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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.
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; Ehrhardt, Anja; Gerber, Peter Arne; Peiper, Matthias; Buhren, Bettina Alexandra; Lichtenberg, Artur; Rezazadeh, Amir; Budach, Wilfried; Matuschek, Christiane.
  • Fischer JC; Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University, 40225, Düsseldorf, Germany.
  • Schmidt AG; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Bölke E; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany. boelke@uni-duesseldorf.de.
  • Keitel V; Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Feldt T; Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Jensen B; Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Freise NF; Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Häussinger D; Department of Gastroenterology, Hepatology and Infectious Diseases, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Schneider EM; Division of Experimental Anesthesiology, University Hospital Ulm, Ulm, Germany.
  • Hermsen D; Central Institute for Laboratory Diagnostics and Clinical Chemistry, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.
  • Kindgen-Milles D; Department of Anesthesiology, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany.
  • Knoefel WT; Department of Surgery and Interdisciplinary Surgical Intensive Care Unit, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
  • Haussmann J; Medicine, Department cBITE, Maastricht, The Netherlands.
  • Tamaskovics B; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Plettenberg C; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Scheckenbach K; Department of Otolaryngology-Head and Neck Surgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
  • Corradini S; Department of Otolaryngology-Head and Neck Surgery, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
  • Rox J; Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany.
  • Balz V; Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University, 40225, Düsseldorf, Germany.
  • Maas K; Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University, 40225, Düsseldorf, Germany.
  • Schmidt L; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Grebe O; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Ehrhardt A; Department of Cardiology and Rhythmology, Petrus Hospital, Wuppertal, Germany.
  • Gerber PA; Institute of Virology, University of Witten/Herdecke, Witten, Germany.
  • Peiper M; Medical Faculty, University of Dusseldorf, Düsseldorf, Germany.
  • Buhren BA; Department of Cardiac Surgery, Medical Faculty, University of Dusseldorf, Düsseldorf, Germany.
  • Lichtenberg A; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Rezazadeh A; Department of Cardiac Surgery, Medical Faculty, University of Dusseldorf, Düsseldorf, Germany.
  • Budach W; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
  • Matuschek C; Department of Radiation Oncology, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University Dusseldorf, Moorenstr. 5, 40225, Düsseldorf, Germany.
Eur J Med Res ; 26(1): 87, 2021 Aug 06.
Article in English | MEDLINE | ID: covidwho-1344125
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccination / Pharmacovigilance / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Informed Consent Topics: Vaccines Limits: Humans Language: English Journal: Eur J Med Res Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: S40001-021-00558-Y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Vaccination / Pharmacovigilance / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 / Informed Consent Topics: Vaccines Limits: Humans Language: English Journal: Eur J Med Res Journal subject: Medicine Year: 2021 Document Type: Article Affiliation country: S40001-021-00558-Y