Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024
Background: Recombinant zoster vaccine (RZV), received its first marketing authorization in October 2017 to prevent herpes zoster and its complications in older adults. The purpose of this study was to provide comprehensively worldwide post-marketing safety information about RZV using data from the...
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Elsevier
2025-02-01
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| Series: | Preventive Medicine Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2211335525000208 |
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| author | Yamin Shu Wenxin Cheng Xucheng He Liu Huang Wei Chen Qilin Zhang |
| author_facet | Yamin Shu Wenxin Cheng Xucheng He Liu Huang Wei Chen Qilin Zhang |
| author_sort | Yamin Shu |
| collection | DOAJ |
| description | Background: Recombinant zoster vaccine (RZV), received its first marketing authorization in October 2017 to prevent herpes zoster and its complications in older adults. The purpose of this study was to provide comprehensively worldwide post-marketing safety information about RZV using data from the Vaccine Adverse Event Reporting System (VAERS). Methods: We searched for and analyzed adverse event (AE) reports of RZV submitted to U.S. VAERS between October 20, 2017 and April 26, 2024. Descriptive analyses included sex, age, time-to-onset, seriousness, most commonly reported AEs, AE of special interest, and cause of death. The empirical Bayesian data mining was employed to identify potential disproportionalities in reporting. Results: During the study period, 1,279,596 AE reports for vaccines were received by VAERS after excluding any duplicates, including 66,849 reports specifically related to RZV. Most reports were classified as non-serious (97.3 %). Among reports with age or sex reported, individuals were mainly 50–79 years (71.2 %) and females (63.1 %). The most commonly reported AEs included injection site reactions, pyrexia, chills, headache and fatigue. A total of 86 reports documenting deaths were identified following RZV vaccination. In addition to cardiovascular events and falls, Guillain-Barre syndrome was the most common cause of death. The median TTO for RZV-related AEs was 1 day in all cohort groups over 50 years old. Conclusion: The safety profile of RZV, based on the large sample post-marketing use, was reassuring and consistent with that observed in clinical trials. Further studies are needed to continue generating real-world safety data and further characterize RZV-AE pairs systematically. |
| format | Article |
| id | doaj-art-8ce5a304fbac40a6827804f3618dae70 |
| institution | Kabale University |
| issn | 2211-3355 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Preventive Medicine Reports |
| spelling | doaj-art-8ce5a304fbac40a6827804f3618dae702025-02-08T05:00:18ZengElsevierPreventive Medicine Reports2211-33552025-02-0150102981Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024Yamin Shu0Wenxin Cheng1Xucheng He2Liu Huang3Wei Chen4Qilin Zhang5Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, ChinaHubei University of Chinese Medicine, Hubei Hospital of Integrated Traditional Chinese and Western Medicine, Wuhan 430015, ChinaDepartment of Pharmacy, Pengzhou Second People's Hospital, Pengzhou 611930, ChinaDepartment of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, ChinaRespiratory Medicine Department, Taizhou Affiliated Hospital of Nanjing University of Chinese Medicine, Taizhou 225300, China; Corresponding authors.Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; Corresponding authors.Background: Recombinant zoster vaccine (RZV), received its first marketing authorization in October 2017 to prevent herpes zoster and its complications in older adults. The purpose of this study was to provide comprehensively worldwide post-marketing safety information about RZV using data from the Vaccine Adverse Event Reporting System (VAERS). Methods: We searched for and analyzed adverse event (AE) reports of RZV submitted to U.S. VAERS between October 20, 2017 and April 26, 2024. Descriptive analyses included sex, age, time-to-onset, seriousness, most commonly reported AEs, AE of special interest, and cause of death. The empirical Bayesian data mining was employed to identify potential disproportionalities in reporting. Results: During the study period, 1,279,596 AE reports for vaccines were received by VAERS after excluding any duplicates, including 66,849 reports specifically related to RZV. Most reports were classified as non-serious (97.3 %). Among reports with age or sex reported, individuals were mainly 50–79 years (71.2 %) and females (63.1 %). The most commonly reported AEs included injection site reactions, pyrexia, chills, headache and fatigue. A total of 86 reports documenting deaths were identified following RZV vaccination. In addition to cardiovascular events and falls, Guillain-Barre syndrome was the most common cause of death. The median TTO for RZV-related AEs was 1 day in all cohort groups over 50 years old. Conclusion: The safety profile of RZV, based on the large sample post-marketing use, was reassuring and consistent with that observed in clinical trials. Further studies are needed to continue generating real-world safety data and further characterize RZV-AE pairs systematically.http://www.sciencedirect.com/science/article/pii/S2211335525000208Vaccine safetyPost-marketingRecombinant zoster vaccineAdverse eventVAERS |
| spellingShingle | Yamin Shu Wenxin Cheng Xucheng He Liu Huang Wei Chen Qilin Zhang Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 Preventive Medicine Reports Vaccine safety Post-marketing Recombinant zoster vaccine Adverse event VAERS |
| title | Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 |
| title_full | Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 |
| title_fullStr | Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 |
| title_full_unstemmed | Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 |
| title_short | Post-marketing safety surveillance for the recombinant zoster vaccine (Shingrix), vaccine adverse event reporting system, United States, October 2017–April 2024 |
| title_sort | post marketing safety surveillance for the recombinant zoster vaccine shingrix vaccine adverse event reporting system united states october 2017 april 2024 |
| topic | Vaccine safety Post-marketing Recombinant zoster vaccine Adverse event VAERS |
| url | http://www.sciencedirect.com/science/article/pii/S2211335525000208 |
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