Nationwide Safety Surveillance Using the Electronic Health Records: The COVID-19 Vaccines Case Study
The real-world safety profiles of COVID-19 mRNA vaccines were not completely understood when these vaccines were first rolled out in 2020. Better ascertainment of their safety profiles will enhance the public’s trust in national vaccination programmes. The Health Sciences Authority (HSA) performed a nationwide post-market safety surveillance of the COVID-19 vaccines on the Singapore population, using electronic health records (EHRs) to supplement the spontaneous adverse event reports in the assessment of potential safety signals associated with the COVID-19 vaccines. Observed-over-expected analyses were first performed to identify potential safety concerns among the shortlisted adverse events of special interest. Self-controlled case-series analyses were subsequently performed to validate potential signals of concern.
Active surveillance and data analytics using EHRs have enhanced HSA’s ability to detect and evaluate potential safety signals with COVID-19 vaccines and have allowed data-driven regulatory decisions to be made relevant to the local setting. HSA hopes to extend the experience with EHRs to the safety monitoring of other drugs and vaccines in the future.