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Infectious Diseases
Patrick, a rider picking up containers of sputum during community outreach in Akowonjo, Lagos. The coronavirus (COVID-19) pandemic has affected many facets of life in Nigeria – educational, economical, commercial, religious and health activities of the nation have either been halted or disrupted.
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During the lockdown, where I would ordinarily pick 12 samples before, I picked only one or two. People could not come out. When you are working and seeing improvement you will be happy. The people that employ us try to encourage us that even it is just one or two, we just carry it and add it to the others.”
Akowanjo, Alimosho, Lagos (01, July, 2020)
How to address the challenges of collecting quality health data under COVID-19 disruptions The COVID-19 pandemic is impacting the fight against HIV, tuberculosis and malaria. Health and community systems are overwhelmed, treatment and prevention programs are disrupted, and resources are diverted. 1
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requent, high-quality and timely data allows countries to quickly identify and respond to changes in epidemiology and to learn which interventions are having most impact. To track the progress of HIV, TB and malaria programme implementation, the Global Fund invests nearly US$ 500 million every three years to support the establishment, rollout and maintenance of routine health management information systems (HMIS) in the implementing countries, with strong results.2 Data from a functional routine HMIS, even not quality checked, can be very helpful for trend analysis. Qualitative data from communities helps to make the entire situation clear. This is why the Global Fund started reinforcing community-based monitoring and reporting, through capacity building and community engagement. But under COVID-19 disruptions, how can we ensure useful data is collected? Effective access to prevention, diagnosis and treatment for infectious diseases and other essential health services has been particularly difficult for vulnerable communities. COVID-19 response measures, such as lockdowns, restrictions on gatherings of people and transport have led to delays or complete stoppages in service delivery at hospitals, laboratories, community health centers and supply chains. Technical solutions and digital health technology have enabled countries and organisations to adapt monitoring, evaluation and surveillance systems to lockdowns and remote working, enabling integrated disease surveillance systems. Examples include additional mobile phones, tablets and laptops for data collection and management, virtual adherence support, telemedicine and data integration applications, as well as video conferencing software. Yet technology alone is not enough One can have access to a highly-effective IDSR (Integrated Disease Surveillance and Response), but in a crisis context, staff usually inputting
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Jinkou Zhao Senior Specialist, Monitoring & Evaluation, The Global Fund
the numbers may be missing… The human factor also plays a role when it comes to prioritising which information should be collected and how it should be interpreted, or how to better coordinate with other health agencies to gather and analyse the data. One good example of how to adapt to the current situation is the COVID-19 monitoring tool launched by the Global Fund, which relies on country-based local fund agents to provide an overview of the performance of each country in implementing the programmes the Global Fund supports under the COVID-19 disruptions.3 This tool is not a rigorous assessment of the country situation but can serve as an early warning system to indicate which activity or component may be going off track so that stronger actions can be taken to further mitigate the impact of COVID-19 on the fights against HIV, TB and malaria. It also helps us drawing trends over time and across countries and regions. If there is any lesson to learn here, it may be that in the COVID-19 era, like in any time of crisis, we must accept compromise Accept, to some extent, unverified results and use them. Look for general trends over time instead of highly accurate data points. Act in an emergent manner, without deep nuances, to win the right momentum. Compromise representativeness but rather do spot checks. And eventually acknowledge with British statistician George E P Box that “all models are wrong, but some are useful”, as they can help estimating the potential negative impact in specific disease or geographic areas to trigger timely mitigation actions. References 1. https://www.theglobalfund.org/media/9819/covid19_mitigatingimpact_report_en.pdf?u=637321467815130000 2. https://www.theglobalfund.org/en/blog/2020-07-21-strengthening-data-systems-to-save-lives/ 3. https://globalfund.exposure.co/disruptions-in-hiv-tb-and-malaria-programs-due-to-covid19
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Working together towards equal, available, and affordable access The pharmaceutical industry is collaborating on an unprecedented scale and stepping up to develop COVID-19 treatments and vaccines. Thomas Cueni, Director General of the IIFPMA, explains how.
Thomas B. Cueni Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
think industry has really stepped up. They are an integral part of the Access to COVID-19 Tools (ACT) Accelerator, they are very engaged in the vaccine development,” said Jeremy Farrar of the Wellcome Trust, in a Chatham House Weekly COVID- 19 Pandemic Briefing. He called to “use the best of what only industry can bring in terms of the know how to develop new products.” This was the perfect set up for me, at the following briefing, where I joined Emma Ross, Senior Consulting Fellow of the Global Health Programme of Chatham House, to answer questions on how the pharmaceutical industry is collaborating on an unprecedented scale to develop COVID-19 technologies and tools, the challenges and concerns the industry faces and the best approaches to adopt to ensure equitable and affordable access to COVID-19 therapeutics and vaccines for all; leaving no one behind. Not business as usual From the get-go, there has been a strong sense across the innovative biopharmaceutical industry that the pandemic is not business as usual. We believed then, as we do now, that fair and equitable access and collaboration are vital and play to the innovative strengths of the biopharmaceutical industry – we launched our commitments in March 2020 and we are tracking what we are doing against them. Partnering to innovate and to scale up Innovative biopharmaceutical companies have wasted no time in setting up collaborations across the board. We are working with academia, biotechs as well as together; both to push forward the science as quickly as possible, as well as to scale up manufacturing to meet the demand for treatments and vaccines. At present, over 20 IFPMA member companies are involved in R&D for therapeutics, vaccines and
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diagnostics, and are involved in 73 clinical trials. While this work is underway, R&D biopharmaceutical companies are maintaining production and distribution to keep supplying essential medicines for patients with other life-threatening diseases. Working together towards equal, available, and affordable access In joining ACT-Accelerator, and in particular working to support the COVAX pillar, IFPMA is fully engaged in helping meet the challenge of manufacturing billions of doses of a vaccine or vaccines that have yet to be tested and found to be safe and effective. In this area, we are the only player that has the know-how, the experience, and the proven track-record to deliver in the volumes and at the scale needed. However, our members would not have been able to investigate solutions against COVID-19 without the innovation ecosystem that relies on intellectual property, or without the collaborative spirit we have seen. Without them we would be unable to ramp up at-risk
The pharmaceutical industry is collaborating on an unprecedented scale to develop COVID-19 technologies and tools.” production in the way we have done. Lessons learnt, emergency preparedness Looking to the future it is apparent that we need to be better prepared for pandemics. There is a role for the industry to support the world in being better prepared. The private sector needs to be involved early on in discussions to prevent future pandemics and to bolster new initiatives and partnerships in areas that need urgent attention, not least neglected tropical diseases, and antimicrobial resistance. Read more at globalcause.co.uk
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Paid for by EIT Health
How collaboration could be key to beating the pandemic
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“rapid response call” was put out by EIT Health in April for projects that would start immediately and have an immediate impact on the COVID-19 pandemic. But these projects need financial support. Over €6 million has been pledged by the European Institute of Innovation and Technology’s (EIT) health branch, EIT Health, to fund 15 specially selected studies, which unite 41 partners across the organisation’s network.
workers to see if any have been re-infected with the virus, and how their immune response differs from those who have not been re-infected despite also being exposed. How likely might COVID-19 re-infection be? Professor Markus Gerhard of the TUM School of Medicine, activity lead of CoViproteHCT, says: “We already knew from preliminary data in China that re-infection might be possible, and that hasn’t changed much. We know there are protective antibodies, but we have also seen re-infection. “We are not yet sure how to define the protective immune response, which is necessary for vaccine development and to safely get people back to work.”
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The fight against COVID-19 has involved organisations across the world uniting to share knowledge, resources and innovation.
We are not yet sure how to define the protective immune response, which is necessary for vaccine development and to safely get people back to work.”
In an effort to determine the immune response to COVID-19, one project, CoViproteHCT, is a collaboration between Technische Universität München (TUM), Fundacion Privada Instituto de Salud Global Barcelona (ISGLOBAL), the University of Barcelona and Mikrogen GmbH, a German biotech specialised in diagnostics for infectious diseases. Testing for COVID-19 markers in blood Several serological assays – tests for certain markers of immune responses in the blood – are being developed to identify individuals who have recovered from COVID-19. However, it is still not clear which types of assay can predict protective immunity. CoViproteHCT will collect blood samples from healthcare personnel who have tested positive, and test them for antibody and cell-based markers for COVID-19 immunity. By monitoring individuals’ blood markers with their actual health status over time, the researchers hope to determine which markers indicate truly protective immunity. After six months, researchers will re-examine these healthcare
Prof Dr Markus Gerhard Deputy Director, Institute for Medical Microbiology, Immunology and Hygiene, Technical University Munich
Written by: Meredith Jone Russell
Benefits to frontline workers could be huge This study will highlight whether or not healthcare personnel who have gone through a COVID-19 infection are protected against re-infection. Plus, validated assays could be used in future vaccine trials to determine the effectiveness of experimental vaccines. “Ultimately, assuming we can identify a protective immune response, the goal will be to work with our company partner in the consortium, Mikrogen, and develop the assay together, so it can be used for routine testing for protective responses in a more formal way,” added Professor Gerhard. Working together is much more efficient – and more supportive Professor Gerhard says: “Working with partners on an operational level is very efficient and supportive. When we want to share an idea, it is usually just a matter of a quick phone call or email. “I’m also hoping that, if our project works out, we will be able to transfer our assay to our partners, and it could reach the market at some point in the future.”
Read more at eithealth.eu/project/ coviprotehct/
EIT Health is one of several Knowledge and Innovation Communities established by the EIT, a body of the European Union. The aim is to jointly address the urgent health challenges of our time with concrete measures and programmes in order to open up new resources for established and young companies and to realise their ideas in common products and services for the European market. EIT Health is a network of around 150 partners from science, research and industry, founded with the understanding that bringing together such diverse perspectives, skills and strengths can drive the kind of healthcare innovations that improve the lives of citizens and patients across Europe.
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Rapid antimicrobial resistance detection for early directed therapies against infectious diseases In recent years, antimicrobial resistance (AMR) has reached proportions of such significance to propel national and global health authorities to regard AMR as today’s “serious threat” worldwide.
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argeting AMR has important clinical implications not only related to diagnosis and management but also prevention of infectious diseases, particularly those causing sepsis. Determinants of deaths associated with antimicrobialresistant pathogens known as causative agents of community and hospital-acquired bloodstream infections (BSIs) remain not fully explained. However, in a metaanalysis of sepsis treatment, the mortality rate in patients who were receiving inappropriate antibiotic therapy was higher than among patients who were appropriately treated.
Professor Maurizio Sanguinetti President, ESCMID
Innovations in diagnostics Infectious diseases diagnostic innovations are broadening the capability for rapid identification and characterisation of BSI pathogens, defining the makeup of antimicrobial-resistant organisms in order to ensure maximal impact at the patient level. This is particularly true for
Gram-negative bacteria (e.g. Enterobacteriaceae), which cause difficult-to-treat infections in immunosuppressed and hospitalized patients, because of multiple resistance mechanisms contributing to each observed phenotype in antibiotic-resistant isolates. In some settings, clinicians are routinely obliged to treat patients with broad-spectrum antibiotics – even when bacterial infection is microbiologically absent – thereby implying the emergence of antibiotic-resistant bacterial organisms. The role of precision medicine We agree that the new “precision medicine” paradigm – which has extensively been used in cancer chemotherapy – should be ever increasingly applied to antimicrobial chemotherapy. In this context, it is worth noting that T2Resistance™ panel has recently been marketed as a nonculture diagnostic test that uses T2 magnetic resonance to detect encoding genes in whole blood samples (www.t2biosystems.
com/products-technology/ pipeline/t2resistance-panel/). The information available from rapid diagnostic testing can be immediately incorporated into clinical decision-making regarding the therapy of Gram-negative bacterial BSIs. Specifically, algorithms for the interpretation of AMR testing and treatment of BSIs may be adopted to achieve a rapid, effective and “molecularlytargeted” antimicrobial chemotherapy regimen for any individual patient. In conclusion, use of rapid diagnostic approaches for AMR detection will likely provide an important means for achieving the balance between administration of new and existing antibiotics and emergence of antimicrobialresistant BSI pathogens. Studies that measure the impact of rapid diagnostics-based interventions on both antimicrobial utilisation and time to effective treatment, as well as that determine if use of rapid diagnostics improves BSI patients’ outcomes are needed.
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