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...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2021-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
| Online Access: | http://dx.doi.org/10.1186/s40545-021-00326-7 |
| _version_ | 1797401273961545728 |
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| author | Rumiko Shimazawa Masayuki Ikeda |
| author_facet | Rumiko Shimazawa Masayuki Ikeda |
| author_sort | Rumiko Shimazawa |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-09T02:07:35Z |
| format | Article |
| id | doaj.art-592f3822d1724cc69d1b30ddf6249031 |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-03-09T02:07:35Z |
| publishDate | 2021-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-592f3822d1724cc69d1b30ddf62490312023-12-07T15:28:03ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112021-12-0114110.1186/s40545-021-00326-712315246Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)Rumiko Shimazawa0Masayuki Ikeda1Department of Clinical Pharmacology,Department of Medical Informatics,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.http://dx.doi.org/10.1186/s40545-021-00326-7 |
| spellingShingle | Rumiko Shimazawa Masayuki Ikeda Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech) Journal of Pharmaceutical Policy and Practice |
| 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 |
| url | http://dx.doi.org/10.1186/s40545-021-00326-7 |
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