Master Question List for COVID-19 (Caused by SARS-Cov-2) Monthly Report 13 July 2021
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Collezione Per Genova
1958-1978: 20 anni di sperimentazioni spaziali in Occidente La collezione copre il ventennio 1958-1978 che è stato particolarmente importante nella storia della esplorazio- ne spaziale, in quanto ha posto le basi delle conoscenze tecnico-scientifiche necessarie per andare nello spa- zio in sicurezza e per imparare ad utilizzare le grandi potenzialità offerte dallo spazio per varie esigenze civili e militari. Nel clima di guerra fredda, lo spazio è stato fin dai primi tempi, utilizzato dagli Americani per tenere sotto con- trollo l’avversario e le sue dotazioni militari, in risposta ad analoghe misure adottate dai Sovietici. Per preparare le missioni umane nello spazio, era indispensabile raccogliere dati e conoscenze sull’alta atmo- sfera e sulle radiazioni che si incontrano nello spazio che circonda la Terra. Dopo la sfida lanciata da Kennedy, gli Americani dovettero anche prepararsi allo sbarco dell’uomo sulla Luna ed intensificarono gli sforzi per conoscere l’ambiente lunare. Fin dai primi anni, le sonde automatiche fecero compiere progressi giganteschi alla conoscenza del sistema solare. Ben presto si imparò ad utilizzare i satelliti per la comunicazione intercontinentale e il supporto alla navigazio- ne, per le previsioni meteorologiche, per l’osservazione della Terra. La Collezione testimonia anche i primi tentativi delle nuove “potenze spaziali” che si avvicinano al nuovo mon- do dei satelliti, che inizialmente erano monopolio delle due Superpotenze URSS e USA. L’Italia, con San Mar- co, diventò il terzo Paese al mondo a lanciare un proprio satellite e allestì a Malindi la prima base equatoriale, che fu largamente utilizzata dalla NASA. Alla fine degli anni ’60 anche l’Europa entrò attivamente nell’arena spaziale, lanciando i propri satelliti scientifici e di telecomunicazione dalla propria base equatoriale di Kourou. -
Study Protocol
Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Clinical Study Protocol Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 IND Sponsor: WCCT Global 3545 Howard Way, Costa Mesa, CA 92626 Maria Apkarian Vice President, Early Clinical Development Email: [email protected] Phone: 714-252-0700; ext: 1019 Funding Sponsor: Vaxart, Inc. Funding Sponsor POC: David N. Taylor, MD Chief Medical Officer Vaxart, Inc. 400 Oyster Point Blvd., Suite 222 South San Francisco, CA 94080 Email: [email protected] Mobile phone: 919-349-6109 Protocol Version Number: 1.1 Amendment 1 Date: 21 September 2018 Confidentiality Statement This document is confidential and is to be distributed for review only to investigators, potential investigators, consultants, study staff, and applicable independent ethics committees or institutional review boards. The contents of this document shall not be disclosed to others without written authorization from Vaxart (or others, as applicable), unless it is necessary to obtain informed consent from potential study subjects. SIGNATURE PAGE/STATEMENT OF COMPLIANCE Version 1.1 Confidential Page 1 of 50 Date: 21Sept 2018 Protocol Number: VXA-G11-201.1 ________________________________________________________________________________ Protocol Title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Protocol Number: VXA-G11-201.1 Vaxart, Inc. ______________________________ ________________ David Taylor Date Chief Medical Officer The trial will be conducted in accordance with the International Conference on Harmonisation (ICH) E6 and the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46). -
Placebos, Randomization and Financial Incentives
1 Placebos, randomization, and financial incentives – oh my! Balancing ethical considerations in clinical research Stephanie Kraft, JD and Kathryn Porter, JD, MPH ITHS Bioethics Core Treuman Katz Center for Pediatric Bioethics Seattle Children’s Research Institute Learning Objectives 1• Describe eight benchmarks for ethical clinical research 2 Discuss how empirical data illustrates limitations of ethics regulations of randomization 3 Identify elements of a proposed research study that warrant ethical deliberation Outline 1 Introduction to a framework for ethical clinical research 2 Case studies: what to do when benchmarks conflict 3 Group discussion and practice applying the framework Why research ethics? Please vote: Do you consider yourself an ethically responsible researcher? Why research ethics? “Isn’t ethics for people who have bad motivations?” • Not just about preventing egregious violations - no such thing as the “ethics police” • Also offers guidance, identifies potential challenges Why research ethics? Please vote: Have you ever faced an ethical challenge in your research that was outside the scope of the IRB? Why research ethics? “Aren’t there regulations for that?” • Research ethics analysis helps flesh out responsibilities above the regulatory floor Why research ethics? Please vote: Have you ever raised an ethics issue to a colleague or PI? Why research ethics? “Is it really my job to worry about ethics?” • Yes! • Ethics analysis is important for all research team members • Framework can empower researchers to identify and -
Top 10 Stories from the June 2021 AMA Special Meeting
Top 10 stories from the June 2021 AMA Special Meeting JUN 17, 2021 Kevin B. O'Reilly News Editor Nearly 700 physicians, residents and medical students gathered for the June 2021 AMA Special Meeting of the AMA House of Delegates (HOD) to consider a wide array of proposals to help fulfill the AMA's core mission of promoting medicine and improving public health. As they have done since the global pandemic was declared last year, the delegates met virtually. Pandemic heroism sets path for work ahead “This is a consequential time in American history, and in the history of medicine,” new AMA President Gerald E. Harmon, MD, said in his inaugural address. The nation is “at war against seemingly formidable adversaries: the COVID-19 pandemic, which has led to the deaths of millions worldwide, and hundreds of thousands here at home, prolonged isolation and its effects on emotional and behavioral health, political and racial tension, and the immense battle to rid our health system—and society—of health disparities and racism.” Watch or read Dr. Harmon’s speech. Susan R. Bailey, MD, now the AMA’s immediate past president, told delegates that “no one has shouldered more in this pandemic than our courageous colleagues on the front lines—brave men and women from every state who have gone above and beyond in service to their patients and communities. You will remain in our hearts and in our thoughts long after this pandemic is over.” Watch or read Dr. Bailey’s speech. Executive Vice President and CEO James L. Madara, MD, detailed the role “a more nimble, focused” AMA played in supporting physicians during a once-in-a-generation public health crisis and how that response can be channeled to advance health equity. -
COVID-19 Vaccination Programme: Information for Healthcare Practitioners
COVID-19 vaccination programme Information for healthcare practitioners Republished 6 August 2021 Version 3.10 1 COVID-19 vaccination programme: Information for healthcare practitioners Document information This document was originally published provisionally, ahead of authorisation of any COVID-19 vaccine in the UK, to provide information to those involved in the COVID-19 national vaccination programme before it began in December 2020. Following authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency being given to the COVID-19 Vaccine Pfizer BioNTech on 2 December 2020, the COVID-19 Vaccine AstraZeneca on 30 December 2020 and the COVID-19 Vaccine Moderna on 8 January 2021, this document has been updated to provide specific information about the storage and preparation of these vaccines. Information about any other COVID-19 vaccines which are given regulatory approval will be added when this occurs. The information in this document was correct at time of publication. As COVID-19 is an evolving disease, much is still being learned about both the disease and the vaccines which have been developed to prevent it. For this reason, some information may change. Updates will be made to this document as new information becomes available. Please use the online version to ensure you are accessing the latest version. 2 COVID-19 vaccination programme: Information for healthcare practitioners Document revision information Version Details Date number 1.0 Document created 27 November 2020 2.0 Vaccine specific information about the COVID-19 mRNA 4 Vaccine BNT162b2 (Pfizer BioNTech) added December 2020 2.1 1. -
Frequently Asked Questions About COVID-19
doh.sd.gov/covid/ Frequently Asked Questions About COVID-19 VACCINE SAFETY Why should I get vaccinated for COVID-19? COVID-19 can cause serious illness or even death. There’s no way to know how COVID-19 will affect you. And if you get sick, you could spread the disease to friends, family, and others around you, putting their lives at risk. Getting a COVID-19 vaccine greatly reduces the risk that you’ll develop COVID- 19. The vaccines prevent nearly 100% of hospitalizations and deaths due to COVID-19. Are the COVID-19 vaccines safe? Yes. The COVID-19 vaccines available in the United States meet the FDA’s rigorous standards for safety and effectiveness. Tens of millions of people in the United States have received COVID-19 vaccines, and all COVID vaccines will continue to be monitored for safety. Serious health effects from vaccines are very rare. It’s highly unlikely that COVID-19 vaccines will cause long-term health problems. Also, there is no evidence at all that they will cause infertility or cancer. Your risk for serious health problems is much lower from the vaccine than your risk if you’re unvaccinated and get COVID-19. COVID-19 can leave you with heart and lung damage and other conditions that require long-term treatment. Vaccines are much safer paths to immunity than the disease itself. How can COVID-19 vaccines be safe since they were developed so fast? Safe COVID-19 vaccines were developed quickly through the use of a century of vaccine experience; technology that was new to vaccines but had been studied for two decades; a coronavirus vaccine already in development at the National Institutes of Health; and tens of thousands of volunteers for clinical trials that enabled rapid accumulation of data on safety and effectiveness. -
Human Challenge Trials for Vaccine Development: Regulatory Considerations
POST ECBS Version ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016 Human Challenge Trials for Vaccine Development: regulatory considerations © World Health Organization 2016 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. -
A Toddler PCV Booster Dose Following 3 Infancy Priming Doses Increases
Vaccine 36 (2018) 2774–2782 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine A toddler PCV booster dose following 3 infancy priming doses increases circulating serotype-specific IGG levels but does not increase protection against carriage ⇑ Ron Dagan a, , Shalom Ben-Shimol a,b, Birgit Simell c, David Greenberg a,b, Nurith Porat a,b, Helena Käyhty d, Noga Givon-Lavi a,b a The Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel b The Pediatric Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel c Institute for Molecular Medicine Finland (FIMM), University of Helsinki, Helsinki, Finland d Department of Vaccination and Immune Protection, National Institute for Health and Welfare (THL), Helsinki, Finland article info abstract Article history: Background: We compared PCV7 serological response and protection against carriage in infants receiving Received 7 January 2018 3 doses (2, 4, 6 months; 3+0 schedule) to those receiving a booster (12 months; 3+1). Received in revised form 30 March 2018 Methods: A prospective, randomized controlled study, conducted between 2005 and 2008, before PCVs Accepted 3 April 2018 were implemented in Israel. Healthy infants were randomized 1:1:1 to receive 3+1, 3+0 and 0+2 (control Available online 11 April 2018 group; 12, 18 months doses). Nasopharyngeal/oropharyngeal swabs were obtained at all visits. Serum serotype-specific IgG concentrations and opsonic activities (OPA) were measured at 2, 7, 13 and 19 Keywords: months. This study was registered with Current Controlled Trials, Ltd. ISRCTN28445844. Pneumococcal conjugate vaccines Results: Overall, 544 infants were enrolled: 3+1 (n = 178), 3+0 (n = 178) and 0+2 (n = 188). -
An Overview of COVID Vaccine Clinical Trial Results & Some Challenges
An overview of COVID vaccine clinical trial results & some challenges DCVMN Webinar December 8th, 2020 Access to COVID-19 tools ACCESSACCESS TO TOCOVID-19 COVID-19 TOOLS TOOLS (ACT) (ACT) ACCELERATOR ACCELERATOR (ACT) accelerator A GlobalA GlobalCollaboration Collaboration to Accelerate tothe AccelerateDevelopment, the Production Development, and Equitable Production Access to New and Equitable AccessCOVID-19 to New diagnostics, COVID-19 therapeutics diagnostics, and vaccines therapeutics and vaccines VACCINES DIAGNOSTICS THERAPEUTICS (COVAX) Development & Manufacturing Led by CEPI, with industry Procurement and delivery at scale Led by Gavi Policy and allocation Led by WHO Key players SOURCE: (ACT) ACCELERATOR Commitment and Call to Action 24th April 2020 ACT-A / COVAX governance COVAX COORDINATION MEETING CEPI Board Co-Chair: Jane Halton Co-Chair: Dr. Ngozi Gavi Board Workstream leads + DCVMN and IFPMA-selected Reps As needed – R&D&M Chair; COVAX IPG Chair Development & Manufacturing Procurement and delivery Policy and allocation (COVAX) at scale Led by (with industry) Led by Led by R&D&M Investment Committee COVAX Independent Product Group Technical Review Group Portfolio Group Vaccine Teams SWAT teams RAG 3 COVAX SWAT teams are being set up as a joint platform to accelerate COVID- 19 Vaccine development and manufacturing by addressing common challenges together Timely and targeted Multilateral Knowledge-based Resource-efficient Addresses specific cross- Establishes a dialogue Identifies and collates Coordinates between developer technical and global joint effort most relevant materials different organizations/ challenges as they are across different COVID-19 and insights across the initiatives to limit raised and/or identified vaccines organizations broader COVID-19 duplications and ensure on an ongoing basis (incl. -
Road to Recovery: Recovering from Post-Acute COVID-19 (Long COVID)
Road to Recovery: Recovering from post-acute COVID-19 (long COVID) Information and Advice Name: _____________________________ Symptoms reported by patients with post-acute (long) COVID-19 2 Recovery from post-acute COVID-19 (long COVID), October 2020 What is COVID-19? Covid-19 is an infectious virus that mainly affects the lungs. It is transmitted through droplets created from sneezing and coughing. The virus enters the body via the nose, mouth and eyes. What is post-acute COVID-19 (long COVID)? It is the term for someone who has not recovered for several weeks or months following the start of symptoms that were suggestive of COVID, whether they were tested for COVID-19 or not. We do not yet know why some people’s recovery takes much longer than others. What are the symptoms of post-acute COVID-19 (long COVID)? The most commonly reported symptoms are: • Fatigue • Muscle, body aches • Difficulty breathing • As well as the physical symptoms listed, it is very common to experience feelings of anxiety and low mood. Controlling shortness of breath Relieving shortness of breath People who have had a respiratory illness can often feel short of breath (SOB) afterwards. Often daily tasks such as walking, getting dressed or doing chores around the house can cause this breathlessness. Feeling like you can’t catch your breath can make you panic or feel frightened. Learning to control these feelings of breathlessness is a skill that will help you to be less troubled by this and enable you to do more. When you are feeling breathless, do not panic. -
Effectiveness of Pfizer-Biontech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021
Morbidity and Mortality Weekly Report Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021 Mark W. Tenforde, MD, PhD1; Samantha M. Olson, MPH1; Wesley H. Self, MD2; H. Keipp Talbot, MD2; Christopher J. Lindsell, PhD2; Jay S. Steingrub, MD3; Nathan I. Shapiro, MD4; Adit A. Ginde, MD5; David J. Douin, MD5; Matthew E. Prekker, MD6; Samuel M. Brown, MD7; Ithan D. Peltan, MD7; Michelle N. Gong, MD8; Amira Mohamed, MD8; Akram Khan, MD9; Matthew C. Exline, MD10; D. Clark Files, MD11; Kevin W. Gibbs, MD11; William B. Stubblefield, MD2; Jonathan D. Casey, MD2; Todd W. Rice, MD2; Carlos G. Grijalva, MD2; David N. Hager, MD, PhD12; Arber Shehu, MD12; Nida Qadir, MD13; Steven Y. Chang, MD, PhD13; Jennifer G. Wilson, MD14; Manjusha Gaglani, MBBS15,16; Kempapura Murthy, MPH15; Nicole Calhoun, LMSW, MPA15; Arnold S. Monto, MD17; Emily T. Martin, PhD17; Anurag Malani, MD18; Richard K. Zimmerman, MD19; Fernanda P. Silveira, MD19; Donald B. Middleton, MD19; Yuwei Zhu, MD2; Dayna Wyatt2; Meagan Stephenson, MPH1; Adrienne Baughman2; Kelsey N. Womack, PhD2; Kimberly W. Hart2; Miwako Kobayashi, MD1; Jennifer R. Verani, MD1; Manish M. Patel, MD1; IVY Network; HAIVEN Investigators On April 28, 2021, this report was posted as an MMWR Early ≥65 years. Vaccination is a critical tool for reducing severe Release on the MMWR website (https://www.cdc.gov/mmwr). COVID-19 in groups at high risk. Adults aged ≥65 years are at increased risk for severe outcomes Randomized clinical trials of vaccines that have received an from COVID-19 and were identified as a priority group to EUA in the United States showed efficacy of 94%–95% in receive the first COVID-19 vaccines approved for use under preventing COVID-19–associated illness (4,5).§ However, an Emergency Use Authorization (EUA) in the United States hospitalization is a rare outcome among patients with (1–3). -
Acceptance of COVID-19 Vaccination in Cancer Patients in Hong Kong: Approaches to Improve the Vaccination Rate
Article Acceptance of COVID-19 Vaccination in Cancer Patients in Hong Kong: Approaches to Improve the Vaccination Rate Wing-Lok Chan 1,* , Yuen-Hung Tricia Ho 1, Carlos King-Ho Wong 2,3 , Horace Cheuk-Wai Choi 4, Ka-On Lam 1, Kwok-Keung Yuen 4, Dora Kwong 1 and Ivan Hung 5 1 Department of Clinical Oncology, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China; [email protected] (Y.-H.T.H.); [email protected] (K.-O.L.); [email protected] (D.K.) 2 Department of Pharmacology and Pharmacy, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China; [email protected] 3 Department of Family Medicine and Primary Care, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China 4 Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China; [email protected] (H.C.-W.C.); [email protected] (K.-K.Y.) 5 Department of Medicine, LKS Faculty of Medicine, The University of Hong Kong, Hong Kong, China; [email protected] * Correspondence: [email protected] Abstract: Emerging efficacy and safety data have led to the authorization of COVID-19 vaccines worldwide, but most trials excluded patients with active malignancies. This study evaluates the intended acceptance of COVID-19 vaccination in cancer patients in Hong Kong. Methods: 660 adult cancer patients received a survey, in paper or electronic format, between 31 January 2021 and 15 Citation: Chan, W.-L.; Ho, Y.-H.T.; February 2021. The survey included patient’s clinical characteristics, perceptions of COVID-19 and Wong, C.K.-H.; Choi, H.C.-W.; Lam, vaccination, vaccine knowledge, cancer health literacy, and Hospital Anxiety and Depression scale K.-O.; Yuen, K.-K.; Kwong, D.; Hung, (HADS).