Tuesday, 26 February 2019

Questions (399)

Clare Daly


399. Deputy Clare Daly asked 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]

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Written answers (Question to Health)

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.