Updated statement on hepatitis B vaccine safety. (June, 2000)

  • Underneath you can find a recent statement that was approved by the VHPB on June 8, 2000 and to which WHO refers on their website.

    Recent letters signed by the Chief Medical Officer of the Ministry of Health in France on May 25, 2000 have again raised concerns that hepatitis B immunization may be linked to new cases or flare ups of multiple sclerosis (MS):

    7 Health care workers who complained of MS and auto-immune disorders have received a letter from the Chief Medical Officer indicating that the experts from the vaccine compensation committee have considered that there was a causal relationship between hepatitis B vaccination and MS and offering an immediate compensation and an annual pension.

    Concerns that hepatitis B vaccination may cause MS comes primarily from case reports resulting in media attention in France and in the US. Current scientific data do absolutely not support the idea that hepatitis B vaccine causes or exacerbates MS. Universal infant and/or adolescent immunization with hepatitis B vaccine is now a policy in 110 countries worldwide and any misinformation has the potential to cause significant damage to these important public health programmes.

    Epidemiological evidence for a causal association requires showing that MS or exacerbation of MS occurs more frequently in HB vaccine recipients than in a comparable group of unvaccinated individuals (age, gender, ethnicity matched). This has never been demonstrated. The scientific data were carefully reviewed by several expert groups, who stated that there is no evidence to support a potential link between hepatitis B vaccination and MS [1,2].
    In addition, recent studies are finding absolutely no evidence for a causal association between hepatitis B vaccines and MS [3].

    For this reason, WHO reinforces the 1992 recommendation to incorporate hepatitis B vaccination into the current infant and/or adolescent immunization programmes and reiterates the recommendation to immunize high risk groups.
    It is important to immunize infants and children against hepatitis B, because the consequences for children who become infected are much more severe than for adults. Those who are infected as children have a 30% risk of developing chronic hepatitis and chronic liver disease.<

    While there is no scientific evidence that there is an increased risk of MS following HB immunization, the risk of HB infection and disease in non-immunized individuals is real. HB causes an estimated 4 million acute infections worldwide each year, and currently there are more than 370 million chronic carriers of HBV, approximately 25% of whom will die from cirrhosis of the liver or primary liver cancer. Any presumed/hypothetical risk of adverse events associated with hepatitis B vaccination must be balanced against these figures.

    HB vaccines are safe, more than 90% effective in preventing disease, and very cost-effective. It is the most powerful tool for the prevention of hepatitis B and its consequences.


    [1] Hall A., Kane M., Roure C., Meheus A.; Multiple Sclerosis and Hepatitis B Vaccine? Meeting report from a WHO / VHPB Meeting, Geneva, September 28-30, 1998.
    Vaccine (1999) 17, 20-21: 2473-2475

    [2] Halsey N.A., Duclos P., Van Damme P., Margolis H.; Hepatitis B Vaccine and Central Nervous System Demyelinating Diseases",
    Pediatr. Infect. Dis. J. (1999), 18: 23-24

    [3] Sadovnick A.D., Scheifele D.W.; School-based hepatitis B vaccination programme and adolescent multiple sclerosis,
    Lancet (2000), 355: 549-550