Tuesday, 26 February 2019
Department of Health
399. To ask the Minister for Health the way in which the Health Products Regulatory Authority plans to monitor the safety of the HPV vaccine Gardasil 9 as a black triangle product; if it is to be administered to girls and boys here simultaneously with other vaccines as proposed by HIQA in its health technology assessment on extending the HPV vaccination to boys; and if he will make a statement on the matter. [9582/19]
The Health Products Regulatory Advisory (HPRA) has advised that Gardasil 9 was authorised by the European Commission to be placed on the market for use across the European Union (EU) in 2015 and as you have noted, is one of a number of medicines/vaccines, which is subject to additional monitoring requirements, identifiable by an inverted black triangle on the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)) and an accompanying explanatory statement.
EU legislation introduced this concept in 2012 to support prompt identification of any new information associated with medicines/vaccines that are subject to additional monitoring, and healthcare professionals and patients/carers are particularly encouraged to report all adverse reactions associated with their use. The main goal of this monitoring activity is to facilitate the collection of additional information as early as possible to further elucidate the risk profile of products when used in clinical practice and to increase awareness about the safe and effective use of the medicines concerned. All newly authorised biological medicines including vaccines are subject to these additional monitoring requirements, usually for the first five years following authorisation and Gardasil 9 is being monitored in this way at EU and national level.
As part of the system for monitoring the safety of medicinal products, the HPRA operates a spontaneous reporting system by which patients/consumers and healthcare professionals can report suspected adverse reactions through various reporting options available through the HPRA website (www.hpra.ie). All reports of suspected adverse reactions received by the HPRA are routinely transmitted to the European Medicines Agency (EMA) EudraVigilance (EV) database for inclusion in global signal detection activities.
In December 2018 the Health Information and Quality Authority completed a health technology assessment (HTA) in relation to extending the national immunisation schedule to include the human papilloma virus (HPV) vaccination of boys.
The HTA recommended that the HPV immunisation programme be extended to include boys and the introduction of 9-valent HPV vaccine. A policy decision has been made to extend the HPV immunisation programme to include boys and introduce 9-valent HPV vaccine starting in September 2019.
The National Immunisation Office are working towards a gender-neutral HPV programme, information on which will be available for parents and healthcare professionals in advance of the start of the gender-neutral programme.
400. To ask the Minister for Health his views on the use by HIQA of Norwegian health technology assessment local data in the absence of validated Irish data on hospitalisation rates for the associated adverse events of the HPV vaccine (details supplied); and if he will make a statement on the matter. [9583/19]
The Health Information and Quality Authority (HIQA) has advised that, in order to assess vaccine safety, they carried out a comprehensive, independent review of all available safety data. A systematic review of all relevant international literature was preformed which encompassed 70,000 trial participants and surveillance of many millions of individuals in cohort studies and had a follow up of up to 10 years. This review, which concluded that the vaccine was safe, included Ireland-specific safety data from the Health Products Regulatory Authority (HPRA).
The HIQA economic model, which assessed the cost-effectiveness of the vaccine, required an estimate of the hospitalisation rate associated with HPV vaccination. In the absence of relevant Irish data, evidence from the Norwegian Medicines Agency, which does report these data, were used.
401. To ask the Minister for Health his views on the HIQA health technology assessment report on extending the HPV vaccine to boys (details supplied); if HIQA included studies in its review that did not conform with the EU, EMA, HPRA, FDA and WHO definition of a serious adverse event; and if so, the definition of such an event HIQA used to select relevant international literature for the purpose of its assessment. [9584/19]
The Health Information and Quality Authority (HIQA) has advised that, in relation to their comprehensive safety assessment, included studies that reported serious and or minor adverse events associated with HPV vaccination. HIQA did not exclude studies based upon their definition of ‘serious adverse event’. Comparisons between studies were difficult as differing definitions were used. However, the within study comparisons of adverse event rates between HPV-vaccinated and non HPV-vaccinated individuals remain valid. Studies consistently show no increase in adverse event rates associated with the HPV vaccine.