125742 S1 M5 5351 c4591001 interim mth6 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-AE220395-0035L002/
P220395-0048L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0035L003/
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 SOLUTION16.1.6 Study Drug Information
Data is presented by site and country
17-Mar-2021 PFIZER CONFIDENTIAL
1
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128778
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/P220395-0054L 0 ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
2
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128779
C4591001
1241 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
1185 GERMANY
17-Mar-2021 PFIZER CONFIDENTIAL
3
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128780
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1195 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
4
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128781
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1197 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
5
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128782
C4591001
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
6
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128783
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
1246 SOUTH AFRICA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
7
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128784
C4591001
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1208 TURKEY
17-Mar-2021 PFIZER CONFIDENTIAL
8
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128785
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;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1209 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 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
17-Mar-2021 PFIZER CONFIDENTIAL
9
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128786
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1212 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1213 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
10
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128787
C4591001
1214 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1217 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221PA2069407OTH/
E220395-0049L 0 ml SOLUTION
1001 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
11
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128788
C459100100  
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-AE220395-0006L004/
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-AE220395-0006L003/
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
Labelled Carton containing 1x Labelled Vial of BNT162b1
0.25mg/0.5ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV10320-A E220395-0001L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
12
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128789
C4591001
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
Labelled Carton containing 1x Labelled Vial of BNT162b1
0.25mg/0.5ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV10320-A E220395-0001L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
1003 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
17-Mar-2021 PFIZER CONFIDENTIAL
13
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128790
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-AE220395-0006L004/
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 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-AE220395-0006L003/
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
Labelled Carton containing 1x Labelled Vial of BNT162a1
0.15mg/0.3ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV20420-A E220395-0002L 0.5 mg/ml SOLUTION
Labelled Carton containing 1x Labelled Vial of BNT162b2
0.15mg/0.3ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV40420-A E220395-0004L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
14
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128791
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
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
15
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128792
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;20-002029 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
16
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128793
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 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
 
17-Mar-2021 PFIZER CONFIDENTIAL
17
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128794
C4591001
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-AE220395-0006L004/
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-AE220395-0006L003/
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
Labelled Carton containing 1x Labelled Vial of BNT162a1
0.15mg/0.3ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV20420-A E220395-0002L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
18
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128795
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Labelled Carton containing 1x Labelled Vial of BNT162b2
0.15mg/0.3ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1) BCV40420-A E220395-0004L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 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
17-Mar-2021 PFIZER CONFIDENTIAL
19
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128796
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 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
20
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128797
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
1009 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 PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
21
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128798
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 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
22
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128799
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-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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1012 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
23
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128800
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
1013 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
24
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128801
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
25
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128802
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/P220395-0034L 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
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
26
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128803
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
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
27
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128804
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 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-AE220395-0006L003/
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
 
17-Mar-2021 PFIZER CONFIDENTIAL
28
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128805
C4591001
1018 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
29
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128806
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
30
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128807
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/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1021 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
31
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128808
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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/P220395-0034L 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
17-Mar-2021 PFIZER CONFIDENTIAL
32
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128809
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
33
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128810
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1027 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
34
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128811
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial 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/P220395-0031L 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
17-Mar-2021 PFIZER CONFIDENTIAL
35
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128812
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-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/P220395-0034L 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
17-Mar-2021 PFIZER CONFIDENTIAL
36
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128813
C4591001
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
37
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128814
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/P220395-0023L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
38
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128815
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/P220395-0032L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
39
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128816
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/P220395-0074L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
40
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128817
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/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1042 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
41
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128818
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1044 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
42
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128819
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-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
 
17-Mar-2021 PFIZER CONFIDENTIAL
43
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128820
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
44
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128821
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
45
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128822
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
17-Mar-2021 PFIZER CONFIDENTIAL
46
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128823
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
47
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128824
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
1054 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
48
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128825
C4591001
1055 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
49
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128826
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
1056 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
50
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128827
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
1057 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
51
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128828
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;20-002221 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
52
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128829
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/P220395-0020L 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
17-Mar-2021 PFIZER CONFIDENTIAL
53
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128830
C4591001
1068 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
54
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128831
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 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
55
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128832
C4591001
1072 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
56
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128833
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 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
57
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128834
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 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
17-Mar-2021 PFIZER CONFIDENTIAL
58
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128835
C4591001
1079 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
59
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128836
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1080 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
60
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128837
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/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1081 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
61
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128838
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-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
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
17-Mar-2021 PFIZER CONFIDENTIAL
62
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128839
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 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
63
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128840
C4591001
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
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
64
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128841
C4591001
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
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
65
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128842
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/P220395-0033L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
66
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128843
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/P220395-0020L 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
 
17-Mar-2021 PFIZER CONFIDENTIAL
67
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128844
C4591001
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
68
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128845
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
1088 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
69
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128846
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/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1089 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
70
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128847
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 0.3 ml Vial BCV40420-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
71
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128848
C4591001
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
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
72
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128849
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/P220395-0031L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
73
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128850
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/P220395-0020L 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
74
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128851
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
17-Mar-2021 PFIZER CONFIDENTIAL
75
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128852
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
17-Mar-2021 PFIZER CONFIDENTIAL
76
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128853
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
17-Mar-2021 PFIZER CONFIDENTIAL
77
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128854
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
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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
78
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128855
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;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1096 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
79
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128856
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 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 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
 
17-Mar-2021 PFIZER CONFIDENTIAL
80
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128857
C4591001
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
81
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128858
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 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/P220395-0044L 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
17-Mar-2021 PFIZER CONFIDENTIAL
82
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128859
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/P220395-0074L 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/P220395-0046L 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
17-Mar-2021 PFIZER CONFIDENTIAL
83
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128860
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/P220395-0023L 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 0.3 ml Vial BCV40420-AE220395-0006L003/
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
 
17-Mar-2021 PFIZER CONFIDENTIAL
84
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128861
C4591001
1109 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
85
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128862
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/P220395-0062L 0 ml SOLUTION
1110 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
86
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128863
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
87
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128864
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/P220395-0023L 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
88
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128865
C4591001
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
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
89
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128866
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
90
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128867
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
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
91
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128868
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
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
92
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128869
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;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1118 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
93
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128870
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;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1120 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
94
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128871
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
95
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128872
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
17-Mar-2021 PFIZER CONFIDENTIAL
96
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128873
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
97
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128874
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 0.3 ml Vial BCV40420-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1124 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
98
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128875
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
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
 
17-Mar-2021 PFIZER CONFIDENTIAL
99
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128876
C4591001
1125 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 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
17-Mar-2021 PFIZER CONFIDENTIAL
100
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128877
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
1126 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0022L 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
17-Mar-2021 PFIZER CONFIDENTIAL
101
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128878
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1127 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
102
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128879
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
103
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128880
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 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
 
17-Mar-2021 PFIZER CONFIDENTIAL
104
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128881
C4591001
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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
105
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128882
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/P220395-0062L 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
1131 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
106
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128883
C45910013  
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
107
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128884
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/P220395-0062L 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
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
108
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128885
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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
109
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128886
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
17-Mar-2021 PFIZER CONFIDENTIAL
110
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128887
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
17-Mar-2021 PFIZER CONFIDENTIAL
111
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128888
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
112
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128889
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 BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 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
17-Mar-2021 PFIZER CONFIDENTIAL
113
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128890
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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
114
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128891
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 PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
115
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128892
C4591001
1141 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
116
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128893
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/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1142 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
117
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128894
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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1145 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
118
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128895
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
 
17-Mar-2021 PFIZER CONFIDENTIAL
119
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128896
C4591001
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
120
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128897
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/P220395-0055L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
121
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128898
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-AE220395-0006L003/
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
122
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128899
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
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-AE220395-0006L003/
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
123
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128900
C4591001
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
1152 UNITED STATES
17-Mar-2021 PFIZER CONFIDENTIAL
124
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128901
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 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;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
125
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128902
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/P220395-0062L 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
126
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128903
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/P220395-0062L 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
17-Mar-2021 PFIZER CONFIDENTIAL
127
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128904
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-AE220395-0006L003/
P220395-0012L 0.5 mg/ml SOLUTION
17-Mar-2021 PFIZER CONFIDENTIAL
128
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128905
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/P220395-0044L 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
17-Mar-2021 PFIZER CONFIDENTIAL
129
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128906
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/P220395-0020L 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
130
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128907
C4591001
1163 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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-AE220395-0006L003/
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
17-Mar-2021 PFIZER CONFIDENTIAL
131
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128908
C4591001
1166 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
132
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128909
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
133
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128910
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-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
17-Mar-2021 PFIZER CONFIDENTIAL
134
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128911
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 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/P220395-0034L 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
17-Mar-2021 PFIZER CONFIDENTIAL
135
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128912
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/P220395-0020L 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
17-Mar-2021 PFIZER CONFIDENTIAL
136
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128913
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 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
17-Mar-2021 PFIZER CONFIDENTIAL
137
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128914
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
1174 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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
 
17-Mar-2021 PFIZER CONFIDENTIAL
138
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128915
C4591001
1177 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
139
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128916
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
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
17-Mar-2021 PFIZER CONFIDENTIAL
140
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128917
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1179 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
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
17-Mar-2021 PFIZER CONFIDENTIAL
141
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128918
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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1204 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 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
17-Mar-2021 PFIZER CONFIDENTIAL
142
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128919
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0046L 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
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
17-Mar-2021 PFIZER CONFIDENTIAL
143
090177e196ac9fb1\Approved\Approved On: 31-Mar-2021 13:41 (GMT) 
FDA-CBER-2021-5683-0128920
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;20-002221 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
1221 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.
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