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125742 45 S211 M5 graff k 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 9 pages

Copyright © 2021 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.The Pediatric Infectious Disease Journal • Volume 40, Number 4, April 2021 www.pidj.com | e137ISSN: 0891-3668/21/4004-e137 DOI: 10.1097/INF .0000000000003043Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.Original Studies Accepted for publication December 12, 2020 *Department of Pediatrics, School of Medicine, University of Colorado, Aurora, CO; †Department of Pathology and…

125742 45 S211 M5 glatman freedman a 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 4 pages

Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 27, No. 11, November 2021 2919In May 2021, the US Food and Drug Administration and the European Medicines Agency expanded H[LVWLQJ DXWKRUL]DWLRQ IRU %17E YDFFLQH 3À]HU%LR17HFK KWWSVZZZSÀ]HUFRP DJDLQVW VHYHUHacute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include its use in adolescents 12–15 years of age (1,2  2Q -XQH   WKH ,VUDHO 0LQLVWU\ RIHealth declared the availability of BNT162b2 vaccine for adolescents…

125742 45 S211 M5 gargano jw 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 6 pages

Morbidity and Mortality Weekly Report MMWR / July 9, 2021 / Vol. 70 / No. 27 977 US Department of Health and Human Services/Centers for Disease Control and PreventionUse of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021 Julia W. Gargano, PhD1,*; Megan Wallace, DrPH1,*; Stephen C. Hadler, MD1; Gayle Langley, MD1; John R. Su, MD, PhD1; Matthew E. Oster, MD1; Karen R. Broder,…

125742 45 S211 M5 delahoy mj 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 6 pages

Morbidity and Mortality Weekly Report MMWR / September 10, 2021 / Vol. 70 / No. 36 1255 US Department of Health and Human Services/Centers for Disease Control and PreventionHospitalizations Associated with COVID-19 Among Children and Adolescents — COVID-NET, 14 States, March 1, 2020–August 14, 2021 Miranda J. Delahoy, PhD1,2; Dawud Ujamaa, MS1,3; Michael Whitaker, MPH1; Alissa O’Halloran, MSPH1; Onika Anglin, MPH1,3; Erin Burns1; Charisse Cummings, MPH1; Rachel Holstein, MPH1; Anita K.…

125742 45 S211 M5 cdc 2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 5 pages

090177e1942b5c14\Final\Final On: 02-Jul-2020 16:51 (GMT)…

125742 45 S211 M5 zachariah p 2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 7 pages

090177e1981d343b\Final\Final On: 20-Sep-2021 19:30 (GMT)…

125742 45 S211 M5 yasuhara j 2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 12 pages

Received: 17 November 2020 |Revised: 13 December 2020 |Accepted: 23 December 2020 DOI: 10.1002/ppul.25245 ORIGINAL ARTICLE: COVID 19 COVID ‐19 and multisystem inflammatory syndrome in children: A systematic review and meta ‐analysis Jun Yasuhara MD1|Kae Watanabe MD2|Hisato Takagi MD, PhD3| Naokata Sumitomo MD, PhD4|Toshiki Kuno MD, PhD5 1Center for Cardiovascular Research, The Abigail Wexner Research Institute and The Heart Center, Nationwide Children's Hospital,Columbus, Ohio, USA 2Division…

125742 45 S211 M5 c4591001 A 6mth P adsl sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 151 pages

file:///J/...45-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-sas.txt[7/5/2023 10:22:53 AM]************************************************************************************************ *****************;** Program Name : adsl.sas **;** Date Created : 17Nov2021 **;**…

125742 45 S211 M5 c4591001 A 6mth P adsl s005 all1 ped6 saf sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 81 pages

file:///J/...1/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-s005-all1-ped6-saf-sas.txt[7/5/2023 10:22:50 AM]***********************************************************************************************; ** Program Name : adsl-s005-all1-ped6-saf.sas **;** Date Created : 15Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adsl fu d21 ped6 sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 30 pages

file:///J/...1)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-fu-d21-ped6-sas.txt[7/5/2023 10:22:51 AM]***********************************************************************************************; ** Program Name : adsl-fu-d21-ped6.sas **;** Date Created : 15Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adsl demo 7d wwo peds eval eff sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 60 pages

file:///J/...asets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-wwo-peds-eval-eff-sas.txt[7/5/2023 10:22:55 AM]***********************************************************************************************; ** Program Name : adsl-demo-7d-wwo-peds-eval-eff.sas **;** Date Created : 15Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adsl demo 7d peds eval eff sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 54 pages

file:///J/...5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adsl-demo-7d-peds-eval-eff-sas.txt[7/5/2023 10:22:49 AM]***********************************************************************************************; ** Program Name : adsl-demo-7d-peds-eval-eff.sas **;** Date Created : 15Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P admh sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 20 pages

file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-admh-sas.txt[7/5/2023 10:22:48 AM]***********************************************************************************************; ** Program Name : admh.sas **;** Date Created : 17Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P addv sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-addv-sas.txt[7/5/2023 10:22:49 AM]***********************************************************************************************; ** Program Name : addv.sas **;** Date Created : 17Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adds sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 7 pages

file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-sas.txt[7/5/2023 10:22:49 AM]***********************************************************************************************; ** Program Name : adds.sas **;** Date Created : 17Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adds s002 all1 ped6 sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 176 pages

file:///J/...0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adds-s002-all1-ped6-sas.txt[7/5/2023 10:23:01 AM]***********************************************************************************************; ** Program Name : adds-s002-all1-ped6.sas **;** Date Created : 15Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adcm sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 20 pages

file:///J/...5-0%20(0211)/0211/m5/datasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adcm-sas.txt[7/5/2023 10:23:02 AM]***********************************************************************************************; ** Program Name : adcm.sas **;** Date Created : 17Nov2021 **;** Programmer Name…

125742 45 S211 M5 c4591001 A 6mth P adc19ef ve cov 7pd2 p wo sg eval sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 12 pages

file:///J/...ets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-p-wo-sg-eval-sas.txt[7/5/2023 10:23:03 AM]************************************************************************************************ *****************;** Program Name : adc19ef-ve-cov-7pd2-p-wo-sg-eval.sas **;** Date Created : 17Nov2021 **; ** Programmer Name: **; ** Purpose : Create…

125742 45 S211 M5 c4591001 A 6mth P adc19ef ve cov 7pd2 p sg eval sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 12 pages

file:///J/...atasets/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-p-sg-eval-sas.txt[7/5/2023 10:22:48 AM]************************************************************************************************ *****************;** Program Name : adc19ef-ve-cov-7pd2-p-sg-eval.sas **;** Date Created : 17Nov2021 **; ** Programmer Name: **; ** Purpose : Create…

125742 45 S211 M5 c4591001 A 6mth P adc19ef ve cov 7pd2 peds wo eval sas

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 11 pages

file:///J/...ts/c4591001/analysis/adam/programs-6mth/125742-45_S211_M5_c4591001-A_6mth-P-adc19ef-ve-cov-7pd2-peds-wo-eval-sas.txt[7/5/2023 10:22:59 AM]************************************************************************************************ *****************;** Program Name : adc19ef-ve-cov-7pd2-peds-wo-eval.sas **;** Date Created : 15Nov2021 **; ** Programmer Name: **; ** Purpose : Create…