摘要:Established in 1999, the Global Advisory Committee on Vaccine Safety advises the World Health Organization (WHO) on vaccine-related safety issues and enables WHO to respond promptly, efficiently, and with scientific rigor to issues of vaccine safety with potential global importance. The committee also assesses the implications of vaccine safety for practice worldwide and for WHO policies. We describe the principles on which the committee was established, its modus operandi, and the scope of the work undertaken, both present and future. We highlight its recent recommendations on major issues, including the purported link between the measles–mumps–rubella vaccine and autism and the safety of the mumps, influenza, yellow fever, BCG, and smallpox vaccines as well as that of thiomersal-containing vaccines. THE SUCCESSFUL IMPLEMEN tation of large-scale comprehensive national immunization programs and the consequent eradication or reduction of smallpox, polio, measles, pertussis, meningococcal meningitis, diphtheria, hepatitis B, congenital rubella syndrome, and tetanus were among the most notable public health achievements of the 20th century. Even in countries where resources for national health programs are severely limited, it has been possible to achieve significant progress. 1 There is good reason to expect that these advances will be sustained in the 21st century. It has been suggested that there are 4 elements of successful public health efforts: highly credible scientific evidence, passionate advocates, media campaigns, and law and regulation, usually at the national level 2 (to which might be added adequate resources and political will). It is thus paradoxical that, as vaccines have become increasingly more effective, safe, and of good quality, public concerns about their safety have increased, especially in the developed world. 3 In recent years, the World Health Organization (WHO) has taken steps to meet these modern challenges to vaccination, including the establishment, in 1999, of the Global Advisory Committee on Vaccine Safety (GACVS). The GACVS provides advice to the WHO on all vaccine-related safety issues, enabling the organization to respond promptly, efficiently, and with scientific rigor to safety issues of potential global importance. 4 The committee also assesses the implications of vaccine safety issues for practice worldwide and for WHO policies. In doing so, the GACVS often draws on the advice, experience, and analysis of outside experts. We report on the principles upon which the GACVS was established, the modus operandi of the committee, and the scope, rather than the details, of the work undertaken by the committee over the past 4 years. We also consider future challenges facing the committee.