Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS
Background and purpose: Serious adverse events following immunization (AEFI) associated with the COVID-19 vaccines, including BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen), and mRNA-1273 (Moderna), have not yet been fully investigated. This study was designed to evaluate the serious AEFI associa...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.921760/full |
| _version_ | 1811330667442601984 |
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| author | Ming-Ming Yan Hui Zhao Zi-Ran Li Jun-Wei Chow Jun-Wei Chow Qian Zhang Yu-Peng Qi Shu-Shan Wu Ming-Kang Zhong Xiao-Yan Qiu |
| author_facet | Ming-Ming Yan Hui Zhao Zi-Ran Li Jun-Wei Chow Jun-Wei Chow Qian Zhang Yu-Peng Qi Shu-Shan Wu Ming-Kang Zhong Xiao-Yan Qiu |
| author_sort | Ming-Ming Yan |
| collection | DOAJ |
| description | Background and purpose: Serious adverse events following immunization (AEFI) associated with the COVID-19 vaccines, including BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen), and mRNA-1273 (Moderna), have not yet been fully investigated. This study was designed to evaluate the serious AEFI associated with these three vaccines.Methods: A disproportionality study was performed to analyze data acquired from the Vaccine Adverse Event-Reporting System (VAERS) between 1 January 2010 and 30 April 2021. The reporting odds ratio (ROR) method was used to identify the association between the COVID-19 vaccines BNT162b2, Ad26.COV2.S, and mRNA-1273 and each adverse event reported. Moreover, the ratio of the ROR value to the 95% CI span was applied to improve the credibility of the ROR. The median values of time from vaccination to onset (TTO) for the three vaccines were analyzed.Results: Compared with BNT162b2 and mRNA-1273, Ad26.COV2.S vaccination was associated with a lower death frequency (p < 0.05). Ad26.COV2.S vaccination was associated with a lower birth defect and emergency room visit frequency than BNT162b2 (p < 0.05). There were 6,605, 830, and 2,292 vaccine recipients who suffered from COVID-19-related symptoms after vaccination with BNT162b2, Ad26.COV2.S, and mRNA-1273, respectively, including people who were infected by COVID-19, demonstrated a positive SARS-CoV-2 test, and were asymptomatic. Serious AEFI, including thromboembolism, hemorrhage, thrombocytopenia, cardiac arrhythmia, hypertension, and hepatotoxicity, were associated with all three vaccines. Cardiac failure and acute renal impairment events were associated with BNT162b2 and mRNA-1273, while seizure events were associated with BNT162b2 and Ad26.COV2.S. The median values of TTO associated with the three vaccinations were similar.Conclusion: These findings may be useful for health workers and the general public prior to inoculation, especially for patients with underlying diseases; however, the risk/benefit profile of these vaccines remains unchanged. The exact mechanism of SARS-CoV-2 vaccine-induced AEFI remains unknown, and further studies are required to explore these phenomena. |
| first_indexed | 2024-04-13T16:07:03Z |
| format | Article |
| id | doaj.art-b5b0594f86a2472d82955a4854c0624d |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-13T16:07:03Z |
| publishDate | 2022-11-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-b5b0594f86a2472d82955a4854c0624d2022-12-22T02:40:22ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-11-011310.3389/fphar.2022.921760921760Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERSMing-Ming Yan0Hui Zhao1Zi-Ran Li2Jun-Wei Chow3Jun-Wei Chow4Qian Zhang5Yu-Peng Qi6Shu-Shan Wu7Ming-Kang Zhong8Xiao-Yan Qiu9Clinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaSchool of Pharmacy, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaUniversity of Nebraska Medical Center College of Pharmacy, Omaha, United StatesClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaClinical Pharmacy Department, Huashan Hospital, Fudan University, Shanghai, ChinaBackground and purpose: Serious adverse events following immunization (AEFI) associated with the COVID-19 vaccines, including BNT162b2 (Pfizer-BioNTech), Ad26.COV2.S (Janssen), and mRNA-1273 (Moderna), have not yet been fully investigated. This study was designed to evaluate the serious AEFI associated with these three vaccines.Methods: A disproportionality study was performed to analyze data acquired from the Vaccine Adverse Event-Reporting System (VAERS) between 1 January 2010 and 30 April 2021. The reporting odds ratio (ROR) method was used to identify the association between the COVID-19 vaccines BNT162b2, Ad26.COV2.S, and mRNA-1273 and each adverse event reported. Moreover, the ratio of the ROR value to the 95% CI span was applied to improve the credibility of the ROR. The median values of time from vaccination to onset (TTO) for the three vaccines were analyzed.Results: Compared with BNT162b2 and mRNA-1273, Ad26.COV2.S vaccination was associated with a lower death frequency (p < 0.05). Ad26.COV2.S vaccination was associated with a lower birth defect and emergency room visit frequency than BNT162b2 (p < 0.05). There were 6,605, 830, and 2,292 vaccine recipients who suffered from COVID-19-related symptoms after vaccination with BNT162b2, Ad26.COV2.S, and mRNA-1273, respectively, including people who were infected by COVID-19, demonstrated a positive SARS-CoV-2 test, and were asymptomatic. Serious AEFI, including thromboembolism, hemorrhage, thrombocytopenia, cardiac arrhythmia, hypertension, and hepatotoxicity, were associated with all three vaccines. Cardiac failure and acute renal impairment events were associated with BNT162b2 and mRNA-1273, while seizure events were associated with BNT162b2 and Ad26.COV2.S. The median values of TTO associated with the three vaccinations were similar.Conclusion: These findings may be useful for health workers and the general public prior to inoculation, especially for patients with underlying diseases; however, the risk/benefit profile of these vaccines remains unchanged. The exact mechanism of SARS-CoV-2 vaccine-induced AEFI remains unknown, and further studies are required to explore these phenomena.https://www.frontiersin.org/articles/10.3389/fphar.2022.921760/fullCOVID-19 vaccine safetyadverse events following immunizationreporting odds ratioBNT162b2Ad26.Cov2.SmRNA-1273 |
| spellingShingle | Ming-Ming Yan Hui Zhao Zi-Ran Li Jun-Wei Chow Jun-Wei Chow Qian Zhang Yu-Peng Qi Shu-Shan Wu Ming-Kang Zhong Xiao-Yan Qiu Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS Frontiers in Pharmacology COVID-19 vaccine safety adverse events following immunization reporting odds ratio BNT162b2 Ad26.Cov2.S mRNA-1273 |
| title | Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS |
| title_full | Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS |
| title_fullStr | Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS |
| title_full_unstemmed | Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS |
| title_short | Serious adverse reaction associated with the COVID-19 vaccines of BNT162b2, Ad26.COV2.S, and mRNA-1273: Gaining insight through the VAERS |
| title_sort | serious adverse reaction associated with the covid 19 vaccines of bnt162b2 ad26 cov2 s and mrna 1273 gaining insight through the vaers |
| topic | COVID-19 vaccine safety adverse events following immunization reporting odds ratio BNT162b2 Ad26.Cov2.S mRNA-1273 |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.921760/full |
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