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Vaccines Working Group

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Charge

Accelerate the evaluation of vaccine candidates by supporting harmonized clinical efficacy trials and a parallel effort to generate biomarkers and other evidence for more rapid approval/authorization. The working group officially completed its charge as of July 31, 2020, but continues to meet on an ad-hoc basis to provide recommendations for ongoing vaccine trials.

Objectives

Check mark indicates completion.

✓ Vaccine Clinical Trials 

The working group coordinated and contributed to the development of harmonized protocols for vaccine evaluation in Phase 3 trials, which importantly allows for the simultaneous assessment of multiple vaccine candidates and the incorporation of new vaccines as they are available. Trials informed by the harmonized protocol for current Phase 3 vaccine studies and for future vaccine candidates are listed on the ACTIV Vaccines page.

✓ Human Challenge Studies

The working group published a Perspective for the New England Journal of Medicine that assess practical considerations and prerequisites for using controlled human infection models (CHIMs), which can be used for human challenge studies, to support SARS-CoV-2 vaccine development.  They conclude that conventional randomized controlled trials involving only natural exposure to SARS-CoV-2 are the fastest and most effective path forward for establishing vaccine safety and efficacy. Parallel development of CHIMs may provide complementary tools to address additional questions such as the duration of immunity and correlates of protection, if such studies can be conducted ethically.

✓ Protective Immune Responses

At the beginning the ACTIV, it was unclear whether there would be sufficient disease incidence in the second half of 2020 to enable expeditious clinical evaluation of vaccine efficacy. To prepare for that contingency, the working group discussed potential interim data packages before Phase 3 efficacy results to enable possible authorization/approval through mechanisms like FDA accelerated approval or Emergency Use Authorization. During the course of the program it became clear that incidence rates in some regions of the world have remained high, enabling relatively rapid clinical evaluation of efficacy. The working group also has contributed to plans for analyses of correlates of protection to enable the approval of future vaccines based on biomarker established through efficacy trials.

Vaccine-Associated Immune Enhancement

The working group has submitted a scientific paper for publication that provides an informed perspective on the historical experience with vaccine-associated enhanced disease (through immunopathologies and antibody-dependent enhancement) and the question of potential vaccine-associated enhanced disease in COVID-19 vaccine development.  

Members

Paula Annunziato, M.D.
Vice President and Therapeutic Area Head, Vaccines Clinical Research
Merck & Co., Inc.

Ann Arvin, M.D.
Lucile Salter Packard Professor of Pediatrics and Professor of Microbiology and Immunology
Stanford University School of Medicine

Beth Bell, M.D.
Clinical Professor, Global Health
University of Washington

Susan Buchbinder, M.D.
Clinical Professor of Medicine, University of California, San Francisco
Director of HIV Prevention Research, San Francisco Department of Public Health

Marco Cavaleri, Ph.D.
Head, Biological Health Threats and Vaccines Strategy
European Medicines Agency

Lawrence Corey, M.D.
Professor, Departments of Laboratory Medicine & Medicine
Member, Division of Vaccine & Infectious Disease (VIDD), Clinical Research, & Public Health Sciences
President & Director Emeritus
Fred Hutchinson Cancer Research Center

Mark Davis, Ph.D.
Professor, Microbiology and Immunology
Director, Stanford Institute for Immunology, Transplantation and Infection
Stanford University School of Medicine

Emilio Emini, Ph.D.
Director, TB & HIV Program
Bill & Melinda Gates Foundation

Gregory Glenn, M.D.
Chief Scientific Officer
Novavax, Inc.

Emmanuel Hanon, Ph.D.
Senior Vice President of Vaccines Research and Development
GlaxoSmithKline

Barton Haynes, M.D.
Frederic M. Hanes Distinguished Professor of Medicine
Director, Duke Human Vaccine Institute
Duke University

Peter Hotez, M.D., Ph.D.
Dean, National School of Tropical Medicine
Baylor College of Medicine
Director, Center for Vaccine Development
Texas Children’s Hospital

Kathrin Jansen, Ph.D. (Co-Chair)
Senior Vice President and Head of Vaccine Research and Development
Pfizer

Antonio Lanzavecchia, M.D.
Senior Vice President and Senior Research Fellow
Vir Biotechnology, Inc.
Director, Institute for Research in Biomedicine, Bellinzona, Switzerland

Douglas Lowy, M.D. (Co-Chair)
Principal Deputy Director
National Cancer Institute, NIH

Peter Marks, M.D., Ph.D.
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

John Mascola, M.D.
Director, Dale and Betty Bumpers Vaccine Research Center
National Institute of Allergy and Infectious Diseases, NIH

Nancy Messonnier, M.D.
Director, Center for the National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention

Nelson Michael, M.D., Ph.D.
Director, Center for Infectious Diseases Research
Walter Reed Army Institute of Research, U.S. Army Medical Research and Development Command

Paul Offit, M.D.
Director, Vaccine Education Center
Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania
Professor, Children’s Hospital of Philadelphia

Hanneke Schuitemaker, Ph.D.
Global Head of Viral Vaccine Discovery and Translational Medicine
Johnson & Johnson
Professor in Virology at the Amsterdam University Medical Center of the University of Amsterdam

Jonathan Seals, Ph.D.
Director, Strategic Science and Technology
Biomedical Advanced Research and Development Authority, HHS

Jim Tartaglia, Ph.D.
Vice President for Research and Development
Sanofi Pasteur

Tonya Villafana, M.P.H., Ph.D.
Vice President, Global Franchise Head, Infection
AstraZeneca

Tal Zaks, M.D., Ph.D.
Chief Medical Officer
Moderna, Inc.

This page last reviewed on September 11, 2020