Hepatitis B vaccine and multiple sclerosis: A case of repeated déjà vu?
Authors: Ding-Shinn Chen
Journal: Journal of Hepatology (2009)

I cannot agree more with Braillon [[1]Braillon A. A new French paradox: HBV vaccination.J Hepatol. 2009; 51: 597-598Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar] that in revealing the results of any study concerning the adverse reactions of treatment or prevention measures, everyone in the chain of releasing the information should be very prudent. This is especially true in relation to the hepatitis B vaccine. The unusually low coverage of hepatitis B vaccination in France can be traced to the alleged concerns about the safety of the hepatitis B vaccine. The allegation started right after the country implemented an active hepatitis B vaccination program in 1994–1995 targeting at pre-adolescents in the first year of secondary schools as well as all infants [[2]Denis E. Levy-Bruhl D. Mass vaccination against hepatitis B: the French example.Curr Top Microbiol Immunol. 2006; 304: 115-129Crossref PubMed Scopus (21) Google Scholar]. Initially, the program was highly successful with a coverage rate of 76% in adolescents. During implementation of the program, reports of demyelinating disorders of the central nervous system (CNS) suspected to be associated with hepatitis B vaccination started to appear. Despite the lack of causal association, the issue caught the attention of mass media and, naturally, the general public then. The pressure cumulated became so great that it led the French health authority to suspend hepatitis B vaccination in a school-based program on October 1, 1998. The French government’s decision was immediately condemned by the World Health Organization (WHO) and the French pediatricians [[3]Dorozynski A. Suspension of hepatitis B vaccination condemned. (News, October 17, 1998). Brit Med J 1998;317:1034.Google Scholar], because it will very possibly result in a loss of public confidence in hepatitis B vaccination, and thus lead other countries to discontinue its use or decide not to introduce a hepatitis B vaccination program that is critical in the control of hepatitis B worldwide [[4]Chen D.S. Hepatitis B vaccination: the key towards elimination and eradication of hepatitis B.J Hepatol. 2009; 50: 805-816Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar]. Indeed, the negative impact could be tremendous, if not handled appropriately. To avoid unnecessary negative impacts to our very successful mass hepatitis B vaccination program in Taiwan [[5]Chen D.S. Hsu N.H.M. Sung J.L. Hsu T.C. Hsu S.T. Kuo Y.T. et al.A mass vaccination program in Taiwan against hepatitis B virus infection in infants of hepatitis B surface antigen-carrier mothers.JAMA. 1987; 257: 2597-2603Crossref PubMed Scopus (287) Google Scholar], right after the suspension of hepatitis B vaccine in France, Taiwan’s Department of Health immediately issued a press release to assure the safety and necessity of hepatitis B vaccination in the country. Fortunately, the French issue did not ferment, and did not affect our program. A premature or immature release of the results of any study concerning adverse reactions of the hepatitis B vaccines may be exploited by anti-vaccination groups, liability lawyers, and most importantly, the media. Even if the results are disproved finally, the media usually does not report them, because of the loss of news worthiness [[6]Zuckerman J.N. Protective efficacy, immunotherapeutic potential, and safety of hepatitis B vaccines.J Med Virol. 2006; 78: 169-177Crossref PubMed Scopus (148) Google Scholar]. The public’s initial wrong image remains, and becomes an obstacle in the implementation of the vaccination program. Unfortunately, despite the rejection of a causal relationship between hepatitis B vaccine and multiple sclerosis [[7]Immunization Safety Review Committee, Institute of Medicine. Immunization Safety Review. Hepatitis B vaccine and demyelinating neurological disorders. Stratton K, Almario D, McCormick MC, editors. The National Academies Press, Washington, DC; 2002.Google Scholar], reports suggesting a risk of multiple sclerosis associated with recombinant hepatitis B vaccine still appeared [[8]Hernan M.A. Jick S.S. Olek M.J. Jick H. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: a prospective study.Neurology. 2004; 63: 838-842Crossref PubMed Scopus (241) Google Scholar]. WHO responded quickly by denying the interpretation of the results of the study [WHO Global Advisory Committee on Vaccine Safety, September 2004; http://www.who.int/vaccine_safety/topics/hepatitisb/multiple_sclerosis/sept_04/en/]. The issue recurred again recently, initiated after an article published by a French group in early October 2008 [[9]Mikaeloff Y. Caridade G. Suissa S. Tardieu M. Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood.Neurology. 2009; 72: 873-880Crossref PubMed Scopus (130) Google Scholar]. Based on subgroup analysis of children having followed the French vaccine recommendations, it was concluded that although hepatitis B vaccination does not increase the risk of CNS inflammatory demyelination in children, the Engerix hepatitis B vaccine appears to increase the risk, especially for the confirmed cases of multiple sclerosis. Although the authors conceded that their results require confirmation in future studies [[9]Mikaeloff Y. Caridade G. Suissa S. Tardieu M. Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood.Neurology. 2009; 72: 873-880Crossref PubMed Scopus (130) Google Scholar], the conclusions of the article very likely have had exerted another negative impact on hepatitis B vaccination, at least in France. The Global Advisory Committee on Vaccine Safety of WHO again responded immediately by concluding that the study did not provide convincing evidence that hepatitis B vaccine, or use of any brand of the vaccine, is associated with an increased risk of acute CNS inflammatory demyelination or multiple sclerosis [WHO Global Advisory Committee on Vaccine Safety, October 8, 2008; http://www.who.int/vaccine_safety/topics/hepatitisb/multiple_sclerosis/oct_2008/en]. In the meantime, the French health products safety agency (Afssaps) also responded promptly in refuting the association [http://www.afssaps.fr/var/afssaps_site/storage/original/application/]. Hopefully, these counteractions will alleviate the low coverage of hepatitis B vaccine in the country. In the real world, there is no perfect means for a given treatment or prevention that bears no risk. In hepatitis B, any presumed risk of untoward events possibly associated with hepatitis B immunoprophylaxis should be weighed against the disease burden caused by the hepatitis B virus. Education of the public and health professionals is essential [[10]Chen D.S. Public health measures to control hepatitis B virus infection in the developing countries of the Asia-Pacific region.J Gastroenterol Hepatol. 2000; 15: E7-E10Crossref PubMed Scopus (27) Google Scholar], and it should include everyone in the chain of releasing the information, right from the sources all the way down to academia and the public.