December 17, 2020 | Clip Of Food and Drug Administration Open Meeting on Moderna COVID-19 Vaccine, Part 1 This clip, title, and description were not created by C-SPAN.

User Clip: Marie Garlock, PhD - USA Patient Network

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by writetomarie
December 17, 2020

Health justice accountability in COVID-19 vaccine approvals: 1. "To control COVID-19, keep control groups going" -- commit to phase 4 trials… read more

Health justice accountability in COVID-19 vaccine approvals: 1. "To control COVID-19, keep control groups going" -- commit to phase 4 trials after EUA. 2. "Nuance needed on numbers" -- clinical trial diversity & retainment is urgent after EUA. 3. "Integrity requires infrastructure" -- adverse event reporting must be streamlined, accessible, 24/7 phone hotline to support patients & clinicians w/ info & adverse event follow up. 4. "Action means action" -- FDA must ensure good manufacturing practice for all COVID-19 vaccines, empower Team Biologics to enforce safe manufacturing & promote public trust.

Slides + USAPN Letter: bit.ly/USAPN-moderna close

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Lindsey Baden M.D. Physician Brigham and Women's Hospital->Infectious Disease
Amanda Cohn Executive Secretary Advisory Committee on Immunization Practices

Marion Gruber Director U.S. Food and Drug Administration->Office of Vaccine Research and Review
James Hildreth M.D. President and CEO Meharry Medical College
Jeannette Lee Professor University of Arkansas->Biostatistics
David Martin M.D. Vice President Moderna->Pharmacovigilance
Jacqueline Miller M.D. Senior Vice President Moderna->Infectious Disease Therapeutics
Melissa Moore M.D. Chief Scientific Officer Moderna->Platform Research
James Neaton Professor University of Minnesota->Biostatistics
Robert Schooley M.D. Professor University of California, San Diego->School of Medicine
Gregg Sylvester M.D. Chief Medical Officer Seqirus->Medical Affairs
Tal Zaks M.D. Chief Medical Officer Moderna
Prabhakara Atreya Director U.S. Food and Drug Administration->Scientific Advisers and Consultants
Archana Chatterjee Senior Associate Dean University of South Dakota->Medical School
Doran Fink Deputy Director U.S. Food and Drug Administration->Vaccines and Related Biological Products Advisory Committee
Oveta Fuller Professor University of Michigan Medical School
Hayley Gans Professor Stanford University->Pediatric Infectious Diseases
Steven Goodman Professor Stanford University->Epidemiology and Health
Mike Kaczynski Project Manager U.S. Food and Drug Administration
David Kim Director Centers for Disease Control and Prevention->Immunization Division
Michael Kurilla Director National Institutes of Health->Division of Clinical Innovation
Peter W. Marks M.D. Director U.S. Food and Drug Administration->Center for Biologics Evaluation and Research
Pamela McInnes Director National Institutes of Health->National Center for Advancing Translational Sciences
Cody Meissner Professor Tufts University->Infectious Diseases
Arnold Monto Professor University of Michigan->Epidemiology
Patrick Moore Professor University of Pittsburgh->Cancer Institute
Paul Offit M.D. Chief Children's Hospital of Philadelphia->Division of Infectious Diseases
Steven Pergam Professor Fred Hutchinson Cancer Research Center
Stanley Perlman M.D. Professor University of Iowa->Immunology
Eric Rubin M.D. Editor in Chief New England Journal of Medicine
Mark Sawyer M.D. Specialist Rady Children's Hospital->Infectious Diseases
Sheldon Toubman Assistant Attorney New Haven Legal Assistance
Melinda Wharton Director Centers for Disease Control and Prevention->Immunization Division