Dáil Éireann Debate, Tuesday - 26 February 2019
400. Deputy Clare Daly asked 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]
Amharc ar fhreagraThe 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.
