Dáil Éireann Debate, Tuesday - 22 November 2022
735. Deputy Jennifer Murnane O'Connor asked the Minister for Health the number of cases of complications related to the most recent Covid-19 vaccine by county in tabular form; and if he will make a statement on the matter. [58057/22]
View answerThe 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 6 September, the HPRA received 20,479 reports describing suspected side effects in association with COVID-19 vaccines, of which 2,558 Were received in 2022. 13,468 were in association with mRNA vaccines (Comirnaty and Spikevax), 6,684 were in association with Adenoviral vector vaccines (Vaxzevria and Covid-19 Jcovden (previously Janssen), 5 were in association with Recombinant adjuvanted spike protein vaccine (Nuvaxovid) and 334 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, eighteen such updates have been published and are accessible from the HPRA website with the most recent publication issued on 19 May: www.hpra.ie/docs/default-source/default-document-library/safety-update-covid-19-vaccines-overview-of-national-reporting-experience-(19052022).pdf?sfvrsn=4
