 184 176 - 391 Norm al Progra m: Lfs af_LB_2.sas (Page 103 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 103 FDA-CBER-2021-5683-0050436 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 9:53 -11 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 7.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 104 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 104 FDA-CBER-2021-5683-0050437 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 9:53 -11 Urina lysis Spec ific Gravity 1.00 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 24APR20 20 10:0 2 -11 Chemi stry Alan ine Amin otransferase [U/L] 15 <= 49 Norm al Albu min [g/L] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 55 40 - 130 Norm al Amyl ase [U/L] 54 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 23 <= 49 Norm al Bili rubin (Serum) [µmol /L] 7.5 <= 20 .4 Norm al Progra m: Lfs af_LB_2.sas (Page 105 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 105 FDA-CBER-2021-5683-0050438 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 10:0 2 -11 Chemi stry C Rea cti ve Protein [mg/L ] <0.3 <= 4.9 Norm al Calci um [mmol/L] 2.45 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 86.6 61.9 - 106 .1 Norm al Ferriti n [µg/L] 72.1 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 11 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.39 <= 5.5 5 Norm al Lip ase [U/L] 25 13 - 60 Norm al Potas sium [mmol/L] 4.4 3.5 - 5.1 Norm al Progra m: Lfs af_LB_2.sas (Page 106 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 106 FDA-CBER-2021-5683-0050439 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 10:0 2 -11 Chemi stry Sodi um [mmol/L] 141 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.18 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.09 <= 0.0 7 High No Baso phils/Leukocytes (Bloo d) [%] 1.6 0.2 - 1.5 High No Eosi nophils (Blood) [109/L] 0.26 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 4.6 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 5.2 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.48 0.4 - 0.51 Norm al Progra m: Lfs af_LB_2.sas (Page 107 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 107 FDA-CBER-2021-5683-0050440 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 10:0 2 -11 Hem ato logy Hem og lobin (Blood) [mmo l/L] 9.1 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.6 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.77 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 31.6 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.63 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 11.3 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.85 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 50.9 40 - 75 Norm al Progra m: Lfs af_LB_2.sas (Page 108 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 108 FDA-CBER-2021-5683-0050441 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day -30 t o 0 24APR20 20 10:0 2 -11 Hem ato logy Plate lets [109/L] 217 146 - 328 Norm al Day 1 05M AY2020 7:39 1 Urina lysis Bili rubin (Urine) [µmo l/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Progra m: Lfs af_LB_2.sas (Page 109 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 109 FDA-CBER-2021-5683-0050442 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 1 05M AY2020 7:39 1 Urina lysis Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 05M AY2020 8:29 1 Chemi stry Alan ine Amin otransferase [U/L] 14 <= 49 Norm al Albu min [g/L] 44 35 - 52 Norm al Alka line Phosphatase [U/L] 55 40 - 130 Norm al Amyl ase [U/L] 51 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 24 <= 49 Norm al Progra m: Lfs af_LB_2.sas (Page 110 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 110 FDA-CBER-2021-5683-0050443 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 1 05M AY2020 8:29 1 Chemi stry Bili rubin (Serum) [µmol /L] 6.2 <= 20 .4 Norm al C Rea cti ve Prote in [mg/L ] <0.3 <= 4.9 Norm al Calci um [mmol/L] 2.31 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 76.9 61.9 - 106 .1 Norm al Ferriti n [µg/L] 59.3 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 11 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.45 <= 5.5 5 Norm al Lip ase [U/L] 26 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 111 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 111 FDA-CBER-2021-5683-0050444 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10025 Day 1 05MA Y2020 8:29 1 Chemis try Potass ium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 532 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.10 <= 0.07 High No Basop hils/Leukocytes (Blood ) [%] 1.7 0.2 - 1.5 High No Eosin ophils (Blood) [109/L] 0.39 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 6.8 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 4.8 4.5 - 5.8 Norm al Program : Lfsa f_LB_2.sas (Page 112 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 112 FDA-CBER-2021-5683-0050445 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 1 05M AY2020 8:29 1 Hem ato logy Hem ato crit [L/L] 0.42 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 8.6 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.8 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.81 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 31.2 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.68 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 11.8 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.81 1.78 - 6.23 Norm al Progra m: Lfs af_LB_2.sas (Page 113 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 113 FDA-CBER-2021-5683-0050446 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 1 05M AY2020 8:29 1 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 48.5 40 - 75 Norm al Plate lets [109/L] 167 146 - 328 Norm al Day 2 06M AY2020 7:40 2 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 114 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 114 FDA-CBER-2021-5683-0050447 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10025 Day 2 06MA Y2020 7:40 2 Urinal ysis pH 6.0 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.015 1.005 - 1038 Norm al Urob ili nogen [µmol/L] norma l Norm al 06MA Y2020 7:55 2 Chemis try Alani ne Amino transferase [U/L] 15 <= 49 Norm al Album in [g/L] 45 35 - 52 Norm al Alkal ine Phosphatase [U/L] 55 40 - 130 Norm al Amyla se [U/L] 52 28 - 100 Norm al Program : Lfsa f_LB_2.sas (Page 115 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 115 FDA-CBER-2021-5683-0050448 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 2 06M AY2020 7:55 2 Chemi stry Aspa rtate Amin otransferase [U/L] 23 <= 49 Norm al Bili rubin (Serum) [µmol /L] 8.7 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] <0.3 <= 4.9 Norm al Calci um [mmol/L] 2.37 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 88.4 61.9 - 106 .1 Norm al Ferriti n [µg/L] 62.0 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 12 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.50 <= 5.5 5 Norm al Progra m: Lfs af_LB_2.sas (Page 116 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 116 FDA-CBER-2021-5683-0050449 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 2 06M AY2020 7:55 2 Chemi stry Lip ase [U/L] 26 13 - 60 Norm al Potas sium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodi um [mmol/L] 141 136 - 145 Norm al Urea Nitro gen [mmol/L] 4.32 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.08 <= 0.0 7 High No Baso phils/Leukocytes (Bloo d) [%] 1.2 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.33 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 5.1 0.5 - 7 Norm al Progra m: Lfs af_LB_2.sas (Page 117 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 117 FDA-CBER-2021-5683-0050450 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 2 06M AY2020 7:55 2 Hem ato logy Erythro cytes (Blo od) [1012/L] 4.9 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.43 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 8.8 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 6.5 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.62 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 24.9 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.81 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 12.5 4 - 12 High No Progra m: Lfs af_LB_2.sas (Page 118 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 118 FDA-CBER-2021-5683-0050451 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 2 06M AY2020 7:55 2 Hem ato logy Neutrop hils (Blood) [109/L] 3.66 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 56.3 40 - 75 Norm al Plate lets [109/L] 208 146 - 328 Norm al Day 8 12M AY2020 7:47 8 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 119 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 119 FDA-CBER-2021-5683-0050452 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 8 12M AY2020 7:47 8 Urina lysis Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 12M AY2020 8:00 8 Chemi stry Alan ine Amin otransferase [U/L] 13 <= 49 Norm al Albu min [g/L] 45 35 - 52 Norm al Alka line Phosphatase [U/L] 60 40 - 130 Norm al Progra m: Lfs af_LB_2.sas (Page 120 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 120 FDA-CBER-2021-5683-0050453 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10025 Day 8 12MA Y2020 8:00 8 Chemis try Amyla se [U/L] 63 28 - 100 Norm al Aspart ate Amino transferase [U/L] 24 <= 49 Norm al Biliru bin (Serum ) [µmol/ L] 56 <= 20. 4 Norm al C Rea ctiv e Protein [mg/L] 0.4 <= 4.9 Norm al Calciu m [mmol/L] 2.41 2.15 - 2.55 Norm al Crea tini ne [µmol/L] 80.4 61.9 - 106.1 Norm al Ferritin [µg/L] 62.2 30 - 400 Norm al Gamm a Gluta myl Trans ferase [U/L] 13 <= 59 Norm al Program : Lfsa f_LB_2.sas (Page 121 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 121 FDA-CBER-2021-5683-0050454 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10025 Day 8 12MA Y2020 8:00 8 Chemis try Gluc ose (Blood) [mmol /L] 5.45 <= 5.55 Norm al Lipa se [U/L] 30 13 - 60 Norm al Potass ium [mmol/L] 43 35 - 51 Norm al Sodiu m [mmol/L] 139 136 - 145 Norm al Urea Nitro g en [mmol/L] 5.18 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.09 <= 0.07 High No Basop hils/Leukocytes (Blood ) [%] 1.5 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.33 0.03 - 0.44 Norm al Program : Lfsa f_LB_2.sas (Page 122 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 122 FDA-CBER-2021-5683-0050455 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 8 12M AY2020 8:00 8 Hem ato logy Eosi nophils/Leukocytes (Bloo d) [%] 5.4 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 5.2 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.46 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 9.1 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 6.2 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.73 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 27.9 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.74 0.26 - 0.87 Norm al Progra m: Lfs af_LB_2.sas (Page 123 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 123 FDA-CBER-2021-5683-0050456 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 8 12M AY2020 8:00 8 Hem ato logy Mon ocytes/Leukocytes (Bloo d) [%] 11.9 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.30 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 53.3 40 - 75 Norm al Plate lets [109/L] 204 146 - 328 Norm al Day 29 02J UN2020 7:40 29 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 124 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 124 FDA-CBER-2021-5683-0050457 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data rec eived on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10025 Day 29 02JUN 2020 7:40 29 Urinal ysis Leuk ocytes (Urine - Dipstic k) [106/L] nega tive Norm al Nitrite nega tive Norm al pH 60 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.020 1.005 - 1.038 Norm al Urob ili nogen [µmol/L] norma l Norm al 02JUN 2020 7:55 29 Chemis try Alani ne Amino transferase [U/L] 13 <= 49 Norm al Album in [g/L] 42 35 - 52 Norm al Program : Lfsa f_LB_2.sas (Page 125 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 125 FDA-CBER-2021-5683-0050458 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 29 02J UN2020 7:55 29 Chemi stry Alka line Phosphatase [U/L] 54 40 - 130 Norm al Amyl ase [U/L] 52 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 21 <= 49 Norm al Bili rubin (Serum) [µmol /L] 7.2 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] <0.3 <= 4.9 Norm al Calci um [mmol/L] 2.34 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 83.1 61.9 - 106 .1 Norm al Ferriti n [µg/L] 70.9 30 - 400 Norm al Progra m: Lfs af_LB_2.sas (Page 126 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 126 FDA-CBER-2021-5683-0050459 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 29 02J UN2020 7:55 29 Chemi stry Gam ma Glutamyl Tran sferase [U/L] 12 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.34 <= 5.5 5 Norm al Lip ase [U/L] 24 13 - 60 Norm al Potas sium [mmol/L] 4.1 3.5 - 5.1 Norm al Sodi um [mmol/L] 140 136 - 145 Norm al Urea Nitro gen [mmol/L] 5.53 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.09 <= 0.0 7 High No Baso phils/Leukocytes (Bloo d) [%] 1.5 0.2 - 1.5 Norm al Progra m: Lfs af_LB_2.sas (Page 127 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 127 FDA-CBER-2021-5683-0050460 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 29 02J UN2020 7:55 29 Hem ato logy Eosi nophils (Blood) [109/L] 0.33 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 5.6 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.9 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.44 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 8.7 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.9 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.87 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 31.7 17 - 47 Norm al Progra m: Lfs af_LB_2.sas (Page 128 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 128 FDA-CBER-2021-5683-0050461 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of l aboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 29 02J UN2020 7:55 29 Hem ato logy Mon ocytes (Blood) [109/L] 0.71 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 12.0 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.90 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 49.2 40 - 75 Norm al Plate lets [109/L] 198 146 - 328 Norm al Day 50 22J UN2020 7:53 49 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 129 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 129 FDA-CBER-2021-5683-0050462 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clea n SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 50 22J UN2020 7:53 49 Urina lysis Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 22J UN2020 8:14 49 Chemi stry Alan ine Amin otransferase [U/L] 11 <= 49 Norm al Progra m: Lfs af_LB_2.sas (Page 130 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 130 FDA-CBER-2021-5683-0050463 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [uni t] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 50 22J UN2020 8:14 49 Chemi stry Albu min [g/L] 42 35 - 52 Norm al Alka line Phosphatase [U/L] 53 40 - 130 Norm al Amyl ase [U/L] 50 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 20 <= 49 Norm al Bili rubin (Serum) [µmol /L] 6.3 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] <0.3 <= 4.9 Norm al Calci um [mmol/L] 2.37 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 83.1 61.9 - 106 .1 Norm al Progra m: Lfs af_LB_2.sas (Page 131 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 131 FDA-CBER-2021-5683-0050464 BioNT ec h RNA Pharmaceuticals GmbH / Listing s - 6. Snap s hot All TLFs Final 1.0 BNT162b 1 BNT162 -01 Created on 20NOV2020 Staburo Gm bH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23OCT 20 20. Listing 16 .2.3-2.2-1: Listi ng of laboratory measurements - BNT16 2b 1 Safety s e t Dose group Subjec t numbe r Visit Assess ment date/ti me Assess- ment day Category Parame te r [unit] Result Norm al range Grade Clinica lly signi fi- cant Evalua tor: comment 1 µg Young er 10025 Day 50 22JUN 2 020 8:14 49 Chemistry Ferritin [ µg/L] 50.7 30 - 400 Norm al Gamm a Glutamyl Transfe rase [U/L] 11 <= 59 Norm al Gluco se (Blood) [mmol/L ] 562 <= 5 55 High No Lipas e [U/L] 25 13 - 60 Norm al Potassi um [mmol/L] 4.4 3.5 - 5.1 Norm al Sodium [mmol/L] 140 136 - 145 Norm al Urea Nitrog e n [mmol/L] 4.46 2.77 - 8.1 Norm al Hem atolo gy Basoph ils (Blood) [109/L] 0.08 <= 0.07 High No Program : Lfsaf_ LB_2.sas (Page 132 of 3808) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 132 FDA-CBER-2021-5683-0050465 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fin al 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 50 22J UN2020 8:14 49 Hem ato logy Baso phils/Leukocytes (Bloo d) [%] 1.4 0.2 - 1.5 Norm al Eosi nophils (Bloo d) [109/L] 0.27 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 4.7 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 4.8 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.43 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 8.6 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.8 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.67 1.05 - 3.24 Norm al Progra m: Lfs af_LB_2.sas (Page 133 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 133 FDA-CBER-2021-5683-0050466 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10025 Day 50 22J UN2020 8:14 49 Hem ato logy Lym phocytes/Leukocytes (Bloo d) [%] 28.8 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.75 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 13.0 4 - 12 High No Neutrop hils (Blood) [109/L] 3.02 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 52.1 40 - 75 Norm al Plate lets [109/L] 217 146 - 328 Norm al 10033 Day -30 t o 0 27APR20 20 9:12 -8 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 134 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 134 FDA-CBER-2021-5683-0050467 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day -30 t o 0 27APR20 20 9:12 -8 Urina lysis Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.02 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al Progra m: Lfs af_LB_2.sas (Page 135 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 135 FDA-CBER-2021-5683-0050468 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day -30 t o 0 27APR20 20 9:18 -8 Chemi stry Alan ine Amin otransferase [U/L] 22 <= 49 Norm al Albu min [g/L] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 71 40 - 130 Norm al Amyl ase [U/L] 60 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 19 <= 49 Norm al Bili rubin (Serum) [µmol /L] 13.3 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.8 <= 4.9 Norm al Calci um [mmol/L] 2.43 2.15 - 2.55 Norm al Progra m: Lfs af_LB_2.sas (Page 136 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 136 FDA-CBER-2021-5683-0050469 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day -30 t o 0 27APR20 20 9:18 -8 Chemi stry Crea tin ine [µmol/L] 82.2 61.9 - 106 .1 Norm al Ferriti n [µg/L] 211 .1 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 23 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.06 <= 5.5 5 Norm al Lip ase [U/L] 31 13 - 60 Norm al Potas sium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodi um [mmol/L] 140 136 - 145 Norm al Urea Nitrog en [mmol/L] 6.82 2.77 - 8.1 Norm al Progra m: Lfs af_LB_2.sas (Page 137 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 137 FDA-CBER-2021-5683-0050470 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10033 Day -30 to 0 27APR20 2 0 9:18 -8 Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.4 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 013 003 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.4 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 5.7 4.5 - 5.8 Norm al Hem atoc rit [L/L] 0.48 0.4 - 0.51 Norm al Hem ogl obin (Blood) [mmol /L] 10.4 8.4 - 10.9 Norm al Leuk ocytes (Blood) [109/L] 5.4 3.9 - 9.8 Norm al Program : Lfsa f_LB_2.sas (Page 138 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 138 FDA-CBER-2021-5683-0050471 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day -30 t o 0 27APR20 20 9:18 -8 Hem ato logy Lym phocytes (Blood) [109/L] 1.63 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 30.2 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.46 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 8.6 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.15 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 58.4 40 - 75 Norm al Plate lets [109/L] 231 146 - 328 Norm al Day 1 05M AY2020 7:33 1 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 139 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 139 FDA-CBER-2021-5683-0050472 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 1 05M AY2020 7:33 1 Urina lysis Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 6.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Progra m: Lfs af_LB_2.sas (Page 140 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 140 FDA-CBER-2021-5683-0050473 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 1 05M AY2020 7:33 1 Urina lysis Urob il inogen [µmol/L] norm al Norm al 05M AY2020 8:59 1 Chemi stry Alan ine Amin otransferase [U/L] 20 <= 49 Norm al Albu min [g/L] 46 35 - 52 Norm al Alka line Phosphatase [U/L] 70 40 - 130 Norm al Amyl ase [U/L] 60 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 19 <= 49 Norm al Bili rubin (Serum) [µmol /L] 15.0 <= 20 .4 Norm al C Reacti ve Protein [mg/L ] 1.3 <= 4.9 Norm al Progra m: Lfs af_LB_2.sas (Page 141 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 141 FDA-CBER-2021-5683-0050474 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 1 05M AY2020 8:59 1 Chemi stry Calci um [mmol/L] 2.36 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 79.6 61.9 - 106 .1 Norm al Ferriti n [µg/L] 198 .5 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 25 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.17 <= 5.5 5 Norm al Lip ase [U/L] 24 13 - 60 Norm al Potas sium [mmol/L] 4.3 3.5 - 5.1 Norm al Sodi um [mmol/L] 140 136 - 145 Norm al Progra m: Lfs af_LB_2.sas (Page 142 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 142 FDA-CBER-2021-5683-0050475 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10033 Day 1 05MA Y2020 8:59 1 Chemis try Urea Nitro g en [mmol/L] 6.32 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 04 02 - 15 Norm al Eosin ophils (Blood) [109/L] 0.12 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.2 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 5.5 4.5 - 5.8 Norm al Hem atoc rit [L/L] 0.47 0.4 - 0.51 Norm al Hem ogl obin (Blood) [mmol /L] 10.2 8.4 - 10.9 Norm al Program : Lfsa f_LB_2.sas (Page 143 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 143 FDA-CBER-2021-5683-0050476 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 1 05M AY2020 8:59 1 Hem ato logy Leu kocytes (Blood) [109/L] 5.5 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.68 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 30.6 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.39 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.1 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.28 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 59.7 40 - 75 Norm al Plate lets [109/L] 221 146 - 328 Norm al Progra m: Lfs af_LB_2.sas (Page 144 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 144 FDA-CBER-2021-5683-0050477 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:20 2 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 6.5 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 145 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 145 FDA-CBER-2021-5683-0050478 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:20 2 Urina lysis Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 06M AY2020 8:35 2 Chemi stry Alan ine Amin otransferase [U/L] 19 <= 49 Norm al Albu min [g/L] 47 35 - 52 Norm al Alka line Phosphatase [U/L] 71 40 - 130 Norm al Amyl ase [U/L] 62 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] <5 <= 49 Norm al Bili rubin (Seru m) [µmol /L] 15.9 <= 20 .4 Norm al Progra m: Lfs af_LB_2.sas (Page 146 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 146 FDA-CBER-2021-5683-0050479 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:35 2 Chemi stry C Rea cti ve Protein [mg/L ] 1.5 <= 4.9 Norm al Calci um [mmol/L] 2.40 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 94.6 61.9 - 106 .1 Norm al Ferriti n [µg/L] 182 .4 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 25 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.67 <= 5.5 5 High No Lip ase [U/L] 27 13 - 60 Norm al Potas sium [mmol/L] 4.2 3.5 - 5.1 Norm al Progra m: Lfs af_LB_2.sas (Page 147 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 147 FDA-CBER-2021-5683-0050480 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:35 2 Chemi stry Sodi um [mmol/L] 139 136 - 145 Norm al Urea Nitro gen [mmol/L] 6.50 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.02 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.4 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.12 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 2.2 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 5.5 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.47 0.4 - 0.51 Norm al Progra m: Lfs af_LB_2.sas (Page 148 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 148 FDA-CBER-2021-5683-0050481 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:35 2 Hem ato logy Hem og lobin (Bloo d) [mmo l/L] 10.2 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.4 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.48 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 27.4 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.39 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.2 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.39 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 62.8 40 - 75 Norm al Progra m: Lfs af_LB_2.sas (Page 149 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 149 FDA-CBER-2021-5683-0050482 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 2 06M AY2020 8:35 2 Hem ato logy Plate lets [109/L] 209 146 - 328 Norm al Day 8 12M AY2020 8:01 8 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al pH 6.5 5 - 7 Norm al Progra m: Lfs af_LB_2.sas (Page 150 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 150 FDA-CBER-2021-5683-0050483 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 8 12M AY2020 8:01 8 Urina lysis Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 12M AY2020 8:25 8 Chemi stry Alan ine Amin otransferase [U/L] 20 <= 49 Norm al Albu min [g/L] 44 35 - 52 Norm al Alka line Phosphatase [U/L] 65 40 - 130 Norm al Amyl ase [U/L] 63 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 21 <= 49 Norm al Progra m: Lfs af_LB_2.sas (Page 151 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 151 FDA-CBER-2021-5683-0050484 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 8 12M AY2020 8:25 8 Chemi stry Bili rubin (Serum) [µmol /L] 12.1 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.8 <= 4.9 Norm al Calci um [mmol/L] 2.31 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 74.3 61.9 - 106 .1 Norm al Ferriti n [µg/L] 176 .0 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 25 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.62 <= 5.5 5 High No Lip ase [U/L] 28 13 - 60 Norm al Progra m: Lfs af_LB_2.sas (Page 152 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 152 FDA-CBER-2021-5683-0050485 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10033 Day 8 12MA Y2020 8:25 8 Chemis try Potass ium [mmol/L] 4.4 3.5 - 5.1 Norm al Sodiu m [mmol/L] 140 136 - 145 Norm al Urea Nitro g en [mmol/L] 550 277 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.4 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.15 0.03 - 0.44 Norm al Eosin ophils/Leukocytes (Blood ) [%] 2.9 0.5 - 7 Norm al Erythroc ytes (Blood) [1012/L] 5.5 4.5 - 5.8 Norm al Program : Lfsa f_LB_2.sas (Page 153 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 153 FDA-CBER-2021-5683-0050486 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 8 12M AY2020 8:25 8 Hem ato logy Hem ato crit [L/L] 0.48 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 10.2 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.2 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 1.47 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 28.2 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.40 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 7.7 4 - 12 Norm al Neutrop hils (Blood) [109/L] 3.16 1.78 - 6.23 Norm al Progra m: Lfs af_LB_2.sas (Page 154 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 154 FDA-CBER-2021-5683-0050487 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data r eceived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 8 12M AY2020 8:25 8 Hem ato logy Neutrop hils/Leukocytes (Bloo d) [%] 60.8 40 - 75 Norm al Plate lets [109/L] 219 146 - 328 Norm al Day 29 02J UN2020 8:12 29 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Nitrite neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 155 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 155 FDA-CBER-2021-5683-0050488 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10033 Day 29 02JUN 2020 8:12 29 Urinal ysis pH 6.0 5 - 7 Norm al Protein [mg/L] nega tive Norm al Speci fic Gravity 1.015 1.005 - 1038 Norm al Urob ili nogen [µmol/L] norma l Norm al 02JUN 2020 8:25 29 Chemis try Alani ne Amino transferase [U/L] 29 <= 49 Norm al Album in [g/L] 43 35 - 52 Norm al Alkal ine Phosphatase [U/L] 60 40 - 130 Norm al Amyla se [U/L] 65 28 - 100 Norm al Program : Lfsa f_LB_2.sas (Page 156 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 156 FDA-CBER-2021-5683-0050489 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 29 02J UN2020 8:25 29 Chemi stry Aspa rtate Amin otransferase [U/L] 18 <= 49 Norm al Bili rubin (Serum) [µmol /L] 8.4 <= 20 .4 Norm al C Rea cti ve Prote in [mg/L ] 2.4 <= 4.9 Norm al Calci um [mmol/L] 2.22 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 72.5 61.9 - 106 .1 Norm al Ferriti n [µg/L] 257 .9 30 - 400 Norm al Gam ma Glutamyl Tran sferase [U/L] 21 <= 59 Norm al Glu cose (Blood) [mmo l/L] 5.12 <= 5.5 5 Norm al Progra m: Lfs af_LB_2.sas (Page 157 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 157 FDA-CBER-2021-5683-0050490 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20 NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 29 02J UN2020 8:25 29 Chemi stry Lip ase [U/L] 39 13 - 60 Norm al Potas sium [mmol/L] 4.2 3.5 - 5.1 Norm al Sodi um [mmol/L] 139 136 - 145 Norm al Urea Nitro gen [mmol/L] 5.53 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.03 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.6 0.2 - 1.5 Norm al Eosi nophils (Blood) [109/L] 0.15 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 3.0 0.5 - 7 Norm al Progra m: Lfs af_LB_2.sas (Page 158 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 158 FDA-CBER-2021-5683-0050491 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 29 02J UN2020 8:25 29 Hem ato logy Erythro cytes (Blood) [1012/L] 5.2 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.45 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 9.4 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.1 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 2.32 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 45.5 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.34 0.26 - 0.87 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 6.7 4 - 12 Norm al Progra m: Lfs af_LB_2.sas (Page 159 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 159 FDA-CBER-2021-5683-0050492 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 29 02J UN2020 8:25 29 Hem ato logy Neutrop hils (Blood) [109/L] 2.25 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 44.2 40 - 75 Norm al Plate lets [109/L] 242 146 - 328 Norm al Day 50 22J UN2020 8:10 49 Urina lysis Bili rubin (Urine) [µmol/L] neg ative Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 160 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 160 FDA-CBER-2021-5683-0050493 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 50 22J UN2020 8:10 49 Urina lysis Nitrite neg ative Norm al pH 5.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Spec ific Gravity 1.01 5 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 22J UN2020 8:26 49 Chemi stry Alan ine Amin otransferase [U/L] 30 <= 49 Norm al Albu min [g/L] 44 35 - 52 Norm al Alka line Phosphatase [U/L] 65 40 - 130 Norm al Progra m: Lfs af_LB_2.sas (Page 161 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 161 FDA-CBER-2021-5683-0050494 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 50 22J UN2020 8:26 49 Chemi stry Amyl ase [U/L] 61 28 - 100 Norm al Aspa rtate Amin otransferase [U/L] 20 <= 49 Norm al Bili rubin (Seru m) [µmol /L] 12.5 <= 20 .4 Norm al C Rea cti ve Protein [mg/L ] 0.9 <= 4.9 Norm al Calci um [mmol/L] 2.34 2.15 - 2.55 Norm al Crea tin ine [µmol/L] 73.4 61.9 - 106 .1 Norm al Ferriti n [µg/L] 201 .3 30 - 400 Norm al Gam ma Glu tamyl Tran sferase [U/L] 25 <= 59 Norm al Progra m: Lfs af_LB_2.sas (Page 162 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 162 FDA-CBER-2021-5683-0050495 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV 20 20 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10033 Day 50 22JUN 2020 8:26 49 Chemis try Gluc ose (Blood) [mmol /L] 5.34 <= 5.55 Norm al Lipa se [U/L] 27 13 - 60 Norm al Potass ium [mmol/L] 43 35 - 51 Norm al Sodiu m [mmol/L] 140 136 - 145 Norm al Urea Nitro g en [mmol/L] 4.82 2.77 - 8.1 Norm al Hem atol ogy Basop hils (Blood) [109/L] 0.02 <= 0.07 Norm al Basop hils/Leukocytes (Blood ) [%] 0.4 0.2 - 1.5 Norm al Eosin ophils (Blood) [109/L] 0.18 0.03 - 0.44 Norm al Program : Lfsa f_LB_2.sas (Page 163 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 163 FDA-CBER-2021-5683-0050496 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 50 22J UN2020 8:26 49 Hem ato logy Eosi nophils/Leukocytes (Bloo d) [%] 3.3 0.5 - 7 Norm al Erythro cytes (Blood) [1012/L] 5.5 4.5 - 5.8 Norm al Hem ato crit [L/L] 0.47 0.4 - 0.51 Norm al Hem og lobin (Blood) [mmo l/L] 9.9 8.4 - 10.9 Norm al Leu kocytes (Blood) [109/L] 5.4 3.9 - 9.8 Norm al Lym phocytes (Blood) [109/L] 2.09 1.05 - 3.24 Norm al Lym phocytes/Leukocytes (Bloo d) [%] 38.7 17 - 47 Norm al Mon ocytes (Blood) [109/L] 0.36 0.26 - 0.87 Norm al Progra m: Lfs af_LB_2.sas (Page 164 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 164 FDA-CBER-2021-5683-0050497 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10033 Day 50 22J UN2020 8:26 49 Hem ato logy Mon ocytes/Leukocytes (Bloo d) [%] 6.7 4 - 12 Norm al Neutrop hils (Blood) [109/L] 2.75 1.78 - 6.23 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 50.9 40 - 75 Norm al Plate lets [109/L] 231 146 - 328 Norm al 10036 Day -30 t o 0 27APR20 20 9:59 -11 Urina lysis Bacte ria [/HPF] neg ative Norm al Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Crysta ls [/HPF] pos itive Abno rmal No Progra m: Lfs af_LB_2.sas (Page 165 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 165 FDA-CBER-2021-5683-0050498 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day -30 t o 0 27APR20 20 9:59 -11 Urina lysis Epith elial Cells [/HPF] 0-2 <= 1 Norm al Erythro cytes (Urine) [/HPF] 3-6 <= 1 Abno rmal No Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] 50 Abno rmal No Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] neg ative Norm al Leu kocytes (Urine - Mic roscopy) [/HPF] 0-2 <= 2 Norm al Nitrite neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 166 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 166 FDA-CBER-2021-5683-0050499 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day -30 t o 0 27APR20 20 9:59 -11 Urina lysis pH 7.0 5 - 7 Norm al Protei n [mg/L] neg ative Norm al Round Epithelial Cells [/HPF] neg ative Norm al Spec ific Gravity 1.01 0 1.00 5 - 1.03 8 Norm al Urob il inogen [µmol/L] norm al Norm al 27APR20 20 10:1 2 -11 Chemi stry Alan ine Amin otransferase [U/L] 11 <= 34 Norm al Albu min [g/L] 45 35 - 52 Norm al Alka line Phosphatase [U/L] 39 35 - 105 Norm al Progra m: Lfs af_LB_2.sas (Page 167 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 167 FDA-CBER-2021-5683-0050500 BioNT ech RNA Pharmaceuticals GmbH / Listing s - 6. Snap shot All TLFs Final 1.0 BNT16 2b 1 BNT16 2-01 Created on 20NOV2020 Staburo G m bH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT 2020. Listing 16.2.3 -2.2-1: List ing of laboratory measurements - BNT16 2b1 Safety s et Dose group Subje ct numb er Visit Asses sment date/t ime Asses s- ment day Catego ry Parame ter [unit] Result Norm al range Grade Clinic ally sign ifi- cant Evalu ator: comment 1 µg Youn ger 10036 Day -30 to 0 27APR20 2 0 10:12 -11 Chemis try Amyla se [U/L] 43 28 - 100 Norm al Aspart ate Amino transferase [U/L] 11 <= 34 Norm al Biliru bin (Serum) [µmol/ L] 63 <= 20. 4 Norm al C Rea ctiv e Protein [mg/L] 0.7 <= 4.9 Norm al Calciu m [mmol/L] 2.42 2.15 - 2.55 Norm al Crea tini ne [µmol/L] 61.0 44.2 - 79.6 Norm al Ferritin [µg/L] 9.2 15 - 150 Low No Labo ratory: Controlled resul t Folli cle Stimulating Horm one [IU/L] 7.9 Miss ing Program : Lfsa f_LB_2.sas (Page 168 of 3808 ) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 168 FDA-CBER-2021-5683-0050501 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measu rements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day -30 t o 0 27APR20 20 10:1 2 -11 Chemi stry Gam ma Glutamyl Tran sferase [U/L] 7 <= 39 Norm al Glu cose (Blood) [mmo l/L] 5.12 <= 5.5 5 Norm al Lip ase [U/L] 40 13 - 60 Norm al Potas sium [mmol/L] 4.6 3.5 - 5.1 Norm al Sodi um [mmol/L] 142 136 - 145 Norm al Urea Nitro gen [mmol/L] 3.82 2.77 - 8.1 Norm al Hem ato logy Baso phils (Blood) [109/L] 0.01 <= 0.0 7 Norm al Baso phils/Leukocytes (Bloo d) [%] 0.3 0.2 - 1.5 Norm al Progra m: Lfs af_LB_2.sas (Page 169 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 169 FDA-CBER-2021-5683-0050502 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day -30 t o 0 27APR20 20 10:1 2 -11 Hem ato logy Eosi nophils (Blood) [109/L] 0.29 0.03 - 0.44 Norm al Eosi nophils/Leukocytes (Bloo d) [%] 7.7 0.5 - 7 High No Erythro cytes (Blood) [1012/L] 4.3 4 - 5.2 Norm al Hem ato crit [L/L] 0.37 0.35 - 0.45 Norm al Hem og lobin (Blood) [mmo l/L] 7.4 7.2 - 9.7 Norm al Leu kocytes (Blood) [109/L] 3.8 4 - 10. 4 Low No Lym phocytes (Blood) [109/L] 1.16 1.22 - 3.56 Low No Lym phocytes/Leukocytes (Bloo d) [%] 30.6 17 - 47 Norm al Progra m: Lfs af_LB_2.sas (Page 170 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 170 FDA-CBER-2021-5683-0050503 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day -30 t o 0 27APR20 20 10:1 2 -11 Hem ato logy Mon ocytes (Blood) [109/L] 0.36 0.25 - 0.85 Norm al Mon ocytes/Leukocytes (Bloo d) [%] 9.5 4 - 12 Norm al Neutrop hils (Blood) [109/L] 1.97 1.91 - 7.34 Norm al Neutrop hils/Leukocytes (Bloo d) [%] 51.9 40 - 75 Norm al Plate lets [109/L] 277 176 - 391 Norm al Day 1 08M AY2020 7:35 1 Urina lysis Bacte ria [/HPF] ++ Abno rmal No Bili rubin (Urine) [µmol/L] neg ative Norm al Casts [/HPF] neg ative Norm al Progra m: Lfs af_LB_2.sas (Page 171 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 171 FDA-CBER-2021-5683-0050504 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of laboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- can t Eval uator: comment 1 µg You nger 10036 Day 1 08M AY2020 7:35 1 Urina lysis Crysta ls [/HPF] neg ative Norm al Epith elial Cells [/HPF] 3-6 <= 1 Abno rmal No Erythro cytes (Urine) [/HPF] neg ative <= 1 Norm al Glu cose (Urine) neg ative Norm al Hem og lobin (Urine) [106/L] neg ative Norm al Keton es [mmol/L] neg ative Norm al Leu kocytes (Urine - Dipsti ck) [106/L] 500 Abno rmal No Leu kocytes (Urine - Mic roscopy) [/HPF] 11-20 <= 2 Abno rmal No Progra m: Lfs af_LB_2.sas (Page 172 of 380 8) 090177e1959f7729\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 172 FDA-CBER-2021-5683-0050505 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fin al 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -2.2-1: Lis ting of l aboratory measurements - BNT 162b1 Safety set Dose grou p Subj ect num ber Visi t Asse ssment date /time Asse ss- men t day Categ ory Param eter [unit] Resul t Norm al rang e Grad e Clini cally sig nifi- …[truncated]