Evidence map›Paper›PMID 42646704›Full record

ArticleVaccines2026

Post-Marketing Safety Surveillance of Autoimmune Diseases Following Bivalent Human Papillomavirus Vaccination in China.

Xueyang Zeng, Xiaoshan Yu, Qiufen Zhang, Biao Rong, Moliang Chen, Huanyang Qi, Xulian Cai, Tingting Qiu, Yang Feng, Shoujie Huang and 2 more

Abstract read
In one paragraph

Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Xueyang ZengXiamen Innovax Biotech Co., Ltd., Xiamen 361022, China.ORCID 0000-0003-1297-9714
Xiaoshan YuXiamen Innovax Biotech Co., Ltd., Xiamen 361022, China.
Qiufen ZhangXiamen Innovax Biotech Co., Ltd., Xiamen 361022, China.
Biao RongXiamen Health and Medical Big Data Center (Xiamen Medicine Research Institute), Xiamen 361008, China.
Moliang ChenXiamen Health and Medical Big Data Center (Xiamen Medicine Research Institute), Xiamen 361008, China.
Huanyang QiXiamen Health and Medical Big Data Center (Xiamen Medicine Research Institute), Xiamen 361008, China.
Xulian CaiXiamen Health and Medical Big Data Center (Xiamen Medicine Research Institute), Xiamen 361008, China.
Tingting QiuXiamen Innovax Biotech Co., Ltd., Xiamen 361022, China.
Yang FengXiamen Chazen Biomedical Technology Co., Ltd., Xiamen 361101, China.
Shoujie HuangThe State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen 361102, China.
Huirong PanXiamen Innovax Biotech Co., Ltd., Xiamen 361022, China.
Lishan YeDepartment of Automation, Tsinghua University, Beijing 100084, China.

Funding

Xiamen Innovax Biotech Co., Ltd. HPV-PRO-013
6 · The paper itself

Abstract

BACKGROUND/

objectivesThe potential of vaccines to trigger autoimmune diseases (ADs) has been extensively investigated and remains a routine focus of vaccine-safety research. This post-marketing, real-world study compared the risk of ADs between females who received bivalent human papillomavirus (HPV) vaccine (Cecolin) and unvaccinated females.

methodsEligible females aged 9-45 years registered in the Xiamen Health and Medical Big Data Center from September 2020 to December 2023 (post-Cecolin period) were enrolled. Cecolin recipients constituted the exposed cohort, and a matched unexposed cohort was generated in a 1:4 ratio based on age and calendar year. Case validation was conducted to determine optimal identification algorithms. Incidence rates (IRs) were calculated and incidence rate ratios (IRRs) with 95% confidence intervals (CIs) were derived from zero-inflated Poisson regression.

resultsOverall incidence of ADs was 70.63 per 100,000 person-years (95% CI: 67.59-73.77) in the post-Cecolin period. Compared with matched unexposed cohorts, vaccinated females showed a significantly lower AD risk in both contemporaneously matched (IRR = 0.23, 95% CI: 0.08-0.65;

conclusionsConsistent with prior evidence, this study provides real-world evidence further confirming that Cecolin vaccination does not increase the risk of ADs. It adds the first large-scale post-marketing safety evidence for this Chinese domestic bivalent HPV vaccine, filling a critical evidence gap. These results may inform vaccination policy and guide post-licensure safety monitoring in China and other countries that have introduced this vaccine.

Indexed as

autoimmune diseaseshuman papillomavirus vaccinepost-marketingreal-worldsafety

Identifiers

PMID42646704
PMCPMC13517141

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.