Sanofi COVID-19 Vaccine Contract
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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. -
PEDIARIX Is a Vaccine
HIGHLIGHTS OF PRESCRIBING INFORMATION • If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior These highlights do not include all the information needed to use vaccine containing tetanus toxoid, the decision to give PEDIARIX should PEDIARIX safely and effectively. See full prescribing information for be based on potential benefits and risks. (5.2) PEDIARIX. • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.3) PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis • Syncope (fainting) can occur in association with administration of Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus injectable vaccines, including PEDIARIX. Procedures should be in place Vaccine], Suspension for Intramuscular Injection to avoid falling injury and to restore cerebral perfusion following Initial U.S. Approval: 2002 syncope. (5.4) • If temperature ≥105°F, collapse or shock-like state, or persistent, ----------------------------- INDICATIONS AND USAGE ---------------------------- PEDIARIX is a vaccine indicated for active immunization against diphtheria, inconsolable crying lasting ≥3 hours have occurred within 48 hours after tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, receipt of a pertussis-containing vaccine, or if seizures have occurred and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants within 3 days after receipt of a pertussis-containing vaccine, the decision born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX to give PEDIARIX should be based on potential benefits and risks. (5.5) may be given as early as 6 weeks of age through 6 years of age (prior to the • For children at higher risk for seizures, an antipyretic may be 7th birthday). -
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. -
Press Release Sanofi Pasteur Sanofi Pasteur Mounts Emergency
Press release Sanofi Pasteur Lyon, France, February 26, 2008 Sanofi Pasteur: www.sanofipasteur.com Media Relations: Tel.: + 33 4 37 37 50 38 Media Relations US: Tel.: + 1 570 839 44 46 Sanofi Pasteur Mounts Emergency Response to Yellow Fever Epidemic in Latin America - Six Million Doses of StamarilTM vaccine shipped in record time to Brazil and Paraguay - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that six million doses of StamarilTM1 yellow fever vaccine have been shipped upon UNICEF’s request to respond to the yellow fever epidemic in Latin America. Brazil received four million doses of StamarilTM vaccine early February and an additional two million doses were shipped to Paraguay over the weekend in response to urgent requests from Health Authorities. “Sanofi Pasteur mobilized its teams to make this public health emergency a priority,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. “This ability to respond to an emergency in record time illustrates the company’s commitment to global health.” The yellow fever vaccine that was provided to Brazil and Paraguay is part of the UNICEF vaccine stockpile which is reserved for outbreak responses. Sanofi Pasteur is currently the only vaccine supplier to the UNICEF yellow fever vaccine stockpile. Sanofi Pasteur is the largest provider of yellow fever vaccine worldwide with 200 million doses of vaccine provided to 150 countries over the past 20 years. About yellow fever Yellow fever is a viral disease that occurs in both rural and urban areas in Africa and South America. There is no treatment for yellow fever, only prevention by immunization. -
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. -
August 2021 Factsheet Access to Vaccines
ACCESS TO HEALTHCARE AND PRICING ACCESS TO VACCINES GRI Standards : 416-1, 416-2 : Customer Health and Safety EXECUTIVE SUMMARY Vaccines have a great impact on public health. The World Health Organization considers immunization to be one of the most effective and cost-effective health interventions. It has eradicated smallpox, reduced the global incidence of polio by 99% to date,1 and dramatically reduced morbidity, disability and mortality due to diphtheria, tetanus, pertussis, tuberculosis and measles. Despite these important achievements, there is still a long way to go: 19.7 million children worldwide still have no access to a full cycle of basic vaccines.2 Due to lower immunization coverage in some countries, we are witnessing a resurgence of diseases that had almost disappeared, such as measles or pertussis. This affects people around the world, including in high-income countries. True to its vision of a world where no one suffers or dies from a vaccine-preventable disease, Sanofi Pasteur is committed to improve sustainable access to vaccines, with the help of key partnerships to provide effective and affordable vaccines and protection for all populations. This document presents some of our key commitments and initiatives illustrating our longstanding dedication to global access to health through prevention and vaccination. 1 WHO Factsheet on Poliomyelitis, last updated July 2019. https://www.who.int/news-room/fact-sheets/detail/poliomyelitis 2 WHO Factsheet on Immunization, last updated July 2020. https://www.who.int/en/news-room/fact-sheets/detail/immunization-coverage Access to Vaccines Factsheet 1 Published August 2021 TABLE OF CONTENTS 1. -
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. -
Expanded-Access Drugs Consentsta00011 Revised Version IRB Approved
University of North Carolina at Chapel Hill Consent to Participate in an Experimental Treatment ______________________________________________________________________________ Consent Form Version Date: April 28, 2017 IRB Protocol #: 17-1178 Title of Protocol : Expanded Access Stamaril Vaccine Principal Investigator : Margaret Vimmerstedt Principal Investigator Department : Campus Health Services Principal Investigator Phone number : 919-966-2281 Principal Investigator Email Address : [email protected] Co-Investigators: Thevy Chai, Ann Chelminski, Amy Sauls Funding Source and/or Sponsor: Sanofi Pasteur ______________________________________________________________________________ What are some general things you should know about compassionate use protocols? You are being asked to take part in an expanded access (“compassionate use”) protocol. You are invited to take part in an Expanded Access Program of Stamaril vaccine. Stamaril vaccine helps protect against yellow fever virus. This document explains why this program is being carried out. It will help you decide whether you wish to take part. Taking part in this program is completely voluntary. If anything in this document is unclear, or if you have any questions about this program, please ask one of the program team members . You may refuse or you may withdraw your consent to participate, for any reason, without penalty. You may not receive any direct benefit from receiving this treatment. There also may be risks of this therapy. Deciding not to be in the study or leaving the study before it is done will not affect your relationship with the Principal Investigator, your regular health care provider, or the University of North Carolina-Chapel Hill. You do not have to be in the protocol study in order to receive health care. -
Summary of Phase 3 Protocol – VAT00008
Summary of Phase 3 protocol – VAT00008 The phase 3 trial follows positive initial results from a phase 2 clinical trial (VAT00002)1. In that trial, the COVID-19 vaccine candidate was administered to 722 adults to assess the safety, reactogenicity and immunogenicity of 3 doses and to identify an optimal vaccine dose. Results showed strong rates of neutralizing antibody response with 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old), across all doses2. A 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine developed by Sanofi Pasteur in combination with GSK’s AS03 adjuvant will be evaluated in a Phase 3 trial (VAT00008)2 for efficacy, immunogenicity and safety compared to a placebo. The trial is conducted in 2 stages, the first with a monovalent (single antigen) vaccine comprising the spike protein of the original SARS-CoV-2 virus (D614) and the second stage with bivalent (2-antigen) vaccine comprising spike protein of D614 and spike protein of the SARS-CoV-2 Beta variant (B.1.351). Participants will be categorized as naïve (not previously infected) and non-naïve (evidence of previous infection) based on serological and virological ascertainment of prior SARS-CoV-2 infection at the time of vaccination. Non-naïve participants will be capped at 20% of the total study population. The primary objective is the prevention of symptomatic COVID-19 with onset at least 14 days after the second injection of the vaccine in SARS-CoV-2 naïve individuals. Safety of the vaccines will be evaluated throughout the study compared to placebo. -
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.