125742 S1 M5 5314 vr mvr 10083 att01

Collection

Pfizer Documents (PHMPT/FDA)

Case

Pfizer Bla Submission

Sub-case

Pfizer 16 Plus Documents

Pages

Download PDF ↗ Live URL (may be dead)

Document text

PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 1Title:Dilutional Linearity Data Listing for VR -MVR-10083
Study Number: N/A
Parent Compound Number(s): PF-07302048
Alternative Compound Identifiers: N/A
Pfizer Vaccine Research and Development
401 N. Middletown Rd.
Pearl River, NY
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
FDA-CBER-2021-5683-0779485
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 2TABLE OFCONTENTS
LIST OF TABLES.....................................................................................................................2
LIST OF TABLES
Table 1.  for the SARS- CoV-2 mNG NT ................................ ...........3
Table2. SARS-CoV-2 mNG NT Validation Data Listing –Dilutional 
Linearity Samples ................................ ................................ ....................... 4
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
FDA-CBER-2021-5683-0779486
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 3Table1. for the SARS-CoV-2 mNG NT
.
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779487
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 4Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0779488
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 5Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779489
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 6Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779490
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 7Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779491
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 8Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779492
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 9Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779493
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 10Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779494
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 11Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779495
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 12Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779496
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 13Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779497
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 14Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779498
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 15Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779499
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 16Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0779500
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 17Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779501
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 18Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779502
PF-07302048 : Dilutional Linearity Data Listing for VR-MVR-10083
VR-MVR-10083-ATT01, Ver. 1.0
PFIZER CONFIDEN TIAL
Page 19Table2.SARS-CoV-2 mNG NT Validation Data Listing –Dilutional Linearity Samples
TDV Batch Plate Barcode Assay Date Sample Sample 
BarcodeMDP Set Analyst Dilution Neut Titer/
This data table w as provided by Early Clinical Development Biostatistics.
090177e1962bdeb9\Approved\Approved On: 09-Feb-2021 13:59 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0779503

Related across Profoundd

Oregon Climate Docs

Ashland — Climate and Energy Action Plan (CEAP) p.345
Q3 What would you change about the draft Climate and Energy Action Plan? Answered: 11 Skipped: 2 # Responses Date 1 I would emphasize how much of the GHG reduction goal can be achieved by city action and how much is de…
Medford — Transportation System Plan 2018-2038 p.341
Table F-1 Continued Summary of Draft 2004-2007 STIP Programmed Improvements – City of Medford Key No. Route Location Fiscal Year Const. Cost ($,000) Work Type Description 10964 I-5 OTIA – South Medford I…
Medford — Transportation System Plan 2018-2038 p.11
LIST OF TABLES Cont inued Number Description Page 8-1 2023 PM Peak Hour Lev el of Service Un signalized Intersection s in Medfo rd UGB ...8-2 8-2 Summary of Intersection Traffic Control Imp rovemen ts.…

Epstein Files

EFTA00070998 — From: Chris DiIon° <MIMI >
From: Chris DiIon° <MIMI > To: EFTA00070998 Subject: Fw: Formal appeal for covered action 2015-016/ Knight Capital TCR & Appendix Date: Sat, 3I Jul 2021 19:02:12 +0000 Attachments: KCG_Appendix_3-20_13_penultimate.docx; …
EFTA00098841 — From: Chris Dilorio
From: Chris Dilorio To: Subject: Fw: Formal appeal for covered action 2015-016/ Knight Capital TCR & Appendix Date: Sun, 18 Jul 2021 16:24:22 +0000 Attachments: KCG_Appendix_3-20_13_penultimate.docx; KCG_TCR_3-20-13-penu…
EFTA00065103 — From: Chris DiIon° <MIMI >
From: Chris DiIon° <MIMI > To: EFTA00065103 Subject: Fw: Formal appeal for covered action 2015-016/ Knight Capital TCR & Appendix Date: Fri, 23 Jul 2021 12:45:00 +0000 Attachments: KCG_Appendix_3-20_13_penultimate.docx; …

Federal Writers' Project

[James Cape]
k), klq Gentbier.bheldon t. ens lore. Tarrant Co,Dist„i7 Page fl PC 240 .4mas Cape,110 or moreoliving at 3101 Clinton ,tort Worth,Texas,was born -a slave to Bob Huston, whenwned a plantation and ranch located in Gonsales…
[Dave Hoffman]
'aouti,ier.arteidon S. .e.tore. Tarnalt co.,Dist*,47 eage FC 240 Dave '1offaan,38, living at 341b Ave. ,J, Fort ;$arth,lexast was born at Avon ,July 1,1900. !Is father, Jessie eoefman, was a breeder and racer of race hor…
[Andrew Jackson Hale]
a5 -t -words ZDITORIAL YIELD COPY Page 1. by 232 Ara. Florease Angermiller, P.W. on F.C. by s. Gmssie Hole, P.'''. ioneer Sxperiences and lea of liarly Deys umra count DISTRICT AO ANDREW JACOON HALE Uvalde, Texas. oNE '"…

Recent News

Misinformation for thee, not me? FDA had similar concerns as COVID vaccine skeptics, docs suggest
FOIA production shows agency wasn't impressed by Pfizer plan to mitigate "endotoxins," complained about insufficient cleaning in manufacturing, had no basis to claim post-vax heart inflammation was rare. Published: Decem…
AI Analysis Finds Natural Origins More Likely for Omicron Variant B.1.1.529
Highlights Potential of New Role for Artificial Intelligence in Biological Weapons Convention (BWC) Monitoring
Pfizer, CDC Withheld Evidence of Myocarditis After COVID Shots, New Documents Reveal
This is a member's only feature. Please join or upgrade Originally published on www.childrenshealthdefense.org by Michael Nevradakis, Ph.D. Pfizer and the Centers for Disease Control and Prevention (CDC) withheld evidenc…