Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 86 pages
Establishment Inspection Report FEI: 1222181 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC. EI Start: 07/19 /2021 Andover, MA EI End: 07/23/2021 1 of 86 TABLE OF CONTENTS SUMMARY .............................................................................................................................. 1 ADMINISTRATIVE DATA ....................................................................................................... 2 PERSONS INTERVIEWED …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
From: Gottschalk, Laura Sent: Saturday, August 21, 2021 11:11 AM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: STN 125742/0 - Final Draft Labels: Carton and Containers Dear Ms. Harkins, We have reviewed your draft Carton and Container labels submitted in…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 1 page
From: Naik, Ramachandra <[email protected]> Sent: Saturday, August 21, 2021 5:29 PM To: Harkins Tull, Elisa <[email protected]>; Smith, Michael (CBER) <[email protected]>; Gottschalk, Laura <[email protected]> Cc: Boyce, Donna <[email protected]>; Devlin, Carmel M <[email protected]> Subject: RE: [E XTERNAL] BLA 125742/0 Status of any additional requests Dear Elisa, Thank you for sending/submitting responses to our…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 31 pages
DEPARTMENT OF HEALTH & HUMAN SERVICES Food & Drug Administrat ion Silver Spring, MD 20993 1 DBSQC/OCBQ ANALYTICAL METHOD REVIEW MEMO To: The file: STN 125742/0 From : Reviewer Date finalized Stamp Supervisor Stamp Emnet Yitbarek (Lead reviewer) 8/20/2021 Kori Francis Hsiaoling Wang 8/19/2021 Tao Pan Esmeralda Alvarado- Facundo 8/20/2021 Muhammad Shahabuddin Anil Choudhary 8/20/2021 Karla Garcia 8/20/2021 James Kenney …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 63 pages
i CM C REVIEW M EMORANDUM Date: AUGUST 2 1, 2021 To: The Biologics License Application (BLA) File STN 125742 From: Xiao Wang, OVRR/ DVP, CMC Product Reviewer Through: Anissa Cheung, OVRR/DVP Keith Peden, Lab Chief, OVRR/DVP Robin Levis, Deputy Director, OVRR/DVP Jerry Weir, Director, OVRR/DVP CC: Ramachandra Naik, Chair, OVRR/DVRPA Capt. Michael Smith, RPM, OVRR/DVRPA Laura Gottschalk, RPM, OVRR/DVRPA Applicant : BioNTech Manufacturing GmbH (in partnership with Pfizer …
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 29 pages
To: F ile STN BL 125742/0 – COVID -19 mRNA Vaccine From : Christian D. Lynch, CSO, CBER/O D/BOS Through: Lori Peters , Branch Chief, CBER/OCBQ/DMPQ /MRBI John Eltermann, Director, CBER/DMPQ Mary A. Malarkey, Director, CBER/OCBQ CC: Ramachandra Naik , Ph.D., RPM , CBER/O VRR/DVRPA/CMC3 Michael Smith, Ph.D., RPM, CBER/OVRR/DVRPA/CMC3 Laura Gottschalk, Ph.D., RPM, CBER/OVRR/DVRPA/CMC3 Kat hleen R. Jones, Ph.D., Biologist, CBER/OCBQ/DMPQ/MRBI Ek aterina Allen,…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 2 pages
From: Gottschalk, Laura < [email protected] > Sent: Wednesday, August 18, 2021 5:20 PM To: Harkins Tull, Elisa < [email protected] > Cc: Smith, Michael (CBER) < [email protected] >; Naik, Ramachandra <[email protected] >; Devlin, Carmel M <[email protected] >; Aghajani Memar, Neda < [email protected] > Subject: [EXTERNAL] STN 1 25742/0 – COMIRNATY (COVID -19 Vaccine, mRNA) - Comments regarding inclusion of draft carton…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
From: Gottschalk, Laura Sent: Saturday, August 21, 2021 10:45 AM To: Harkins Tull, Elisa <[email protected]> Cc: Devlin, Carmel M <[email protected]>; Aghajani Memar, Neda <[email protected]>; Smith, Michael (CBER) <[email protected]>; Naik, Ramachandra <[email protected]> Subject: RE: [EXTERNAL] RE: STN 125742/0: Comment regar ding vial labels Dear Elisa, We acknowledge that additional information regarding the diluent name…
Pfizer Documents (PHMPT/FDA)
· Pfizer Bla Submission
/ Pfizer 16 Plus Documents
· 3 pages
From: Naik, Ramachandra Sent: Friday, August 20, 2021 2:08 PM To: Boyce, Donna < [email protected] > Cc: Malarkey, Mary < [email protected] >; Gruber, Marion < [email protected] >; Harkins Tull, Elisa < [email protected] >; Rohlfing, Paul < [email protected] >; Aghajani Memar, Neda <[email protected] >; Smith, Michael (CBER) <[email protected] >; Gottschalk, Laura < [email protected] > Subject: RE: Lot…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Meher R Juttukonda · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $462,000 — Abstract. It has become increasingly clear that the cerebrovascular system is under assault in many individuals infected with COVID-19. In recent studies, patients with hypertension were found at a two-fold increased risk of dying from COVID-19 infection, and 100% of infected patients who received a…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
JOHN P COOKE · BOSTON UNIVERSITY MEDICAL CAMPUS · 2021 · $721,633 — ABSTRACT Determinants of COVID19-induced venous thrombosis and targeted therapy assessed with bioengineered Vein-Chip Challenge: Increasing evidence shows that SARS-CoV-2, which is the novel coronavirus that causes COVID- 19, is able to trigger the formation of blood clots within the veins of patien…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Elizabeth Gray · UNIVERSITY OF HOUSTON · 2021 · $28,747 — Abstract The increasing world-wide prevalence of obesity is a worrying public health problem and crisis. Coexistence of obesity, hypertension and diabetes significantly increases the risk of kidney dysfunction. In obesity, concentrations of angiotensin II (Ang II) increase, while those of Ang-(1-7) …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Eric D Lazartigues · SOUTHEAST LOUISIANA VETERANS HEALTH CARE · 2021 — With prevalence higher than 33% in United States, hypertension is a major risk factor contributing to cardiovascular diseases (CVD) and global mortality, hence remaining an increasingly important medical and public health issue. According to the Veterans’ Affairs (VA) Office of Research & Developmen…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Prasant Mohapatra · UNIVERSITY OF CALIFORNIA AT DAVIS · 2021 · $1,459,457 — Revised Abstract: The COVID-19 pandemic constitutes a significant challenge to health care systems in the United States and abroad. A systemic compromise of the organism following SARS-CoV-2 infection has emerged as an important factor associated with COVID-19 severity, disproportionally affecting o…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Pamela Susan Douglas · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $1,210,912 — Project Summary In response to NOT-HL-20-757, Notice of Special Interest (NOSI): Availability of Administrative Supplements and revision Supplements on Coronavirus Disease 2019 (COVID-19), and PA-18-591 Administrative Supplements for existing NIH Grants and Cooperative Agreements, the enclosed admin…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Heather Hickman · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · 2021 · $260,347 — The emergence of SARS-CoV-2 in human populations in 2019 has resulted in a global pandemic with staggering morbidity and mortality. In humans, coronavirus-induced disease 2019 (COVID-19) is characterized by decreased lung function and increased pro-inflammatory cytokine production. As the immune m…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Giovanna Tosato · DIVISION OF CLINICAL SCIENCES - NCI · 2021 · $855,728 — We have focused on 4 related areas. 1) Our previous studies have identified a critical role of Delta4 (Dll4), an endothelial-specific membrane-bound ligand for Notch1 and Notch4, as a regulator of endothelial cell function. Dll4 is selectively expressed in the developing endothelium and is required …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Liang Cao · DIVISION OF BASIC SCIENCES - NCI · 2021 · $1,530,925 — Related to the specific goals above, we conducted various studies to support biomarker driven early-stage drug development: 1. Application of new or novel biomarkers in early stage trials of highly unique therapeutic agents. A) We supported marker investigation of Dr. Andrea Apolo by investigating t…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Mark Knepper · NATIONAL HEART, LUNG, AND BLOOD INSTITUTE · 2021 · $142,521 — ---- The COVID-19 epidemic has resulted in disruption of normal laboratory activities in the Knepper lab, causing a shift of effort to computational and bioinformatic projects to maintain productivity by laboratory members. Some of this effort is focused on COVID-19 itself, leveraging our expertise …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Abraam M. Yakoub · UNIVERSITY OF NORTH DAKOTA · 2021 · $253,705 — Summary Coronavirus Disease of 2019 (COVID-19) is a US and global public health crisis. It has led to the deaths of hundreds of thousands in the US and worldwide. COVID-19 is caused by a novel beta-coronavirus (CoV) known as Severe Acute Respiratory Syndrome (SARS)-CoV-2, which was reported to cause…