Karen Kingston _ Session 110 - Revisiting

Session 110: Revisiting
June 24th, 2022 • 20K views • 234 likes • 11 dislikes
Corona Investigative Committee @Corona-Investigative-Committee • 15K Followers
https://odysee.com/@Corona-Investigative-Committee:5/s110en:0
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Documents:
pfizer-inc-covid-19-vaccine-contract.pdf
https://www.hhs.gov/sites/default/files/pfizer-inc-covid-19-vaccine-contract.pdf

August 23, 2021 Approval Letter - Comirnaty
https://www.fda.gov/media/151710/download

November 8, 2021 Summary Basis for Regulatory Action - Comirnaty
https://www.fda.gov/media/151733/download

Comprehensive NDC SPL Data Elements File (NSDE)
https://www.fda.gov/industry/structured-product-labeling-resources/nsde

These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY.
COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use Initial U.S. Approval: 2021
COMIRNATY- covid-19 vaccine, mrna injection, suspension
Pfizer Laboratories Div Pfizer Inc
FULL PRESCRIBING INFORMATION: CONTENTS
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=48c86164-de07-4041-b9dc-f2b5744714e5&version=1

SEPTEMBER 13, 2021
Pfizer received FDA BLA license for its COVID-19 vaccine
https://dailymed.nlm.nih.gov/dailymed/dailymed-announcements-details.cfm?date=2021-09-13

LABEL: COMIRNATY- covid-19 vaccine, mrna injection, suspension
https://dailymed.nlm.nih.gov/dailymed/druginfo.cfm?setid=48c86164-de07-4041-b9dc-f2b5744714e5

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products - Guidance for Industry
https://www.fda.gov/media/89036/download

The immunogenicity of therapeutic proteins- what you don’t know can
hurt YOU and the patient - SBIA REdI Spring 2014
https://web.archive.org/web/20210305025747/https://www.fda.gov/media/89071/download

The immunogenicity of therapeutic proteins - SBIA REdI Fall 2014
https://www.fda.gov/media/91668/download

Immunogenicity of Protein-based Therapeutics
Principal Investigator: Zuben E. Sauna, PhD
Office / Division / Lab: OTAT / DPPT / HB
https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/immunogenicity-protein-based-therapeutics
"General Overview
A major problem with protein-based therapeutics is their immunogenicity, that is, their tendency to trigger an unwanted immune response against themselves. One form of immune response is activation of B cells, which produce antibodies that bind to the proteins and reduce or eliminate their therapeutic effects. Such antibodies can also cause complications that can be life-threatening."

PowerPoint-Präsentation
BNTX _JPM presentation 2021_vF2.pdf
https://investors.biontech.de/static-files/82c9e451-7503-4217-a51f-ee7fb6497b17?fbclid=IwAR2MRfUtXExUeD54qiqbk6jnRay-kOfp74ZKeBIGobChqyLAcqToU2uxm7Q

Superantigenic character of an insert unique to SARS-CoV-2 spike supported by skewed TCR repertoire in patients with hyperinflammation
Mary Hongying Cheng https://orcid.org/0000-0001-5833-8221,
She Zhang https://orcid.org/0000-0001-9265-4498,
Rebecca A. Porritt https://orcid.org/0000-0002-0973-5092, +5 ,
Magali Noval Rivas, Lisa Paschold, Edith Willscher, Mascha Binder,
Moshe Arditi https://orcid.org/0000-0001-9042-2909 moshe.arditi@cshs.org, and
Ivet Bahar https://orcid.org/0000-0001-9959-4176
moshe.arditi@cshs.org-5Authors Info & Affiliations
Contributed by Ivet Bahar, June 29, 2020 (sent for review May 26, 2020; reviewed by Talal A. Chatila, Ruth Nussinov, and Celia A. Schiffer)
September 28, 2020
117 (41) 25254-25262
https://doi.org/10.1073/pnas.2010722117
https://www.pnas.org/doi/full/10.1073/pnas.2010722117
https://www.pnas.org/doi/epdf/10.1073/pnas.2010722117

US 2020/0061185 A1
PREFUSION CORONAVIRUS SPIKE PROTEINS AND THEIR USE
https://patents.google.com/patent/US20200061185A1/en?oq=US+2020%2f0061185+A1
https://patentimages.storage.googleapis.com/e9/1f/3a/c72f6a8603a3b5/US20200061185A1.pdf

SARS-like WIV1-CoV poised for human emergence
Vineet D. Menachery, Boyd L. Yount Jr., Amy C. Sims, +14 , Kari
Debbink, Sudhakar S. Agnihothram, Lisa E. Gralinski, Rachel L. Graham,
Trevor Scobey, Jessica A. Plante, Scott R. Royal, Jesica Swanstrom,
Timothy P. Sheahan, Raymond J. Pickles, Davide Corti, Scott H. Randell,
Antonio Lanzavecchia, Wayne A. Marasco, and Ralph S. Baric
rbaric@email.unc.edu-14Authors Info & Affiliations
Edited by Peter Palese, Icahn School of Medicine at Mount Sinai, New
York, NY, and approved January 6, 2016 (received for review September
4, 2015)
March 14, 2016
113 (11) 3048-3053
https://doi.org/10.1073/pnas.1517719113
https://www.pnas.org/content/113/11/3048
https://www.pnas.org/doi/epdf/10.1073/pnas.1517719113

Epub 2020 Aug 20.
Surveillance of SARS-CoV-2 infection among frontline health care workers in Wuhan during COVID-19 outbreak
Xin Tong 1, Mingzhe Ning 2, Rui Huang 1, Bei Jia 1, Xiaomin Yan 1, Yali Xiong 1, Weihua Wu 1, Jiacheng Liu 1, Yuxin Chen 2, Chao Wu 1
Affiliations expand
PMID: 32816387 PMCID: PMC7461296 DOI: 10.1002/iid3.340
https://pubmed.ncbi.nlm.gov/32816387/
https://pubmed.ncbi.nlm.nih.gov/32816387/
https://onlinelibrary.wiley.com/doi/10.1002/iid3.340
https://onlinelibrary.wiley.com/doi/epdf/10.1002/iid3.340
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7461296/pdf/IID3-8-840.pdf

MAJOR ARTICLE| VOLUME 48, ISSUE 8, P890-896, AUGUST 01, 2020
Absence of nosocomial transmission of coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 in the prepandemic phase in Hong Kong
Vincent C.C. Cheng, MD 1
Shuk-Ching Wong, MNurs 1
Vivien W.M. Chuang, FRCPath
Ivan F.N. Hung, MD
Pak-Leung Ho, MD
Kwok-Yung Yuen, MD
DOI: 10.1016/j.ajic.2020.05.018
Published:May 24, 2020DOI:https://doi.org/10.1016/j.ajic.2020.05.018
https://doi.org/10.1016/j.ajic.2020.05.018
https://www.ajicjournal.org/action/showPdf?pii=S0196-6553%2820%2930280-7

First case of postmortem study in a patient vaccinated against SARS-CoV-2
Torsten Hansen,a,⁎ Ulf Titze,a Nidhi Su Ann Kulamadayil-Heidenreich,b Sabine Glombitza,c Johannes Josef Tebbe,b Christoph Röcken,d Birte Schulz,a Michael Weise,b and Ludwig Wilkensc
Int J Infect Dis. 2021 Jun; 107: 172–175.
PMCID: PMC8051011 PMID: 33872783
Published online 2021 Apr 16. doi: 10.1016/j.ijid.2021.04.053
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051011/?fbclid=IwAR12NBR4je94tPxOGzLV4b8ORrXSZIX8iWIkIB8bJfuxBILKddCqFxejpu8
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8051011/pdf/main.pdf
saved as PMC8051011.pdf

Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Briefing Document- FDA
VRBPAC-09.17.21-Meeting-Briefing-Document-FDA.pdf
https://www.fda.gov/media/152176/download

Inhalt:
* eine Säuglings- und Kleinkindstudie von Pfizer:
"Es ist statistisch und klinisch unmöglich, eine klinische Studie
durchzuführen, die beweist, dass ein Impfstoff wirksamer ist als
das natürliche Immunsystem eines Kindes."
* BLA/FDA-Zulassung (nicht durch EUA-Forschung abgeschirmt)
* Neue Erkenntnisse über den 2-SP-Spike:
"Es handelt sich um einen waffenfähigen trimerisierten Präfusionsspike
mit 2 Prolin Modifikationen, auch bekannt als optimierte Codons in
Comirnaty und allen anderen COVID-19 Schüssen"
* Über die Operation Warp Speed Verträge, insbesondere den DoD/Pfizer-Vertrag

Hier geht´s zum Deutschen Stream:
https://odysee.com/s110de

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