465. Deputy Gillian Toole asked the Minister for Health if the HPRA (Health Product Regulatory Authority) warning system will be inspected and upgraded in light of findings from the Food and Drug Administration in the United States where warnings about adverse events relating to Messenger RNA Covid vaccines were not on alerts. [75302/26]

The Health Products Regulatory Authority (HPRA) is the national competent authority responsible for monitoring the safety of medicines, including vaccines, in Ireland.

In Ireland, the HPRA participated in vaccine safety surveillance through the European Medicines Regulatory Network.

The safety of COVID-19 vaccines authorised for use in Ireland was monitored through this European network, which brought together the national competent authorities (NCAs) of European Member States under the coordination of the European Medicines Agency (EMA). Coordinated action ensured that COVID-19 vaccines and treatments were closely monitored and used as safely as possible.

This work began with preparations for intensified safety monitoring of COVID-19 vaccines prior to the commencement of immunisation campaigns. In November 2020, before the first vaccines were authorised, EMA and NCAs in EU Member States published a dedicated intensified safety monitoring plan. The plan established a framework with refined methodologies suitable for the rapid collection and review of the high volume of safety data expected from the planned vaccination campaigns.

During 2021 and 2022, people in the EU and EEA received almost 1 billion doses of COVID-19 vaccines, making this the largest vaccination programme in history. The network’s intensified monitoring plan enabled pharmacovigilance activities to be scaled up, supporting the continuous and timely review of safety data. Approximately 2.8 million suspected adverse reaction reports were screened in EudraVigilance, the EU’s safety database to support detection and characterisation of safety signals. In addition, real-world evidence (RWE) from pharmacoepidemiologic studies complemented the intensified monitoring programme and helped to further characterise emerging safety issues. There was also increased expert cooperation, with additional committee meetings and ad hoc expert groups established, as needed.

These activities rapidly expanded knowledge of vaccine safety during this period. Monitoring confirmed that the vast majority of side effects associated with COVID-19 vaccines were mild or moderate, occurred soon after vaccination and were short-lived. Rare or very rare side effects that had not emerged during clinical development because of their low frequency were quickly detected and assessed, allowing prompt action to minimise risks to the public.

Transparency, communication and engagement were also strengthened during this period at both national and European levels. The HPRA published regular updates on national reporting experience and highlighted key outcomes from EU safety monitoring activities, while the EMA in parallel issued regular updates on overall EU-level safety assessments. These communications aimed to provide the public with as much information as possible about the regulatory measures taken to support the safe use of COVID-19 vaccines, including the processes used to monitor their safety.

Following the COVID-19 pandemic, the network conducted self-assessments of its response, including its safety monitoring activities, and published a report on the EMA website. The European Court of Auditors and the European Commission also carried out broader reviews of the EU’s overall management of the pandemic. Collectively, these assessments identified the accelerated access to vaccines and therapeutics, together with the scaling up of safety monitoring activities, as key strengths of the response. Overall, the coordinated European approach provided a robust framework for detecting, assessing and communicating vaccine safety risks throughout the pandemic.