Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports
Human papillomavirus (HPV) vaccination is central to preventing cervical and other HPV-associated cancers. Although clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated adverse events (AEs) reported to the U.S. Vaccine Adv...
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| Format: | Article |
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2539590 |
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| author | Yonglong Su Yirong Huang Jinbao Wei Xinjin Wang Yanyan Zhou Xiaohong Wu Honghong Fu |
| author_facet | Yonglong Su Yirong Huang Jinbao Wei Xinjin Wang Yanyan Zhou Xiaohong Wu Honghong Fu |
| author_sort | Yonglong Su |
| collection | DOAJ |
| description | Human papillomavirus (HPV) vaccination is central to preventing cervical and other HPV-associated cancers. Although clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated adverse events (AEs) reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for Cervarix® (bivalent), Gardasil® (quadrivalent), and Gardasil-9® (9-valent) between January 2006 and December 2024. Domestic VAERS reports listing ≥1 HPV vaccine were extracted, deduplicated, and classified by brand. Disproportionality analyses were performed using reporting odds ratios (RORs) and 95% confidence intervals (CIs), adjusting for multiplicity with a 5% Benjamini – Hochberg false discovery rate (FDR). Time-to-onset was assessed with Kaplan–Meier analysis. This analysis of 76,575 HPV vaccine adverse event reports shows improving safety profiles across vaccine generations. Serious adverse events decreased significantly from Cervarix® (33.4%) to Gardasil® (16.2%) to Gardasil-9® (7.8%). The most common signals were presyncope for Cervarix® (ROR 11.5) and administration errors for Gardasil® and Gardasil-9®, including inappropriate scheduling (ROR 19.5) and incorrect storage (ROR 12.1). Most adverse events (82.9%) occurred within 7 d post-vaccination, with 62.5% occurring on the same day. Gardasil-9® exhibited the narrowest IQR for time to onset (0–1 d), compared to other HPV vaccines. HPV vaccines demonstrate a consistent, favorable safety profile in U.S. real-world practice. Most reported AEs were acute vasovagal reactions, and strongest signals reflected preventable errors. Strengthening provider education in cold-chain management and schedule adherence may further enhance vaccine safety. Continued active surveillance is recommended. |
| format | Article |
| id | doaj-art-1615ca5482e64d07b7870c3d07e11dd9 |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-1615ca5482e64d07b7870c3d07e11dd92025-08-20T03:58:14ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2539590Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reportsYonglong Su0Yirong Huang1Jinbao Wei2Xinjin Wang3Yanyan Zhou4Xiaohong Wu5Honghong Fu6Xiamen Haicang Hospital, Xiamen, Fujian Province, ChinaFujian Medical University Union Hospital, Fuzhou, Fujian Province, ChinaXiamen Haicang Hospital, Xiamen, Fujian Province, ChinaFujian Institute for Food and Drug Quality Control, Fuzhou, Fujian Province, ChinaXiamen Haicang Hospital, Xiamen, Fujian Province, ChinaXiamen Haicang Hospital, Xiamen, Fujian Province, ChinaFujian Institute for Food and Drug Quality Control, Fuzhou, Fujian Province, ChinaHuman papillomavirus (HPV) vaccination is central to preventing cervical and other HPV-associated cancers. Although clinical trials have established favorable safety profiles, long-term, brand-specific real-world data remain limited. We evaluated adverse events (AEs) reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for Cervarix® (bivalent), Gardasil® (quadrivalent), and Gardasil-9® (9-valent) between January 2006 and December 2024. Domestic VAERS reports listing ≥1 HPV vaccine were extracted, deduplicated, and classified by brand. Disproportionality analyses were performed using reporting odds ratios (RORs) and 95% confidence intervals (CIs), adjusting for multiplicity with a 5% Benjamini – Hochberg false discovery rate (FDR). Time-to-onset was assessed with Kaplan–Meier analysis. This analysis of 76,575 HPV vaccine adverse event reports shows improving safety profiles across vaccine generations. Serious adverse events decreased significantly from Cervarix® (33.4%) to Gardasil® (16.2%) to Gardasil-9® (7.8%). The most common signals were presyncope for Cervarix® (ROR 11.5) and administration errors for Gardasil® and Gardasil-9®, including inappropriate scheduling (ROR 19.5) and incorrect storage (ROR 12.1). Most adverse events (82.9%) occurred within 7 d post-vaccination, with 62.5% occurring on the same day. Gardasil-9® exhibited the narrowest IQR for time to onset (0–1 d), compared to other HPV vaccines. HPV vaccines demonstrate a consistent, favorable safety profile in U.S. real-world practice. Most reported AEs were acute vasovagal reactions, and strongest signals reflected preventable errors. Strengthening provider education in cold-chain management and schedule adherence may further enhance vaccine safety. Continued active surveillance is recommended.https://www.tandfonline.com/doi/10.1080/21645515.2025.2539590Human papillomavirus vaccinesvaccine safetypharmacovigilanceVAERSreal-world evidence |
| spellingShingle | Yonglong Su Yirong Huang Jinbao Wei Xinjin Wang Yanyan Zhou Xiaohong Wu Honghong Fu Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports Human Vaccines & Immunotherapeutics Human papillomavirus vaccines vaccine safety pharmacovigilance VAERS real-world evidence |
| title | Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports |
| title_full | Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports |
| title_fullStr | Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports |
| title_full_unstemmed | Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports |
| title_short | Real-world safety of HPV vaccines over 18 y: A comprehensive analysis of U.S. VAERS reports |
| title_sort | real world safety of hpv vaccines over 18 y a comprehensive analysis of u s vaers reports |
| topic | Human papillomavirus vaccines vaccine safety pharmacovigilance VAERS real-world evidence |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2539590 |
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