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Hepatitis B Vaccine and Concerns about Multiple Sclerosis (MS)
Numerous studies have evaluated a possible relationship between hepatitis B
vaccination and multiple sclerosis (MS). The weight of the available scientific
evidence does not support the suggestion that hepatitis B vaccine causes or
worsens MS.
What is multiple sclerosis (MS)?
Multiple sclerosis (MS) is a disease of the central nervous system characterized
by the destruction of the myelin sheath surrounding neurons, resulting in the
formation of "plaques." Because they involve the destruction of the myelin
sheath that covers nerve tissue, diseases such as MS are known as "demyelinating"
diseases.
MS is a progressive and usually fluctuating disease with exacerbations
(patients feeling worse) and remissions (patients feeling better) over many
decades. In many patients with MS, permanent disability and even death can
occur. The cause of MS is unknown. The most widely held hypothesis is that MS
occurs in patients with a genetic susceptibility and is "triggered" by certain
environmental factors.
MS is 3 times more common in women than men, with diagnosis usually made as
young adults; however, it has been estimated that between 2 to 5% of cases begin
before age 16. Since MS is not widely recognized as a childhood disorder,
diagnosis is often missed or delayed. In addition, many of its symptoms are
similar to those of other pediatric neurological conditions, leukodystrophies
and metabolic disorders. Diagnosis in childhood is difficult due to the lack of
universally accepted diagnostic criteria.
Does hepatitis B vaccination cause MS?
Most published scientific studies do not support a causal relationship between
hepatitis B vaccination and MS or other demyelinating diseases. Examples of this
scientific evidence are as follows:
- Extensive pre-licensure clinical trials did not document such an effect.
- Hundreds of millions of people worldwide have received hepatitis B vaccine without developing MS (or any other autoimmune disease). This finding provides important evidence as well as an appropriate framework for assessing this possible association– namely, that if vaccination causes MS, it does so extremely rarely.
- Due to the large number of vaccinations administered worldwide,
surveillance systems in the United States, France, and elsewhere (Quast,
1991) expect to receive reports of MS that are only temporally (by chance
alone) associated with vaccines.
- According to a study published in the Oct. 8, 2000, online issue of
Neurology (Mikaeloff, 2008), the majority of children vaccinated
against hepatitis B are not at an increased risk of developing CNS
inflammatory demyelination. 349 children with a first episode of acute CNS
inflammatory demyelination before age 16 were matched to 2,941 healthy
controls and evaluated for use of hepatitis B vaccination. When subjects
were restricted to those compliant with vaccination, children who received a
specific type of hepatitis B vaccine (Engerix B) more than 3 years earlier
were found to have a slightly increased risk of developing an acute CNS
demyelinating event and a slightly higher risk of having a confirmed
diagnosis of MS. The findings in this paper cannot be taken as confirmation
that the vaccine caused MS. Further studies are needed to confirm this
observation, and then, if confirmed, to determine whether this is a causal
relationship.
- A study conducted in France from 1994 to 2003 (Mikaeloff, 2007) did not
find a relationship between vaccination for hepatitis B and the development
of childhood-onset multiple sclerosis. The 143 cases included children with
onset of MS before age of 16 years. 1,122 control subjects were selected
randomly from the general French population. The rate of a first episode of
MS was not increased for hepatitis B vaccination.
- A study was conducted using Vaccine Safety Datalink (VSD) project to assess the association between hepatitis B vaccination and demyelinating
diseases such as MS among members of 3 large managed care organizations (MCOs)
on the west coast of the United States (Verstraeten, 2001). The study included 422
adult cases (people with demyelinating disease) and 921 matched controls (people of similar age, gender, and MCO status who did not have demyelinating
disease). The researchers concluded that hepatitis B vaccination was not
associated with demyelinating disease in the study population.
- Ascherio and colleagues (2001) evaluated the possible association between hepatitis B vaccination and MS. The study included 192 women with MS and 645 controls. The
authors concluded that there was no association between hepatitis B
vaccination and MS.
- A study was conducted in Europe to evaluate whether MS relapses were associated with receipt of hepatitis B, tetanus, or influenza vaccines (Confavreux,
2001). The study included 643 individuals with relapsing MS. The researchers
concluded that there was no evidence of an association between recent
receipt of hepatitis B vaccine (or tetanus or influenza vaccination) and MS
relapses.
- Sadovnick and Scheifele (2000) investigated multiple sclerosis in 578,308 adolescents in British Columbia before and after hepatitis B vaccination programs were
implemented. The authors found no evidence of a link between hepatitis B vaccination and multiple sclerosis or other demyelinating disease.
- An analysis of a U.S. pharmacy benefits management database did not find a statistically significant association between claims for hepatitis B vaccination and subsequent claims for treatment of CNS demyelinating disorders (Zipp, 1999).
What has been done to examine the suggested association between hepatitis B vaccine and neurological disorders?
CDC and the National Institutes of Health (NIH) asked the National Academy of
Sciences, Institute of Medicine to establish an independent expert committee to
review hypotheses about existing and emerging immunization safety concerns. The
review will involve an assessment of factors such as the biologic mechanisms of
the hypothesis, competing alternative hypotheses, as well as the available
scientific evidence to date.
In 2002, the IOM reviewed the evidence of a possible causal association
between hepatitis B vaccine and demyelinating neurological disorders, including
MS in adults. The committee found that the epidemiological evidence does not
support a causal relationship between hepatitis B vaccine in adults and multiple
sclerosis.
Should I delay hepatitis B vaccination until more is known?
No. Results from studies that have examined the possible association between hepatitis B vaccination and MS are reassuring and support current recommendations for immunizing against hepatitis B. Concern regarding the alleged association between hepatitis B vaccination and MS must be weighed against the vaccine's ability to prevent risks associated with hepatitis B virus infection. For more information, visit Viral Hepatitis B.
What research has been conducted to look at the possible link between vaccines and autoimmune diseases?
CDC takes concerns about vaccines and immune system diseases and disorders very
seriously. Researchers at CDC and elsewhere have conducted studies to examine
the possible link between vaccines and autoimmune conditions like MS, diabetes,
and asthma. These studies have been reassuring, providing no evidence to suggest
a link between vaccines and autoimmune conditions.
As part of ongoing vaccine safety surveillance, CDC will continue to conduct
research to examine the effects vaccines may have on the immune system.
Related Publications
Ascherio A, Zhang SM, Hernan MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis.* New England Journal of Medicine 2001;344(5):327–332.
Confavreux C, Suissa S, Saddier P et al. Vaccinations and the risk of relapse in multiple sclerosis.* New England Journal of Medicine 2001;344(5):319–326.
DeStefano F, Weintraub ES, Chen RT. Hepatitis B vaccine and risk of multiple sclerosis [letter]. Pharmacoepidemiology and Drug Safety 2007;16(6):705–707.
Fourrier A, Touze E, Alperovitch A, Begaud B. Association between hepatitis B vaccine and multiple sclerosis: a case-control study. Pharmacoepidemiology & Drug Safety 1999;8:S140–141.
Herrolen L, DeKeyser J, Ebinger G. Central nervous system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet 1991;338(8776):1174–1175.
Lewis E, Shinefield HR, Woodruff BA, Black SB, DeStefano F, Chen RT, Ensor R.
Safety of neonatal hepatitis B vaccine administration. Pediatric Infectious Disease Journal
2001;20: 10489-1054.
Mikaeloff Y, Caridade G, Rossier M, Suissa S, Tardieu M. Hepatitis B
vaccination and the risk of childhood-onset multiple sclerosis. Arhcilves of Pediatricks and Adolescent Medicine 2007: 161(12):
1214-15.
Niu MT, Rhodes P, Salive M, Davis DM, Black S, Shinefield H, Chen RT,
Ellenberg SS. Comparative safety of two recombinant hepatitis B vaccines in
children: data from the Vaccine Adverse Event Reporting System (VAERS) and
Vaccine Safety Datalink (VSD). Journal of Clinical Epidemiology 1998;
51(6):503-510.
Quast U, Herder C, Zwisler O. Vaccination of patients with encephalomyelitis disseminata. Vaccine 1991;9(4):228–230.
Sadovnik AD, Scheifele DW. School-based hepatitis B vaccination programme and adolescent multiple sclerosis. Lancet 2000;355(9203):549–550.
Sturkenboom MCJM, Abenhaim L, Wolfson C, Roulet E, Heinzelf O, Gout O. Vaccinations, demyelination, and multiple sclerosis study (VDAMS). Pharmacoepidemiology & Drug Safety 1999;8:S170–171.
Touzé E, Gout O, Verdier-Taillefer MH, Lyon-Caen O, Alpérovitch A. The first episode of central nervous system demyelinization and hepatitis B vaccination. Revue Neurologique 2000;156(3):242–246.
Verstraeten T, DeStefano F, Jackson L, Benson P, Okoro C, Black S, Shinefield H., Mullooly J, Chen R.; VSD Team. Risk of demyelinating disease after hepatitis B vaccination—West Coast, United States, 1995–1999. Paper presented at the 50th Annual Epidemic Intelligence Service Conference, 2001, Atlanta GA.
Yu O, Bohlke K, Hanson CA, Delaney K, Rees TG, Zavitkovsky A, Ray P, Mullooly
J, Black SB, Benson P, Thompson WW, Davis RL, Jackson LA. Hepatitis B vaccine and risk of autoimmune thyroid disease: a Vaccine Safety Datalink study.
Pharmacoepidemiology and Drug Safety 2007;16(7a):736-745.
Zipp F, Weil JG, Einhaupl KM. No increase in demyelinating diseases after hepatitis B vaccination. Nature Medicine 1999;5(9):964–965.
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