125742 45 S211 M5 c4591001 interim ado patient batches

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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 0.2 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 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 SOLUTION16.1.6 Study Drug Information
Data is presented by site and country
07-Apr-2021  CONFIDENTIAL
1
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229061
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/P220395-0056L 0 ml SOLUTION
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/P220395-0022L 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
07-Apr-2021  CONFIDENTIAL
2
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229062
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/P220395-0022L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
3
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229063
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1197 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
4
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229064
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
5
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229065
C4591001
1229 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
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
07-Apr-2021  CONFIDENTIAL
6
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229066
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
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
7
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229067
C4591001
1207 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1209 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
8
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229068
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
9
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229069
C4591001
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1217 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
10
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229070
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1001 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 EE3813 NC2075485/P220395-0077L 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 EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
11
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229071
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
1002 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/P220395-0020L 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 EJ0553Z PA2085061/P220395-0070L 0.5 mg/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
07-Apr-2021  CONFIDENTIAL
12
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229072
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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.45 ml Vial EJ0553Z PA2085061/P220395-0070L 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/P220395-0044L 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
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
07-Apr-2021  CONFIDENTIAL
13
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229073
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-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
14
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229074
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
15
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229075
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
1007 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 0.2 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 ED3938 PA2074300/P220395-0022L 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 0.45 ml Vial EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
16
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229076
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/P220395-0032L 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
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
07-Apr-2021  CONFIDENTIAL
17
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229077
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
18
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229078
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
19
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229079
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
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
20
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229080
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
1012 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-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 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
21
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229081
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
22
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229082
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/P220395-0031L 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
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
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
07-Apr-2021  CONFIDENTIAL
23
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229083
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 NC2075485/P220395-0068L 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
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
07-Apr-2021  CONFIDENTIAL
24
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229084
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-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 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/P220395-0033L 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
07-Apr-2021  CONFIDENTIAL
25
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229085
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 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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
26
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229086
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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
07-Apr-2021  CONFIDENTIAL
27
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229087
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
28
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229088
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 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
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
07-Apr-2021  CONFIDENTIAL
29
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229089
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 NC2075485/P220395-0074L 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
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
07-Apr-2021  CONFIDENTIAL
30
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229090
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
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
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
31
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229091
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
32
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229092
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
33
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229093
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
34
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229094
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
35
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229095
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
36
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229096
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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
07-Apr-2021  CONFIDENTIAL
37
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229097
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
 
07-Apr-2021  CONFIDENTIAL
38
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229098
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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
07-Apr-2021  CONFIDENTIAL
39
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229099
C4591001
1046 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 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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
40
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229100
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
41
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229101
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
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
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
42
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229102
C4591001
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
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
43
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229103
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
44
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229104
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 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0046L 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
07-Apr-2021  CONFIDENTIAL
45
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229105
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
1057 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
46
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229106
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 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
47
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229107
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
48
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229108
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/P220395-0020L 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
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
07-Apr-2021  CONFIDENTIAL
49
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229109
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 NC2075485/P220395-0074L 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
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
07-Apr-2021  CONFIDENTIAL
50
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229110
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0033L 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
07-Apr-2021  CONFIDENTIAL
51
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229111
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 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
52
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229112
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
53
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229113
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 NC2075485/P220395-0068L 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 0.2 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/P220395-0033L 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
07-Apr-2021  CONFIDENTIAL
54
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229114
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 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1080 UNITED STATES
07-Apr-2021  CONFIDENTIAL
55
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229115
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
56
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229116
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
57
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229117
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/P220395-0046L 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
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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
58
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229118
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;20-002108 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
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 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
59
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229119
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
60
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229120
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
61
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229121
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 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
62
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229122
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
63
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229123
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 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/P220395-0046L 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
07-Apr-2021  CONFIDENTIAL
64
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229124
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0044L 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
07-Apr-2021  CONFIDENTIAL
65
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229125
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
66
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229126
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
67
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229127
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;20-002108 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
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
07-Apr-2021  CONFIDENTIAL
68
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229128
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
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
07-Apr-2021  CONFIDENTIAL
69
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229129
C4591001
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
70
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229130
C4591001
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
71
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229131
C4591001
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
72
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229132
C4591001
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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/P220395-0031L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
73
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229133
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
74
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229134
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
75
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229135
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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
76
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229136
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
77
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229137
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/P220395-0046L 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
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 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
78
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229138
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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/P220395-0034L 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
07-Apr-2021  CONFIDENTIAL
79
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229139
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0031L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1110 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
80
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229140
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 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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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/P220395-0034L 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
07-Apr-2021  CONFIDENTIAL
81
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229141
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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
07-Apr-2021  CONFIDENTIAL
82
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229142
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/P220395-0031L 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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
83
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229143
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
84
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229144
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 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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
85
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229145
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
86
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229146
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
87
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229147
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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0032L 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
07-Apr-2021  CONFIDENTIAL
88
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229148
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0045L 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
07-Apr-2021  CONFIDENTIAL
89
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229149
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
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
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
90
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229150
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
91
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229151
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/P220395-0031L 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
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
07-Apr-2021  CONFIDENTIAL
92
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229152
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 NC2075485/P220395-0068L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
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
07-Apr-2021  CONFIDENTIAL
93
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229153
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/P220395-0022L 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
1126 UNITED STATES
07-Apr-2021  CONFIDENTIAL
94
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229154
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-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/P220395-0022L 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/P220395-0031L 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/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
95
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229155
C4591001
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 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1128 UNITED STATES
07-Apr-2021  CONFIDENTIAL
96
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229156
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-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 NC2075485/P220395-0068L 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;20-002221 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
07-Apr-2021  CONFIDENTIAL
97
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229157
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
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
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/P220395-0022L 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
07-Apr-2021  CONFIDENTIAL
98
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229158
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;20-002221 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1130 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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 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
07-Apr-2021  CONFIDENTIAL
99
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229159
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
100
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229160
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/P220395-0034L 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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
101
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229161
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
1134 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
102
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229162
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-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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
103
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229163
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
104
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229164
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
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
07-Apr-2021  CONFIDENTIAL
105
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229165
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
106
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229166
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 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/P220395-0044L 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
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
07-Apr-2021  CONFIDENTIAL
107
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229167
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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;20-002108 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
07-Apr-2021  CONFIDENTIAL
108
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229168
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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;20-002108 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
07-Apr-2021  CONFIDENTIAL
109
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229169
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
110
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229170
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
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
111
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229171
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/P220395-0032L 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
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
07-Apr-2021  CONFIDENTIAL
112
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229172
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
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
07-Apr-2021  CONFIDENTIAL
113
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229173
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/P220395-0022L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1149 UNITED STATES
07-Apr-2021  CONFIDENTIAL
114
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229174
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-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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
115
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229175
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/P220395-0022L 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/P220395-0062L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
116
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229176
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
117
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229177
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/P220395-0055L 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 ED3938 PA2074300/P220395-0022L 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
07-Apr-2021  CONFIDENTIAL
118
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229178
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/P220395-0045L 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
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
07-Apr-2021  CONFIDENTIAL
119
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229179
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0055L 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
07-Apr-2021  CONFIDENTIAL
120
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229180
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/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
121
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229181
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
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
07-Apr-2021  CONFIDENTIAL
122
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229182
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 ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
1166 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
07-Apr-2021  CONFIDENTIAL
123
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229183
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 EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
124
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229184
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
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
07-Apr-2021  CONFIDENTIAL
125
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229185
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 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
126
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229186
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/P220395-0065L 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
127
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229187
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/P220395-0020L 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/P220395-0032L 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
07-Apr-2021  CONFIDENTIAL
128
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229188
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
129
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229189
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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0055L 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
07-Apr-2021  CONFIDENTIAL
130
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229190
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 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 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
07-Apr-2021  CONFIDENTIAL
131
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229191
C4591001
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
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 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
07-Apr-2021  CONFIDENTIAL
132
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229192
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 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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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
07-Apr-2021  CONFIDENTIAL
133
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229193
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 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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/P220395-0062L 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 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
07-Apr-2021  CONFIDENTIAL
134
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229194
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/P220395-0046L 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/P220395-0020L 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/P220395-0065L 0 ml SOLUTION
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/P220395-0020L 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/P220395-0065L 0 ml SOLUTION
07-Apr-2021  CONFIDENTIAL
135
090177e196b9960e\Approved\Approved On: 07-Apr-2021 15:54 (GMT) 
FDA-CBER-2022-5812-0229195
C4591001
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 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 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 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2
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