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Prevention: The Concept of Preventive Risk Reduction, Illustrated by the COVID-19 Pandemic. Risk assessment and risk management based on the precautionary principle are instruments to protect humans and the environment against uncertain threats and risks. At the same time, however, trade-offs must always be made in order to maintain cultural, economic and social objectives and to honor the principle of proportionality. Notwithstanding the need for continuous risk reduction, society must distance itself from the idea that science can predict all dangerous events and developments and exclude them through preventive action. At best, risk analyses are able to identify the possible threats and uncover weaknesses in the system. In addition, risk assessments help us to make better decisions in the conflict of objectives between the secondary consequences of taking risks (such as exposure in the event of a pandemic) and the secondary consequences of the protective measures taken (economic, social, cultural consequences). In this sense, decisions about acceptability of risks or risk reduction measures always reflect a combination of scientific knowledge with balancing judgments.
Sepsis and the COVID-19 Pandemic: Challenges and Chances for Developing a Better Health System in Germany. Sepsis is the most serious complication of infectious diseases including patients critically illwith COVID-19. In 2017, sepsis was estimated to affect close to 50 million people and to cause or contribute to 11 million deaths, with over 3 million of those deaths being in children or adolescents.The WHO considers that most deaths from sepsis are preventable and therefore urges all member states to integrate sepsis in their national health strategy. However, this is not yet the case for Germany, although – compared to other western industrial countries – sepsis mortality rates in Germany are very high. The COVID-19 pandemic has presented the world with the most serious health threat in living memory, which until July 2021 resulted in more than 4 million deaths and unprecedented social and economic disruption. It has reminded us that infectious diseases still present a major global health threat. In contrast to the poor recognition of sepsis from other infections, the response to the pandemic has also been unprecedented in most countries in terms of instituting effective public health measures, and the global scientific community has come together to produce robust research evidence and novel vaccines in record time. Thus, a positive legacy for the COVID‑19 pandemic in Germany and around the globe would reduce the global burden of sepsis by making pandemic preparedness, infection prevention and control, sepsis and antimicrobial resistance integral parts of national infection control and management strategies.
The Concept of Health in Immunology and Infection Biology: Nine Opportunities for the Future. Looking at our individual immune systems, one might get the impression that health is mostly a personal matter. However, infection biology immediately points to the fact that health is the outcome of a global joint effort undertaken not only by all humans, but actually by all living beings. From the very large to the very small, health is based on a fragile balance and the successful collaboration of numerous single entities in a highly sensitive and complex network that connects our innermost world with that of the outside. Diseases have been with us forever, and in the course of time, they shaped our political and cultural community. Yet, they also are one of the main drivers of evolutionary development. In that capacity, they have promoted progress from simple life forms to complex beings, i. e., ourselves. Thus, health can also be seen as the product of innumerable tiny coincidences. Politics, academia and society should ensure prevention of future detrimental (or harmful) coincidences with such tragic outcomes.
19. Einsatz gentechnologischer Methoden in der Impfstoffentwicklung gegen das SARS-CoV-2-Virus
(2021)
In seinem Beitrag stellt Martin Korte die Suche nach einem wirksamen Corona-Impfstoff, insbesondere mit Blick auf die Rolle der Gentechnik, dar. Neben dem Virus selbst werden verschiedene Angriffspunkte für Impfstoffe mit unterschiedlichen Eigenschaften vorgestellt. Hauptangriffsziel sei das sog. Spike-Protein, ein Protein in der Hülle der Viren, welches das Andocken an bestimmte Rezeptoren der Wirtszellen ermögliche. Zu den verschiedenen bereits zugelassenen oder in der Entwicklung befindlichen Impfstoffarten gehören RNA-Impfstoffe, vektorbasierte Impfstoffe, rekombinante proteinbasierte Impfstoffe, inaktivierte Virusvektoren sowie DNA-Impfstoffe, von denen einige näher vorgestellt werden. Die Entwicklung der Impfstoffe gegen SARS-CoV-2 sei einem im Vergleich zur herkömmlichen Impfstoffentwicklung (die viele Jahre dauert) beschleunigten Zeitplan gefolgt, der auch durch gentechnologische Plattformen, fortgeschrittene Sequenzierungen und genetische Editierungsmöglichkeiten, also präzise gentechnikbasierte Veränderungen in der Sequenz der DNA- und RNA-Impfstoffe, ermöglicht worden sei. Die Entwicklung sei auch durch Erkenntnisse aus der Entwicklung von Impfstoffen gegen früher aufgetretene, ähnliche SARS-Viren beschleunigt worden. Bestehende Herstellungsprozesse habe man übernehmen und Phase I/II-Studien bereits ineinander verschachtelt starten können. Phase-III-Studien seien bereits nach der Zwischenanalyse der Phase I/II-Ergebnisse begonnen worden. Auf diese Art und Weise, begleitet und genehmigt von den Zulassungsbehörden, seien mehrere klinische Studienphasen parallel durchgeführt, aber keine Zulassungsphase übersprungen oder mit kleineren Kohortenzahlen als bei der Zulassung anderer Impfstoffe gearbeitet worden.
Insgesamt hält Martin Korte fest, dass innerhalb von nur zwölf Monaten mehrere Impfstoffe gegen SARS-CoV-2 in Europa, USA und GB zugelassen worden seien, davon zwei mRNA-Impfstoffe und zwei vektorbasierte Impfstoffe. Dies wäre ohne sichere und effiziente gentechnologische Verfahren nicht möglich gewesen. Eine riesige Herausforderung bestehe nun darin 7–9 Milliarden Impfdosen herzustellen und über die gesamte Welt gerecht zu verteilen. Zudem seien parallel Impfstoffplattformen zu entwickeln, die sich laufend an mutierte Virusvarianten anpassen können, was auch zulassungstechnisch eine große Herausforderung sein werde.