Róisín Shortall (Dublin North West, Social Democrats)
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2291. To ask the Minister for Health the information available to him on potential adverse events in young persons taking each of the Covid-19 vaccines approved by the European Medicines Agency; and if he will make a statement on the matter. [37263/21]

Catherine Connolly (Galway West, Independent)
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3325. To ask the Minister for Health the number of persons who have reported suspected adverse reactions to a Covid-19 vaccine via the HPRA Covid-19 Vaccine Adverse Reaction Reporting Form; the person or body that is monitoring and analysing the data collected via the HPRA Covid-19 Vaccine Adverse Reaction Reporting Form; the reports he has received from the HPRA with regard to the data collected via these forms; the details of any patterns that have emerged with regard to the symptoms and duration of same; and if he will make a statement on the matter. [41348/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 2291 and 3325 together.

The Health Products Regulatory Authority (HPRA), as the regulatory authority in Ireland for medicines, medical devices and other healthcare products is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland.

As part of its remit, the HPRA operates the national adverse reaction database, to which members of the public and healthcare professionals are encouraged to submit any suspected adverse reactions to. All suspected adverse reaction reports received by the HPRA are entered into the national database for national monitoring and subsequently submitted to the European Medicines Agency’s (EMA's) adverse reaction database for inclusion in global signal detection and monitoring activities.

Up to 7 July, the HPRA received 11,445 reports describing suspected side effects in association with COVID-19 vaccines, of which 6011 were in association with mRNA vaccines (Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna)), 5361 in association with Adenoviral vector vaccines (Vaxzevria and Covid-19 Vaccine Janssen) and 73 reports were in association with vaccines where the brand was not known or provided at the time of reporting.

The majority of regularly reported suspected side effects are consistent with the types of events typically observed following vaccination, including those described in the product information for the individual vaccines. Whilst not experienced by everyone, all vaccines have some side effects, the vast majority of which are mild to moderate in nature. These side effects need to be continuously balanced against the benefits in preventing COVID-19 illness. Overall, the national reporting experience continues to support the favourable assessment that the benefits of COVID-19 vaccines outweigh the risks.

The HPRA has been publishing regular public safety updates on reporting experience with the COVID-19 vaccines, including information on the numbers and nature of these reports. To date, nine such updates have been published and are accessible from the HPRA website with the most recent publication issued on 15 July: www.hpra.ie/homepage/medicines/safety-notices/item?t=/safety-update-covid-19-vaccines-overview-of-national-reporting-experience-15-july-2021&id=7cee0f26-9782-6eee-9b55-ff00008c97d0