Chicago Scientific COVID-19 Vaccine Work Group

Chicago Scientific COVID-19 Vaccine Work Group

This work group will independently evaluate whether or not the proper scientific and regulatory review has taken place prior to approval by the FDA for use of Pfizer's and Moderna's vaccines under Emergency Use Authorization (EUA). Work group members have nationally recognized expertise in areas including vaccines, infectious diseases, clinical trials, statistics, regulatory affairs, and public health.

The work group met on December 21 and, after reviewing numerous materials posted on the FDA website, concluded that the FDA’s evaluation of Moderna's clinical trial data was rigorous, and the decision-making process for issuing the EUA for the Moderna vaccine was transparent and sound. The FDA’s decision to issue an EUA for the Moderna COVID-19 vaccine was grounded in science, with careful consideration of currently known benefits and risks, in the setting of a public health emergency. Accelerated vaccine development and approval did not sacrifice scientific standards or the integrity of the FDA evaluation process. Read the full Work Group Report: December 21, 2020.

The work group met on December 13 and, after reviewing numerous materials posted on the FDA website, concluded that the FDA’s evaluation of Pfizer’s clinical trial data was rigorous, and the decision-making process for issuing the EUA for the Pfizer-BioNTech vaccine was transparent and sound. The FDA’s decision to issue an EUA for the Pfizer-BioNTech COVID-19 vaccine was grounded in science, with careful consideration of currently known benefits and risks, in the setting of a public health emergency. Accelerated vaccine development and approval did not sacrifice scientific standards or the integrity of the FDA evaluation process. Read the full Work Group Report: December 13, 2020.

Work Group Members

Anup Malani, PhD, JD
Lee and Brena Freeman Professor, University of Chicago Law School

Eve Shapiro, MPH
Director of Data and Evaluation, West Side United

Elizabeth Aquino, PhD, RN
Associate Professor, DePaul University School of Nursing

Daniel Johnson, MD
Professor of Pediatrics, University of Chicago Medicine/Comer Children’s Hospital Department of Pediatrics

Kelly Michelson, MD, MPH
Attending Physician, Ann & Robert H. Lurie Children's Hospital of Chicago
Professor of Pediatrics and Julia and David Uihlein Professor of Bioethics and Medical Humanities, Northwestern University Feinberg School of Medicine

Robert A. Weinstein, M.D.
The C. Anderson Hedberg MD, Professor of Internal Medicine, Rush University Medical Center
Chairman Emeritus, Department of Medicine, Cook County Hospital

Yuan Ji, PhD
Professor of Biostatistics, Department of Public Health Sciences, The University of Chicago

Charlesnika T. Evans
Professor of Preventive Medicine, Northwestern University

Ann Muñana, MSN, MJ, RN
Senior Manager, State Licensing and Regulation, Chamberlain University

Larry Goodman
President Emeritus, Rush University 
Retired CEO, Rush University Medical Center and the Rush University System for Health

Latania K. Logan, MD, MSPH
Associate Professor of Pediatric Infectious Diseases, Rush University Medical Center, Rush Medical College

Stephanie Y. Crawford, PhD, MPH
Professor, Department of Pharmacy Systems, Outcomes and Policy
Executive Associate Dean for Faculty Affairs and Strategic Initiatives, University of Illinois at Chicago College of Pharmacy

Wayne H. Giles, MD, MS
Dean, UIC School of Public Health

Phoenix A. Matthews, Ph.D.
Professor and Associate Dean for Equity and Inclusion, University of Illinois at Chicago, College of Nursing

Horace E Smith, MD
Assistant Professor of Pediatrics (Hematology, Oncology, and Stem Cell Transplantation, Ann & Robert H. Lurie Children’s Hospital of Chicago, 
Northwestern University Feinberg School of Medicine

Sonali M. Smith, MD
Elwood V. Jensen Professor in Medicine, Chief, Section of Hematology/Oncology, Director, Lymphoma Program, University of Chicago Medicine

William Wong, MD, MPH, FACP
Occupational Medicine Physician, Corporate Health, Northwestern Medicine.
Health System Clinician, Northwestern University Feinberg School of Medicine.