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-====== BioNTech ======
-===== Development of mRNA Vaccine Technology =====
-On October 16, 2019, Nature published an article describing BioNTech's successes in testing experimental [[immunotherapy]] vaccines for cancer, and suggested the progress could be applied to solve problems like rabies and pandemic influenza.((Dolgin, E. (2019). //Unlocking the potential of vaccines built on messenger RNA.// Nature, 574(7778), S10–S12. https://doi.org/10.1038/d41586-019-03072-8))
-==== Clinical Trials Pfizer FOIA ====
-BioNTech RNA Pharmaceuticals GmbH Confidential Interim Clinical Study Report
-BNT162-01 Page 1 of 1 Version: 2.0  Date: 26 Nov 2020 ((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf))
-== 16.1.13 ==
-List of sponsor personnel who materially affected the trial conduct
-The following table presents a list of sponsor personnel who materially affected the trial conduct.
-The full list of all involved sponsor personnel is maintained in the trial master file (looking for it)
-  * Name                          Role
-  * Özlem Türeci, MD Chief Medical Officer (Sponsor’s medically qualified person) b
-  * Svetlana Shpyro, MD Medical Expert
-  * Dr. Stefan Liebscher Biostatistician (External BioNTech Consultant)
-  * Sean Murphy Biostatistician (External BioNTech Consultant)
-  * Dr. Christopher Marshallsay Head Scientific-Medical Writing a
-  * Dr. Frans van Huizen Senior Scientific / Medical Writer
-  * Dr. David Langer Clinical Study Manager
-  * Dr. Stefanie Bolte Clinical Study Manager
-  * Martin Bexon, MD Medical Monitor (External BioNTech Consultant)
-  * Amélie Caneparo Pharmacovigilance Manager
-  * Claudia Müller Clinical Data Manager (External BioNTech Consultant)
-  * Dr. Tania Palanche Senior Clinical Data Manager
-a) Document owner fulfills the requirements of the author according to ICH E3.
-b) Corresponds to the medical officer defined in ICH E3. ((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-sponsor-personnel-list.pdf))
-{{ ::biontech_trial_officials.png?600 |}}
-==== Destroying BNT162b2 Placebo Group In 180 days ====
-Random sample - vaccine dates are squished together above dose type BNT162b2 or Placebo.
-((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_c4591001-interim-mth6-randomization-sensitive.pdf))
-{{ ::bnt162b2_or_placebo_chart_ended_180_days.png |}}
-==== Adverse Events ====
-BioNTech RNA Pharmaceuticals GmbH /
-Tables - 6. Snapshot All TLFs Final 1.0 BNT162b1
-BNT162-01 Created on 20NOV2020 Staburo GmbH.
-Based on clean SDTM data received on 03NOV2020. Data cut-off: 23OCT2020.
-Table 14.3.1-3.2.2-1: Frequency of subjects with TEAEs related to IMP by SOC and PT - BNT162b1
-NOTE - Influenza like illness
-{{ ::table_14.3.1-3.2.2-1_page_512_0f_2151.png |}}
-pdf page 512/2151((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf))
-==== REFERENCES ====
-page 140/2151 - REFERENCES((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf))
-Boraschi D, Del Giudice G, Dutel C, et al. Ageing and immunity: addressing immune
-senescence to ensure healthy ageing. Vaccine 2010; 28(21): 3627-31.
-Destexhe E, Prinsen MK, van Schöll I, et al. Evaluation of C-reactive protein as an
-inflammatory biomarker in rabbits for vaccine nonclinical safety studies. J Pharmacol
-Toxico. Methods 2013; 68: 367-73.
-Doener F, Hong HS, Meyer I, et al. RNA-based adjuvant CV8102 enhances the
-immunogenicity of a licensed rabies vaccine in a first-in-human trial. Vaccine 2019; 37:
--26.
-Kamphuis E, Junt T, Waibler Z, et al. Type I interferons directly regulate lymphocyte
-recirculation and cause transient blood lymphopenia. Blood 2006; 108: 3253-61.
-Mulligan M, Lyke KE, Kitchinet N, et al. Phase I/II study of COVID-19 RNA vaccine
-BNT162b1 in adults. Nature 2020; 586(7830): 589-93.
-Taylor DN, Treanor JJ, Sheldon EA, et al. Development of VAX128, a recombinant
-hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune
-response. Vaccine 2012; 30: 5761-9.
-Tsai MY, Hanson NQ, Straka RJ, et al. Effect of influenza vaccine on markers of
-inflammation and lipid profile. J Lab Clin Med. 2005; 145: 323-7.
-US FDA Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent
-Volunteers Enrolled in Preventive Vaccine Clinical Trials.
-Walsh EE, Frenck R, Falsey AR, et al. Safety and Immunogenicity of Two RNA-Based
-Covid-19 Vaccine Candidates. N Engl J Med. 2020; 383(25): 2439-50.((https://phmpt.org/wp-content/uploads/2022/05/125742_S1_M5_5351_bnt162-01-interim3-report-body.pdf))