Active Surveillance of Adverse Events Following Human Papillomavirus Vaccination: Feasibility Pilot Study Based on the Regional Health Care Information Platform in the City of Ningbo, China

Abstract

Background Comprehensive safety data for vaccines from post-licensure surveillance, especially active surveillance, could guide administrations and individuals to make reasonable decisions on vaccination. Therefore, we designed a pilot study to assess the capability of a regional health care information platform to actively monitor the safety of a newly licensed vaccine. Objective This study aimed to conduct active surveillance of human papillomavirus (HPV) vaccine safety based on this information platform. Methods In 2017, one of China’s most mature information platforms with superior data linkage was selected. A structured questionnaire and open-ended interview guidelines were developed to investigate the feasibility of active surveillance following HPV vaccination using the regional health care information platform in Ningbo. The questionnaire was sent to participants via email, and a face-to-face interview was conducted to confirm details or resolve discrepancies. Results Five databases that could be considered essential to active surveillance of vaccine safety were integrated into the platform starting in 2015. Except for residents' health records, which had a coverage rate of 87%, the data sources covered more than 95% of the records that were documented in Ningbo. All the data could be inherently linked using the national identity card. There were 19,328 women who received the HPV vaccine, and 37,988 doses were administered in 2017 and 2018. Women aged 30-40 years accounted for the largest proportion. Quadrivalent vaccination accounted for 73.1% of total vaccination, a much higher proportion than that of bivalent vaccination. Of the first doses, 60 (60/19,328, 0.31%) occurred outside Ningbo. There were no missing data for vaccination-relevant variables, such as identity card, vaccine name, vaccination doses, vaccination date, and manufacturer. ICD-10 coding could be used to identify 9,180 cases using a predefined list of the outcomes of interest, and 1.88% of these cases were missing the identity card. During the 90 days following HPV vaccination, 4 incident cases were found through the linked vaccination history and electronic medical records. The combined incident rate of rheumatoid arthritis, optic neuritis, and Henoch-Schonlein purpura was 8.84/100,000 doses of bivalent HPV, and the incidence rate of rheumatoid arthritis was 3.75/100,000 doses of quadrivalent HPV. Conclusions This study presents an available approach to initiate an active surveillance system for adverse events following HPV vaccination, based on a regional health care information platform in China. An extended observation period or the inclusion of additional functional sites is warranted to conduct future hypothesis-generating and hypothesis-confirming studies for vaccine safety concerns.

Active Vaccine Safety Surveillance: Global Trends and Challenges in China

“…Step 9: analysis on a remote research environment. Health Data Science [64]. The database covered the entire city and integrated the essential data sources for the active surveillance of the HPV vaccine, including immunization program registration, EMR, resident health records, and death surveillance, and this was inherently linked through a unique national identifier.…”

Progress of Active Surveillance for Vaccine Safety in China

“…Thus, the denominator of cohorts, vaccination statuses, and occurrences of clinical events are all captured through database linkages. In addition to VSD, in 2009, the United States developed another nationallyrepresentative program, called for Post-Licensure Rapid Immunization Safety Monitoring program (PRISM), which used 9 immunization information systems and 4 national health insurers' data to cover 38 million individuals in active safety surveillance of influenza H1N1 pandemic vaccine (7).…”

“…In China, a study demonstrated that the regional health information platform (RHIP) of Ningbo City could actively monitor human papillomavirus (HPV) vaccine safety; however, due to low HPV vaccine coverage, the system was limited to hypothesis testing ( 8 ). In the future, strength-of-association analyses will be conducted for vaccines having high coverage levels among Ningbo infants, and, for vaccines with low coverage, by integrating data from multiple RHIPs to provide sufficient sample sizes for assessment of causal relationships.…”

Effects of message framing and evidence type on health information behavior: the case of promoting HPV vaccination

“…Updegraff et al (2015) revealed that loss-framed messages were more effective, especially when exposed to high-risk behaviors. Now people still doubt the safety and efficacy of the HPV vaccine, and HPV vaccination is considered a relatively high-risk behavior (Liu et al, 2020), in which loss-framed messages have a stronger effect than the gainframed messages on intention towards HPV vaccination. Therefore, we propose the following hypothesis:…”

“…(3) Control variables. Those five core control variables are gender, age, education, whether they have heard of HPV, and whether they have heard of the HPV vaccination (Nan, 2012;Kim and Nan, 2015;Liu et al, 2020). The questionnaire is in Appendix.…”