Document text
C4591001
1231 ARGENTINA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0035L002/P220395-0048L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0035L003/P220395-0048L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A EU2065896/E220395-0004L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0054L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION16.1.6 Study Drug Information
Data is presented by site and country
08-Oct-2021 CONFIDENTIAL
1
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224695
C4591001
1226 BRAZIL
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1241 BRAZIL
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
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 (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
2
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224696
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0056L 0 ml SOLUTION
1185 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 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
08-Oct-2021 CONFIDENTIAL
3
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224697
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1195 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1197 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1202 GERMANY
08-Oct-2021 CONFIDENTIAL
4
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224698
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1203 GERMANY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 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 (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
5
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224699
C4591001
1230 SOUTH AFRICA
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) 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 (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
6
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224700
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;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 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;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1208 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
7
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224701
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1209 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1210 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1212 TURKEY
08-Oct-2021 CONFIDENTIAL
8
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224702
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1213 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1214 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
9
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224703
C4591001
1217 TURKEY
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial ED3938 EU2074330/E220395-0036L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407OTH/E220395-0049L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (diluent) DK2074;20-002221 PA2069407OTH/E220395-0059L 0 ml SOLUTION
1001 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
10
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224704
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Labelled Carton containing 1x Labelled Vial of BNT162b1
0.25mg/0.5ml in Mylar bag containing 4 kits for Protocol
C4591001 (Stage 1)BCV10320-A E220395-0001L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589 20-001592 0 ml SOLUTION
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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1002 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) 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
08-Oct-2021 CONFIDENTIAL
11
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224705
C4591001
1003 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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
08-Oct-2021 CONFIDENTIAL
12
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224706
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 (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
13
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224707
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
14
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224708
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1007 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b1 0.5 mg/ml 0.3 ml Vial BCV10420-A E220395-0006L004/P220395-0009L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
15
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224709
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EE8493Y PA2087473/P220395-0073L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) 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
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
16
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224710
C4591001
1008 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EE8493Y PA2087473/P220395-0073L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
17
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224711
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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
18
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224712
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1011 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
19
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224713
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1012 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
20
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224714
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
1013 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
21
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224715
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
22
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224716
C4591001
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1016 UNITED STATES
08-Oct-2021 CONFIDENTIAL
23
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224717
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1018 UNITED STATES
08-Oct-2021 CONFIDENTIAL
24
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224718
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 (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
25
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224719
C4591001
1019 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
26
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224720
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1021 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
27
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224721
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1022 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
28
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224722
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1024 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
29
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224723
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1027 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
30
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224724
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1028 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
31
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224725
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1030 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
32
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224726
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1036 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
33
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224727
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1038 UNITED STATES
08-Oct-2021 CONFIDENTIAL
34
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224728
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
35
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224729
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EE8493Y PA2087473/P220395-0073L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
36
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224730
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1044 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
37
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224731
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1046 UNITED STATES
08-Oct-2021 CONFIDENTIAL
38
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224732
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
39
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224733
C4591001
1047 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
40
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224734
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) 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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
41
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224735
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
42
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224736
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1055 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
43
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224737
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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
44
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224738
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
45
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224739
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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1066 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
46
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224740
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1068 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
47
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224741
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1071 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
48
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224742
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1072 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
49
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224743
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
1073 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
50
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224744
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;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
1077 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
51
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224745
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1079 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
52
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224746
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
53
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224747
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
54
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224748
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1082 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
55
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224749
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1083 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
08-Oct-2021 CONFIDENTIAL
56
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224750
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
1084 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
08-Oct-2021 CONFIDENTIAL
57
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224751
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
58
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224752
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
59
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224753
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;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1087 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
60
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224754
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
61
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224755
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
62
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224756
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
63
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224757
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1090 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
64
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224758
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;20-002108 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
65
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224759
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1092 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
66
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224760
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1093 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
08-Oct-2021 CONFIDENTIAL
67
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224761
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1094 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
08-Oct-2021 CONFIDENTIAL
68
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224762
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
69
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224763
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1096 UNITED STATES
08-Oct-2021 CONFIDENTIAL
70
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224764
C4591001109
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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
71
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224765
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1097 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
72
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224766
C4591001
1098 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1101 UNITED STATES
08-Oct-2021 CONFIDENTIAL
73
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224767
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1107 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
74
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224768
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
1109 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2072393/P220395-0019L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
75
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224769
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0033L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
76
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224770
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
77
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224771
C4591001
1111 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
78
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224772
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1112 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
79
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224773
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
80
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224774
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
81
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224775
C4591001
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1118 UNITED STATES
08-Oct-2021 CONFIDENTIAL
82
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224776
C45910011 18
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
83
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224777
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
84
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224778
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 (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-A PA2074998/P220395-0060L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
85
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224779
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
86
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224780
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1124 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-A PA2071394/P220395-0029L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
87
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224781
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1125 UNITED STATES
08-Oct-2021 CONFIDENTIAL
88
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224782
C45910011 2
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
89
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224783
C4591001
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
90
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224784
C4591001
1127 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
91
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224785
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
92
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224786
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002221 PA2069407/P220395-0031L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
93
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224787
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial 21-DP-00481 PA2096820/P220395-0078L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
1131 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
08-Oct-2021 CONFIDENTIAL
94
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224788
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
95
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224789
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
96
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224790
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1134 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
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 (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
97
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224791
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
98
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224792
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial EE8493Z PA2077905/P220395-0026L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
99
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224793
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1136 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) 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
08-Oct-2021 CONFIDENTIAL
100
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224794
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 (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A PA2070104/P220395-0008L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002108 PA2067774/P220395-0013L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
101
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224795
C4591001
1140 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-A PA2074172/P220395-0053L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EE8493Y PA2087473/P220395-0073L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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
08-Oct-2021 CONFIDENTIAL
102
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224796
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
1141 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
103
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224797
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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
104
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224798
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) EJ0553Z PA2085061/P220395-0070L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001592 PA2064251/P220395-0005L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1145 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
105
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224799
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1146 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
08-Oct-2021 CONFIDENTIAL
106
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224800
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 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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1147 UNITED STATES
08-Oct-2021 CONFIDENTIAL
107
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224801
C45910011 47
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK1589;20-001776 PA2065311/P220395-0007L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial DK2074;20-002029 PA2067775/P220395-0030L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
1149 UNITED STATES
08-Oct-2021 CONFIDENTIAL
108
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224802
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 (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.3 ml Vial BCV40420-A E220395-0006L003/P220395-0012L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
109
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224803
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0065L 0 ml SOLUTION
1150 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-B PA2074173/P220395-0051L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0032L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
110
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224804
C4591001
1152 UNITED STATES
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2071395/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-B PA2072396/P220395-0016L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2071396/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-C PA2072439/P220395-0047L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072442/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial BCV40620-D PA2072765/P220395-0042L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) BCV40720-C PA2074071/P220395-0052L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0023L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0068L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0074L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 NC2075485/P220395-0077L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0020L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0044L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0046L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
111
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224805
C4591001
Investigational Product Description Vendor Lot No. Pfizer Lot No. Strength/Potency Dosage Form
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0055L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0062L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) 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 (12-15 years old) ED3938 PA2074300/P220395-0021L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) ED3938 PA2074300/P220395-0022L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.2 ml Vial (12-15 years old) EE3813 PA2074838/P220395-0024L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) ER9449Z PA2096794/P220395-0082L 0.5 mg/ml SOLUTION
BNT162b2 0.5 mg/ml 0.45 ml Vial (12-15 years old) (Booster) ER9449Z PA2096794/P220395-0079L 0.5 mg/ml SOLUTION
BNT162b2SA 0.5 mg/ml 0.45 ml Vial (Booster) 21-DP-00481 PA2096820/P220395-0078L 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 (12-15 years old) DK2074;20-002221 PA2069407/P220395-0034L 0 ml SOLUTION
Sodium Chloride Injection USP, 0.9% vial (12-15 years old) DK2074;20-002221 PA2069407/P220395-0045L 0 ml SOLUTION
08-Oct-2021 CONFIDENTIAL
112
090177e1984422cd\Approved\Approved On: 08-Oct-2021 15:25 (GMT)
FDA-CBER-2022-5812-0224806
C4591001
…[truncated]