Today was the first time I have been 'jolted' - not in regards to leronlimab or the news about Pfizer's BNT162b2 - but in regards to fear for the investment I have made (way too big for my little middle-class retirement situation).
Three things calmed my nerves:
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First: Am deeply grateful for the various points of view from both the pragmatist and the faithful (or whatever terms they prefer) on this board on the news. Calming, at least for me, to hear the exchanges between them.
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Second: The Pfizer website. Admittedly, don’t know the EAU or FDA approval process but a couple things sounded familiar and/or reassuring. Also raised lots of questions for dummies like me for folks on this board about this being a review of a Phase 3 interim analysis. Appears the vaccine still requires FDA approval and faces other regulatory hurdles and the CEO is reasonably clarifying that.
‘-Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
-Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
-Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints’
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Third:
President-elect Joe Biden named 13 health experts to his Transition COVID-19 Advisory Board today. (Link and some names below.)
Do we (or the management or the Advisory or new docs on the team that have led clinical trials) know any of them? Heck, this board is so esteemed- there could be some of them that are some of us!
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https://www.npr.org/sections/live-updates-202...sory-board
Co-Chairs and Advisory Board Members:
CO-CHAIRS
Dr. David Kessler
David A. Kessler, MD, is Professor of Pediatrics and Epidemiology and Biostatistics at UCSF. Dr. Kessler served as FDA Commissioner from 1990 to 1997, appointed by President George H.W. Bush and reappointed by President Bill Clinton.
Dr. Vivek Murthy
Vivek Murthy, MD, MBA, served as the 19th Surgeon General of the United States from 2014-2017. As the Vice Admiral of the US Public Health Service Commissioned Corps, he commanded a uniformed service of 6,600 public health officers globally. The officers focused on helping underserved populations, protecting the nation from Ebola and Zika, responding to the Flint water crisis, and natural disasters such as hurricanes.
Dr. Marcella Nunez-Smith
Marcella Nunez-Smith, MD, MHS, is an Associate Professor of Internal Medicine, Public Health, and Management at Yale University and the Associate Dean for Health Equity Research at the Yale School of Medicine. Dr. Nunez-Smith’s research focuses on promoting health and healthcare equity for structurally marginalized populations.
MEMBERS
Dr. Luciana Borio
Luciana Borio, MD, is VP, Technical Staff at In-Q-Tel. She is also a senior fellow for global health at the Council on Foreign Relations. Dr. Borio specializes in biodefense, emerging infectious diseases, medical product development, and complex public health emergencies. She served in senior leadership positions at the FDA and National Security Council, including as Assistant Commissioner for Counterterrorism Policy and Acting Chief Scientist at the FDA, and Director of FDA’s Office of Counterterrorism and Emerging Threats.
Dr. Rick Bright
Rick Bright, PhD, is an American immunologist, virologist, and former public health official. Dr. Bright was the director of the Biomedical Advanced Research and Development Authority (BARDA) from 2016 to 2020 and the Deputy Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. He also previously served as an advisor to the World Health Organization and the United States Department of Defense. His career has focused on the development of vaccines, drugs, and diagnostics to address emerging infectious diseases and national security threats.
Dr. Ezekiel Emanuel
Ezekiel J. Emanuel, MD, PhD, is an oncologist and Vice Provost for Global Initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. From January 2009 to January 2011, he served as special advisor for health policy to the director of the White House Office of Management and Budget. Since 1997, he has served as chair of the Department of Bioethics at The Clinical Center of the National Institutes of Health (NIH).
Dr. Atul Gawande
Atul Gawande, MD, MPH, is the Cyndy and John Fish Distinguished Professor of Surgery at Brigham and Women’s Hospital, Samuel O. Thier Professor of Surgery at Harvard Medical School, and Professor of Health Policy and Management at Harvard T.H. Chan School of Public Health. Dr. Gawande is also the founder and chair of Ariadne Labs, a joint center between Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health for health systems innovation, and of Lifebox, a nonprofit organization making surgery safer globally. He previously served as a senior advisor in the Department of Health and Human Services in the Clinton Administration.
Dr. Celine Gounder
Celine Gounder, MD, ScM, FIDSA is a Clinical Assistant Professor at the NYU Grossman School of Medicine and cares for patients at Bellevue Hospital Center. From 1998 to 2012, Dr. Gounder studied TB and HIV in South Africa, Lesotho, Malawi, Ethiopia and Brazil. While on faculty at Johns Hopkins, Dr. Gounder was the Director for Delivery for the Gates Foundation-funded Consortium to Respond Effectively to the AIDS/TB Epidemic. She later served as Assistant Commissioner and Director of the Bureau of Tuberculosis Control at the NYC Department of Health and Mental Hygiene.
Dr. Julie Morita
Julie Morita, MD, is Executive Vice President of the Robert Wood Johnson Foundation (RWJF). Morita previously served as the Health Commissioner for the City of Chicago for nearly two decades. She is a member of the American Academy of Pediatrics and has served on many state, local, and national health committees, including the CDC’s Advisory Committee on Immunization Practices, and the National Academy of Sciences’ Committee on Community Based Solutions to Promote Health Equity in the United States.
Dr. Michael Osterholm
Michael Osterholm, PhD, MPH, is Regents Professor, McKnight Presidential Endowed Chair in Public Health and the director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Dr. Osterholm previously served as a Science Envoy for Health Security on behalf of the State Department. For 24 years (1975 to 1999), he worked in the Minnesota Department of Health; the last 15 years as state epidemiologist.
Ms. Loyce Pace
Loyce Pace, MPH, is the Executive Director and President of Global Health Council. Over the course of her career, Loyce has championed policies for access to essential medicines and health services worldwide. Ms. Pace has worked with Physicians for Human Rights and Catholic Relief Services, and previously served in leadership positions at the LIVESTRONG Foundation and the American Cancer Society.
Dr. Robert Rodriguez
Dr. Robert Rodriguez graduated from Harvard Medical School and currently serves as a Professor of Emergency Medicine at the UCSF School of Medicine, where he works on the frontline in the emergency department and ICU of two major trauma centers. He has authored over 100 scientific publications and has led national research teams examining a range of topics in medicine, including the impact of the COVID-19 pandemic on the mental health of frontline providers. In July 2020, Dr. Rodriguez volunteered to help with a critical surge of COVID-19 patients in the ICU in his hometown of Brownsville, Texas.
Dr. Eric Goosby
Eric Goosby, MD, is an internationally recognized expert on infectious diseases and Professor of Medicine at the UCSF School of Medicine. During the Clinton Administration, Dr. Goosby was the founding director of the Ryan White CARE Act, the largest federally funded HIV/AIDS program. He went on to become the interim Director of the White House’s Office of National AIDS Policy. In the Obama Administration, Dr. Goosby was appointed Ambassador-at-Large and implemented the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR). After serving as the U.S. Global AIDS Coordinator, he was appointed by the UN Secretary General as the Special Envoy for TB.
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Full announcement list at: https://buildbackbetter.com/press-releases/bi...ory-board/
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