Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine in individuals aged 16-26 years in Chongqing, China

• Main Authors: Yuan-yuan Zhang (Author), Jia-Wei Xu (Author), Yang Liu (Author), Wei Qiu (Author), Pei-Ning Bai (Author), Yi Zeng (Author), Qing Wang (Author)
• Format: Book
• Published: Taylor & Francis Group, 2023-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.1080/21645515.2023.2281700; 2164-554X; 2164-5515
• Keywords: Human papillomavirus (HPV); 9-valent human papillomavirus vaccine; safety; post-marketing; Immunologic diseases. Allergy; RC581-607; Therapeutics. Pharmacology; RM1-950
• Source: Human Vaccines & Immunotherapeutics, Vol 19, Iss 3 (2023)

ABSTRACTThe safety of human papillomavirus (HPV) vaccines, one of the major challenges to public vaccination, has been controversial. This study assessed the adverse reactions of 9-valent HPV (9vHPV) vaccines. This open-label, observational, multi-center, post-marketing study assessed the safety of 9vHPV administered according to local clinical practice. All post-marketing adverse events (AEs) reports received between December 2019 and November 2021 in Chongqing were analyzed. A total of 1000 individuals aged 16-26 years provided safety data post-vaccination; The most common AEs (60.1%) experienced by 9vHPV vaccine recipients were vaccination-site AEs (pain, swelling, induration) and non-vaccination-site AEs (dizzy, weak, fever). Vaccination-site AEs most were mild-to-moderate in intensity. Discontinuations and HPV 9-related serious AEs were rare (0.3% and 0.0%, respectively). Eight SAEs were reported during the study but none were considered as related to the study vaccine. The 9vHPV vaccine was generally well tolerated in subjects aged 16-26 years; Vaccination-site AEs were more common with 9vHPV.