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 You are here Home Research & Training Medical Research Initiatives ACTIV
 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
 ACTIV
    
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Contact Us Vaccines Working Group On this page Charge
		Objectives
		Members
 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 of 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 published a manuscript in *Science Translational Medicine* 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. ✓ Impact of Vaccines on Transmission The Phase 3 vaccine efficacy trials primarily assessed the impact of vaccination on prevention of symptomatic COVID-19 disease, and secondarily measured an indicator of SARS-CoV-2 infection. The working group evaluated proposed study designs to directly evaluate the impact of vaccination on infection and transmission of SARS-CoV-2 infection by vaccinated participants and advised on plans to advance these studies. Correlates of Protection The working group identified the important role of correlates of protection in accelerating the evaluation of vaccine efficacy in populations outside those that participated in efficacy trials and of future vaccine candidates in the context of authorized or approved vaccines. Proposed approaches for correlates analyses were reviewed and studies are ongoing and are expected to also provide insights into vaccine efficacy against viral variants. 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
 **Gary Dubin, M.D.**
			Head, Global Medical Office
			Takeda Pharmaceutical Co. Ltd.
 **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 April 8, 2021
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