Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Dec 12, 2019
Date Accepted: Mar 30, 2020
Date Submitted to PubMed: Apr 2, 2020
A feasibility study for active surveillance of adverse events following HPV vaccine: based on the regional healthcare information platform in Ningbo city of China
ABSTRACT
Background:
The comprehensive safety data of vaccine from post-licensure surveillance, especially the active surveillance, could guide administrations and individuals to make reasonable decisions on vaccination. Therefore, we designed a pilot study to assess the capability of the regional healthcare information platform for actively monitoring the safety of the new licensure vaccine.
Objective:
Conducting an active surveillance system of vaccine safety based on this information platform.
Methods:
In 2017, one of China’s best data linkage maturity information platform was selected. A structured questionnaire and open-ended interview guidelines were developed to investigate the feasibility of active surveillance following the HPV vaccine using the regional healthcare information platform in Ningbo. The questionnaire sent through email and a face to face interview conducted to confirm more details or any doubts.
Results:
Five databases could be an essential part of active surveillance of vaccine safety, and all of them have integrated into the platform since 2015. Except for the database of residents' health records with a coverage rate of 87%, the other databases have covered more than 95% of records that occurred in this city. All these databases can be inherently linked together with the national identity card. There are 15 909 women taken the HPV vaccine by Oct 2018 and no missing observed in its relevant variables, such as identity card, vaccine name, vaccination dosages, vaccination date, manufacture, batch number. Moreover, among the target women aged 9~45 years, the total missing rate of the identity card of outcomes of interest was 50/22619(0.22%), and no missing data founded in new-onset date and diagnosis date of diseases.
Conclusions:
The study presented an available approach to initiate an active surveillance system for adverse events after the HPV vaccine, basing on the regional healthcare information platform in China. Moreover, the extended observation period or the integration of seemingly functional sites is a warrant to engage in hypothesis-generation and hypothesis-confirmation studies for vaccine safety concerns in the future. Clinical Trial: None
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