Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing
Fischer JC, Schmidt AG, Bölke E, Keitel V, Feldt T, Jensen B, Freise NF, Häussinger D, Schneider EM, Hermsen D, Kindgen-Milles D, Knoefel WT, Haussmann J, Tamaskovics B, Plettenberg C, Scheckenbach K, Corradini S, Rox J, Balz V, Maas K, Schmidt L, Grebe O, Erhardt A, Gerber PA, Peiper M, Buhren BA, Lichtenberg A, Rezazadeh A, Budach W, Matuschek C (2021)
Publication Type: Journal article
Publication year: 2021
Journal
Book Volume: 26
Article Number: 87
Journal Issue: 1
DOI: 10.1186/s40001-021-00558-y
Abstract
Background: COVID-19 infection is a major threat to patients and health care providers around the world. One solution is the vaccination against SARS-CoV-2. Methods: We performed a comprehensive query of the latest publications on the prevention of viral infections including the recent vaccination program and its side effects. Results: The situation is evolving rapidly and there is no reasonable alternative to population-scale vaccination programs as currently enrolled. Conclusion: Therefore, regulatory authorities should consider supplementing their conventional mandate of post-approval pharmacovigilance, which is based on the collection, assessment, and regulatory response to emerging safety findings.
Involved external institutions
Universitätsklinikum Düsseldorf
Germany (DE)
Universitätsklinikum Ulm
Germany (DE)
Heinrich-Heine-Universität Düsseldorf
Germany (DE)
Klinikum der Universität München (LMU Klinikum)
Germany (DE)
Universität Witten/Herdecke
Germany (DE)
Germany (DE)
Universitätsklinikum Ulm
Germany (DE)
Heinrich-Heine-Universität Düsseldorf
Germany (DE)
Klinikum der Universität München (LMU Klinikum)
Germany (DE)
Universität Witten/Herdecke
Germany (DE)
How to cite
APA:
Fischer, J.C., Schmidt, A.G., Bölke, E., Keitel, V., Feldt, T., Jensen, B.,... Matuschek, C. (2021). Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing. European Journal of Medical Research, 26(1). https://doi.org/10.1186/s40001-021-00558-y
MLA:
Fischer, Johannes C., et al. "Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging safety data but also for hypothesis generation and testing." European Journal of Medical Research 26.1 (2021).
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