Thursday, 7 November 2019
Department of Health
I am advised by the Health Products Regulatory Authority (HPRA) that suspected adverse reaction reporting rates are highly variable and are influenced by a number of factors, including the seriousness of the reaction/event, their ease of recognition and the extent of use of a particular medicine. Reporting rates may also be stimulated by promotion and publicity about a medicine. The number of reports received should not be used as a basis for determining the incidence of reactions/events as neither the total number of reactions/events occurring nor the number of patients using a medicine is known. Numerical comparisons should not be made between reactions/events associated with different medicines as comparisons may be misleading because of the limitations of the data.
The level of reporting of suspected adverse reactions/events associated with Gardasil vaccines is indicative of the positive response to calls for reporting of national experience associated with use of the vaccine following its introduction into the national immunisation programme in May 2010. According to the HPRA the extensive media coverage that vaccines have received in recent years has raised awareness of the need to report suspected adverse reactions/events associated with vaccination, thereby contributing in part to the volume of reports received.
The majority of reports received by the HPRA for Gardasil have been consistent with the expected pattern of adverse reactions/events for this vaccine, as described in the approved product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). The SmPC and PL are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of the medicine. The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side-effects of the medicine concerned. SmPCs for all products currently authorised in Ireland are accessible from the HPRA website. The package leaflet (PL) reflects the more comprehensive information described in the SmPC but is required to be presented in an abbreviated and easy-to-read format for patients. Copies of the SmPC and PL for Gardasil are accessible via the HPRA website.
It is important to note that reports submitted to the HPRA concern ‘suspected’ adverse reactions/events. This means that the effects experienced may represent side effects associated with the vaccine/vaccination process, or may be coincidental in terms of timing, due to an underlying or previously undiagnosed condition that would have occurred in the absence of vaccination.
The HSE National Immunisation Office is responsible for managing vaccine procurement and distribution, developing training and communication materials for the public and health professionals. All vaccines administered through the Primary Childhood Immunisation Schedule and School Immunisation Programme are provided free of charge.
As the question raised by the Deputy is a matter for the National Immunisation Office, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.