From 1994 to 1997, the French Agency for the Safety of Health Products (Afssaps) received a higher number of reports of adverse reactions concerning the hepatitis B vaccine. These reports concerned a temporal link between the vaccine and central demyelinating disorders, mainly cases of multiple sclerosis, but also of autoimmune diseases such as rheumatoid arthritis or lupus.¹. As early as 1997, several complaints were filed. An association of hepatitis B vaccine victims, the Hepatitis B Vaccine Network (REVAHB), estimates that a total of 2 people have suffered a serious post-vaccination side effect and should receive compensation².

The General Directorate of Health paid compensation to more than a hundred health workers who had been compulsorily vaccinated: their cases were treated as accidents at work.^2,3,13. On the other hand, the lawsuits brought following a non-compulsory immunization are much more difficult and only a few cases have been won by the plaintiffs.⁴.

These judgments do not mean that a link between the vaccine and multiple sclerosis has been proven. In a 2007 article in a forensic journal, the D^re Clothilde Rougé-Maillard explains that the legal causal link is a very different concept from the medical causal link⁴. In January 2008, 29 criminal proceedings were investigated by Judge Marie-Odile Berthela-Geoffroy, in charge of this case for ten years.^5,6.

As with the potential link between autism and the MMR vaccine, the public reacted strongly to this widely publicized data. As early as 1998, Afssaps looked into four studies in order to assess the potential link between hepatitis B vaccine and these demyelinating diseases. Agency verdict: If there is a link, its occurrence is extremely rare and much lower than the risk of fulminant hepatitis and cirrhosis of the liver¹.

However, in October 1998, the pre-adolescent hepatitis B vaccination program in school was suspended. According to medical authorities, this immunization did not allow adequate monitoring of any individual contraindications.¹. Immunization of newborns and people at risk has however been maintained.

About ten other research have been published since². All except two concluded that there was no link^1,7. The first is a case-control survey carried out in Great Britain and published in 2004⁸. Its methodology has been strongly criticized, in particular because the statistical link had been established from only 11 vaccinated subjects who, moreover, presented a high risk of multiple sclerosis.¹.

The second study reporting a link is much more recent, since it was published in early October 2008⁹. This case-control survey was conducted in France and funded by the Ministry of Health. It does not show an increased risk of a first attack of multiple sclerosis, except in a subgroup of children who followed the vaccination schedule and received the vaccine. Engerix B^®. In the latter, the risk is markedly increased.

The National Pharmacovigilance Commission (CNP), notified in advance of this publication, convened a meeting on September 30, 2008. Conclusion: the analysis of the subgroup of children presents many weaknesses and an error of interpretation. In addition, the results are questionable and are the result of chance. CNP also rejects the hypothesis that the vaccine Engerix B^®, because it is made from yeast, can cause multiple sclerosis⁷. This vaccine is the most used in France.

According to the CNP, there is therefore no question of modifying the recommendations concerning vaccination against hepatitis B in France on the basis of these two biased studies. Currently, the French medical authorities recommend the vaccination of infants, people at risk and that of unvaccinated children and adolescents.

The French Institute for Health Surveillance estimates that from 1994 to 2007, around 20 new infections, 000 acute hepatitis, 8 chronic infections and 000 fulminant hepatitis were prevented, thanks to the high vaccination coverage of adolescents.¹⁰. The current vaccination coverage is considered very insufficient, less than 30% in infants and around 40% in pre-adolescents⁷.