UPDATE ON PFIZER MONEY TO U.S. TREASURY
The Complete 6-page Document
On Feb. 16 I posted 2 documents at covidandvaxfaqs.substack.com/p/pfizer-money-wired-via-fda-to-treasury. The first was the first page of the May 6, 2021 Pfizer Biologics License Application (BLA) for its Covid-19 mRNA vax. The second document was the August 23, 2021 FDA Approval Letter for the vax.
The former showed that Pfizer wired over 2.875 million dollars to the U.S. Treasury via the FDA.
Now Geoff has provided me with the complete 6 page document from May 6, 2021. Geoff is helping to prepare evidence for prosecution of the Pandemic Conspirators. These documents may help either to provide direct evidence or to lead to direct evidence (possibly with help via leads from readers — Wink).
So here is the complete May 6, 2021 6-page Pfizer BLA. I converted the PDF to a Word doc and also included a link to the PDF at the end of this post.
Pfizer Global Regulatory Affairs
Pfizer Inc.
400 Arcola Road Collegeville, PA 19426
Global Product Development
06 May 2021
Marion Gruber, Ph.D. Director
Office of Vaccines Research and Review Food and Drug Administration
Center for Biologics Evaluation and Research Document Control Center
10903 New Hampshire Avenue WO71, G112
Silver Spring, MD 20993-0002
THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE SECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR REGISTRATION OF PRODUCTS FOR PFIZER INC OR ITS AFFILIATED COMPANIES. THIS DOCUMENT SHOULD NOT BE DISCLOSED OR USED, IN WHOLE OR IN PART, FOR ANY OTHER PURPOSE WITHOUT THE PRIOR WRITTEN CONSENT OF PFIZER INC.
Re: BLA 125742
COVID-19 mRNA Vaccine (BNT162/PF-07302048)
Part 1 of the Original Submission – Rolling Biologics License Application (BLA) Request for Priority Review Designation
Dear Dr. Gruber,
Please find enclosed Part 1 of the Original Submission of the rolling Biologics License Application (BLA) for the BNT162b2 vaccine candidate developed by BioNTech and Pfizer under BB-IND 19736 for the prevention of COVID-19 caused by SARS-CoV-2 in individuals ≥16 years of age. This vaccine was granted Fast Track Designation for individuals >18 years of age on 07 July 2020. The Grant Fast Track Designation Letter is provided in Module 1.7.4. Submission of this BLA as a rolling application was agreed during the teleconference of 16 April 2021.
BioNTech and Pfizer are requesting Priority Review Designation for this BLA. It meets the criteria for Priority Review Designation, as outlined in the 2014 Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics because BNT162b2 prevents a serious and life-threatening condition (COVID-19) and, if approved, would provide a significant improvement in safety and effectiveness because there are currently no vaccines licensed for the prevention of COVID-19 in the US. The Priority Review Designation Request is provided in Module 1.2.
A wire transfer for $2,875,842.00 was made to the U.S. Department of Treasury (TREAS
NYC 33 Liberty Street, New York, NY 10045) on 05 May 2021 (User Fee ID# PD3017966) for the user fee for this application. A copy of the user fee cover sheet (Form 3397) is provided in Module 1.1.
The purpose of this submission is to provide the complete non-clinical and clinical contents of the application. This submission is provided in electronic Common Technical Document (eCTD) format. The Table of Contents is attached. Part 2 of the Original Submission of the BLA containing the rest of the BLA contents will be submitted on 21 May 2021.
Additionally, as agreed during the teleconference of 16 April 2016, sequencing data requested by the Agency on 09 March 2021 will be provided by 07 June 2021.
Any reference not included with this submission is available upon request.
In addition, via email on 10 August 2020, it was agreed that BioNTech could be provided their US License Number upon submission of the BLA (as opposed to at approval). We kindly request the US License Number for BioNTech at this time with agreement that they will not use it until after the BLA is approved.
Should you have any questions regarding this submission, or require additional information, please contact me via phone at 215-280-5503; via facsimile at 845-474-3500; or via e-mail at elisa.harkinstull@pfizer.com.
Sincerely, Elisa Harkins
Global Regulatory Lead
Global Regulatory Affairs – Vaccines CC: Ramachandra S. Naik, Ph.D.
BLA 125742 Part 1 Table of Contents
MODULE 1
1
Administrative Information and Prescribing Information
1.1
Forms
FDA 356h Form: Application Form
FDA 3397 Form: User Fee Cover Sheet
FDA 3674 Form: Certification of Compliance with ClinicalTrials.gov
1.2
Cover Letters
Cover Letter
Priority Review Designation Request
1.3
Administrative Information
1.3.1
Contact/Sponsor/Applicant Information
1.3.1.4
Transfer of Obligation
Transfer of Obligation
1.3.3
Debarment Certification
Debarment Certification
1.3.4
Financial Certification and Disclosure
Financial Certification and Disclosure - Summary Note
Financial Certification and Disclosure - Bias Statement
Financial Certification and Disclosure - Form FDA 3454
Financial Certification and Disclosure - Form FDA 3455
1.3.5
Patent and Exclusivity
1.3.5.3
Exclusivity Claim
Notice of Claimed Exclusivity
1.4
References
1.4.3
List of authorized persons to incorporate by reference
Letter of Authorization to Appoint US Agent
1.6
Meetings
1.6.3
Correspondence Regarding Meetings
Correspondence Regarding Meetings
1.7
Fast Track
1.7.4
Correspondence regarding fast track/rolling review
Grant Fast Track Designation Letter
1.9
Pediatric Administrative Information
1.9.2
Request for Deferral of Pediatric Studies
Request for Deferral of Pediatric Studies
1.9.4
Proposed Pediatric Study Request and Amendments
Agreed initial Pediatric Study Plan
1.9.6
Other Correspondence Regarding Pediatric Exclusivity/Study Plans
Letter of FDA Agreement with initial Pediatric Study Plan
1.12
Other Correspondence
1.12.5
Request for Waiver
Waiver Request for FDA-Designated Suffix for Biologics
MODULE 2
2
CTD SUMMARIES
2.2
Introduction to Summary
2.4
Nonclinical Overview
2.5
Clinical Overview
2.6
Nonclinical Written and Tabulated Summaries
2.6.1
Introduction
2.6.2
Pharmacology Written Summary
2.6.3
Pharmacology Tabulated Summary
2.6.4
Pharmacokinetics Written Summary
2.6.5
Pharmacokinetics Tabulated Summary
2.6.6
Toxicology Written Summary
2.6.7
Toxicology Tabulated Summary
2.7
Clinical Summary
2.7.1
Summary of Biopharmaceutic Studies and Associated Analytical Methods
2.7.3
Summary of Clinical Efficacy
2.7.4
Summary of Clinical Safety
2.7.5
References
2.7.6
Synopses of Individual Studies
MODULE 4
4
NON-CLINICAL STUDY REPORTS
4.2
Study Reports
4.2.1
Pharmacology
4.2.1.1
Primary Pharmacodynamics
R-20-0085 - COVID-19: Immunogenicity Study of the LNP-Formulated Modrna Encoding the Viral S Protein-V9
R-20-0112 - Characterizing the Immunophenotype in Spleen and Lymph Node of Mice Treated with SARS-COV-2 Vaccine Candidates
R-20-0211 - In vitro Expression of BNT162b2 Drug Substance and Drug Product
VR-VTR-10671 - BNT162b2 (V9) Immunogenicity and Evaluation of Protection against SARS- CoV-2 Challenge in Rhesus Macaques
VR-VTR-10741 - Structural and Biophysical Characterization of SARS-CoV-2 Spike Glycoprotein (P2 S) as a Vaccine Antigen
4.2.2
Pharmacokinetics
4.2.2.2
Absorption
PF-07302048_06Jul20_072424 - A Single Dose Rat Pharmacokinetic Study of ALC-0315 and ALC-0159 Following Intravenous Bolus Injection of PF-07302048 Nanoparticle Formulation in Wistar Han Rats
4.2.2.3
Distribution
R-20-0072 - Expression of Luciferase-Encoding ModRNA After I.M. Application of GMP-Ready Acuitas LNP Formulation
185350 - A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats
4.2.2.4
Metabolism
01049-20008 - In Vitro Metabolic Stability of ALC-0315 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and Human Liver Microsomes
01049-20009 - In Vitro Metabolic Stability of ALC-0315 in CD-1/ICR Mouse, Sprague Dawley Rat, Cynomolgus Monkey, and Human Liver S9 Fractions
01049-20010 - In Vitro Metabolic Stability of ALC-0315 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and Human Hepatocytes
01049-20020 - In Vitro Metabolic Stability of ALC-0159 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and Human Liver Microsomes
01049-20021 - In Vitro Metabolic Stability of ALC-0159 in CD-1/ICR Mouse, Sprague Dawley Rat, Cynomolgus Monkey, and Human Liver S9 Fractions
01049-20022 - In Vitro Metabolic Stability of ALC-0159 in CD-1/ICR Mouse, Sprague Dawley Rat, Wistar Han Rat, Cynomolgus Monkey, and Human Hepatocytes
PF-07302048_05Aug20_043725 - Investigation of the Biotransformation of ALC-0159 and ALC- 0315 In Vitro and In Vivo in Rats
4.2.3
Toxicology
4.2.3.2
Repeat-Dose Toxicity
38166 - Repeat-Dose Toxicity Study of Three LNP-Formulated RNA Platforms Encoding for Viral Proteins by Repeated Intramuscular Administration to Wistar Han Rats
38166 - SEND Datasets
20GR142 - 17-Day Intramuscular Toxicity Study of BNT162b2 (V9) and BNT162b3c in Wistar Han Rats with a 3-Week Recovery
20GR142 - SEND Datasets
4.2.3.5
Reproductive and Developmental Toxicity
4.2.3.5.1
Fertility and Early Embryonic Development
20256434 - (RN9391R58) - Combined Fertility and Developmental Study (Including Teratogenicity and Postnatal Investigations) of BNT162b1, BNT162b2 and BNT162b3 by the
Intramuscular Route in the Wistar Rat
4.3
Literature References
MODULE 5
5
CLINICAL STUDY REPORTS
5.2
Tabular Listing of All Clinical Studies
Tabular Listing
Listing of Clinical Sites and CVs
5.3
Clinical Study Reports
5.3.1
Reports of Biopharmaceutic Studies
5.3.1.4
Reports of Bioanalytical and Analytical Methods for Human Studies
VR-MVR-10080 - Report on Method Validation of a Cepheid Xpert Express PCR Assay to Detect SARS-CoV-2
VR-MVR-10081 - Method Validation Report for the Elecsys Anti-SARS-CoV-2 Assay
VR-MVR-10083 - Validation Report for the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay
VR-MQR-10211 - Qualification Report for a Single-plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 S1 Protein in Human Sera
VR-MQR-10212 - Qualification Report for a Single-plex Direct Luminex Assay (dLIA) for Quantitation of IgG Antibodies to SARS-CoV-2 RBD Protein in Human Sera
VR-MQR-10214 - Qualification of the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay
VR-TM-10293 - Single-plex Luminex Assay for Quantitation of IgG Antibodies to SARS-CoV- 2S1 Protein in Human Serum
VR-TM-10294 - Single-plex Luminex Assay for Quantitation of IgG Antibodies to SARS-CoV-2 RBD Protein in Human Serum
VR-TM-10298 - Manual 96-well Neutralization Assay for the Detection of Functional Antibodies to SARS-CoV-2 in Test Serum
VR-TM-10304 - Test Method for the SARS CoV-2 Nucleocapsid (N) Antigen Detection Assay
VR-SOP-LC-11120 - Data Review Procedures for Direct Luminex Immunoassays in LIMS v6
SHI-SOP-10011 - Manual 96-well Neutralization Assay for the Detection of Functional Antibodies to SARS-CoV-2 in Test Serum using Cytation 7 Image Reader
5.3.5
Reports of Efficacy and Safety Studies
5.3.5.1
Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
C4591001 - A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of SARS-CoV-2 RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
C4591001 - Final Analysis Interim CSR
C4591001 - 6-Month Update Interim CSR
C4591001 - Case Report Forms
C4591001 - ADaM and SDTM Datasets
C4591001 - ADaM and SDTM Supplemental Datasets
BNT162-01 - A Multi-Site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and
Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-19 Using Different Dosing Regimens in Healthy Adults
BNT162-01 - Interim CSR v3.0
BNT162-01 - Case Report Forms
BNT 162-01 - ADaM and SDTM Datasets
5.3.6
Postmarketing Experience
Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Cumulatively through 28-Feb-2021
5.4
Literature References
Excellent work! Thank you so much. I'm sure my fellow digital soldiers on Substack and elsewhere are collecting these types of documents, as I do, to try to preserve the record for future historians.