2023 Before We Have Enough Doses for the Whole World
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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. -
Information and Communication Guide on Vaccines
Module 2 EUROPEAN NURSE Information and Communication Guide ON VACCINES The European Specialist Nurses Organisation (ESNO) is a non-profit organisation with the goal to facilitate and provide an effective framework for communication and co-operation between the European Specialist Nurses Organisations and its constituent members. ESNO represents the mutual interests and benefits of these organisations to the wider European community in the interest of the public health. Members of ESNO consist of individual European specialist nurses member organizations and associates, both institutional and individual. The organisation focusses on enhancing the capacity and capability of specialists nurses to deliver hight quality healthcare by raising and harmonise specialist nursing education standards and actively contribute to health themes and threats, providing the best possible expertise, both national and in European cross border context. A publication from the European Specialist Nurses Organisation April 2021 - www.esno.org Copyright: ©2021 European Specialist Nurses Organisation. All rights reserved. No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the publisher, except in the case of brief quotations embodied in critical reviews and certain other noncommercial uses permitted by copyright law. CONTENTS Vaccination 1 Introduction 5 2 Principles of vaccination 6 2.1 Principle -
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 101 the Very Last Day That I Was a Pediatric Resident. Um, Many
Vaccines 101 The very last day that I was a pediatric resident. Um, many years ago, a toddler walked into the emergency room and uh, and progressively got sicker and sicker. That's Dr. Katherine Edwards, a world expert in pediatric infectious disease in vaccinology. She's also a professor of pediatrics at Vanderbilt university and she's been working on vaccines for 40 years. I did a spinal tap on her and realized that she had Haemophilus influenza, typ e B meningitis, Haemophilus influenza, type B or HIB is it bacteria normally found in our nose and throat that can lead to very serious life threatening infections and no matter what I did in that day and into the night in terms of prompt antibiotics and she'd just been sick a few hours and, and fluids and all the, you know, ventilators and all the best things that modern medicine, she died, the vaccine for hip was not available until the 1990s. And until it did become available, hip disease affected approximately 25,000 children each year with things like meningitis, pneumonia, and bloodstream infections. And at that time in the hospital that I was practicing at any one time, there were generally five or six patients that had Haemophilus meningitis or invasive disease or some complication of this particular infection. And we knew that from the basic science that if you had antibody to the capsule or to the coat of the organism, that you were protected from disease. But we really didn't know how to make little kids make antibody. -
Bcch 2019-20 Flu Vaccine – Oncology Clinic
BCCH 2019-20 FLU VACCINE – ONCOLOGY CLINIC We are providing influenza vaccines for patients who are on therapy and have platelets > 50,000 and ANC over 0.5 (and expected to stay above 0.5 for the next 48 hours, in order to minimize risk of admission in case of fever). Please do not schedule appointments for flu shots only. Please advise the family that immunization of all family members is recommended. The Oncology Outpatient Clinic is not providing immunizations for family members or for those patients who are OFF therapy. Flu shots can be given by family doctors to patients and their families, or they can get a flu shot at the BCCH drop-in Family Immunization clinic in the Ambulatory Care Building, across from the Ambulatory Care Pharmacy on week days in the fall months. Pediatric oncology patients can also get a flu shot at almost any community pharmacy at no cost as they are considered “at risk.” Age Dose** Doses required 6 months – 9 years 0.5 mL IM 1 or 2* > 9 years 0.5 mL IM 1 Less than 6 months Not recommended *Two doses administered at least 4 weeks apart are recommended for children under 9 years of age who are receiving influenza vaccine for the first time. **The recommended site of vaccination is the deltoid muscle for adults and older children. The preferred site for infants and young children is the anterolateral aspect of the thigh. Contraindications: • Febrile illness • Thimerosal sensitivity Special considerations: • Egg allergic individuals (including those who have experienced anaphylaxis following egg ingestion) can be immunized with inactivated influenza vaccine (such as Flulaval tetra) • Thimerosal allergic patients should be vaccinated using Agriflu which can be obtained from local public health units, (but not in the oncology clinic). -
Outcome Reporting Bias in COVID-19 Mrna Vaccine Clinical Trials
medicina Perspective Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials Ronald B. Brown School of Public Health and Health Systems, University of Waterloo, Waterloo, ON N2L3G1, Canada; [email protected] Abstract: Relative risk reduction and absolute risk reduction measures in the evaluation of clinical trial data are poorly understood by health professionals and the public. The absence of reported absolute risk reduction in COVID-19 vaccine clinical trials can lead to outcome reporting bias that affects the interpretation of vaccine efficacy. The present article uses clinical epidemiologic tools to critically appraise reports of efficacy in Pfzier/BioNTech and Moderna COVID-19 mRNA vaccine clinical trials. Based on data reported by the manufacturer for Pfzier/BioNTech vaccine BNT162b2, this critical appraisal shows: relative risk reduction, 95.1%; 95% CI, 90.0% to 97.6%; p = 0.016; absolute risk reduction, 0.7%; 95% CI, 0.59% to 0.83%; p < 0.000. For the Moderna vaccine mRNA-1273, the appraisal shows: relative risk reduction, 94.1%; 95% CI, 89.1% to 96.8%; p = 0.004; absolute risk reduction, 1.1%; 95% CI, 0.97% to 1.32%; p < 0.000. Unreported absolute risk reduction measures of 0.7% and 1.1% for the Pfzier/BioNTech and Moderna vaccines, respectively, are very much lower than the reported relative risk reduction measures. Reporting absolute risk reduction measures is essential to prevent outcome reporting bias in evaluation of COVID-19 vaccine efficacy. Keywords: mRNA vaccine; COVID-19 vaccine; vaccine efficacy; relative risk reduction; absolute risk reduction; number needed to vaccinate; outcome reporting bias; clinical epidemiology; critical appraisal; evidence-based medicine Citation: Brown, R.B. -
Ethics of Vaccine Research
COMMENTARY Ethics of vaccine research Christine Grady Vaccination has attracted controversy at every stage of its development and use. Ethical debates should consider its basic goal, which is to benefit the community at large rather than the individual. accines truly represent one of the mira- include value, validity, fair subject selection, the context in which it will be used and Vcles of modern science. Responsible for favorable risk/benefit ratio, independent acceptable to those who will use it. This reducing morbidity and mortality from sev- review, informed consent and respect for assessment considers details about the pub- eral formidable diseases, vaccines have made enrolled participants. Applying these princi- lic health need (such as the prevalence, bur- substantial contributions to global public ples to vaccine research allows consideration den and natural history of the disease, as health. Generally very safe and effective, vac- of some of the particular challenges inherent well as existing strategies to prevent or con- cines are also an efficient and cost-effective in testing vaccines (Box 1). trol it), the scientific data and possibilities way of preventing disease. Yet, despite their Ethically salient features of clinical vac- (preclinical and clinical data, expected brilliant successes, vaccines have always been cine research include the fact that it involves mechanism of action and immune corre- controversial. Concerns about the safety and healthy subjects, often (or ultimately) chil- lates) and the likely use of the vaccine (who untoward effects of vaccines, about disturb- dren and usually (at least when testing effi- will use and benefit from it, safety, cost, dis- ing the natural order, about compelling indi- cacy) in very large numbers. -
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. -
HIV Vaccine Development Dr. Patricia Fast 1
HIV Vaccine Development Dr. Patricia Fast HIV Vaccine Development Dr. Patricia Fast (MD, PhD) Senior Technical Advisor, International AIDS Vaccine Initiative Adjunct Clinical Associate Professor, Infectious Disease, Pediatrics Stanford University School of Medicine How It Began 1984 • Human Immunodeficiency Virus (HIV-1) discovered as the cause of AIDS • Prediction: a vaccine will soon be developed! Non-Human Primate Models Focusing on this dominant model • Simian Immunodeficiency Virus (SIV) lead to a bias – SIV Mac 239 causes AIDS-like disease in Macaques almost impossible to neutralize • SHIV hybrid (with HIV Envelope) allows research into neutralizing antibodies in macaques • Chimpanzees can be infected by HIV, but seldom get AIDS False starts • Traditional vaccine approaches fail in NHP model . Killed SIV does not really protect against SIV o Initial positive result was an artifact . Live attenuated SIV protects, but is not safe o Attenuated vaccine was shown to regain virulence The screen versions of these slides have full details of copyright and acknowledgements 1 HIV Vaccine Development Dr. Patricia Fast How would an AIDS vaccine work? A note about virus biology • HIV has many mechanisms to escape immune recognition e.g. : . Rapid formation of variation . Structural aspects How would an AIDS vaccine work? Immune Mechanisms • T cells . Kill virus-infected cells . Slow down or stop replication of viruses within cells . Can directly kill virus infected cells . Secrete substances that block viral replication Can neutralize virus when they prevent entry; by binding viral envelope protein or the cellular receptors HIV is extremely variable Europe and North America East Africa Southern Africa, India and China Part of an HIV phylogenetic tree The screen versions of these slides have full details of copyright and acknowledgements 2 HIV Vaccine Development Dr. -
COVID-19 Vaccine Trials
COVID-19 VACCINE TRIALS SUMMARY OF PFIZER AND MODERNA COVID-19 VACCINE RESULTS Some of the most common concerns voiced involve the A review of unblinded reactogenicity data from the speed with which these vaccines were developed and final analysis which consisted of a randomized subset whether they are safe or not. How were the companies of at least 8,000 participants 18 years and older in able to get these vaccines developed and ready for the phase 2/3 study demonstrates that the vaccine distribution so fast? Were they tested in persons who was well tolerated, with most solicited adverse events are most vulnerable? Are the vaccines safe? resolving shortly after vaccination. Even though COVID-19 vaccines were developed at While the vaccine was well tolerated overall, and side an extraordinary speed, companies were required effects lasted for only a day or two, persons taking to take all of the regulatory and operational steps the vaccine should be aware that the side effects normally required for all vaccine trials, so none of are more than is seen in general for the flu vaccine these steps were skipped. What did occur that does and be prepared for them. Most side effects were not normally occur was some upfront financial mild to moderate and included injection-site pain, assistance from the federal government (Moderna redness and swelling at the injection site, fatigue/ accepted, Pfizer declined) and federal regulatory tiredness, headache, chills, muscle pain, and joint agencies working closely with the companies, pain. “Severe” side effects, defined as those that providing near real-time data with companies prevent persons from continuing daily activities were receiving review and advice more quickly. -
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.