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

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
Letter to the Editor
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
European Journal of Medical Research, 6 August 2021; 26(87)
Open Access
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.