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Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)

Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTe...

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Autores principales: Shimazawa, Rumiko, Ikeda, Masayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165345/
https://www.ncbi.nlm.nih.gov/pubmed/34059124
http://dx.doi.org/10.1186/s40545-021-00326-7
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author Shimazawa, Rumiko
Ikeda, Masayuki
author_facet Shimazawa, Rumiko
Ikeda, Masayuki
author_sort Shimazawa, Rumiko
collection PubMed
description Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In Japan, 10 fatal cases (five men and women) have been reported to date. Four of the five women died of ICH and the other died of aspiration pneumonia, whereas all five men died of causes other than stroke. This imbalance is incompatible with the mortality data on cardiovascular diseases in the National Statistics, which show no apparent disparity between sexes or between hemorrhagic and ischemic stroke. Cumulatively, our analysis reveals a disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine. Although we understand that the benefits of tozinameran still outweigh the risks, we believe that a causal link with the vaccine is not proven but possible and warrants further analysis.
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spelling pubmed-81653452021-06-01 Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech) Shimazawa, Rumiko Ikeda, Masayuki J Pharm Policy Pract Commentary Reports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In Japan, 10 fatal cases (five men and women) have been reported to date. Four of the five women died of ICH and the other died of aspiration pneumonia, whereas all five men died of causes other than stroke. This imbalance is incompatible with the mortality data on cardiovascular diseases in the National Statistics, which show no apparent disparity between sexes or between hemorrhagic and ischemic stroke. Cumulatively, our analysis reveals a disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine. Although we understand that the benefits of tozinameran still outweigh the risks, we believe that a causal link with the vaccine is not proven but possible and warrants further analysis. BioMed Central 2021-05-31 /pmc/articles/PMC8165345/ /pubmed/34059124 http://dx.doi.org/10.1186/s40545-021-00326-7 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 Commentary
Shimazawa, Rumiko
Ikeda, Masayuki
Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title_full Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title_fullStr Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title_full_unstemmed Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title_short Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)
title_sort potential adverse events in japanese women who received tozinameran (bnt162b2, pfizer-biontech)
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165345/
https://www.ncbi.nlm.nih.gov/pubmed/34059124
http://dx.doi.org/10.1186/s40545-021-00326-7
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