Written answers

Wednesday, 21 April 2021

Department of Health

Vaccination Programme

Photo of Peadar TóibínPeadar Tóibín (Meath West, Aontú)
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2172. To ask the Minister for Health if his Department or the HSE have a centralised reporting system for flagging the side effects of Covid-19 vaccines; and if so, the details of the way the system works. [20024/21]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority (HPRA) is the regulatory authority in Ireland for medicines, medical devices and other healthcare products. As part of its remit in terms of monitoring the safety of medicines/vaccines on the market in Ireland, the HPRA operates the national adverse reaction (side effect) database. Healthcare professionals as well as members of the public are encouraged to submit reports of suspected adverse reactions to medicines/vaccines via various reporting options including:

- An online system which may be accessed via the HPRA website homepage (www.hpra.ie/report).

- A specific COVID-19 downloadable report form, which is also available at the link above, and can be completed and emailed to medsafety@hpra.ie or posted to the HPRA - By email to medsafety@hpra.ie.

All adverse reaction reports received are individually assessed, relevant follow up information is requested as appropriate, processed and entered into the HPRA’s national pharmacovigilance database. Reports are subsequently sent to EudraVigilance (EV), the European Medicines Agency’s (EMA’s) database of suspected adverse reactions, where the data are analysed to detect new safety signals. While the safety of COVID-19 vaccines is being monitored according to the guidelines that apply to all medicines and vaccines, the EMA together with medicines agencies across the EU, have outlined several additional measures for COVID-19 vaccines in a Safety Monitoring Plan. In addition, for each COVID-19 vaccine, a specific risk management plan (RMP) is agreed at the time of approval by EU regulators, which sets out amongst other things, any specific safety monitoring activities for that vaccine. The RMP is a living document and will be continually updated as more information becomes available.

To establish whether an adverse effect is caused by a vaccine, regulators look for new evidence from adverse reaction reports, studies or other sources including the RMP, about possible additional effects or an increased risk of known side effects associated with the vaccine compared with a non-vaccinated population or with historical data obtained before the COVID-19 vaccines were introduced. Where appropriate, suitable regulatory action will be taken. Further information on the HPRA’s adverse reaction reporting system was included in the HPRA Drug Safety Newsletter Edition 101 which was published on the HPRA’s website and circulated to healthcare professionals.

Anonymised data from the EV database are publically accessible for review at www.adrreports.eu.

The HPRA is publishing periodic overviews of national reporting experience on its website with the most recent update published on . The next update is expected to be published on Thursday 22ndApril. The HPRA also provides a weekly update to the NPHET, summarising adverse reaction reports received and information on reports of interest. The HPRA is also represented on the NIAC and also updates this group on key relevant safety information and adverse reaction reports.


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