Post-licensure safety monitoring of human papillomavirus vaccines in Jiangsu Province, China from 2019 to 2023

Abstract

The five types of human papillomavirus (HPV) vaccines have been administered in Jiangsu Province. In this study, we evaluated the safety profiles of HPV vaccines using records collected from the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) and the Jiangsu Province Vaccination Integrated Service Management Information System (JSEIRS) from January 2019 to August 2023. Demographic characteristics of cases, symptoms, and clinical diagnosis were summarized from reported adverse events following immunization (AEFI) in the CNAEFIS. Administered doses of the five HPV vaccines were retrieved from the JSEIRS Disproportionality Analysis (DPA) was applied to detect potential positive signals for specific adverse events associated with HPV vaccination. A total of 115, 104, 3, 167, and 277 cases of AEFI following 2-valent HPV vaccine (adsorbed), 2-valent HPV vaccine (E. coli), 2-valent HPV vaccine (P. pastoris), 4-valent HPV vaccine (S. cerevisiae) and 9-valent HPV vaccine (S. cerevisiae) administration were reported, respectively. Common adverse reactions (fever, redness and induration) were the most frequently reported AEFI after HPV vaccination, while fatigue, myalgia, dizziness, rash, and itching were the most commonly reported systemic symptoms. DPA suggests that urticaria is an AEFI that should be of particular concern after HPV vaccination. In all, HPV vaccines showed satisfactory safety profiles in the Jiangsu Province. Further active surveillance studies are warranted to yield more comprehensive post-marketing safety data.