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

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 p...

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Detalles Bibliográficos
Autores principales: Fischer, Johannes C., Schmidt, Albrecht G., Bölke, Edwin, Keitel, Verena, Feldt, Torsten, Jensen, Björn, Freise, Noemi F., Häussinger, Dieter, Schneider, E. Marion, Hermsen, Derik, Kindgen-Milles, Detlef, Knoefel, Wolfram Trudo, Haussmann, Jan, Tamaskovics, Balint, Plettenberg, Christian, Scheckenbach, Kathrin, Corradini, Stefanie, Rox, Jutta, Balz, Vera, Maas, Kitti, Schmidt, Livia, Grebe, Olaf, Erhardt, Anja, Gerber, Peter Arne, Peiper, Matthias, Buhren, Bettina Alexandra, Lichtenberg, Artur, Rezazadeh, Amir, Budach, Wilfried, Matuschek, Christiane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Letter to the Editor
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343366/
https://www.ncbi.nlm.nih.gov/pubmed/34362461
http://dx.doi.org/10.1186/s40001-021-00558-y
Descripción
Sumario: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.

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