Dáil Éireann Debate, Wednesday - 7 February 2018
202. Deputy Thomas Pringle asked the Minister for Health if research has been carried out with regard to the ingredients contained in a vaccine (details supplied); and if he will make a statement on the matter. [6230/18]
Amharc ar fhreagraThe 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 the enzyme thiaminase is not added during the manufacture of Gardasil HPV vaccine and is not used as an ingredient in the final medicine. Like all other medicines manufactured using cell technologies, trace amounts of residual proteins from these cells, which would include any residual thiaminase, may be present in the final Gardasil product. Gardasil meets EU regulatory requirements by limiting these proteins to microgram amounts at which level they have no discernible effect. Prior to each batch being placed on the market, testing is carried out to confirm that the level of residual proteins is less than the specified limit.
Other medicinal products manufactured using such cells, including some insulin products, are used daily and over a long duration (often years), compared to Gardasil which is administered once or a maximum of three times.
Gardasil is approved centrally by the European Commission, acting on the recommendation of the European Medicines Agency, for all EU Member States.
Most instances of thiamine deficiency appear to be as a result of lack of dietary intake and/or in instances of intake of foods rich in thiaminase. Neither scenario applies to Gardasil or other medicines manufactured using similar cell technology.
