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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...

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Autores principales: Walach, Harald, Klement, Rainer J., Aukema, Wouter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
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.
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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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