ArticleVaccines2026
Post-Marketing Safety Surveillance of Autoimmune Diseases Following Bivalent Human Papillomavirus Vaccination in China.
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.
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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.
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Authors and funding
12 authors.
Funding
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.
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