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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
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 p...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BioMed Central
2021
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343366/ https://www.ncbi.nlm.nih.gov/pubmed/34362461 http://dx.doi.org/10.1186/s40001-021-00558-y |
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| author | 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 Erhardt, Anja Gerber, Peter Arne Peiper, Matthias Buhren, Bettina Alexandra Lichtenberg, Artur Rezazadeh, Amir Budach, Wilfried Matuschek, Christiane |
| author_facet | 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 Erhardt, Anja Gerber, Peter Arne Peiper, Matthias Buhren, Bettina Alexandra Lichtenberg, Artur Rezazadeh, Amir Budach, Wilfried Matuschek, Christiane |
| author_sort | Fischer, Johannes C. |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-8343366 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2021 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-83433662021-08-06 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 Erhardt, Anja Gerber, Peter Arne Peiper, Matthias Buhren, Bettina Alexandra Lichtenberg, Artur Rezazadeh, Amir Budach, Wilfried Matuschek, Christiane Eur J Med Res Letter to the Editor 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. BioMed Central 2021-08-06 /pmc/articles/PMC8343366/ /pubmed/34362461 http://dx.doi.org/10.1186/s40001-021-00558-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Letter to the Editor 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 Erhardt, Anja Gerber, Peter Arne Peiper, Matthias Buhren, Bettina Alexandra Lichtenberg, Artur Rezazadeh, Amir Budach, Wilfried Matuschek, Christiane 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 |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Letter to the Editor |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343366/ https://www.ncbi.nlm.nih.gov/pubmed/34362461 http://dx.doi.org/10.1186/s40001-021-00558-y |
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