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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: How Hateful Extremists Are Exploiting the Pandemic
COVID-19 How hateful extremists are exploiting the pandemic July 2020 Contents 3 Introduction 5 Summary 6 Findings and recommendations 7 Beliefs and attitudes 12 Behaviours and activities 14 Harms 16 Conclusion and recommendations Commission for Countering Extremism Introduction that COVID-19 is punishment on China for their treatment of Uighurs Muslims.3 Other conspiracy theories suggest the virus is part of a Jewish plot4 or that 5G is to blame.5 The latter has led to attacks on 5G masts and telecoms engineers.6 We are seeing many of these same narratives reoccur across a wide range of different ideologies. Fake news about minority communities has circulated on social media in an attempt to whip up hatred. These include false claims that mosques have remained open during 7 Since the outbreak of the coronavirus (COVID-19) lockdown. Evidence has also shown that pandemic, the Commission for Countering ‘Far Right politicians and news agencies [...] Extremism has heard increasing reports of capitalis[ed] on the virus to push forward their 8 extremists exploiting the crisis to sow division anti-immigrant and populist message’. Content and undermine the social fabric of our country. such as this normalises Far Right attitudes and helps to reinforce intolerant and hateful views We have heard reports of British Far Right towards ethnic, racial or religious communities. activists and Neo-Nazi groups promoting anti-minority narratives by encouraging users Practitioners have told us how some Islamist to deliberately infect groups, including Jewish activists may be exploiting legitimate concerns communities1 and of Islamists propagating regarding securitisation to deliberately drive a anti-democratic and anti-Western narratives, wedge between communities and the British 9 claiming that COVID-19 is divine punishment state. -
July 2020 Strategies for Emerging Infectious Diseases
THE AMERICAN WWW.CAYMANCHEM.COM ASSOCIATION OF IMMUNOLOGISTS AT ISSUE NEW THE DOWNLOAD Virus Life Cycle Infographic Infographic Cycle Life Virus JULY 2020 Resources for Your Research Your for Resources Informative Articles Informative CAYMAN CURRENTS: CAYMAN IN THIS ISSUE OF THE THE OF ISSUE THIS IN DISEASES INFECTIOUS EMERGING AAI Looks Back: How Honolulu’s Chinatown FOR STRATEGIES "Went Up in Smoke" A history of the first plague outbreak in Hawai’i, page 30 ANTIVIRAL 28 No. Permit CAYMAN CURRENTS PA Gettysburg, PAID 20852 20852 20852 20852 MD MD MD MD Rockville, Rockville, Rockville, Rockville, 650, 650, 650, 650, Suite Suite Suite Suite Pike, Pike, Pike, Pike, Rockville Rockville Rockville Rockville 1451 1451 1451 1451 Postage U.S. Non-Proft Org. Non-Proft IMMUNOLOGISTS IMMUNOLOGISTS IMMUNOLOGISTS IMMUNOLOGISTS OF OF OF OF ASSOCIATION ASSOCIATION ASSOCIATION ASSOCIATION AMERICAN AMERICAN AMERICAN AMERICAN THE THE THE THE 2020 advanced Course in Immunology Now Virtual! I July 26–31, 2020 IN THIS ISSUE Director: Wayne M. Yokoyama, M.D. Washington University School of Medicine in St. Louis x4 Executive Offce The American Association Don’t miss the premier course in immunology for research scientists! of Immunologists x8 Public Affairs This intensive course is directed toward advanced trainees and scientists who wish to expand or update 1451 Rockville Pike, Suite 650 their understanding of the feld. Leading experts will present recent advances in the biology of the Rockville, MD 20852 20 Members in the News immune system and address its role in health and disease. This is not an introductory course; Tel: 301-634-7178 attendees will need to have a frm understanding of the principles of immunology. -
COVID-19 Vaccine Weekly Update
Ramona Whittington From: Roxana Cruz Sent: Tuesday, February 23, 2021 10:02 PM To: [email protected]; [email protected]; Myrta Garcia; Lindsay Lanagan; catherine.threatt; [email protected]; Medical Directors; Dental Directors; [email protected]; [email protected] Cc: ClinicalTeam; Cassandra Caravello; Jana Eubank; Daniel Diaz; Shelby Tracy; Nancy Gilliam; Ramona Whittington Subject: COVID-19 Vaccine Weekly Update: Week 11 (02/22/2021) Attachments: COVIDVaccineAllocation-Week11_final.pdf; americanlungassociation_vaccineeducationtoolkit.pdf; ACP_Addressing Mistrust About COVID-19 Vaccines.pdf; COVIDVaccineAllocation-Week10.pdf Dear Fellow CMOs and Vaccine Coordinators, We hope you are well and that your communities have recovered since last week’s winter storm. As I am sure you know by now, COVID vaccine distribution was put on hold last week 2/15‐ 2/19 (Week 10) due to the inclement weather. Per the weekly DSHS Call today, the following updates were provided: • 100K of 1st dose vaccine not shipped/distributed • 300K of 2nd dose vaccine not shipped/distributed • 1 million vaccine doses will be distributed this week, to include last and this week’s allotments. • 600k 1st doses will go to 563 providers in 230 counties • Mass vaccination clinics this week: Dallas, Tarrant, Harris Counties COVID‐19 Vaccine Weekly Update: Week 11 (02/22/2021) During week 11, there were 61 health center sites that received allocations that total 18,550 doses this week. Vaccine Allocations for Week 11 (02/22/2021) attached w/orange highlighted health center sites. Vaccine Allocations for Week 10 (02/15/2022) although previously sent out, we have attached this list again for your reference. -
Coalition Communication: Healthcare
Updated 1/15/2021 Coalition Communication: Healthcare COVID-19 UPDATES We need your help in sharing information about the COVID-19 vaccine. KEY STATS Vaccine.coronavirus.ohio.gov is an online resource for Ohioans to learn which providers received a COVID-19 vaccine allotment and how to contact them. Data as of 1/14/2021 Tentative dates to start vaccinating these Phase 1B populations are: • Jan. 19, 2021—Ohioans 80 years of age and older. PUBLIC HEALTH • Jan. 25, 2021—Ohioans 75 years of age and older; those with severe ADVISORY SYSTEM congenital or developmental disorders. • Feb. 1, 2021—Ohioans 70 years of age and older; employees of K-12 schools that wish to remain or return to in-person or hybrid learning. • Feb. 8, 2021—Ohioans 65 years of age and older. When a new age group begins, vaccinations may not be complete for the previous age group. It will take a number of weeks to distribute all of the vaccines given the limited doses available. If you are older than 65, please connect with an Area Agencies on Aging about questions or if you need transportation assistance. For more information, visit aginig.ohio.gov or call 1-866-243-5678. More information can be found at coronavirus.ohio.gov. 21-DAY TRENDS INDUSTRY INFORMATION Case Average 7,316 ■ The Ad Council and the COVID Collaborative have released a series of Death Average 73 videos, available in a YouTube playlist, feature an introduction from Dr. Anthony Fauci and include experts leading healthcare organizations. Hospitalization 293 Average ■ BlackDoctor.org’s Making It Plain: What Black America Needs to Know ICU Admission 29 About COVID-19 and Vaccines aired on January 7 and is now available on- Average demand on YouTube. -
Do Vaccines Reduce Long-COVID Symptoms?
Do Vaccines Reduce Long-COVID Symptoms? One of the many important questions about long-COVID is whether COVID-19 vaccination can reduce symptoms in those experiencing long-COVID. While some patients report a lessening of symptoms, it is unknown whether this is causally related to the vaccine, or merely reflective of the fact that most patients’ symptoms improve over time. In addition, some patients also report a worsening of symptoms. But since there is currently a poor understanding of the causes and risk factors for long-COVID, all patient experiences following vaccination need to be carefully assessed. For example, one observational and uncontrolled study (not yet peer-reviewed) released in March 2021 compared 44 vaccinated long-COVID patients with 22 “I’ve heard from people who say they no longer matched unvaccinated participants. Those who received the vaccine showed a have ‘brain fog,’ their gastrointestinal problems small overall improvement in long-COVID symptoms, with a decrease in have gone away, or they stopped suffering from worsening symptoms (5.6% vaccinated vs. 14.2% unvaccinated) and increase in the shortness of breath they’ve been living with symptom resolution (23.2% vaccinated vs. 15.4% unvaccinated).1 Additionally, since being diagnosed with COVID-19.” an informal survey of more than 900 patients with long-COVID by Survivor - Akiko Iwasaki, PhD Corps, a patient advocacy group for those with long-COVID, found that only Professor of immunobiology at Yale School of 39% of patients reported improvements following vaccination. -
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. -
Vaccines and Related Biological Products Advisory Committee 162Nd Meeting
Food and Drug Administration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee 162nd Meeting December 10, 2020 Web-Conference Silver Spring, Maryland 20993 MEMBERS Chair Acting Chair Hana El Sahly, M.D. + Arnold Monto, M.D. Expertise: Vaccines, Infectious Diseases Thomas Francis Jr. Collegiate Professor Term: 06/21/2019 – 01/31/2022 of Public Health Associate Professor Professor of Epidemiology Department of Molecular Virology and Department of Epidemiology Microbiology University of Michigan Department of Medicine School of Public Health Section of Infectious Diseases Ann Arbor, MI 48109 Baylor College of Medicine Houston, TX 77030 Hayley Gans, M.D. Expertise: Pediatrics, Infectious Diseases Paula Annunziato, M.D. *** Term: 06/21/2019 – 01/31/2023 Expertise: Industry Representative Professor of Pediatrics Term: 2/01/2020 – 01/31/2024 Department of Pediatrics Vice President and Therapeutic Area Head Stanford University Medical Center Vaccines Clinical Research Stanford, CA 94305 Merck North Wales, PA 19454 Holly Janes, Ph.D. + Expertise: Biostatistics Archana Chatterjee, M.D., Ph.D. Term: 02/01/2020 – 01/31/2023 Expertise: Pediatrics, Infectious Diseases Associate Member Term: 06/21/2019 – 01/31/2023 Fred Hutchinson Cancer Research Center Dean Chicago Medical School Vaccine and Infectious Disease Division Vice President for Medical Affairs Division of Public Health Sciences Rosalind Franklin University Seattle, WA 98109 North Chicago, IL 60064 CAPT Amanda Cohn, M.D. Expertise: Pediatrics, -
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. -
A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report
THE NATIONAL ACADEMIES PRESS This PDF is available at http://www.nap.edu/24731 SHARE A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report DETAILS 296 pages | 6 x 9 | PAPERBACK ISBN 978-0-309-45729-3 | DOI: 10.17226/24731 CONTRIBUTORS GET THIS BOOK Gillian J. Buckley and Brian L. Strom, Editors; Committee on a National Strategy for the Elimination of Hepatitis B and C; Board on Population Health and Public Health Practice; Health and Medicine FIND RELATED TITLES Division; National Academies of Sciences, Engineering, and Medicine Visit the National Academies Press at NAP.edu and login or register to get: – Access to free PDF downloads of thousands of scientific reports – 10% off the price of print titles – Email or social media notifications of new titles related to your interests – Special offers and discounts Distribution, posting, or copying of this PDF is strictly prohibited without written permission of the National Academies Press. (Request Permission) Unless otherwise indicated, all materials in this PDF are copyrighted by the National Academy of Sciences. Copyright © National Academy of Sciences. All rights reserved. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report Gillian J. Buckley and Brian L. Strom, Editors Committee on a National Strategy for the Elimination of Hepatitis B and C Board on Population Health and Public Health Practice Health and Medicine Division A Report of Copyright © National Academy of Sciences. All rights reserved. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by the American Association for the Study of Liver Diseases, the Infectious Diseases Society of America, the National Viral Hepatitis Roundtable, and the U.S. -
UMBC Alumnae Racing to Develop Coronavirus Vaccine
Newsletter SPRING 2020 To our UMBC/Meyerhoff families: We hope you and your families are all doing well during this strange and stressful time of Covid- 19. Although the world has changed quickly with so many things shut down and many of us sheltering at home, we hope this newsletter will represent a ray of sunshine during a dark and difficult time. Please enjoy this positive representation of our student and alumni community. MPA Board UMBC Alumnae Racing to Develop Coronavirus Vaccine Kizzmekia Corbett ’08, M16, biological sciences, says it feels like she’s “living in a constant adrenaline rush.” Maybe that’s because she and her team at the Vaccine Research Center at the National Insti- tute of Allergy and Infectious Diseases have been working around the clock for weeks. They’re racing to develop a vaccine for the coronavirus faster than it can race across the globe. “To be living in this moment where I have the opportunity to work on something that has imminent global importance…it’s just a surre- al moment for me,” Corbett says. Despite it feeling surreal, the advances Corbett and her team are making are very real, and they’re setting records. “We are making better progress than I could have ever hoped for,” she says. After three months of studies in test tubes and in animals, the vaccine her team developed is about to enter a phase I clinical trial, a crucial hur- dle on the way to FDA approval. Read the complete article about Kizzmekia and her team’s efforts to develop a Covid-19 vaccine in the latest UMBC magazine at https:// Kizzmekia Corbett, NIH magazine.umbc.edu/umbc-alumnae-racing-to-develop- coronavirus-vaccine/.