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The Safety of COVID-19 Vaccinations—We Should Rethink the Policy
Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database o...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8294615/ https://www.ncbi.nlm.nih.gov/pubmed/34202529 http://dx.doi.org/10.3390/vaccines9070693 |
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author | Walach, Harald Klement, Rainer J. Aukema, Wouter |
author_facet | Walach, Harald Klement, Rainer J. Aukema, Wouter |
author_sort | Walach, Harald |
collection | PubMed |
description | Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy. |
format | Online Article Text |
id | pubmed-8294615 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-82946152021-07-22 The Safety of COVID-19 Vaccinations—We Should Rethink the Policy Walach, Harald Klement, Rainer J. Aukema, Wouter Vaccines (Basel) Article Background: COVID-19 vaccines have had expedited reviews without sufficient safety data. We wanted to compare risks and benefits. Method: We calculated the number needed to vaccinate (NNTV) from a large Israeli field study to prevent one death. We accessed the Adverse Drug Reactions (ADR) database of the European Medicines Agency and of the Dutch National Register (lareb.nl) to extract the number of cases reporting severe side effects and the number of cases with fatal side effects. Result: The NNTV is between 200–700 to prevent one case of COVID-19 for the mRNA vaccine marketed by Pfizer, while the NNTV to prevent one death is between 9000 and 50,000 (95% confidence interval), with 16,000 as a point estimate. The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy. MDPI 2021-06-24 /pmc/articles/PMC8294615/ /pubmed/34202529 http://dx.doi.org/10.3390/vaccines9070693 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Walach, Harald Klement, Rainer J. Aukema, Wouter The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title | The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title_full | The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title_fullStr | The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title_full_unstemmed | The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title_short | The Safety of COVID-19 Vaccinations—We Should Rethink the Policy |
title_sort | safety of covid-19 vaccinations—we should rethink the policy |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8294615/ https://www.ncbi.nlm.nih.gov/pubmed/34202529 http://dx.doi.org/10.3390/vaccines9070693 |
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