自発報告システムからの新型コロナウイルス感染症後の安全性シグナル検出

抄録

External factors severely afecting in a short period of time the spontaneous reporting of adverse events (AEs) can signifcantly impact drug safety signal detection. Coronavirus disease 2019 (COVID19) represented an enormous challenge for health systems, with over 767 million cases and massive vaccination campaigns involving over 70% of the worldwide population.

This study investigates the potential masking efect on certain AEs caused by the substantial increase in reports solely related to COVID-19 vaccines within various spontaneous reporting systems (SRSs). Three SRSs were used to monitor AEs reporting before and during the pandemic, namely, the World Health Organisation (WHO) global individual case safety reports database (VigiBase®), the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER).

Findings revealed a sudden over-reporting of 35 AEs (≥ 200%) during the pandemic, with an increment of the RRF value in 2021 of at least double the RRF reported in 2020. This translates into a substantial reduction in signals of disproportionate reporting (SDR) due to the massive inclusion of COVID-19 vaccine reports. To mitigate the masking efect of COVID-19 vaccines in post-marketing SRS analyses, we recommend utilizing COVID-19-corrected versions for a more accurate assessment.