019736 S70 M5 vr mqr 10211 10212 pq

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

27

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FDA-CBER-2021-5683-1072736
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 2
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072737
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 3
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072738
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 4
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072739
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 5
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072740
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 6
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072741
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 7
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072742
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 8
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072743
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 9
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072744
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 10
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072745
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 11
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072746
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 12
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072747
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 13
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072748
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 14
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072749
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 15
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072750
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 16
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072751
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 17
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072752
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 18
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072753
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 19
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072754
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 20
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072755
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 21
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072756
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 22
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072757
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 23
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072758
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 24
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072759
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
Page 25
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072760
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 26
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072761
SARS-CoV-2 dLIA Precision Qualification Data for Documentation re VR-MQR-10211 and VR-MQR-10212   
PFIZER CONFIDENTIAL
Page 27
090177e194aed916\Approved\Approved On: 18-Aug-2020 20:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-1072762