Europe. The EMEA has issued a public statement that recent evidence supports safety of thiomersal-containing vaccines for human use. Thiomersal is an antimicrobial organic mercury compound used either in the early stages of manufacturing, or as a preservative in some vaccines. The antimicrobial action of thiomersal relates to ethylmercury, which is released after breakdown of thiomersal into ethylmercury and thiosalicylate. Previously, the Committee for Proprietary Medicinal Products (CPMP), while stating that thiomersal vaccines posed no health risk, had advised the general use of vaccines without thiomer-sal and other mercury containing preservatives as a global measure for reducing environmental exposure to mercury. In March 2004, the CPMP reviewed the latest evidence relating to the safety of thiomersal-containing vaccines including several well-designed epidemiological studies. Based on this review, the CPMP has concluded that

• there is no association between vaccination with thiomersal-containing vaccines and specific neurodevelopmental disorders;

• the immunisation with vaccines containing thiomersal continues to offer outstanding benefits to the general population, including infants;

• the presence of thiomersal and other preservatives should be stated on the label of the vaccine and a warning regarding the risk of sensitization in relation to thiomersal and other preservatives should be included in the Summary of Product Characteristics and package leaflets of such preparations;

• in line with the global goal of reducing exposure to mercury, the development of vaccines without thiomersal or with the lowest possible levels of thiomersal and other mercury containing preservatives should continue to be promoted.

Reference:

EMEA Statement, EMEA/CPMP/VEG/1194/04/Adopted, 24 March 2004. Available from URL: http://www.emea.eu.int