Dáil Éireann Debate, Tuesday - 29 September 2026
698. Deputy Gillian Toole asked the Minister for Health the examination of the Health Products Regulatory Authority pharmacovigilance processes is being carried out in light of the recent British Medical Journal findings (September 16th 2026) of a faulty algorithm in the US Centre for Disease Control Vaccine Adverse Event Reporting System. [68072/26]
Amharc ar fhreagraThe article published in the British Medical Journal on 16 September 2026 relates to vaccine safety surveillance arrangements in the United States, including the Vaccine Adverse Event Reporting System (VAERS), which is operated by the US authorities.
In Ireland, the Health Products Regulatory Authority (HPRA) participates in vaccine safety monitoring through the European Medicines Regulatory Network, coordinated by the European Medicines Agency (EMA). The safety of COVID-19 vaccines authorised for use in Ireland was monitored through this established European pharmacovigilance system, which brought together the regulatory authorities of the EU and EEA Member States.
Prior to the commencement of COVID-19 vaccination programmes, the EMA and national competent authorities, including the HPRA, developed and implemented an intensified safety monitoring plan. This framework was designed to support the rapid collection, assessment and review of the large volume of safety data expected during the vaccination campaign.
During the pandemic, almost one billion doses of COVID-19 vaccines were administered across the EU and EEA. The enhanced monitoring arrangements enabled the continuous review of safety information, including approximately 2.8 million suspected adverse reaction reports received through EudraVigilance, the EU's system for managing and analysing information on suspected adverse reactions to medicines. These activities were supported by pharmacoepidemiological studies, real-world evidence and enhanced cooperation between European regulatory authorities and scientific experts.
The monitoring system enabled the timely identification, assessment and communication of vaccine safety issues. It confirmed that the vast majority of reported side effects were mild or moderate and short-lived, while also facilitating the detection and evaluation of rare and very rare adverse events, allowing appropriate regulatory action to be taken where necessary.
Throughout this period, the HPRA and EMA maintained a strong focus on transparency and public communication, providing regular updates on vaccine safety monitoring activities and emerging safety information.
Following the pandemic, reviews and self-assessments of the European regulatory response, including pharmacovigilance activities, were undertaken. These assessments found that the coordinated European approach to vaccine safety monitoring provided a robust framework for the detection, assessment and communication of vaccine safety risks during the COVID-19 pandemic.
