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Informed consent and informed intervention: SARS-CoV-2 vaccinations not just call for disclosure of newly emerging
Johannes C Fischer1, Albrecht G Schmidt2, Edwin Bölke3
1Institute for Transplantation Diagnostics and Cell Therapeutics, Medical Faculty, University Hospital Dusseldorf, Heinrich-Heine-University, 40225, Düsseldorf, Germany.
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.
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