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From the Factory to the Frontlines the Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine
From the Factory to the Frontlines The Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine What This Strategy Aims to Do This report to Congress details a strategy to achieve the principal purpose and objective of Operation Warp Speed (OWS): ensuring that every American who wants to receive a COVID-19 vaccine can receive one, by delivering safe and effective vaccine doses to the American people beginning January 2021. The leadership of OWS has committed to being transparent with Congress, the media, and the American people. OWS has provided regular briefings on topics of interest to Congress and the media and will continue to provide updates and announcements as OWS reaches new milestones. Congress has been a vital partner in the all-of-America response to the COVID-19 pandemic. With support provided through emergency supplemental and flexible discretionary funding, OWS has now made strong progress toward a safe and effective COVID-19 vaccine, with multiple candidates in Phase 3 clinical trials. Simultaneously, OWS and partners are developing a plan for delivering a safe and effective product to Americans as quickly and reliably as possible. Experts from the Department of Health and Human Services (HHS) are leading vaccine development, while experts from the Department of Defense (DoD) are partnering with the Centers for Disease Control and Prevention (CDC) and other parts of HHS to coordinate supply, production, and distribution of vaccines. Successful implementation of the national COVID-19 vaccination program requires precise coordination across federal, state, local, tribal, and territorial governments and among many public and private partners. -
COVID-19. Rarely Does the World Offer Proof of an Academic Argument, and Even More Rarely in a Single Word Or Term
PREFACE TO THE PAPERBACK uU COVID-19. Rarely does the world offer proof of an academic argument, and even more rarely in a single word or term. But there it is. COVID-19 has shown us in the starkest terms—life and death—what happens when we don’t trust science and defy the advice of experts. As of this writing, the United States leads the world in both total cases and total deaths from COVID-19, the disease caused by the novel coronavirus that appeared in 2019. One might think that death rates would be highest in China, where the virus first emerged and doctorswere presumably caught unpre- pared, but that is not the case. According to The Lancet— the world’s premier medical journal—as of early October 2020, China had confirmed 90,604 cases of COVID-19 and 4,739 deaths, while the United States had registered 7,382,194 cases and 209,382 deaths.1 And China has a population more than four times that of the United States. If the United States had a pandemic pattern similar to China, we would have seen only 22,500 cases and 1128 deaths. While COVID-19 has killed people across the globe, death rates have been far higher in the United States than in other wealthy countries, such as Germany, Iceland, South Korea, New Zealand, and Taiwan, and even than in some much poorer x • Preface to the Paperback countries, such as Vietnam.2 The Johns Hopkins University School of Medicine puts the US death rate per 100,000 people at 65.5.3 In Germany it is 11.6. -
Administration of Donald J. Trump, 2020 Remarks on Coronavirus
Administration of Donald J. Trump, 2020 Remarks on Coronavirus Vaccine Development November 13, 2020 The President. Thank you very much. Thank you. It's beautiful out here this time of year. In the past 9 months, my administration has initiated the single greatest mobilization in U.S. history, pioneering, developing, and manufacturing therapies and vaccines in record time. Numbers like nobody has seen before. No medical breakthrough of this scope and magnitude has ever been achieved this rapidly, this quickly. And we're very proud of it, and I had tremendous help from the military—generals, admirals—and many of the great people at the White House. Operation Warp Speed is unequaled and unrivaled anywhere in the world, and leaders of other countries have called me to congratulate us on what we've been able to do, and we've helped many countries with their ventilators and all of the problems they were having. And I'd like to congratulate everyone involved in this effort. It's been an incredible effort. As a result of Operation Warp Speed, Pfizer announced on Monday that its "China virus" vaccine is more than 90-percent effective. This far exceeds any and all expectations. Nobody thought they'd get to that level. And we have others coming which we think will be at equal level—maybe more, if that's possible. In July, my administration reached an agreement with Pfizer to provide $1.95 billion to support the mass manufacturing and distribution of 100 million doses, with the option to purchase a total of 600 million doses shortly thereafter. -
Case 1:21-Cv-00756 ECF No. 1, Pageid.1 Filed 08/27/21 Page 1 of 49
Case 1:21-cv-00756 ECF No. 1, PageID.1 Filed 08/27/21 Page 1 of 49 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF MICHIGAN JEANNA NORRIS, on behalf of herself ) and all others similarly situated, ) ) Plaintiffs, ) ) v. ) ) CLASS ACTION COMPLAINT SAMUEL L. STANLEY, JR. ) FOR DECLARATORY AND in his official capacity as President of ) INJUNCTIVE RELIEF Michigan State University; DIANNE ) BYRUM, in her official capacity as Chair ) JURY TRIAL DEMANDED of the Board of Trustees, DAN KELLY, ) in his official capacity as Vice Chair ) of the Board of Trustees; and RENEE ) JEFFERSON, PAT O’KEEFE, ) BRIANNA T. SCOTT, KELLY TEBAY, ) and REMA VASSAR, in their official ) capacities as Members of the Board of ) Trustees of Michigan State University, ) and JOHN and JANE DOES 1-10, ) ) Defendants. ) Plaintiff and those similarly situated, by and through their attorneys at the New Civil Liberties Alliance (“NCLA”), hereby complains and alleges the following: INTRODUCTORY STATEMENT a. By the spring of 2020, the novel coronavirus SARS-CoV-2, which can cause the disease COVID-19, had spread across the globe. Since then, and because of the federal government’s “Operation Warp Speed,” three separate coronavirus vaccines have been developed and approved more swiftly than any other vaccines in our nation’s history. The Food and Drug Administration (“FDA”) issued an Emergency Use Authorization (“EUA”) for the Pfizer- 1 Case 1:21-cv-00756 ECF No. 1, PageID.2 Filed 08/27/21 Page 2 of 49 BioNTech COVID-19 Vaccine (“BioNTech Vaccine”) on December 11, 2020.1 Just one week later, FDA issued a second EUA for the Moderna COVID-19 Vaccine (“Moderna Vaccine”).2 FDA issued its most recent EUA for the Johnson & Johnson COVID-19 Vaccine (“Janssen Vaccine”) on February 27, 2021 (the only EUA for a single-shot vaccine).3 b. -
Eka-Weekly-Covid-Update-12
Weekly COVID-19 Update From EKA December 2, 2020 Coronavirus Deaths Soar The US has reported more than 13.5 million cases and 268,000 deaths. Globally, there have been 63 million cases and 1.47 million fatalities. In November alone, one of every 76 Americans tested positive for COVID-19, and the country reported 36,918 deaths – a toll greater than American losses in the Korean War. The Safer at Home order has been in place in Los Angeles since March 19. Previous EKA COVID-19 updates Our previous COVID-19 updates can be found here. Feel free to share our updates with friends and colleagues. We hope you find the information in the EKA updates and the questions they raise to be informative. If you have any COVID-19 government or communications questions, please reach out to any EKA team members. Confirmed Or Suspected Cases Of COVID-19 At Work – What Do You Need To Do The Health Department has created a document that updates the close contact definition and requirements around who must quarantine and isolate. Also provided is additional updated information on the management of symptomatic staff or visitors. Click here to view FAQs for Managers Coronavirus Disease (COVID-19) from the Los Angeles County Department of Public. Click here to view Protocols for Office Worksites. Click here to view some of the protections that employers are required to put in place. Click here to view the office worksite toolkit. OPENING/ CLOSING & RESTRICTIONS New LA County Order The Los Angeles County Health Officer Safer at Home Health Officer Order took effect on Monday and ends on December 20, 2020. -
Covid-19 Vaccination Disparities and Hesitancy
COVID-19 VACCINATION DISPARITIES AND HESITANCY + Stanley Thompson, MD, MHA, FACEP + David Hogan, DO, MPH, FACEP + Khadeja Haye, MD, MBA, FACOG teamhealth.com COVID-19 VACCINATION DISPARITIES AND HESITANCY Numerous studies have shown that the COVID-19 pandemic has disproportionately affected people of color in the United States. Black, Hispanic or Latinx, and Native American people are approximately four times more likely to be hospitalized and nearly three times more likely to die of COVID-19 than their majority counterparts. There are numerous reasons for these disparities, many of which are the same as other findings of disparity in other disease states (i.e. the social determinants of medicine). We know that vaccination is the key to preventing COVID-19 in all people. Vaccinated People – What We Know America’s vaccination effort is among the best in the world. However, where race is known, people of color are getting vaccinated at lower rates than white Americans. The Kaiser Family Foundation analysis reveals a significant disparity where race is known (about 54%) for those who have received at least one dose of vaccine as of April 13, 2021. It shows the racial/ethnic breakdown as White Americans 65%, Hispanic or Latinx 11%, Black 9%, Asian 5%, Indigenous American or Alaskan 2%, Native Hawaiian <1%, and Multiple race 9%. A YouGov poll further supports and illustrates this point as well. Among White adults polled, 26% have gotten the vaccine, compared to 17% of Black adults and 11% of Hispanic adults. Access to Vaccines A big part of what is occurring is disparate access to vaccination. -
Administration of Donald J. Trump, 2020 Remarks on Coronavirus
Administration of Donald J. Trump, 2020 Remarks on Coronavirus Vaccine Development and an Exchange With Reporters May 15, 2020 The President. Thank you very much. It's very hot today. Please, sit down. This is going to be a very hot one, and we apologize to everybody out there that's going to suffer through it. But you know what? It's better than bad weather. And it's great to be in the Rose Garden. I want to especially thank this group for joining us as we announce a historic, groundbreaking initiative in our ongoing effort to rapidly develop and manufacture a coronavirus vaccine. We're joined by Secretary Steven Mnuchin, Secretary Mark Esper, Secretary Alex Azar, Chairman of the Joint Chiefs of Staff General Mark Milley, FDA Director Dr. Stephen Hahn, Director of the National Institute of Health Dr. Francis Collins, Dr. Fauci, Dr. Birx. We're joined by a very terrific group of professionals. Tomorrow will mark 30 days since we released the White House guidelines for a safe and phased opening of America. That's what we're doing. It's the opening of America. We're going to have an amazing year next year. We're going to have a great transition into the fourth quarter. As of this morning, almost every State has taken steps to begin reopening, and the American people are doing an extraordinary job of continuing to take precautions while, at the same time, wanting to start—and they will be starting—to resume their American way of life. We will be reigniting our economic engines. -
COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic
United States Government Accountability Office Report to Congressional Addressees November 2020 COVID-19 Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations GAO-21-207 November 2020 COVID-19 Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Highlights of GAO-21-207, a report to Emergency Use Authorizations congressional addressees Why GAO Did This Study What GAO Found The U.S. had about 10.3 million Through Operation Warp Speed—a partnership between the Department of cumulative reported cases of COVID- Health and Human Services (HHS) and the Department of Defense (DOD)—the 19 and about 224,000 reported deaths federal government is accelerating efforts to develop vaccines and therapeutics as of November 12, 2020. Given this for COVID-19. A typical vaccine development process can take approximately 10 catastrophic loss of life as well as the years or longer, but efforts under Operation Warp Speed seek to greatly pandemic’s effects on the U.S. accelerate this process by completing key steps simultaneously (see figure). As economy, effective and safe vaccines of October 15, 2020, Operation Warp Speed publicly announced financial and therapeutics are more important support for the development or manufacturing of six COVID-19 vaccine than ever. candidates totaling more than $10 billion in obligations. It has also announced The CARES Act includes a provision financial support for the development of therapeutics, such as a $450 million for GAO to report on its ongoing award to manufacture a monoclonal antibody treatment (a treatment that uses monitoring and oversight efforts related laboratory-made antibodies, which also may be able to serve as a prevention to the COVID-19 pandemic. -
When Physicians Engage in Practices That Threaten the Nation's Health
Opinion When Physicians Engage in Practices VIEWPOINT That Threaten the Nation’s Health Philip A. Pizzo, MD In December 2020, less than a year after severe acute young people are not harmed by the virus and cannot Departments of respiratory syndrome coronavirus 2 was identified as spread the disease; reportedly pressured the Centers for Pediatrics and the cause of the coronavirus pandemic, an extraordi- Disease Control and Prevention to issue guidance (later Microbiology and nary collaboration between scientists, the pharmaceuti- reversed)statingthatasymptomaticindividualsneednot Immunology, Stanford 4 University School of cal industry, and government led to 2 highly efficacious, be tested ; and made unsupported claims about the im- Medicine, Stanford, safe vaccines being approved by the US Food and Drug munity conferred by surviving infection. Nearly all pub- California. Administration to prevent coronavirus disease 2019 lic health experts were concerned that his recommen- (COVID-19) infection.1,2 Had the US been in its expected dations could lead to tens of thousands (or more) of David Spiegel, MD role as a global leader in medicine and public health, this unnecessary deaths in the US alone. Department of Psychiatry and would have been a fitting capstone of US commitment to History is a potent reminder of tragic circum- Behavioral Sciences, science and how that can change the course of morbid- stances when physicians damaged the public health, Stanford University ity and mortality related to a frightening new disease. from promoting eugenics to participating in the human School of Medicine, Stanford, California. However, a less flattering story emerged about the experiments that took place in Tuskegee to asserting er- inadequate US response to COVID-19. -
Political Polarization and the Dissemination of Misinformation: the United States Pandemic Response As a Cautionary Tale
The University of Maine DigitalCommons@UMaine Honors College Spring 5-2021 Political Polarization and the Dissemination of Misinformation: the United States Pandemic Response as a Cautionary Tale Mary Giglio Follow this and additional works at: https://digitalcommons.library.umaine.edu/honors Part of the American Politics Commons This Honors Thesis is brought to you for free and open access by DigitalCommons@UMaine. It has been accepted for inclusion in Honors College by an authorized administrator of DigitalCommons@UMaine. For more information, please contact [email protected]. POLITICAL POLARIZATION AND THE DISSEMINATION OF MISINFORMATION: THE UNITED STATES PANDEMIC RESPONSE AS A CAUTIONARY TALE by Mary K. Giglio A Thesis Submitted in Partial Fulfillment of the Requirements for a Dual-Degree with Honors (International Affairs and Political Science) The Honors College The University of Maine May 2021 Advisory Committee: Richard Powell, Professor of Political Science, Advisor Mark Brewer, Professor of Political Science, Honors College Lora Pitman, Adjunct Assistant Professor of Political Science Asif Nawaz, Assistant Professor of History and International Affairs Zachary Rockwell Ludington, Assistant Professor of Spanish i ABSTRACT This thesis discusses the failings of the United States response to the COVID-19 pandemic, and how it has been shaped by the nation’s intense political polarization and the widespread dissemination of misinformation. In this thesis, I critically examine the government’s initial response to the pandemic, including its lack of preparedness and the ineffectiveness of its eventual policies. I also attempt to explain the influence of political polarization on the states, resulting in congressional gridlock, as well as wildly varying policies regarding lockdowns and mask mandates. -
Dr. Rick Bright, One of the Nation's Leading Experts in Pandemic
THIRD ADDENDUM TO THE COMPLAINT OF PROHIBITED PERSONNEL PRACTICE AND OTHER PROHIBITED ACTIVITY BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBMITTED BY DR. RICK BRIGHT I. Introduction Dr. Rick Bright, one of the nation’s leading experts in pandemic preparedness and response, and an internationally recognized expert in the fields of immunology, therapeutic intervention, and vaccine and diagnostic development, was abruptly removed from his position as Director of the Biomedical Advanced Research and Development Authority (“BARDA”) and transferred to a limited position at the National Institutes of Health (“NIH”) in retaliation for his whistleblowing activity under 5 U.S.C. § 2302(b)(8)(A). Specifically, and as detailed in his initial Complaint of Prohibited Personnel Practice filed with the Office of Special Counsel (“OSC”) on May 5, 2020, Secretary of Health and Human Services, Alex Azar, and other HHS political leaders engaged in an overtly hostile and career-derailing campaign of retaliation against Dr. Bright because he raised concerns about the Trump administration’s chaotic and reckless response to the COVID-19 pandemic. Shortly after cases of COVID-19 were identified in the United States, Dr. Bright sounded the alarm about the shortage of critical supplies, such as masks, respirators, swabs, and syringes that were necessary to combat COVID-19. In response, HHS political leadership leveled baseless criticisms against him and sidelined him because of his insistence that the Trump administration address these shortages and invest in vaccine development as well. Dr. Bright continued to speak out about the inevitable devastation that would be wrought by this virus at a time President Trump and his administration were intentionally lying to the American people about the serious threat posed by COVID-19 to the public health and safety.1 Dr. -
UNITED STATES TRAVEL and TOURISM ADVISORY BOARD April
UNITED STATES TRAVEL AND TOURISM ADVISORY BOARD April 23, 2021 The Honorable Gina Raimondo Secretary of Commerce Washington, D.C. 20230 Dear Madam Secretary: Thank you for placing your confidence in us to make recommendations regarding the use of technology to aid in the recovery and improve the resilience of the travel and tourism industry. In addition to the previous recommendations made on the use of technology to facilitate travel and security, the U.S. Travel and Tourism Advisory Board has developed additional recommendations in response to the COVID-19 crisis. We have divided our recommendations by timeframe. Our first two recommendations cover the short-term and request that: (i) the U.S. Government provide clear recommended standards for technology providers regarding vaccine, previous infection, and testing verification, and (ii) the U.S. Government make COVID-19 mitigating therapeutics available as soon as possible to the industry. Our third recommendation covers the next ten years and focuses on how technology can be used to identify and defeat emerging pathogenic threats before they are able to inflict significant damage to our citizens, our industry and our nation. This threat is existential to our industry, primarily because of our inability to rapidly and effectively detect who is infected. Technology can be used to solve this problem if standards are developed and adopted by the U.S. Government and protocols are properly deployed. This will mitigate future threats and dramatically reduce the likelihood of future airborne diseases from propagating through the traveling community and our citizenry undetected. Recommendation #1: That the U.S Government take a leadership role in recommending secure technology standards where users, rather than centralized organizations, store and control data used for vaccine, previous infection and testing verification for COVID-19 and future disease outbreaks.