[Hepatitis B vaccination. Advocating for a protection principle]

Hepatitis B is a worldwide disease. More than 350 million persons are chronic carriers and around one-quarter of these chronic carriers will develop cirrhosis or liver cancer within 30 years. Since 1981, more than a billion doses of hepatitis B vaccine have been used worldwide and it is considered one of the safest vaccines ever produced. The suggestion of a link between hepatitis B vaccine and demyelinating diseases has arisen because of case reports, although inevitably some people will develop symptoms of demyelination by chance after receiving hepatitis B vaccine. Scientific data could never demonstrate a causal association between hepatitis B vaccine and central nervous system diseases, including MS. However, the hypothesis of a potential causal relationship between vaccination and multiple sclerosis (MS) and other demyelinating diseases was brought to public debate by the French Health Authority after the publication of these cases. Since 1998, in France, several court decisions held pharmaceutical companies responsible for the development of multiple sclerosis in patients who were given hepatitis B vaccine on two grounds: the chronological coincidence between vaccination and the development of the plaintiffs' MS, and the fact that a causal link between the two cannot be excluded, although the Appeals Court did declare that "it is indisputable that there is no definite scientific evidence of a relation between vaccination and the onset of the disease". On 1st October 1998, the French Minister of Health decided to stop hepatitis B vaccination in schools. Stopping immunization on the basis of unfounded worries has led to decreased vaccine coverage levels among children. Two recent studies published in the N Engl J Med in February 2001 confirm the lack of evidence of an association between hepatitis B vaccination and multiple sclerosis. The Académie nationale de Médecine should be consulted about this major public health issue.