Global Vaccine Safety

Safety of vaccine formulations

Extract from report of GACVS meeting of 29-30 November 2006, published in the WHO Weekly Epidemiological Record on 19 January 2007

This session stemmed from a recommendation made at the last GACVS meeting that the Committee should start looking proactively into the real and perceived safety of preservatives and other inactive ingredients in vaccine formulations. The limited information provided about excipients, in contrast to the active components in vaccines, was highlighted. This is a challenge for drug regulators and industry in the areas of quality assurance, and it is likewise a challenge for health professionals in terms of communicating risks. The infrequent administration of vaccines makes it unlikely that small amounts of excipients are toxic. However, this may change with the development of therapeutic vaccines, which might be administered repeatedly. A mechanism must be established to secure more information about detailed vaccine formulations and to rigorously review the safety of excipients.

A GACVS subgroup was established to examine this issue in further detail. The subgroup will report on its work, including identifying priorities and establishing a listing of excipients and conceivable adverse effects, at the June 2007 meeting of the Committee.