Accelerating COVID-19 Therapeutic Interventions and Vaccines
Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership created to develop a coordinated research strategy for prioritizing and speeding up development of COVID-19 vaccines and pharmaceutical products. ACTIV is led by the Foundation for the National Institutes of Health (FNIH).[1]
History
ACTIV was announced by the National Institutes of Health on April 17, 2020.[1:1]
Starting in June 2020, Robert Malone has been an invited participant of the ACTIV Therapeutics Clinical Working Group.[2]
On June 8, 2021, the ACTIV-6 study began examining repurposed drugs to treat COVID-19. The four drugs included in the study are ivermectin, fluvoxamine, fluticasone and montelukast.[3]
Participants
ACTIV is a collaboration between a number of agencies, corporations and non-profit organizations:[1:2]
- AbbVie
- Amgen
- AstraZeneca
- Bill & Melinda Gates Foundation
- Biomedical Advanced Research and Development Authority (BARDA)
- Bristol-Myers Squibb
- Centers for Disease Control and Prevention (CDC)
- Dewpoint Therapeutics
- Eisai
- Eli Lilly
- European Medicines Agency (EMA)
- Food and Drug Administration (FDA)
- Foundation for the National Institutes of Health (FNIH)
- Fred Hutchinson Cancer Center
- Genentech
- Gilead Sciences
- GlaxoSmithKline (GSK)
- HHS-DOD COVID-19 Countermeasures Acceleration Group (CAG) (formerly Operation Warp Speed)
- Johnson & Johnson
- Merck
- Moderna
- National Institutes of Health (NIH)
- Novartis
- Novavax
- Pfizer
- Rhythm Therapeutics
- Roche
- RTI International
- Sanofi
- Takeda Pharmaceuticals
- United States Department of Defense (DOD)
- United States Department of Veterans Affairs (VA)
- Vir Biotechnology
Executive Committee
The ACTIV Executive Committee is made up of representatives from various agencies of the U.S. government and pharmaceutical companies.[4]
| Name | Organization | Role |
|---|---|---|
| Larry Tabak | National Institutes of Health (NIH) | Co-Chair |
| William Pao | Roche | Co-Chair |
| Gary Disbrow | Biomedical Advanced Research and Development Authority (BARDA) | Member |
| Mikael Dolsten | Pfizer | Member |
| Anthony Fauci | National Institute of Allergy and Infectious Diseases (NIAID) | Member |
| Gary Gibbons | National Institutes of Health (NIH) | Member |
| Peter Marks | Food and Drug Administration (FDA) | Member |
| Gary Dubin | Takeda Pharmaceuticals | Member |
| Janet Woodcock | Food and Drug Administration (FDA) | Member |
Preclinical Working Group
ACTIV's pre-clinical working group includes:[5]
| Name | Organization | Role |
|---|---|---|
| Christine Colvis | National Center for Advancing Translational Sciences | Co-Chair |
| John Young | Roche | Member |
| Peter Adams | United States Department of Health of Human Services | Member |
| Annaliesa Anderson | Pfizer | Member |
| James Anderson | National Institutes of Health | Member |
| Ralph Baric | University of North Carolina at Chapel Hill | Member |
| Kara Carter | Dewpoint Therapeutics | Member |
| Marc Charette | National Heart, Lung, and Blood Institute | Member |
| Tomas Cihlar | Gilead Sciences | Member |
| Michael Diamond | Washington University School of Medicine in St. Louis | Member |
| Ken Duncan | Bill & Melinda Gates Foundation | Member |
| Prabhavathi Fernandes | National Biodefense Science Board | Member |
| Joshua Fessel | National Heart, Lung, and Blood Institute | Member |
| Clint Florence | National Institute of Allergy and Infectious Diseases | Member |
| Greg Gatto | RTI International | Member |
| Jay Grobler | Merck | Member |
| Nancy Haigwood | Oregon National Primate Research Center; Oregon Health & Science University | Member |
| Judith Hewitt | National Institute of Allergy and Infectious Diseases | Member |
| Sheri Hild | National Institutes of Health | Member |
| Samantha Jonson | National Center for Advancing Translational Sciences | Member |
| Isis Kanevsky | Pfizer | Member |
| Kent Lloyd | University of California, Davis | Member |
| Joanne Lumsden | National Center for Advancing Translational Sciences | Member |
| Cat Lutz | Jackson Laboratory | Member |
| Stephen Mason | Pfizer | Member |
| Frank Nestle | Sanofi | Member |
| Elizabeth Ottinger | National Center for Advancing Translational Sciences | Member |
| David Payne | GlaxoSmithKline | Member |
| Louise Pitt | United States Army Medical Research Institute of Infectious Diseases | Member |
| Antonello Punturieri | National Heart, Lung, and Blood Institute | Member |
| Srinivas Rao | Sanofi | Member |
| Jay Rappaport | Tulane National Primate Research Center | Member |
| Roland Zahn | Janssen | Member |
Therapeutics Clinical Working Group
Members of the ACTIV Therapeutics Clinical Working Group include:[6]
| Name | Organization | Position |
|---|---|---|
| Ruxandra Draghia-Akli | Janssen | Co-Chair |
| Sarah Read | National Institute of Allergy and Infectious Diseases | Co-Chair |
| Neil Aggarwal | National Heart, Lung, and Blood Institute | Member |
| John Beigel | National Institute of Allergy and Infectious Diseases | Member |
| Samuel Bozzette | National Center for Advancing Translational Sciences | Member |
| Jeremy Brown | National Institute of Neurological Disorders and Stroke | Member |
| Tim Buchman | Division of Research, Innovation and Ventures (DRIVe), Biomedical Advanced Research and Development Authority (BARDA) | Member |
| Timothy Burgess | Uniformed Services University of the Health Sciences | Member |
| Joan Butterton | Merck | Member |
| Sylva Collins | Office of Biostatistics, Food and Drug Administration | Member |
| Judith Currier | University of California, Los Angeles, AIDS Clinical Trial Group | Member |
| Angelo DeClaro | Center for Drug Evaluation and Research | Member |
| Mark Eisner | Genentech | Member |
| John Farley | Office of Infectious Diseases, Food and Drug Administration | Member |
| Joshua Fessel | National Heart, Lung, and Blood Institute | Member |
| Carl Garner | Eli Lilly | Member |
| David Goff | National Heart, Lung, and Blood Institute | Member |
| Keith Gottesdiener | Rhythm Pharmaceuticals | Member |
| Elizabeth Higgs | National Institute of Allergy and Infectious Diseases | Member |
| David Hone | Defense Threat Reduction Agency | Member |
| W. Keith Hoots | National Heart, Lung, and Blood Institute | Member |
| Andrei Kindzelski | National Heart, Lung, and Blood Institute | Member |
| Jacqueline Kirchner | Bill and Melinda Gates Foundation | Member |
| Walter Koroshetz | National Institute of Neurological Disorders and Stroke | Member |
| Lisa LaVange | University of North Carolina Gillings School of Global Public Health | Member |
| Elliot Levy | Amgen | Member |
| Joanne Lumsden | National Center for Advancing Translational Sciences | Member |
| Hilary Marston | National Institute of Allergy and Infectious Diseases | Member |
| John Mellors | University of Pittsburgh School of Medicine | Member |
| Sandeep Menon | Pfizer | Member |
| Naimish Patel | Sanofi | Member |
| Amy Patterson | National Heart, Lung, and Blood Institute | Member |
| Amanda Peppercorn | GlaxoSmithKline | Member |
| Martha Petrovick | MIT Lincoln Laboratory | Member |
| L. Revell Phillips | Joint Science and Technology Office for Chemical and Biological Defense | Member |
| Mike Poole | COVID-19 Therapeutics Accelerator | Member |
| Michael Proschan | National Institute of Allergy and Infectious Diseases | Member |
| Lora Reineck | National Heart, Lung, and Blood Institute | Member |
| Ronald Reisler | Davis Defense Group, Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense | Member |
| Yves Rosenberg | National Heart, Lung, and Blood Institute | Member |
| Daniel Rubin | Center for Drug Evaluation and Research, Food and Drug Administration | Member |
| Pamela Tenaerts | Clinical Trial Transformation Initiative, Duke Clinical Research Institute | Member |
| Peter Stein | Office of New Drugs, Center for Drug Evaluation and Research | Member |
| Christine Sizemore | Division of International Relations, Fogarty International Center | Member |
| Peter Wung | Sanofi | Member |
| Robert Malone | RW Malone MD, LLC | Invited Participant[2:1] |
Clinical Trial Capacity Working Group
The ACTIV Clinical Trial Capacity Working Group includes:[7]
| Name | Organization | Role |
|---|---|---|
| Elizabeth Desrosiers | Merck | Co-Chair |
| Michael Kurilla | National Center for Advancing Translational Sciences | Co-Chair |
| Lionel Bascles | Sanofi | Member |
| Myron Cohen | Institute for Global Health and Infectious Diseases | Member |
| Lawrence Corey | Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center | Member |
| Victoria Davey | United States Department of Veterans Affairs | Member |
| James Dickens | Office of Rare Diseases Research, National Center for Advancing Translational Sciences | Member |
| Jim Doroshow | National Cancer Institute | Member |
| Carlos Garner | Eli Lilly | Member |
| David Goff | National Heart, Lung, and Blood Institute | Member |
| Penny Heaton | Bill & Melinda Gates Medical Research Institute | Member |
| George Mensah | Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute | Member |
| Seema Nayak | National Institute of Allergy and Infectious Diseases | Member |
| Manizhe Payton | National Institute of Allergy and Infectious Diseases | Member |
| Laura Resnansky | Genentech | Member |
| Christine Sizemore | Fogarty International Center | Member |
| Badhri Srinivasan | Novartis | Member |
| Peter Stein | Food and Drug Administration | Member |
| Therese Takas | AstraZeneca | Member |
| Mike Vincent | Pfizer | Member |
| Gail Weinmann | National Heart, Lung, and Blood Institute | Member |
Vaccines Working Group
The ACTIV Vaccines Working Group includes:[8]
| Name | Organization | Role |
|---|---|---|
| Kathrin Jansen | Pfizer | Co-Chair |
| Douglas Lowy | National Cancer Institute | Co-Chair |
| Paula Annunziato | Merck | Member |
| Ann Arvin | Stanford University School of Medicine | Member |
| Beth Bell | University of Washington | Member |
| Susan Buchbinder | University of California, San Francisco, San Francisco Department of Public Health | Member |
| Marco Cavaleri | European Medicines Agency | Member |
| Lawrence Corey | Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center | Member |
| Mark Davis | Stanford Institute for Immunology, Transplantation and Infection | Member |
| Gary Dubin | Takeda Pharmaceuticals | Member |
| Emilio Emini | Bill & Melinda Gates Foundation | Member |
| Gregory Glenn | Novavax | Member |
| Emmanuel Hanon | GlaxoSmithKline | Member |
| Barton Haynes | Duke Human Vaccine Institute | Member |
| Peter Hotez | National School of Tropical Medicine, Texas Children’s Hospital Center for Vaccine Development | Member |
| Antonio Lanzavecchia | Vir Biotechnology, Institute for Research in Biomedicine | Member |
| Peter Marks | Center for Biologics Evaluation and Research, Food and Drug Administration | Member |
| John Mascola | Dale and Betty Bumpers Vaccine Research Center | Member |
| Nancy Messonnier | National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention | Member |
| Nelson Michael | Center for Infectious Disease Research | Member |
| Paul Offit | Vaccine Education Center, Perelman School of Medicine, Children’s Hospital of Philadelphia | Member |
| Hanneke Schuitemaker | Johnson & Johnson, Amsterdam University Medical Center | Member |
| Jonathan Seals | Biomedical Advanced Research and Development Authority (BARDA) | Member |
| Jim Tartaglia | Sanofi Pasteur | Member |
| Tonya Villafana | AstraZeneca | Member |
| Tal Zaks | Moderna | Member |
TRACE Working Group
The TRACE Working Group includes:[9]
| Name | Organization | Role |
|---|---|---|
| Christine Colvis | National Center for Advancing Translational Sciences | Co-Chair |
| John Young | Roche | Co-Chair |
| Michael Abram | AstraZeneca | Member |
| Andrew Charles Adams | Eli Lilly | Member |
| James Anderson | Division of Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health | Member |
| Matthew Arnegard | Office of Research Infrastructure Programs, National Institutes of Health | Member |
| Ralph Baric | University of North Carolina at Chapel Hill | Member |
| Dipanwita Basu | Small Business Innovation Research and Small Business Technology Transfer, National Institutes of Health | Member |
| Lisa Bentley | Biomedical Advanced Research and Development Authority (BARDA) | Member |
| David Blazes | Bill & Melinda Gates Foundation | Member |
| Kyle Brimacombe | National Center for Advancing Translational Sciences | Member |
| Rodney Brister | National Center for Biotechnology Information | Member |
| Liliana Brown | National Institute of Allergy and Infectious Diseases | Member |
| Patricia Brown-Augsburger | Eli Lilly | Member |
| Paula Bryant | National Institute of Allergy and Infectious Diseases | Member |
| Rhonda Cardin | Pfizer | Member |
| Kara Carter | Dewpoint Therapeutics | Member |
| Cristina Cassetti | National Institute of Allergy and Infectious Diseases | Member |
| Patrick Chain | Los Alamos National Laboratory | Member |
| Marc Charette | National Heart, Lung, and Blood Institute | Member |
| Tomas Cihlar | Gilead Sciences | Member |
| Ryan Connor | National Center for Biotechnology Information, National Library of Medicine | Member |
| Michael Diamond | Washington University in St. Louis | Member |
| Groves Dixon | Moderna | Member |
| Philip Dormitzer | Pfizer | Member |
| Ken Duncan | Bill & Melinda Gates Foundation | Member |
| Ann Eakin | National Institute of Allergy and Infectious Diseases | Member |
| Richard Eastman | National Center for Advancing Translational Sciences | Member |
| Philip Ebert | Eli Lilly | Member |
| Darin Edwards | Moderna | Member |
| Emily Erbelding | National Institute of Allergy and Infectious Diseases | Member |
| Karl Erlandson | Biomedical Advanced Research and Development Authority (BARDA) | Member |
| Mark Esser | AstraZeneca | Member |
| Lydia Fleischmann | National Center for Biotechnology Information, National Library of Medicine | Member |
| Clint Florence | National Institute of Allergy and Infectious Diseases | Member |
| Barney Graham | Dale and Betty Bumpers Vaccine Research Center, National Institute of Allergy and Infectious Diseases | Member |
| Jay Grobler | Merck | Member |
| Rajesh Gupta | Vir Biotechnology | Member |
| Nancy Haigwood | Oregon National Primate Research Center | Member |
| Matthew Hall | National Center for Advancing Translational Sciences | Member |
| Christy Hebner | Vir Biotechnology | Member |
| Judith Hewitt | National Institute of Allergy and Infectious Diseases | Member |
| Lorraine Horgan | Brii Biosciences | Member |
| Bin Hu | Los Alamos National Laboratory | Member |
| Bolyn Hubby | Vir Biotechnology | Member |
| Kathrin Jansen | Pfizer | Member |
| Daniel Jernigan | National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention | Member |
| Samantha Jonson | National Center for Advancing Translational Sciences | Member |
| Nicole Kallewaard | Eli Lilly | Member |
| Isis Kanevsky | Pfizer | Member |
| Jacqueline Kirchner | Bill & Melinda Gates Foundation | Member |
| Bette Korber | Los Alamos National Laboratory | Member |
| Emily Lee | National Center for Advancing Translational Sciences | Member |
| Jiani Li | Gilead Sciences | Member |
| Po-E Li | Los Alamos National Laboratory | Member |
| Kent Lloyd | University of California Davis School of Medicine | Member |
| Chien-Chi Lo | Los Alamos National Laboratory | Member |
| Yueh-Ming Loo | AstraZeneca | Member |
| Cat Lutz | Jackson Laboratory | Member |
| Duncan MacCannell | National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention | Member |
| Aron Marchler-Bauer | National Center for Biotechnology Information, National Library of Medicine | Member |
| David Margolis | Brii Biosciences | Member |
| Ross Martin | Gilead Sciences | Member |
| John Misasi | Dale and Betty Bumpers Vaccine Research Center, National Institute of Allergy and Infectious Diseases | Member |
| Ajay Nirula | Eli Lilly | Member |
| Steve Oberste | Centers for Disease Control and Prevention | Member |
| Rolando Pajon | Moderna | Member |
| L. Revell Phillips | Defense Threat Reduction Agency | Member |
| Danielle Porter | Gilead Sciences | Member |
| Diane Post | National Institute of Allergy and Infectious Diseases | Member |
| Kim Pruitt | National Center for Biotechnology Information, National Library of Medicine | Member |
| Lisa Purcell | Vir Biotechnology | Member |
| Jay Rappaport | Tulane National Primate Center | Member |
| Sujatha Rashid | American Type Culture Collection | Member |
| Joni Rutter | National Center for Advancing Translational Sciences | Member |
| Erica Ollmann Saphire | Center for Infectious Disease and Vaccine Research, La Jolla Institute for Immunology | Member |
| Migun Shakya | Los Alamos National Laboratory | Member |
| Steve Sherry | National Center for Biotechnology Information, National Library of Medicine | Member |
| Jack Stapleton | University of Iowa | Member |
| Kimberly Stemple | National Institute of Allergy and Infectious Diseases | Member |
| Timothy Stenzel | Food and Drug Administration | Member |
| Katie Streicher | AstraZeneca | Member |
| Nancy Sullivan | Dale and Betty Bumpers Vaccine Research Center, National Institute of Allergy and Infectious Diseases | Member |
| Jenny Svarovskaia | Gilead Sciences | Member |
| Carla Talarico | Moderna | Member |
| Kanny Wan | National Center for Advancing Translational Sciences | Member |
| David Wentworth | Centers for Disease Control and Prevention | Member |
| Chunlin Xiao | National Center for Biotechnology Information, National Library of Medicine | Member |
| Li Yan | Brii Biosciences | Member |
| David Yarmosh | American Type Culture Collection | Member |
| Roland Zahn | Janssen/Johnson & Johnson | Member |
| Theo Zainal | United States Navy | Member |
| Qing Zhu | Brii Biosciences | Member |
Activities
ACTIV has run a series of clinical trials related to COVID-19 vaccines and therapeutics:
External links
ACTIV. National Institutes of Health (NIH). Retrieved April 1, 2022, from http://archive.today/2022.01.11-042823/https://www.nih.gov/research-training/medical-research-initiatives/activ ↩︎ ↩︎ ↩︎
Malone, R. (2021). RWM CV. Squarespace. https://web.archive.org/web/20230621060440/https://static1.squarespace.com/static/550b0ac4e4b0c16cdea1b084/t/60b61dbe39f1e800244e53e4/1622547902895/RWM+CV+1+June+2021+.pdf ↩︎ ↩︎
Naggie, S., National Center for Advancing Translational Sciences (NCATS), & Vanderbilt University Medical Center. (2023, May 4). ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications. ClinicalTrials.gov. https://web.archive.org/web/20230518153157/https://clinicaltrials.gov/ct2/show/NCT04885530 ↩︎
ACTIV Public-Private Partnership. (2022). National Institutes of Health. https://web.archive.org/web/20220402051949/https://www.nih.gov/sites/default/files/research-training/initiatives/activ/activ-org-chart_3.2.22.pdf ↩︎
Preclinical Working Group. (2022, March 8). National Institutes of Health (NIH). http://archive.today/2022.04.02-062343/https://www.nih.gov/research-training/medical-research-initiatives/activ/preclinical-working-group ↩︎
Therapeutics Clinical Working Group. (2022, March 8). National Institutes of Health (NIH). http://archive.today/2023.07.02-204924/https://www.nih.gov/research-training/medical-research-initiatives/activ/therapeutics-clinical-working-group ↩︎
Clinical Trial Capacity Working Group. (2020, December 23). National Institutes of Health (NIH). http://archive.today/2023.07.03-013941/https://www.nih.gov/research-training/medical-research-initiatives/activ/clinical-trial-capacity-working-group ↩︎
Vaccines Working Group. (2021, April 8). National Institutes of Health (NIH). http://archive.today/2023.07.03-024616/https://www.nih.gov/research-training/medical-research-initiatives/activ/vaccines-working-group ↩︎
TRACE Working Group. (2021, June 21). National Institutes of Health. https://web.archive.org/web/20241113202014/https://www.nih.gov/research-training/medical-research-initiatives/activ/trace-working-group ↩︎