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Vaccines and Related Biological Products Advisory Committee 162Nd Meeting

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Vaccines and Related Biological Products Advisory Committee 162Nd Meeting Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 MEMBERS Chair Acting Chair Hana El Sahly, M.D. + Arnold Monto, M.D. Expertise: Vaccines, Infectious Diseases Thomas Francis Jr. Collegiate Professor Term: 06/21/2019 – 01/31/2022 of Public Health Associate Professor Professor of Epidemiology Department of Molecular Virology and Department of Epidemiology Microbiology University of Michigan Department of Medicine School of Public Health Section of Infectious Diseases Ann Arbor, MI 48109 Baylor College of Medicine Houston, TX 77030 Hayley Gans, M.D. Expertise: Pediatrics, Infectious Diseases Paula Annunziato, M.D. *** Term: 06/21/2019 – 01/31/2023 Expertise: Industry Representative Professor of Pediatrics Term: 2/01/2020 – 01/31/2024 Department of Pediatrics Vice President and Therapeutic Area Head Stanford University Medical Center Vaccines Clinical Research Stanford, CA 94305 Merck North Wales, PA 19454 Holly Janes, Ph.D. + Expertise: Biostatistics Archana Chatterjee, M.D., Ph.D. Term: 02/01/2020 – 01/31/2023 Expertise: Pediatrics, Infectious Diseases Associate Member Term: 06/21/2019 – 01/31/2023 Fred Hutchinson Cancer Research Center Dean Chicago Medical School Vaccine and Infectious Disease Division Vice President for Medical Affairs Division of Public Health Sciences Rosalind Franklin University Seattle, WA 98109 North Chicago, IL 60064 CAPT Amanda Cohn, M.D. Expertise: Pediatrics, Vaccines Term: 02/01/2020 – 01/31/2024 Chief Medical Officer + Not Attending National Center for Immunizations and **Consumer Representative Respiratory Diseases ***Industry Representative Centers for Disease Control and Prevention < Alternate Industry Representative Atlanta, GA 30333 ^ Via Teleconference Page 1 of 7 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 MEMBERS (Cont’d) Michael Kurilla, M.D., Ph.D. Steven Pergam, M.D., M.P.H. Expertise: Infectious Diseases, Pathology Expertise: Infectious Diseases Term: 08/6/2018 – 01/31/2021 Term: 02/01/2020 – 01/31/2024 Director, Division of Clinical Innovation Medical Director National Center for Advancing Translation Infection Prevention Sciences Seattle Cancer Care Alliance National Institutes of Health Seattle, WA 98109 Bethesda, MD 20852 Andrea Shane, M.D., M.P.H., M.Sc. + Myron Levine, M.D., D.T.P.H., F.A.A.P + Expertise: Pediatric & Infectious Diseases Expertise: Infectious Diseases Term: 02/01/2018 – 01/31/2022 Term: 05/9/2018 – 01/31/2022 Chief, Division of Pediatric Infectious Simon & Bessie Grollman Distinguished Diseases Professor Marcus Professor of Hospital Epidemiology Associate Dean for Global Health, and Infection Control Vaccinology & Infectious Diseases Emory University School of Medicine & University of Maryland School of Medicine Children’s Healthcare of Atlanta Baltimore, MD 21201 Atlanta, GA 30322 H. Cody Meissner, M.D. Paul Spearman, M.D. + Expertise: Infectious Diseases Expertise: Pediatric & Infectious Diseases Term: 08/6/2018 – 1/31/2022 Term: 05/9/2018 – 01/31/2022 Professor of Pediatrics Director, Division of Infectious Diseases Tufts University School of Medicine Albert B. Sabin Chair in Pediatric Director, Pediatric Infectious Disease Infectious Diseases Tufts Medical Center Cincinnati Children’s Hospital Boston, MA 02111 Medical Center Professor, Department of Pediatrics Paul Offit, M.D. University of Cincinnati School Expertise: Infectious Diseases of Medicine Term: 02/01/2018 – 01/31/2022 Cincinnati, OH 45229 Professor of Pediatrics Division of Infectious Diseases Abramson Research Building The Children’s Hospital of Philadelphia Philadelphia, PA 19104 Page 2 of 7 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 MEMBERS (Cont’d) Geeta K. Swamy, M.D. + Sheldon Toubman, J.D. ** Expertise: Infectious Diseases Expertise: Law/Consumer Representative Term: 08/6/2018 – 01/31/2022 Term: 08/22/2017 – 01/31/2021 Senior Associate Dean Staff Attorney Vice Chair for Research & Faculty New Haven Legal Assistance Association Development New Haven, CT 06510 Associate Professor Department of Obstetrics & Gynecology Division of Maternal-Fetal Medicine Duke University Durham, NC 27710 Gregg Sylvester, M.D., M.P.H. < + Expertise: Alternate Industry Representative Term: 2/01/2020 – 01/31/2024 Vice President Medical Affairs Seqirus Inc. Summit, NJ 07901 TEMPORARY VOTING MEMBERS A. Oveta Fuller, Ph.D. James Hildreth, Sr., Ph.D., M.D. African Studies Center Professor International Institute Department of Internal Medicine Associate Professor of Microbiology School of Medicine and Immunology, Medical School President and Chief Executive Officer University of Michigan Meharry Medical College Ann Arbor, MI 48109 Nashville, TN 37205 Juan Gea-Banacloche, M.D. Professor of Medicine Senior Associate Consultant Division of Infectious Diseases Mayo Clinic Phoenix, AZ 85054 Page 3 of 7 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 TEMPORARY VOTING MEMBERS (Cont’d) David Kim, M.D., MA Patrick Moore, M.D., M.P.H. CAPT, U.S. Public Health Services Distinguished and American Cancer Director, Division of Vaccines Society Professor Office of Infectious Disease and Pittsburgh Foundation Chair HIV/AIDS Policy in Innovative Cancer Research Office of Assistant Secretary for Health University of Pittsburgh Cancer Institute U.S. Department of Health and Pittsburgh, PA 15213 Human Services Washington, DC 20024 Stanley Perlman, M.D., Ph.D. Professor Jeannette Lee, Ph.D. Departments of Microbiology and Professor Immunology Department of Biostatistics Professor of Pediatrics University of Arkansas for Medical Sciences Mark Stinksi Chair in Virology Little Rock, AR 72701 University of Iowa Iowa City, IA 52242 Ofe r Levy, M.D., Ph.D. Staff Physician & Principal Investigator Eric Rubin, M.D., Ph.D. Director, Precision Vaccines Program Editor-in-Chief Division of Infectious Diseases New England Journal of Medicine Boston Children’s Hospital Adjunct Professor Professor, Harvard Medical School Department of Immunology and Associate Member Infectious Diseases Broad Institute Harvard TH Chan School of Public Health Massachusetts Institute of Technology Associate Physician Cambridge, MA 02140 Brigham and Women’s Hospital Boston, MA 02115 Pamela McInnes, DDS, MSc. Retired, Deputy Director National Center for Advancing Translational Sciences National Institutes of Health Bethesda, MD 20892 Page 4 of 7 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 TEMPORARY VOTING MEMBERS (Cont’d) Mark Sawyer, M.D., F.A.A.P. Ralph Tripp, Ph.D. Professor of Clinical Pediatrics Professor, Department of Infectious Diseases Division of Infectious Diseases Department of Infectious Diseases Vice Chair for Education Member, Biomedical & Health Department of Pediatrics Sciences Institute University of California San Diego University of Georgia School of Medicine Athens, GA 30602 Director, UC San Diego Pediatrics Residency Program Melinda Wharton, M.D., M.P.H. Rady Children’s Hospital San Diego Director, Immunizat ion Services Division La Jolla, CA 92093 National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Atlanta, GA 30333 SPEAKER(S) AND GUEST SPEAKER(S) Steven Goodman, M.D., Ph.D. Nancy Messonnier, M.D. Professor of Medicine Director Associate Dean for Clinical and National Center for Immunization and Translational Research Respiratory Diseases Professor of Epidemiology and Population Deputy Director for Infectious Diseases Health, and Medicine Centers for Disease Control and Prevention Stanford, University Atlanta, GA 30333 Stanford, CA 94305 Anita Patel, PharmD, MS Aron Hall, DVM, MSPH, Dipl ACVPM Senior Adviser and Lead for Pandemic Chief, Respiratory Viruses Branch Medical Care and Countermeasures Division of Viral Diseases Influenza Coordination Unit National Center for Immunization and Centers for Disease Control and Prevention Respiratory Diseases Atlanta, GA 30333 Centers for Disease Control and Prevention Atlanta, GA 30333 Page 5 of 7 Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 FDA PARTICIPANTS/SPEAKERS Doran Fink, M.D., Ph.D. CDR Valerie Marshall, M.P.H., P.M.P. Deputy Director Senior Public Health Advisor Division of Vaccines and Related Division of Viral Products Products Applications Immediate Office of the Director Office of Vaccines Research and Review Office of Vaccines Research and Review Center for Biologics Evaluation and Research Center for Biologics Evaluation and Research Food and Drug Administration Food and Drug Administration Silver Spring, MD 20993 Silver Spring, MD 20993 Marion Grube r, Ph.D. Je rry We ir, Ph.D. Director Director, Division of Viral Products Office of Vaccines Research and Review Office of
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