Preparing Pandemic Vaccine Capacity

Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.

A review on water-saving agriculture in Europe

This paper aims to analyze the research on the current situation of water-saving agriculture development in Europe. Water-saving agriculture in Europe started early, governments and farmers in various countries have a strong awareness of water-saving in agriculture and have achieved certain results. Due to the global spread of the COVID-19 pandemic, the lack of up-to-date field research, the complexity of various agricultural disciplines and categories, and the lack of information sharing, the current cognition of recent progress in the development of water-saving agriculture in Europe is not comprehensive enough. This paper selects four representative European countries: Spain, Germany, Italy, and Denmark as the research objects. Based on the existing research of Chinese and Western scholars, this paper analyzes and studies the current situation of water-saving agriculture in Europe. It has far-reaching significance for other countries in the world to have further development in water-saving agriculture and to protect water resources.

Scalability of digital psychological innovations for refugees: A comparative analysis in Egypt, Germany, and Sweden

E-mental health interventions may offer innovative means to increase access to psychological support and improve the mental health of refugees. However, there is limited knowledge about how these innovations can be scaled up and integrated sustainably into routine services. This study examined the scalability of a digital psychological intervention called Step-by-Step (SbS) for refugees in Egypt, Germany, and Sweden. We conducted semi-structured interviews (n = 88) with Syrian refugees, and experts in SbS or mental health among refugees in the three countries. Data collection and analysis were guided by a system innovation perspective. Interviewees identified three contextual factors that influenced scalability of SbS in each country: increasing use of e-health, the COVID-19 pandemic, and political instability. Nine factors lay at the interface between the innovation and potential delivery systems, and these were categorised by culture (ways of thinking), structure (ways of organising), and practice (ways of doing). Factors related to culture included: perceived need and acceptability of the innovation. Acceptability was influenced by mental health stigma and awareness, digital trust, perceived novelty of self-help interventions, and attitudes towards non-specialist (e-helper) support. Factors related to structure included financing, regulations, accessibility, competencies of e-helpers, and quality control. Factors related to practice were barriers in the initial and continued engagement of end-users. Many actors with a potential stake in the integration of SbS across the three countries were identified, with nineteen stakeholders deemed most powerful. Several context-specific integration scenarios were developed, which need to be tested. We conclude that integrating novel e-mental health interventions for refugees into routine services will be a complex task due to the many interrelated factors and actors involved. Multi-stakeholder collaboration, including the involvement of end-users, will be essential.

Developing an aid for virtual clinics for education and identification of lipohypertrophy during the Covid-19 pandemic: Diabetesclinic@ home

Aims/objectives: To develop an app to support virtual diabetes clinics to help people with diabetes to check themselves for lipos and to discuss what they found during the virtual consultation. Method(s): Collaborative project between clinical teams and medical illustrators in Swansea Bay University Health Board, academics in Swansea University and Eli Lilly under a Collaborative Working Agreement. The teams worked together to develop the content, animations, and a learning technologist developed progressive web app (PWA). The app was tested by diabetes patient groups in Wales, as well as HCP groups, Welsh Academy for Nurses in Diabetes (WAND) and Diabetes Specialist Nurses (DSN) forum prior to launch in June 2021. Result(s): Between 28th June 2021 and 11th November 2022 the app had 827 unique users and 124 returning users. Users came from 15 different countries including UK, Australia, USA, Germany, Brazil and Saudi Arabia. The proportion of UK users were 480 (60%) England, 265 (34%) Wales, and 19 (2%) Scotland. A total of 41 users completed the feedback form;of those 11 (27%) did not know about lipos prior to using the app, 11 (27%) found a lipo using the app, 14 (34%) said they made changes to injection technique after using the app and 37 (90%) said their knowledge of lipos increased following using the app. Conclusion(s): A PWA can help to aid virtual clinics an provide education for people with diabetes. The diabetesclinic@ home app improved knowledge and detection of lipos and improved injection technique.

Food Bank Operations during the COVID-19 Pandemic in Germany

The COVID-19 pandemic has a substantial impact on food bank operations. This article aims to provide an overview of the challenges and responses of food banks in Germany. Publicly available data was used and surveys were conducted among 948 food banks, at three time points in 2020. More than half of participating food banks were closed in spring, whereas nearly all were open again in summer. Food banks implemented alternative modes of food distribution and response measures to stay open. However, they seem to be less resilient to challenges like COVID-19, in particular due to their reliance on volunteers.Copyright © 2021 Taylor & Francis Group, LLC.

What counts, safety and security or hygiene? Suggestions on the reopening of major events under pandemic conditions in Germany

PurposeBetween 2020 and spring 2022, health safety was the new pressing concern among the risks at major events. It seemed that it – respectively hygiene as part of infection control – was as important as event safety if an event in Germany was to be approved. Problems aroused in terms of an equal implementation in practice. This article therefore addresses how safety and hygiene aspects interacted during event planning and implementation phases.Design/methodology/approachThe authors draw on qualitative data from a German research project. They use results from eleven semi-structured expert interviews and four field observations at major events. One guiding assumption in the content analysis is that there are major interrelations between event and health safety concepts, which become visible during planning and the implementation of event-related technical, organisational and personal measures.FindingsThe empirical data shows that hygiene is not perceived as an integral part of event safety, but rather as a disconnected pillar beside the "classical” event safety. This is reflected in an imbalanced attention as well as in separate, disintegrated concepts. This disconnectedness leaves room for unwanted interplays between event and health safety as well as potential legitimacy facades.Originality/valueMost studies to date focus on the effectiveness of hygiene concepts and impacts of COVID-19 on the event sector in general without taking a closer look at interactions between event safety and health safety.

Continuity despite crises: Germany's euro policy in the light of the pandemic, war and inflation

After a decade of reforming and stabilising the Economic and Monetary Union (EMU), it has been put to a triple test: the COVID-19 pandemic, the war in Ukraine, and the return of inflation have posed serious challenges to the eurozone that call for policy responses. Against the background of recent advances in European integration theory, we assess whether and how these challenges have led to a change in the EMU policy of the eurozone's most powerful member, Germany. We conceptualise three ideal-typical policy options for Germany to deal with EMU's challenges and we search for traces of policy learning from past eurozone crisis management. On the basis of semi-structured interviews with German political elites, we cannot identify any significant change in Germany's EMU policy. We conclude that the unwavering continuity of Germany's euro policy makes further substantial integration in EMU unlikely. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

The COVID-19 framing dataset: How secondary data can be used to explore paradoxical attitudes during the COVID-19 pandemic

We present a data set containing data of five cross-cultural framing studies conducted during the COVID-19 pandemic (Austria, Germany, U.K. and U.S.). The dataset covers data on participants' conspiracy mentality, distrust in science, risk aversion, individualism-collectivism and the endorsement of preventive behaviors such as vaccination willingness. In addition, across all studies, we collected data of a newly developed scale measuring paradoxical, anti-prevention attitudes during the COVID-19 pandemic (2020-2021). We think that authors interested in the interplay of different traits and COVID-19 attitudes could be interested in the secondary use of the data set, and especially in the newly developed Paradox of Prevention Scale. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Dynamic modelling of changes in emotional and behavioural problems in children and adolescents during the COVID-19 pandemic

Aims: Children and adolescents were affected in various ways by the measures due to COVID-19 pandemic. The aims of this study were to investigate and compare the effects on mental health across age, to identify latent class trajectories of emotional and behavioural problems over 12-months and to examine the association of classes of trajectories with baseline demographic and clinical predictors. Method(s): Children (n = 1854) and adolescents (n = 1243) from the general population were assessed baseline, at 6-, 9-, and 12-month follow-up. They were eligible if they were residents in Austria, Germany, or Switzerland, were parents/caregivers of a child aged between 7 and 10 years or adolescents >=11 years, had sufficient German language skills and provided informed consent. Results and Conclusion(s): Significant age-effects were found regarding type and frequency of problems. While children had the largest increase in aggressive behaviours, adolescents reported the largest increase in emotional problems. Sociodemographic variables, exposure to and appraisal of COVID-19, psychotherapy before COVID-19 and parental mental health significantly predicted change in problemscores (F >= 3.69, p <= .001). Using growth mixture modelling, a oneclass solution was detected for the trajectory of aggressive behaviours and a two- and three-class solution for withdrawn/depression and anxiety/depression. A substantial proportion of children and adolescents experienced age-related mental health problems during the different stages of the COVID-19 pandemic. These results suggest that psychological problems of specific sub-groups should be monitored over the longer-term and interventions to improve communication, emotion regulation, and appraisal style should be offered to risk groups.

The Impact of the Sars-Cov-2 Pandemic (COVID-19) on the Incidence of Newly Diagnosed Multiple Myeloma Patients Using a Federated Network of Real-World Evidence in US and Germany

Objectives: COVID-19 had an impact on health care, including diagnostics. Early diagnosis of MM is a critical factor for prognosis. We examined the impact of COVID-19 on incidence of NDMM patients and on characteristics in NDMM patients in US and in Germany. Method(s): 44,164 NDMM patients were identified in TriNetX federated network across 55 healthcare organizations in US between January 2018 and December 2021. A bivariate analysis examined changes in patient characteristics in two cohorts before (Cohort 1;n=25513) and after (Cohort 2;n=18.651) the start of the COVID-19 pandemic in March 2020. 4172 NDMM patients were identified in the German database in a sample of across >100 healthcare organizations in the same time period. Similarly, bivariate analysis examined changes in patient characteristics before (Cohort 1;n=2252) and after (Cohort 2;n=1920) the start of pandemic. Result(s): Analysis of US data showed a significant decrease in incidence of NDMM. Bivariate analysis revealed that NDMM patients in Cohort 2 have a significantly higher risk profile compared with patients in Cohort 1, higher incidence of renal failure (13.5% v. 15.43%), heart failure (10.3% v 11.26%), bone lesions (12.6% v. 13.05%) and anemia (26.8% v. 29.75%). The German data indicated an increased risk profile in Cohort 2, with higher reporting of renal impairment (12.3% v. 15.5%) and cardiac impairment (8.3% v. 10.9%). The higher risk profile was reflected in a significant increase of all SLiM-CRAB criteria, notably hypercalcemia (24.1 % v. 36.9%), bone marrow plasma cell infiltration (28.1% v. 36.8%) and free light chain involvement (27.3% v. 41.3%). Conclusion(s): The results provide real-world evidence of a change in risk profile for patients with NDMM during COVID-19. This higher risk profile is observed in both the US and Germany, and may negatively impact outcomes such as progression-free and five-year overall survival.Copyright © 2023

Survey and 10-day diary data on infant nutrition, development, and home learning environment during the COVID-19 pandemic from the LEARN-COVID pilot study

The LEARN-COVID pilot study collected data on infants and their parents during the COVID-19 pandemic. Assessments took place between April and July 2021. Parents (N = 357) from Switzerland (predominantly), Germany, and Austria answered a baseline questionnaire on their behaviour related to the pandemic, social support, infant nutrition, and infant regulation. Subsequently, parents (n = 222) answered a 10- day evening diary on infant nutrition, infant regulation, parental mood, and parental soothing behaviour. Data and documentation are stored on Zenodo, https://doi. org/10.5281/zenodo.6946048. These data may be valuable to researchers interested in infant development and parenting during the pandemic as well as to researchers interested in daily variability in infant behaviour, parenting, and nutrition. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Data from the German Family Panel pairfam: The supplementary COVID-19 survey

The COVID-19 pandemic had major implications for private and family lives. The German Family Panel pairfam conducted an online survey regarding the experiences during the pandemic. The survey was conducted from May to July 2020. It includes instruments introduced in previous pairfam waves as well as new modules on topics that proved particularly relevant during the COVID-19 pandemic. The resulting dataset encompasses a sample of 3,182 respondents from all German federal states ranging in age from 17-47 years. The data has already been used in a variety of scientific publications and is available for research and teaching purposes. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Lifelong Learning-Studying in the European Higher Education Area with COVID-19

Lifelong learning comprises all learning undertaken throughout life, with a view to improving knowledge, qualifications and competences within a personal, civic, social or employment-related perspective. This EU definition, which is still valid today, was laid down in the document 'Creating a European area of lifelong learning in 2001.' Lifelong learning has many advantages. Both of the authors did feel the need for some additional tasks, new knowledge and further input. As the tax law requires certain criteria to accept the costs, we did search which options the German state hold and privately hold Universities offer for a certain type of graduation, especially a diploma from a technical college. There is always a possibility for lifelong learning if that's really desired and then COVID-19 happened. Luckily the EU based universities managed that challenge maybe even better that the German universities. There is still research needed for online evaluation of students or exams and the usage of computers during the exam and it will be challenging and hard to detect and identify dishonest students.

ID: 218414 Queen Mary University London Postgraduate Certification in Neuromodulation- Accreditation in Neuromodulation

Introduction: There is a distinct unmet need in structured, curriculum based, unbiased education in neuromodulation. Current teaching is through sporadic industry workshops, cadaver courses and peer proctorship. The COVID pandemic has created a unique opportunity where online platforms have enabled education to be delivered remotely in both synchronous and asynchronously. The William Harvey Research Institute, Queen Mary University, London, UK have initiated University based accreditation- Post Graduate Certificate in neuromodulation (PGCert) that provides candidate a qualification in one academic year through part-time study. Method(s): The program underwent rigorous staged university approval process (figure 1). To ensure market feasibility, two short proof of concept CPD programs "Executive Education in Neuromodulation (EEPIN)" were delivered in 2021. These courses attracted 87 candidates across Australia, Singapore, India, Germany, Poland, Czech Republic, Ireland, and UK. The faculty includes key opinion leaders that will deliver the program ensuring the candidates gain academic background and specialist skills to understand safe practice of neuromodulation. The PGCert advisory board has been established to ensure strict governance in terms of content and unbiased delivery confirming ACCME guidance. In order to obtain PGCert, candidates are required to complete 4 x 15 credit modules (60 credits). The four modules include Anatomy & Neurophysiology;Patient care and Procedurals skills;Devices and available technology;Intrathecal drug delivery for cancer and non-cancer pain. The modular nature of the program is designed to provide cumulative knowledge, from basic science to clinical application in line with the best available evidence. The modules comprise nine lectures, spreading over three consecutive days, followed by a written assignment with 40 direct contact hours in each module. The webpage can be accessed at Results: The anonymous data from EEPIN reported on Likert scale 1-5: Objectives defined 30.6% - 4 and 69.4% -5;Relevance of topics 10.2%- 4 and 89.8% -5;Content of presentations 22.4%- 4 and 77.6% -5;Organization 24.5% -4 and 69.4% -5;Candidate faculty interaction 14.3% -4 and 81.6% -5. 97% of the EEPIN candidates recommended the program to others whilst 81.8% expressed their strong interest to enroll for university-based post graduate qualification if offered. Conclusion(s): This PGcert Neuromodulation is a unique, university accredited program that provides qualification in neuromodulation with access to a flexible online e-learning platform to discuss and exchange ideas, share knowledge in candidate's own time. This will support the ongoing need for formal curriculum-based education in neuromodulation. Disclosure: Kavita Poply, PHD: None, Phillippe Rigoard: None, Jan Kallewaard, MD/PhD: None, FRANK J.P.M. HUYGEN, MD PhD: ABBOTT: Speakers Bureau:, Saluda: Consulting Fee:, Boston Scientific: Consulting Fee:, Grunenthal: Speakers Bureau:, Pfizer: Speakers Bureau:, Ashish Gulve, FRCA, FFPMRCA, FFPMCAI, DPMed, FCARCSI, MD, MBBS: None, Ganesan Baranidharan, FRCA: None, Sam ELDABE, MD, FRCA, FFPMRCA: Medtronic: Consulting Fee:, Medtronic: Contracted Research:, Mainstay Medical: Consulting Fee:, Saluda Medical: Consulting Fee:, Boston Scientific: Contracted Research:, Saluda Medical: Contracted Research:, James Fitzgerald, MA,PhD: St Jude Medical: Consultant: Self, Medtronic: Consulting Fee:, UCB: Contracted Research:, Merck: Contracted Research:, Serge Nikolic, MD: None, Stana Bojanic, BSc MBBS FRCS (SN): Abbott: Contracted Research:, Habib Ellamushi: None, Paresh Doshi, MS MCh: None, Preeti Doshi, MBBS, MD, FRCA: None, Babita Ghai, MBBS, MD, DNB: None, Marc Russo, MD: Presidio Medical: Ownership Interest:, Saluda Medical: Ownership Interest:, Boston Scientific: Contracted Research: Self, Mainstay Medical: Contracted Research: Self, Medtronic: Contracted Research: Self, Nevro: Contracted Research: Self, Saluda Medical: Contracted Research: Self, Presidio Medical: Contracted Research: Self, Freedom Ne ro: Ownership Interest - Own Stocks: Self, Lungpacer: Ownership Interest - Own Stocks: Self, SPR Therapeutics: Ownership Interest - Own Stocks: Self, Lawrence Poree, MD,MPH,PHD: Medtronic: Consulting Fee: Self, Saluda Medical: Contracted Research: Family, Nalu Medical: Contracted Research: Family, Gimer Medical: Consulting Fee: Self, Nalu Medical: Consulting Fee: Self, Saluda Medical: Consulting Fee: Self, Nalu: Ownership Interest:, Saluda Inc: Ownership Interest:, Alia Ahmad: None, Alaa Abd Sayed, MD: Medtronic, Abbott, SPR and StimWave: Consulting Fee:, Salim Hayek, MD,PhD: None, CHRISTOPHER GILLIGAN, MD MBA: Persica: Consulting Fee: Self, Saluda: Consulting Fee: Self, Mainstay Medical: Contracted Research: Self, Sollis Therapeutics: Contracted Research: Self, Iliad Lifesciences, LLC: Owner: individuals with legal ownership in a company:, Vivek Mehta: NoneCopyright © 2023

GERMANY'S HTA AGENCY SEEKS SUPPORT ON TRANSPARENCY ABOUT COVID-19 AGENTS

"EMA should support the international research community by publishing clinical study reports on medicine and vaccine trials at the time of marketing authorization and to inform treatment decisions." [...]Weiseler and Kaiser are acutely aware of the pressures that regulators are under in the face of a rising death toll, soaring infection and morbidity, and the wideranging economic and social consequences of extensive lock-downs. "Because of the severity of the current situation, regulators are aiming to accelerate the marketing authorization process," IQWiG comments, noting that first treatments have already been evaluated by regulators, as recently seen with the fast emergency use authorization of the antiviral remdesivir by the FDA, and that EMA has also started a "rolling review" of remdesivir. Data-sharing push The international research community is already undertaking coordinated efforts- IQWiG cites the living mapping and living systematic review of COVID-19 studies-to compile all emerging information on medicines and vaccines for the virus, it says, with a view to ensuring the optimal planning and conduct of research.

Changing Vaccine Assessment Criteria and Focus Towards Prevention Strategies

Objectives: To understand changes to granting access to novel vaccines by NITAG and payers and how prevention has become a focus in many markets Methods: Secondary research by studying various NITAG documents and published articles followed by primary research with experts in EU4 and UK Results: For NITAG recommendations, disease burden, vaccine efficacy, vaccine safety, followed by Epidemiology and mathematical modelling are conducted by most Western countries. Published studies on efficacy, effectiveness and reactogenicity are considered as key reference. UK specifically takes into account health economic modelling outputs. Recommendations in other markets are also considered in making local decisions. For vaccine funding payers consider the efficacy, durability and dosing regimen as key drivers, followed by aspects of strain coverage, formulation and storage. Platform were not considered by payers, while physicians considered it to be very important. For cost containment reasons, many NITAGs issue a recommendation for a narrow patient population Payers in all markets indicated that there is focus or prioritization of prevention strategies from ongoing COVID-19 pandemic and are likely to remain. UK for instance has increased its prevention budgets;however, this does not mean there is higher willingness to pay. In Germany there is no ring-fenced prevention specific budget. Conclusion(s): Severity of the disease is an important criterion in assessing the burden, an influential factor in vaccine decision making. In all countries in focus, Payers anticipate that the evaluation of new vaccines launched post-COVID-19 to be faster. Structural changes in Italy (restructure of AIFA and new NITAG) and UK (new public health agency), add to uncertainties on timelines. The length of the evaluation process will depends mainly on pre-work done with availability of local data on burden, epidemiology, and cost-effectiveness modelling.Copyright © 2023

Regulating with Flexibility: The Pandemic Effect

Inspectors checking compliance with current good manufacturing practice (CGMP) have not been able to visit sites because of travel controls, social distancing rules, and other safety regulations. Challenges with checking compliance GMP is a key means for checking the safety and quality standards of new processes, and plant alterations and expansions, particularly on existing manufacturing sites. At the national level in Europe, controls on COVID-19 vaccines development and distribution are in danger of fragmenting as governments pursue their own methods for speeding up R&D and for providing access to specific groups of patients. [...]once COVID-19 is no longer categorized as a health emergency, many exemptions and relaxations of rules could be withdrawn.

Parliamentarism in the Pandemic: Contemporary Challenges

Parliamentary democracy has been stress-tested in the COVID-19 pandemic. The Parliament, as the representation of the people, must be able to work and make unpopular decisions to protect society. Only in a transparent and legitimate decision-making process is it possible to win the support of the people. Parliamentarism in the pandemic must function effectively and safely. Also important is a legally secure election of the parliament in times of crisis to have a legislator legitimised by the people. In times of crisis, a functioning parliamentary system is particularly important for a democracy. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Getting it right in the pandemic

In a research paper that warrants close scrutiny by hospital administrators everywhere, Min Liu and colleagues find that none of 420 healthcare workers deployed to a hospital in Wuhan were infected with the virus, despite caring for severely ill patients and performing aerosol generating procedures over 6-8 weeks.3 The workers wore surgical masks and N95 respirators as well as protective suits and gowns, goggles, gloves, and face shields. The US and the UK missed the just right "Goldilocks zone” of hospital capacity by building temporary hospitals that remained mostly empty.6 How did this happen? "Bad modelling based on insufficient data,” says one expert. Missing the Goldilocks zone of hospital capacity during covid-19.

Is the Biggest Hindrance to Educational Success "Virtually" Solved?

It started with a simple little filler in "USA Today" 25 years ago. It showed a broken student desk with cobwebs on it and offered data on "average yearly absences" in Japan, Germany, and the United States. Assessing my own data, I verified that they were on point and proceeded to discuss why this was a major hurdle for our kids and what could be done. Now, 25 years later, I am revisiting this topic, but through the virtual lens, including new data.