§ Ian LucasTo ask the Secretary of State for Health if he will make a statement on progress towards the replacement of thiomersal as a preservative in vaccines. [48832]
§ Ms BlearsThe European Committee for Proprietary Medicinal Products (CPMP) has developed regulatory guidance entitled "Points to Consider on the Reduction, Elimination or Substitution of Thiomersal in Vaccines". This regulatory guidance has come into operation since May 2001. It sets out recommendations and strategy for reducing, eliminating and substituting thiomersal as a preservative in vaccines. As indicated in this regulatory guidance, in an initial stage, a manufacturer may choose to reduce the amount of thiomersal while developing a thiomersal-free formulation with or without a substitute preservative. Since reducing or eliminating thiomersal could have an impact on microbiological quality, antigenicity, immunogenicity, reactogenicity and stability of vaccines, substantial developmental and validation work is necessary before such modifications can be implemented.