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HPV

Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine: Comment

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Dear Editor, we would like to share ideas on the publication “Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine in individuals aged 16–26 years in Chongqing, China.”Citation1  The 9-valent HPV (9vHPV) vaccine’s safety was evaluated in this study. The study examined adverse event complaints that Chongqing received from December 2019 to November 2021. After being vaccinated, 1000 people between the ages of 16 and 26 submitted safety information. In addition to non-vaccination-site adverse effects like weakness, fever, and dizziness, vaccination-site adverse effects like pain, swelling, and induration were the most frequently reported adverse events among vaccine recipients. The majority of vaccination-site incidents were mild to moderate intensity. Serious side effects and discontinuations associated with the 9vHPV vaccination were uncommon. Throughout the trial, eight significant adverse events were recorded; however, none of them were thought to be vaccination-related.

This study’s observational design, which could add bias and confounding variables, is one of its weaknesses. Furthermore, the study only assessed negative incidents that were recorded in Chongqing, which means that it may not accurately reflect the experiences of people in other areas. In order to further evaluate the safety of the 9vHPV vaccination, randomized controlled trials may be conducted as a future avenue for this research. To increase generalizability, volunteers in these trials may come from various geographical areas. Long-term follow-up studies could also be carried out to assess the vaccine’s general safety profile and the durability of adverse events.

Authors’ contribution

HD 50% ideas, writing, analyzing, approval

vW 50% ideas, supervision, approval.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.

Reference

  • Zhang YY, Xu JW, Liu Y, Qiu W, Bai PN, Zeng Y, Wang Q. Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine in individuals aged 16–26 years in Chongqing, China. Hum Vaccin Immunother. 2023 Dec 15;19(3):2281700. doi:10.1080/21645515.2023.2281700.