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 Ehrhardt; Peter Arne Gerber; Matthias Peiper; Bettina Alexandra Buhren; Artur Lichtenberg; Amir Rezazadeh; Wilfried Budach; Christiane Matuschek

doi:10.1186/s40001-021-00558-y

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

Eur J Med Res. 2021 Aug 6;26(1):87. doi: 10.1186/s40001-021-00558-y.

Authors

Johannes C Fischer¹, Albrecht G Schmidt², Edwin Bölke³, Verena Keitel⁴, Torsten Feldt⁴, Björn Jensen⁴, Noemi F Freise⁴, Dieter Häussinger⁴, E Marion Schneider⁵, Derik Hermsen⁶, Detlef Kindgen-Milles⁷, Wolfram Trudo Knoefel^{8

9}, Jan Haussmann², Balint Tamaskovics², Christian Plettenberg¹⁰, Kathrin Scheckenbach¹⁰, Stefanie Corradini¹¹, Jutta Rox¹, Vera Balz¹, Kitti Maas², Livia Schmidt², Olaf Grebe¹², Anja Ehrhardt¹³, Peter Arne Gerber¹⁴, Matthias Peiper¹⁵, Bettina Alexandra Buhren², Artur Lichtenberg¹⁵, Amir Rezazadeh², Wilfried Budach², Christiane Matuschek²

Affiliations

¹ Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University, 40225, Düsseldorf, Germany.
² Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
³ Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany. boelke@uni-duesseldorf.de.
⁴ Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
⁵ Division of Experimental Anesthesiology, University Hospital Ulm, Ulm, Germany.
⁶ Central Institute for Laboratory Diagnostics and Clinical Chemistry, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.
⁷ Department of Anesthesiology, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany.
⁸ Department of Surgery and Interdisciplinary Surgical Intensive Care Unit, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
⁹ Medicine, Department cBITE, Maastricht, The Netherlands.
¹⁰ Department of Otolaryngology-Head and Neck Surgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
¹¹ Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.
¹² Department of Cardiology and Rhythmology, Petrus Hospital, Wuppertal, Germany.
¹³ Institute of Virology, University of Witten/Herdecke, Witten, Germany.
¹⁴ Medical Faculty, University of Dusseldorf, Düsseldorf, Germany.
¹⁵ Department of Cardiac Surgery, Medical Faculty, University of Dusseldorf, Düsseldorf, Germany.

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.

Publication types

Letter

MeSH terms

COVID-19 / immunology
COVID-19 / prevention & control*
COVID-19 / virology
COVID-19 Vaccines / administration & dosage*
Disclosure
Humans
Informed Consent / standards*
Pharmacovigilance*
SARS-CoV-2 / immunology*
Vaccination / standards*

Substances

COVID-19 Vaccines