Human Papillomavirus vaccines - national monitoring experience
Human papillomavirus (HPV) vaccines are offered as part of the HSE Schools Immunisation Programme, and further information is available on the HSE website.
From the time of first authorisation of Gardasil in 2006 and up to 31 December 2024, the HPRA has received 1581 reports of suspected side effects associated with the use of the HPV vaccines (Gardasil, Gardasil 9, Cervarix, with a few reports for which the brand of vaccine is not known) that have occurred in Ireland.
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 HPV vaccines.
Since its authorisation, information on HPV vaccines has been published by the HPRA in our Drug Safety Newsletters and other publications. Separately, updates on the national monitoring experience were published on the HPRA (then IMB) website during the first year of the HSE Schools Immunisation Programme, and the final update was published in July 2011. All publications are available upon request.
IMB_Update on National Monitoring Experience with Gardasil_Jul 2011 PDF : 36 KB | 30/06/2011 IMB_Update on National Monitoring Experience with Gardasil_Feb 2011 PDF : 35 KB | 01/02/2011 IMB_Update on National Monitoring Experience with Gardasil_Dec 2010 PDF : 34 KB | 01/12/2010 IMB_Update on National Monitoring Experience with Gardasil_Nov 2010 PDF : 80 KB | 01/11/2010 IMB_Update on National Monitoring Experience with Gardasil_Oct 2010 PDF : 34 KB | 30/09/2010 The following information was published in relation to HPV vaccines in the HPRA DSN and MIMS Ireland: Drug Safety Newsletter Edition 71 December 2015 PDF : 367 KB | 01/12/2015 HPRA article in MIMS Ireland - August 2011 PDF : 478 KB | 31/07/2011 Drug Safety Newsletter Edition 43- August 2011 PDF : 73 KB | 08/01/2011 Drug Safety Newsletter Edition 39- November 2010 PDF : 111 KB | 01/11/2010 Drug Safety Newsletter Edition 37 May 2010 PDF : 52 KB | 30/04/2010European Medicines Agency publications
The HPV vaccine was first authorised by the European Commission to be placed on the market for use across the EEA in 2006. To be granted authorisation, the company responsible for marketing the HPV vaccines (Gardasil, Gardasil 9, and Cervarix) had to provide evidence that the vaccines met clear and predefined standards of quality, safety and efficacy. Further information regarding the authorisation process, steps taken before and after authorisation and the outcome of ongoing monitoring and other regulatory activities for Gardasil Gardasil 9, and Cervarix is available on the website of the European Medicines Agency .
Information regarding suspected side effects for all vaccines and medicines is also available to the public via the European Database for Suspected Adverse Drug Reaction Reports, known as EudraVigilance.
The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC meet once a month at the EMA (at which the HPRA participate) and the highlights of each PRAC meeting are published on the EMA and HPRA's website every month.