Global Vaccine Safety

Statement from the Global Advisory Committee on Vaccine Safety on aluminium-containing vaccines

The Global Advisory Committee on Vaccine Safety reports no evidence of a health risk from aluminium-containing vaccines

At present there is no evidence of a health risk from aluminium-containing vaccines or any justification for changing current vaccination practices. The Global Advisory Committee on Vaccine Safety (GACVS) suggests more research is required to determine if there are links between macrophagic myofasciitis (MMF) and aluminum-containing vaccines.

Deltoid muscle biopsies performed in France in a number of patients with a variety of complaints have revealed in a small number the presence of a minute inflammatory focus of macrophages with associated necrosis. These localised lesions, called MMF, have been shown to contain aluminium salts. Since the location of the lesions in the deltoid muscle coincides with the usual site of injection for vaccines, it would appear that these microscopic lesions are related to immunization. In addition, scientists from the Groupe d’études et de recherche sur les maladies musculaires acquises et dysimmunitaires (GERMAAD) have suggested that vaccination and localized MMF lesions might be associated with a multi-system disorder. However, it remains possible that the finding is only coincidental.

On the advice of the GACVS, WHO initiated a broad consultation on the issue, holding consultations in September 1999 with experts, GERMMAD scientists, and interested pharmaceutical companies. The need was identified to determine why macrophagic inflammation persists in a small number of subjects following immunization, and whether this histological lesion may or may not be responsible for generalized symptoms in some patients. These questions can only be resolved by epidemiologic studies comparing individuals with and without the lesion.

French study reviewing association between local MMF lesions and any generalized illness has been completed in 2003 and concluded that the persistence of aluminium-containing macrophages at the site of a previous vaccination is not associated with specific clinical symptoms or disease.

Results of animal studies conducted in monkeys1 and rats that looked at long-term persistence of aluminium and histopathologic changes at the vaccine injection site, as well as comparative studies of macrophagic function in patients with MMF and healthy subjects, further support the idea that MMF represent a simple marker of vaccination with long-term persistence of aluminium at the injection site and local inflammatory response to it, without other symptoms or consequences.

From the most recent evidence available, there is no reason to conclude that a health risk exists as a result of administration of aluminium-containing vaccines, nor is there any good reason for changing current vaccination practice. The GACVS will continue to review the evidence that might emerge from on-going studies.

The GACVS is a scientific advisory body established by WHO to provide a reliable and independent scientific assessment of vaccine safety issues in order to respond promptly, efficiently and with scientific rigour to such issues. Membership includes experts from around the world in the fields of epidemiology, paediatrics, internal medicine, pharmacology and toxicology, infectious diseases, public health, immunology and autoimmunity, drug regulation, and safety.

Page last updated: 23 October 2008
Page last reviewed: 3 December 2008