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- Title
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.
- Authors
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
- 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.
- Subjects
VACCINATION complications; SARS-CoV-2; COVID-19; MEDICAL personnel; VACCINATION
- Publication
European Journal of Medical Research, 2021, Vol 26, Issue 1, p1
- ISSN
0949-2321
- Publication type
Letter
- DOI
10.1186/s40001-021-00558-y