European Journal of Medical Research (Aug 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
- Johannes C. Fischer,
- Albrecht G. Schmidt,
- Edwin Bölke,
- Verena Keitel,
- Torsten Feldt,
- Björn Jensen,
- Noemi F. Freise,
- Dieter Häussinger,
- E. Marion Schneider,
- Derik Hermsen,
- Detlef Kindgen-Milles,
- Wolfram Trudo Knoefel,
- Jan Haussmann,
- Balint Tamaskovics,
- Christian Plettenberg,
- Kathrin Scheckenbach,
- Stefanie Corradini,
- Jutta Rox,
- Vera Balz,
- Kitti Maas,
- Livia Schmidt,
- Olaf Grebe,
- Anja Erhardt,
- Peter Arne Gerber,
- Matthias Peiper,
- Bettina Alexandra Buhren,
- Artur Lichtenberg,
- Amir Rezazadeh,
- Wilfried Budach,
- Christiane Matuschek
Affiliations
- Johannes C. Fischer
- Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University
- Albrecht G. Schmidt
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Edwin Bölke
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Verena Keitel
- Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Torsten Feldt
- Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Björn Jensen
- Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Noemi F. Freise
- Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Dieter Häussinger
- Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- E. Marion Schneider
- Division of Experimental Anesthesiology, University Hospital Ulm
- Derik Hermsen
- Central Institute for Laboratory Diagnostics and Clinical Chemistry, Medical Faculty, Heinrich-Heine University
- Detlef Kindgen-Milles
- Department of Anesthesiology, Medical Faculty, Heinrich Heine University
- Wolfram Trudo Knoefel
- Department of Surgery and Interdisciplinary Surgical Intensive Care Unit, Medical Faculty, Heinrich Heine University
- Jan Haussmann
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Balint Tamaskovics
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Christian Plettenberg
- Department of Otolaryngology–Head and Neck Surgery, Medical Faculty, Heinrich Heine University
- Kathrin Scheckenbach
- Department of Otolaryngology–Head and Neck Surgery, Medical Faculty, Heinrich Heine University
- Stefanie Corradini
- Department of Radiation Oncology, University Hospital, LMU Munich
- Jutta Rox
- Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University
- Vera Balz
- Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University
- Kitti Maas
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Livia Schmidt
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Olaf Grebe
- Department of Cardiology and Rhythmology, Petrus Hospital
- Anja Erhardt
- Institute of Virology, University of Witten/Herdecke
- Peter Arne Gerber
- Medical Faculty, University of Dusseldorf
- Matthias Peiper
- Department of Cardiac Surgery, Medical Faculty, University of Dusseldorf
- Bettina Alexandra Buhren
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Artur Lichtenberg
- Department of Cardiac Surgery, Medical Faculty, University of Dusseldorf
- Amir Rezazadeh
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Wilfried Budach
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- Christiane Matuschek
- Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf
- DOI
- https://doi.org/10.1186/s40001-021-00558-y
- Journal volume & issue
-
Vol. 26,
no. 1
pp. 1 – 3
Abstract
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.
