Vol. 528 No. 3
129 Mr. G. Mitchell asked the Minister for Health and Children if mercury is an ingredient in certain vaccines; if so, the vaccine in which this is so; if his attention has been drawn to the fact that patients can have a reaction to this ingredient; if his attention has further been drawn to the fact that in the US persons are informed of the possible side effects before being offered vacci nation; and if he will make a statement on the matter. [30270/00]
I have had inquiries made of the Irish Medicines Board, which is the expert authority in Ireland regarding medicinal products, about this matter. I understand that, while mercury itself is not an ingredient in any vaccines authorised by the board, an organomercuric compound, Thiomersal, is used as an anti-microbial preservative in some vaccines for human use. In addition to its anti-microbial capacity it may perform other functions affecting antigenicity and stability. Manufacturers and authorities generally have accepted the use of anti-microbial compounds because the pharmacopeial methods recommended for the preparation of sterile products by physical means such as heat and-or filtration cannot in general be applied to the active ingredients of vaccines.
The use of Thiomersal in vaccines has been considered on a number of occasions by the scientific committees of the European Medicines Agency in which the Irish Medicines Board participates. In July 1999 they recommended that all medicinal products containing Thiomersal be required to state in the patient information leaflet that: "this medicinal product contains Thiomersal as a preservative and it is possible that you-your child may experience an allergic reaction". "Tell your doctor if you-your child has any known allergies". Companies were required by the Irish Medicines Board to implement this statement by the end of June 2000.
In addition, the biotechnology working party of the Committee for Proprietary Medicinal Products has recently (16 November 2000 CPMP-BWP-2517-00) issued a consultation document entitled Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in Vaccines. This document has been released for consultation with a deadline for comments of February 2001 and encourages authorisation holders to reduce and-or eliminate or substitute Thiomersal. It is recognised that this is a complex task which may require additional clinical studies before it can be implemented.
