Global Vaccine Safety

Hepatitis B vaccination and multiple sclerosis: update

January 2004

At its meeting of 3-4 December 2003, the committee considered an unpublished abstract and oral presentation of a study that drew on data from the United Kingdom General Practice Research Database (GPRD) in proposing a possible association between hepatitis B vaccination and the onset of multiple sclerosis (MS). The authors reported an apparent increase in risk of onset of MS within 3 years of vaccination, using a case-control method. The committee concluded that the details provided of the methods used and the patient data submitted were insufficient to address concerns regarding the likelihood of selection bias that might have distorted the conclusions. The latter were based on small numbers so that the element of a chance finding could not be discounted. The committee concluded, on the basis of the information and argument put before it, that the findings do not provide a basis for changing policy with respect to hepatitis B immunization.