Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024
Objective: Respiratory syncytial virus (RSV) vaccines, including Arexvy and Abrysvo, received approval in May 2023. The study aims to review the post-licensure safety of RSV vaccines by investigating adverse events using the Vaccine Adverse Event Reporting System (VAERS). Methods: We included VAERS...
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Elsevier
2025-08-01
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| Series: | Preventive Medicine Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2211335525001895 |
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| author | Junchao Li Zhiyuan Zhang Meixiang Wang |
| author_facet | Junchao Li Zhiyuan Zhang Meixiang Wang |
| author_sort | Junchao Li |
| collection | DOAJ |
| description | Objective: Respiratory syncytial virus (RSV) vaccines, including Arexvy and Abrysvo, received approval in May 2023. The study aims to review the post-licensure safety of RSV vaccines by investigating adverse events using the Vaccine Adverse Event Reporting System (VAERS). Methods: We included VAERS reports of RSV vaccination in United States between May 3, 2023, and December 27, 2024. The study performed descriptive analysis, clinical review of death and pre-specified conditions, and data mining using empirical Bayesian methods. Results: VEARS received 6790 U.S. reports following administration of RSV vaccines. The median age of vaccine recipients was 71 years, with females comprising 64.9 %. Guillain-Barré syndrome (GBS) was the most common adverse event among serious reports. Injection site reaction was the most common non-serious report. 53 reports mention death, and the most frequent cause was sudden cardiac death. We identified 19 reports of anaphylaxis, 14 reports of cellulitis within 7 days of onset, and 81 reports of GBS. 63.2 % of vaccinees during pregnancy did not report adverse event, and the most common adverse event, was preterm delivery. Data mining displayed that various preferred terms were not identical based on vaccine and age stratification adverse event. Conclusions: The study reviewed the post-licensure safety of RSV vaccines and suggested that a significant proportion of adverse events were not serious, which aligned with previous studies. Preterm delivery and GBS following the administration of RSV vaccines require continuous monitoring. Additionally, inappropriate administration of Arexvy in pregnant individuals should be paid attention to. |
| format | Article |
| id | doaj-art-3c8340e649204b0fa5a916ddb115df7c |
| institution | DOAJ |
| issn | 2211-3355 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Preventive Medicine Reports |
| spelling | doaj-art-3c8340e649204b0fa5a916ddb115df7c2025-08-20T02:40:04ZengElsevierPreventive Medicine Reports2211-33552025-08-015610315010.1016/j.pmedr.2025.103150Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024Junchao Li0Zhiyuan Zhang1Meixiang Wang2Department of Cardiology, The Affiliated Taizhou People's Hospital of Nanjing Medical University, Taizhou School of Clinical Medicine, Nanjing Medical University, Taizhou 225300, ChinaDepartment of Cardiology, The Affiliated Taizhou People's Hospital of Nanjing Medical University, Taizhou School of Clinical Medicine, Nanjing Medical University, Taizhou 225300, ChinaCorresponding author.; Department of Cardiology, The Affiliated Taizhou People's Hospital of Nanjing Medical University, Taizhou School of Clinical Medicine, Nanjing Medical University, Taizhou 225300, ChinaObjective: Respiratory syncytial virus (RSV) vaccines, including Arexvy and Abrysvo, received approval in May 2023. The study aims to review the post-licensure safety of RSV vaccines by investigating adverse events using the Vaccine Adverse Event Reporting System (VAERS). Methods: We included VAERS reports of RSV vaccination in United States between May 3, 2023, and December 27, 2024. The study performed descriptive analysis, clinical review of death and pre-specified conditions, and data mining using empirical Bayesian methods. Results: VEARS received 6790 U.S. reports following administration of RSV vaccines. The median age of vaccine recipients was 71 years, with females comprising 64.9 %. Guillain-Barré syndrome (GBS) was the most common adverse event among serious reports. Injection site reaction was the most common non-serious report. 53 reports mention death, and the most frequent cause was sudden cardiac death. We identified 19 reports of anaphylaxis, 14 reports of cellulitis within 7 days of onset, and 81 reports of GBS. 63.2 % of vaccinees during pregnancy did not report adverse event, and the most common adverse event, was preterm delivery. Data mining displayed that various preferred terms were not identical based on vaccine and age stratification adverse event. Conclusions: The study reviewed the post-licensure safety of RSV vaccines and suggested that a significant proportion of adverse events were not serious, which aligned with previous studies. Preterm delivery and GBS following the administration of RSV vaccines require continuous monitoring. Additionally, inappropriate administration of Arexvy in pregnant individuals should be paid attention to.http://www.sciencedirect.com/science/article/pii/S2211335525001895RSVVAERSAdverse eventPost-licensure safetyArexvyAbrysvo |
| spellingShingle | Junchao Li Zhiyuan Zhang Meixiang Wang Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 Preventive Medicine Reports RSV VAERS Adverse event Post-licensure safety Arexvy Abrysvo |
| title | Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 |
| title_full | Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 |
| title_fullStr | Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 |
| title_full_unstemmed | Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 |
| title_short | Post-licensure safety of respiratory syncytial virus vaccines, Vaccine Adverse Event Reporting System, United States, May 2023–December 2024 |
| title_sort | post licensure safety of respiratory syncytial virus vaccines vaccine adverse event reporting system united states may 2023 december 2024 |
| topic | RSV VAERS Adverse event Post-licensure safety Arexvy Abrysvo |
| url | http://www.sciencedirect.com/science/article/pii/S2211335525001895 |
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