| アブストラクト | 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(R) (bivalent), Gardasil(R) (quadrivalent), and Gardasil-9(R) (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(R) (33.4%) to Gardasil(R) (16.2%) to Gardasil-9(R) (7.8%). The most common signals were presyncope for Cervarix(R) (ROR 11.5) and administration errors for Gardasil(R) and Gardasil-9(R), 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(R) 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. |
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| ジャーナル名 | Human vaccines & immunotherapeutics |
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| Pubmed追加日 | 2025/8/1 |
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| 投稿者 | Su, Yonglong; Huang, Yirong; Wei, Jinbao; Wang, Xinjin; Zhou, Yanyan; Wu, Xiaohong; Fu, Honghong |
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| 組織名 | Xiamen Haicang Hospital, Xiamen, Fujian Province, China.;Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.;Fujian Institute for Food and Drug Quality Control, Fuzhou, Fujian Province,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40746171/ |
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