Global Vaccine Safety

The Global Advisory Committee on Vaccine Safety rejects association between Hepatitis B vaccination and multiple sclerosis (MS)

November 2002

The Global Advisory Committee on Vaccine Safety (GACVS) has concluded that there is no association between administration of the hepatitis B vaccine and multiple sclerosis (MS). Since 1982, hepatitis B vaccine has been given to over 500 million people around the world. The hepatitis B vaccine is the first and only vaccine that prevents liver cancer by preventing hepatitis B infection.

There has been extensive use of hepatitis B vaccine in France in recent years, with more than 25 million people being vaccinated. Several case reports have raised concerns that hepatitis B immunization may be linked to new cases or relapse of multiple sclerosis (MS). As a result of public and professional concern, on 1 October 1998 the French Ministry of Health temporarily suspended the school-based adolescent hepatitis B vaccine programme. It nevertheless maintained the recommendations for universal infant immunization and administration of the vaccine to adults at special risk, and reiterated its support for adolescent vaccination. The French decision was misunderstood and interpreted as a ban on hepatitis B immunization, generating widespread concern in other countries.

There are three possible explanations of the observation linking MS with hepatitis B vaccination: 1) coincidence, due to the large number of hepatitis B vaccine doses administered, many of them in age groups in which MS first occurs; 2) "triggering", i.e. an increased risk of demyelination following hepatitis B vaccine which would act as a "trigger" in individuals predisposed to develop MS or other central nervous system demyelinating disease; and 3) a true causal association between hepatitis B vaccination and MS or other demyelinating disease.

By 2001, more than 700 cases of central demyelinating diseases with a close match to the natural epidemiologic distribution of MS had been reported to the French authorities, the majority in adult females. No cases were reported among children less than 25 months despite vaccination of 1.8 million babies. Overall, 9 epidemiological studies have been carried out to estimate the risk (if any) of an association between vaccination with hepatitis B and a first attack or relapse of multiple sclerosis. Despite a slightly elevated odds ratio observed in the initial studies, none showed a statistically significantly elevated risk, and the most recent studies do not indicate any excess risk. The analysis of data from spontaneous reports and results of epidemiological studies do not support a causal relationship between MS and hepatitis B vaccination. The most likely explanation is a coincidental association.

The conclusions of a recent report of the United States Institute of Medicine on an association between hepatitis B and demyelinating neurological disorders also did not support a causal relationship between hepatitis B vaccine administered to adults and multiple sclerosis or a relapse of multiple sclerosis. The GACVS has concluded that there is no reason to suggest that the recommendations for universal infant and adolescent immunization coverage with hepatitis B vaccine should change.

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.