Document text
C4591001
1231 ARGENTINA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0035L002/P220395-0048L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0035L003/P220395-0048L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A EU2065896/E220395-0004L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0054L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION16.1.6 Study Drug Information
Data is presented by site and country
19-Nov-2020 CONFIDENTIAL
1
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128593
C4591001
1226 BRAZIL
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1241 BRAZIL
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
19-Nov-2020 CONFIDENTIAL
2
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128594
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1185 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
3
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128595
C4591001
1194 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1195 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1197 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
4
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128596
C4591001
1202 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1203 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1229 SOUTH AFRICA
19-Nov-2020 CONFIDENTIAL
5
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128597
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1230 SOUTH AFRICA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1246 SOUTH AFRICA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
6
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128598
C4591001
1247 SOUTH AFRICA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1205 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1207 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
19-Nov-2020 CONFIDENTIAL
7
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128599
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1208 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1209 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
8
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128600
C4591001
1210 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1212 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1213 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
9
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128601
C4591001
1214 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1217 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
1001 UNITED STATES
19-Nov-2020 CONFIDENTIAL
10
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128602
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Labelled Carton containing 1x Labelled
Vial of BNT162b1 0.25mg/0.5ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV10320-A E220395-0001L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1002 UNITED STATES
19-Nov-2020 CONFIDENTIAL
11
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128603
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Labelled Carton containing 1x Labelled
Vial of BNT162b1 0.25mg/0.5ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV10320-A E220395-0001L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
1003 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
12
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128604
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Labelled Carton containing 1x Labelled
Vial of BNT162a1 0.15mg/0.3ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV20420-A E220395-0002L 0.5 mg/ml SOLUTION
Labelled Carton containing 1x Labelled
Vial of BNT162b2 0.15mg/0.3ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV40420-A E220395-0004L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1005 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
13
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128605
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1006 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
19-Nov-2020 CONFIDENTIAL
14
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128606
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1007 UNITED STATES
19-Nov-2020 CONFIDENTIAL
15
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128607
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Labelled Carton containing 1x Labelled
Vial of BNT162a1 0.15mg/0.3ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV20420-A E220395-0002L 0.5 mg/ml SOLUTION
Labelled Carton containing 1x Labelled
Vial of BNT162b2 0.15mg/0.3ml in Mylar
bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV40420-A E220395-0004L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
16
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128608
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1008 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
17
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128609
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1009 UNITED STATES
19-Nov-2020 CONFIDENTIAL
18
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128610
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
19
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128611
C4591001
1011 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1012 UNITED STATES
19-Nov-2020 CONFIDENTIAL
20
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128612
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
1013 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
21
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128613
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
22
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128614
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1015 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
23
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128615
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1016 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
24
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128616
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1018 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
25
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128617
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1019 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
26
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128618
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1021 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
27
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128619
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1022 UNITED STATES
19-Nov-2020 CONFIDENTIAL
28
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128620
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1024 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
29
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128621
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1027 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
30
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128622
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1028 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
31
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128623
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1030 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
32
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128624
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1036 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
33
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128625
C4591001
1037 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
34
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128626
C4591001
1038 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1039 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
35
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128627
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1042 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
36
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128628
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1044 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
37
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128629
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1046 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
19-Nov-2020 CONFIDENTIAL
38
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128630
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
39
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128631
C4591001
1047 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1048 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
40
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128632
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1052 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
41
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128633
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1054 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
42
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128634
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1055 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
43
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128635
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1056 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
44
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128636
C4591001
1057 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
45
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128637
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1066 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
46
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128638
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1068 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
47
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128639
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1071 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
48
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128640
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1072 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
49
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128641
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1073 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
50
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128642
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
1077 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
51
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128643
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1079 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
52
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128644
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1080 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
53
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128645
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1081 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
54
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128646
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1082 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
55
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128647
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1083 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
56
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128648
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1084 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
57
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128649
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1085 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
19-Nov-2020 CONFIDENTIAL
58
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128650
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
59
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128651
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1087 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
60
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128652
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1088 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
61
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128653
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1089 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
62
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128654
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1090 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
63
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128655
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1091 UNITED STATES
19-Nov-2020 CONFIDENTIAL
64
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128656
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
65
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128657
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1092 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
66
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128658
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1093 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
67
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128659
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1094 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
68
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128660
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1095 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
69
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128661
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1096 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
70
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128662
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1097 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
71
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128663
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1098 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
72
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128664
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1101 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
73
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128665
C4591001
1107 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
74
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128666
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1109 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
75
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128667
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1110 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
76
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128668
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1111 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
77
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128669
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1112 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
78
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128670
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1114 UNITED STATES
19-Nov-2020 CONFIDENTIAL
79
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128671
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1116 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
80
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128672
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1117 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
81
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128673
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1118 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
82
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128674
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1120 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
83
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128675
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1121 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
84
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128676
C4591001
1122 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1123 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
85
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128677
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
86
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128678
C4591001
1124 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
87
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128679
C4591001
1125 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
88
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128680
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1126 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
89
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128681
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1127 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
90
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128682
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1128 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
91
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128683
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1129 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
92
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128684
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1130 UNITED STATES
19-Nov-2020 CONFIDENTIAL
93
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128685
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1131 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
94
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128686
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1133 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
95
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128687
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
96
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128688
C4591001
1134 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
97
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128689
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1135 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
98
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128690
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1136 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
99
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128691
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1139 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
100
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128692
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1140 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
101
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128693
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1141 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
102
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128694
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1142 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
103
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128695
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1145 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
104
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128696
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1146 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
105
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128697
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
106
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128698
C4591001
1147 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
107
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128699
C4591001
1149 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
108
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128700
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1150 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
109
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128701
C4591001
1152 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
110
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128702
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1156 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
111
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128703
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1157 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
112
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128704
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1161 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
113
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128705
C4591001
1162 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
114
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128706
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1163 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
115
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128707
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1166 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1167 UNITED STATES
19-Nov-2020 CONFIDENTIAL
116
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128708
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1168 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
117
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128709
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1169 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
118
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128710
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1170 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
119
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128711
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1171 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
120
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128712
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1174 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
121
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128713
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1177 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
122
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128714
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1178 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
123
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128715
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1179 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
124
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128716
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1204 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
125
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128717
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1218 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1219 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
126
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128718
C4591001
1220 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1221 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1223 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
127
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128719
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1224 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
128
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128720
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1232 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
129
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128721
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1235 UNITED STATES
19-Nov-2020 CONFIDENTIAL
130
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128722
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1248 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
131
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128723
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1251 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
132
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128724
C4591001
1252 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1254 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
133
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128725
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1258 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
134
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128726
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1260 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1261 UNITED STATES
19-Nov-2020 CONFIDENTIAL
135
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128727
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1264 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
136
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128728
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1265 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
137
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128729
C4591001
1269 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
1270 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
19-Nov-2020 CONFIDENTIAL
138
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128730
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
19-Nov-2020 CONFIDENTIAL
139
090177e19590fe2e\Approved\Approved On: 19-Nov-2020 16:13 (GMT)
FDA-CBER-2021-5683-0128731