France suspends adolescent hepatitis B vaccinations (Oct 3) The French Health Minister, Bernard Kouncher, announced on October 1, 1998 that he had ordered a suspension of France's national hepatitis B vaccination program for middle school children. His decision came just four years after the program was started, according to a story from the Associated Press. Public health experts in Europe and the U.S. were dismayed by the decision, fearing that it may slow efforts to control hepatitis B around the world. Kouncher attributed the suspension to fears that hepatitis B vaccine could cause demyelinating diseases like multiple sclerosis (MS). The issue has reverberated in France since 1996, when MS patients appeared on French TV talk shows saying that their disease was caused by hepatitis B vaccine. In explaining his action, the Minister said that "it cannot be excluded that the vaccination might reveal or facilitate central nervous system problems." According to the AP story, a French court of law ruled recently that "there was sufficient evidence to conclude there was a connection between the SmithKline Beecham vaccine and multiple sclerosis symptoms in two people." A ruling is pending in a similar case against Pasteur-Merieux, another hepatitis B vaccine maker in France. Just days before the French announcement, the Viral Hepatitis Prevention Board (VHPB), a group of hepatitis experts from the U.S. and Europe, met with officials of the World Health Organization (WHO) in Geneva to evaluate all available evidence on the possible relationship between hepatitis B vaccine and demyelinating disease. Immediately after that meeting, WHO issued a communiquÈ saying in part that "WHO believes that available scientific data does not demonstrate a causal association between HB immunization and central nervous system diseases, including MS." "WHO is concerned that the decision taken yesterday [by France] may lead to loss of public confidence in this vaccine, and decisions by other countries to suspend or delay introduction of HB vaccine," the communiquÈ continued. "WHO strongly recommends that all countries already using hepatitis B vaccine as a routine vaccine in their national immunization programmes continue to do so, and that countries not yet using the vaccine begin as soon as possible." Experts at the VHPB meeting also released a draft report concluding that "evidence in favour of an increased risk [of CNS demyelinating disease] following vaccination is weak and does not meet the criteria for causality." The full draft report is available at www.who.int/gpv-documents/. The U.S.-based National Multiple Sclerosis Society released a similar statement, citing several studies in the U.S. and Europe that have found no evidence of a link between hepatitis B vaccination and MS. According to the AP story and observers close to the situation, the French decision was propelled by political fallout from criminal prosecutions against former French Ministry of Health officials alleging that they allowed blood products tainted with HIV to reach the French population in the 1980s. The AP story reported that a former prime minister, Laurent Fabius, and two other ministers will stand trial for their roles in the scandal. In making the decision to suspend middle school vaccinations, the French Ministry reportedly relied in part on data from recent internal studies assessing the alleged association between hepatitis B vaccination and demyelinating disease. The data have not yet been released publicly. The French decision does not affect the routine immunization of infants and high-risk adults in the country. France and nearly 100 other countries have incorporated hepatitis B vaccination into their childhood immunization programs, although only a small number of countries are vaccinating adolescents. Over one billion doses of hepatitis B vaccine have been administered since 1981. Editor's Note: Vaccination critics on both sides of the Atlantic have alleged a causal link between MS and hepatitis B vaccination, based mainly on individual case reports and theories of biologic plausibility. But several respected scientific groups have found no epidemiologic evidence of a link. We will provide more coverage of this story in future issues of the Hepatitis Control Report.