Operation Warp Speed Timeline
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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. -
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. -
COVID-19 UPDATE November 23, 2020 Global Total Cases – 59,025,871 Total Deaths – 1,393,889
COVID-19 UPDATE November 23, 2020 Global Total cases – 59,025,871 Total deaths – 1,393,889 United States Total cases – 12,369,978 Total deaths – 257,415 On Wednesday, the United States surpassed 250,000 coronavirus deaths. The total number of patients hospitalized with COVID-19 in the United States has reached new highs every day since November 11, when hospitalizations first surpassed the April peak. One week before the end of the month, the United States has already recorded its highest monthly case total in November, reporting more than 3,075,000 cases. The number of November cases could exceed four million, more than double the total in October. Trump Administration • The Centers for Disease Control and Prevention urged Americans against traveling for Thanksgiving and to limit gatherings to people in the same household as Covid-19 rages in the U.S. o “Celebrating virtually or with the people you live with is the safest choice this Thanksgiving,” the agency said on its website on Thursday. “Travel may increase your chance of getting and spreading COVID-19.” o For people considering traveling for the holiday, the agency offered a checklist of risks and standard advice such as wearing a face covering and staying 6 feet away from people “who don’t live with you.” People hosting Thanksgiving guests at home should observe precautions that could include having an outdoor meal with family and friends, have people bring their own food and drink, and opening windows if the gathering is indoors. • In a call last week, Centers for Disease Control and Prevention Director Robert Redfield and Health and Human Services Secretary Alex Azar encouraged governors to help build confidence in vaccines and stressed the importance of wearing masks. -
So Many People Are Perplexed with the Covid-19 Lockdowns, Mask Requirements, Social Distancing, Loss of Jobs, Homes, and Their Very Sanity
So many people are perplexed with the Covid-19 lockdowns, mask requirements, social distancing, loss of jobs, homes, and their very sanity. What lies behind all of this? There have been so many conflicting reports that one has to ask the question, Is there even a pandemic at all? Was there ever one? Let’s have a look. ======================== Strange advance hints (predictive programming) – A 1993 Simpsons episode called “Marge in Chains” actually accurately predicted the coronavirus outbreak. One scene depicted a boardroom meeting between government officials and major media moguls. The chairman opened with these words: “I’d like to call to order this secret conclave of America’s media empires. We are here to come up with the next phony baloney crisis to put Americans back where they belong…” Suddenly a delegate from NBC chimed in: “Well I think…” Then the chairman interrupted him, saying: “NBC, you are here to listen and not speak!” He then said: “I think we should go with a good old fashioned health scare.” Everyone then nodded in approval. Next, a female delegate remarked: “A new disease–no one’s immune–it’s like The Summer of the Shark, except instead of the shark, it’s an epidemic.” – Another Simpsons episode called “A Totally Fun Thing that Bart will Never Do Again,” first aired on April 29, 2012, featured an emergency broadcast announcing the outbreak of the deadly “Pandora Virus,” and how it was “spreading rapidly.” The announcer then said: “This unprecedented threat requires a world-wide quarantine. All ships must remain at sea until further notice. -
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. -
Officials Call on States to Expand Groups Getting COVID-19 Vaccines
Officials call on states to expand groups getting COVID-19 vaccines by Melissa Jenco, News Content Editor Editor's note:For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19. Federal health officials are releasing COVID-19 vaccine doses they had been withholding and are encouraging states to open vaccination to broader groups of people. "This next phase reflects the urgency of the situation we face," Health and Human Services Secretary Alex M. Azar II, J.D., said Tuesday. "Every vaccine dose that is sitting in a warehouse rather than going into an arm could mean one more life lost or one more hospital bed occupied." Azar said states should start vaccinating everyone 65 years and older and people ages 16 or 18 to 64 (depending on the vaccine) who have documented underlying conditions. The recommendation is a change from the initial recommendations on priority groups made by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices last month. "We are telling states today they should open vaccination to all of their most vulnerable people," Azar said. "That is the most effective way to save lives now." Administration of vaccines from Pfizer-BioNTech and Moderna started in December among health care workers and residents of long-term care facilities, and roughly 9 million people have received at least one dose. However, that is significantly behind the 20 million officials predicted by the end of December. Azar blamed reporting lags and states micromanaging who could get a dose. He noted nearly 38 million doses, including 25 million first doses, have been distributed to states. -
Supreme Court of the United States
No. 15-____ IN THE Supreme Court of the United States IN RE: AVANDIA MARKETING, SALES PRACTICES & PRODUCTS LIABILITY LITIGATION: GLAXOSMITHKLINE LLC, Petitioner, v. ALLIED SERVICES DIVISION WELFARE FUND, UFCW LOCAL 1776 AND PARTICIPATING EMPLOYERS HEALTH AND WELFARE FUND, AND UNITED BENEFIT FUND, Respondents. On Petition For A Writ Of Certiorari To The United States Court of Appeals For the Third Circuit PETITION FOR A WRIT OF CERTIORARI Nina M. Gussack John H. Beisner Anthony C.H. Vale Counsel of Record Yvonne M. McKenzie Jessica D. Miller PEPPER HAMILTON LLP Geoffrey M. Wyatt 3000 Two Logan Square SKADDEN, ARPS, SLATE, Eighteenth & Arch Streets MEAGHER & FLOM LLP Philadelphia, PA 19103 1440 New York Ave., NW (215) 981-4000 Washington, DC 20005 (202) 371-7000 [email protected] Attorneys for Petitioner i QUESTIONS PRESENTED This case involves claims by third-party payors (“TPPs”) that they overpaid for Avandia, a prescrip- tion diabetes medication manufactured by petitioner, GlaxoSmithKline (“GSK”). The TPPs claim that GSK failed to disclose risk information, entitling them to recovery under the Racketeer Influenced and Corrupt Organizations Act, even though they do not allege that Avandia was ineffective; that it injured any one of their plan participants; or that they stopped cover- ing it after learning about the drug’s alleged risks. The Third Circuit nevertheless held that the TPPs could plausibly allege that GSK’s representations had an “inflationary effect” on the drug’s price. In so ruling, the Third Circuit expressly declined to follow the Eleventh Circuit, which had previously rejected similar claims, and also departed from several other appellate decisions rejecting similar “fraud on the market” theories. -
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. -
Dân Chúa on Line Số 67 - Tháng 1.2021 Nguyệt San Công Giáo Trong Số Này Katholische on Line
Dân Chúa on line số 67 - tháng 1.2021 Nguyệt San Công Giáo Trong Số Này Katholische on line . Lá Thư Chủ Nhiệm. Monthly Catholic on line . Lịch Phụng vụ tháng Một 2021. Email: [email protected] . Năm Mục vụ Giới Trẻ 2021. Herausgeber: Franz Xaver e.V. Ghen và ghét. Dân Chúa Katholische on line . Khi Nào Trẻ Em DÂN CHÚA ÂU CHÂU Có Thể Chích Ngừa Covid-19? Chủ nhiệm: Lm Stêphanô Bùi Thượng Lưu . Những Ai Đã Góp Phần Sáng Chế Phụ tá chủ nhiệm: Lm Paul Đào Văn Thạnh Thuốc Ngừa Covid-19?. Thư ký : Sr. Anne Marie Nguyễn Thị Hường . Khát vọng Hòa Bình. Chủ biên thần học : Lm Vincent Lê Phú Hải omi . Đánh giá đời sống thiêng liêng Chủ biên văn hóa: Sh Bonaventure Trần Công Lao qua 4 điểm cốt yếu. hình bìa : Trần Anh Dũng omi. Một năm đặc biệt để làm chứng DÂN CHÚA ÚC CHÂU cho tình yêu gia đình. 715 Sydney Rd. Brunswick, Victoria 3056 . Loài Người Đã Được Tạo Dựng Tel.: (03) 9386-7455 / Fax: (03) 9386-3326 Hay Do Tiến Hóa?. Chủ nhiệm: Lm. Nguyễn Hữu Quảng SDB . Nguồn gốc vũ trụ theo Thánh Kinh Chủ bút: Rev. James Võ Thanh Xuân và khoa học. Phụ tá Chủ bút: Trần Vũ Trụ . Thiên Chúa Sáng Tạo Vũ Trụ Tổng Thư Ký: Sr. Nguyễn Thùy Linh, FMA Và Con Người. Ban kỹ thuật: Hiệp Hải . Trái đất có thể khóc không?. NHÀ KHẢO CỔ NGƯỜI ANH TIN RẰNG Mục đích & Tôn CHỈ Dân Chúa ÔNG ĐÃ TÌM THẤY NGÔI NHÀ Mục đích: Góp phần vào việc phục vụ tập thể Công THỜI THƠ ẤU CỦA CHÚA GIÊSU Giáo Việt Nam và đồng bào để cùng thăng tiến toàn . -
Kentucky Hospital Research & Education Foundation Emergency
Kentucky Hospital Research & Education Foundation Emergency Preparedness Update for September 3, 2020 National Preparedness Month (ASPR) National Preparedness Month (NPM) is recognized each September to promote family and community disaster planning now and throughout the year. As our nation continues to respond to COVID-19, there is no better time to be involved this September. The 2020 NPM theme is "Disasters Don't Wait. Make Your Plan Today." Ready.gov has built a NPM toolkit for stakeholders to distribute through their communication channels. The toolkit includes weekly themes, social media and graphics, videos, and other resources. This week, we remind individuals to create a family disaster kit. A disaster supplies kit is a collection of basic items your household may need in an emergency. Make sure your kit is stocked with the items from this FEMA checklist. This year, addition emergency supplies are needed in your kit to help prevent the spread of coronavirus. Be sure you kit includes these CDC-recommended supplies: Two cloth face coverings for everyone age 2 and older Hand sanitizer with at least 60% alcohol, and bar or liquid soap Disinfecting wipes to disinfect surfaces ---------- KY COVID-19 - Daily Summary New cases today: 906; Total 509,885 New deaths today: 10; Total 976 Total PCR Tests: 839,705; Positivity Rate: 4.53% See Governor’s Press Releases: https://governor.ky.gov/news ---------- Four Midwestern states are seeing worrying COVID-19 spikes Most of the Midwest had been spared the worst of Covid-19 — until now. The coronavirus is always restless, always searching for new people in new places to infect.