Paul Kehoe (Wexford, Fine Gael)
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420. To ask the Minister for Health if he will address matters (details supplied) regarding vaccine safety; and if he will make a statement on the matter. [17920/18]

Simon Harris (Wicklow, Fine Gael)
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Thiomersal is a mercury-containing compound that has been used since the 1930s to prevent contamination in some vaccines.  Thiomersal is NOT the same as methyl mercury, which can accumulate in the body and become toxic.  A European review of the available evidence concluded that there is no evidence of harm from thiomersal in vaccines other than hypersensitivity reactions.  The World Health Organization has concluded that there is no evidence of mercury toxicity in infants, children, or adults exposed to thiomersal in vaccines.  

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and quality of all medicines including vaccines that are licensed in Ireland.  I am informed by the HPRA that there is no thiomersal in any of the vaccines used in the childhood immunisation programme in Ireland.  

Aluminium has been used in vaccines for many decades to improve the body's response to vaccination.  It is a component of the HPV vaccine Gardasil and several other vaccines.  The World Health Organization's (WHO) Global Advisory Committee on Vaccine safety (an expert clinical and scientific advisory body) has concluded that there is no evidence of a health risk from aluminium-containing vaccines.  

The safety of the aluminium adjuvant used in Gardasil has been established in clinical studies and the level of aluminium present is tightly controlled as part of the quality control testing of the vaccine.  Gardasil which contains amorphous aluminium hydroxyphosphate sulphate adjuvant was tested in non-clinical safety assessment studies where daily monitoring for physical signs did not reveal any notable effects on any physiological function.  In addition, the safety of Gardasil was tested in human clinical studies and no signs of concern were identified.  Apart from the expected immune response and local injection site reactions, there was no evidence of systemic effects (such as effects on CNS, respiratory, cardiovascular, and renal systems) caused by HPV L1 VLP vaccines such as Gardasil from study data and there is no data to suggest that Gardasil crosses the blood brain barrier.  The pharmacological evaluation of Gardasil focused on the evaluation of primary pharmacodynamics (i.e. immunogenicity) as the vaccine did not show any effects apart from the expected immune response.   

The contract for the supply of pandemic influenza vaccine during the 2009 pandemic included clauses concerning indemnification of the manufacturers.  As all of the vaccines used in the State's immunisation programmes have been approved for use in the European Union by the European Medicines Agency there is no requirement for indemnity.