Investigators find no overall link between
hepatitis B vaccine and MS.
Details
A study evaluating the potential that hepatitis
B vaccination increases the risk of developing
MS found no general increase in risk from
exposure to the vaccine. However, the investigators
did find a possible hint that a specific
brand of the vaccine may increase the risk
of MS, but that finding requires confirmation.
The study, led by Yann Mikaeloff, MD, PhD
(Assistance Publique-Hôpitaux de Paris,
INSERM), evaluated vaccination records of
349 children in France who had experienced
a neurologic episode. Most previous studies
have found no link between MS and hepatitis
B vaccine, which can prevent serious health
problems associated with hepatitis B virus
infection. The study will appear in the journal
Neurology (early online publication, October
8, 2008).
Background: Hepatitis B virus causes some
4 million acute infections worldwide annually.
More than 350 million individuals are chronic
carriers of the virus
after infection, and some 25% of those (some 5,000 per year in the U.S.) will
die as a consequence of cirrhosis of the liver or liver cancer brought on by
the viral infection. Vaccination against hepatitis B has been established to
be safe and effective in helping to prevent infection and subsequent liver
disease.
However, in recent years, concerns have been
raised that vaccination against hepatitis B
virus might increase risk for developing a
variety of diseases, including MS. The concerns
related to MS were due in part to a report
from France in the mid-1990s of a possible
increase in autoimmune diseases, including
MS, after hepatitis B vaccination. Efforts
to confirm this report had been unsuccessful
and two separate reports concluded that there
was no evidence of an association between vaccination
and the risk either of developing MS or having
MS relapses (The New England Journal of
Medicine,
February 1, 2001). The World Health Organization
and, separately, the Institute of Medicine
reviewed all available data and concluded that
there was no association between hepatitis
B and MS.
The Study: Dr. Mikaeloff's team evaluated
cases selected from patients enrolled in "KIDSEP," which
compiles information on children with neurological
disorders in France. They selected 403 patients
who had one neurologic episode caused by
inflammation/demyelination between January
1, 1994, and December 31, 2003, before the
age of 16 years, and born in France. They
matched each case with up to 12 controls
selected from the general population of France.
The team sent a questionnaire to all participants,
and requested a copy of the child's vaccination
history. Of the original group, 349 cases
and 2941 controls responded and provided
enough information to be included in the
analysis.
Of the group who experienced a neurologic
episode, 24.4% had been vaccinated in the
three years before symptom onset, compared
to 27.3% of the controls. There was no association
between the development of confirmed MS and
general hepatitis B vaccination. However,
children who eventually developed MS were
significantly more likely to have received
a particular vaccine, Engerix B. In their
paper, the authors suggest that since the
link between MS and the Engerix B vaccine
was the only one to emerge from among a number
of analyses, it could have been due to chance.
These results warrant confirmation to determine
if indeed this link holds up and if any significant
difference exists among vaccine brands.
Comment: "These results show no association
between MS and hepatitis B vaccination, which
is consistent with most other studies on
this subject" says Paul O'Connor, MD,
National Scientific and Clinical Advisor. "Hepatitis
B is a serious disease and people should
not avoid vaccination if it is otherwise
needed because of a fear of developing MS"
With information from the National MS Society
(USA)
National Research and Clinical Programs
Offert en français.
Disclaimer
The Multiple Sclerosis Society of Canada is an independent, voluntary health
agency and does not approve, endorse or recommend any specific product or therapy,
but provides information to assist individuals in making their own decisions.
