Hepatitis B Vaccines are Safe and Provide Protection
against Serious and Life Threatening Liver Diseases
including Cancer of the Liver
Recent news reports have questioned the safety of
hepatitis B vaccines and have suggested an association between the
vaccine and multiple sclerosis and other autoimmune disorders.
Unfortunately, these reports have not included the results of scientific
studies showing no evidence of increased risk of developing multiple
sclerosis or other autoimmune diseases in people who have received
hepatitis B vaccine as compared with unvaccinated persons. Experts have
carefully reviewed the available data and have concluded that the HBV is
safe and that there is no scientific evidence of a causal
relationship between hepatitis B vaccine and multiple sclerosis.
The stories in the media have focused on anecdotal
reports of adults and children who developed several different disorders
after vaccination. Because the disorders developed shortly after
hepatitis B vaccination, it has been (falsely) concluded that the
disorders might have been caused by hepatitis B vaccines. It is
understandable that people who develop multiple sclerosis (or other
disorders of unknown causes) want answers to the question of what caused
them to develop the disease. Most physicians are familiar with instances
where vaccines (or other drugs) have been falsely assumed to cause
diseases because of a temporal or chance relationship.
Hepatitis B infection is not a risk factor for
developing multiple sclerosis. Therefore, there is no biological reason
to anticipate that hepatitis B vaccine would cause this disorder.
Hepatitis B vaccination is recommended for young
adults - the same age when multiple sclerosis typically develops. As
such, some cases of multiple sclerosis develop in persons who have
received hepatitis B vaccination as a coincidence. Moreover, other
studies have shown that administering vaccines, including influenza
vaccine, has not led to exacerbations in persons who have multiple
sclerosis. Case-control studies in Europe and the United States have
revealed that persons who develop multiple sclerosis are no more likely
to have received hepatitis B vaccines than matched controls. Supporting
this finding are data from follow-up of large populations that reveal no
evidence of increased risk of developing multiple sclerosis among
Several expert groups have reviewed the available
information and found no evidence of a causal relationship between
hepatitis B vaccine and multiple sclerosis or related disorders:
- The Institute of Medicine reviewed the available
data in 1994 and concluded that the evidence was insufficient to
accept or reject a causal relation between hepatitis B vaccines and
Guillian-Barre syndrome, optic neuritis, multiple sclerosis, or
- The French government conducted an expert review
in 1997 which concluded that there was no evidence for a causal link
between hepatitis B vaccine and multiple sclerosis following reports
in the French press similar to the recent reports in the United
- The World Health Organization conducted a review
of the available data in 1997 and the experts concluded that the
scientific data do not support the idea that hepatitis B vaccine
causes or exacerbates multiple sclerosis.
The Centers for Disease Control and Prevention and the
Food and Drug Administration maintain the Vaccine Adverse Events
Reporting System. The reports of multiple sclerosis and related
disorders received by this system are fewer than would be expected to
occur by chance alone. Also, post-licensure surveillance by
manufacturers revealed no evidence of increased risk of these or other
related disorders. The existence of the reports and database are
indicative that the surveillance system is in place but the news reports
inappropriately interpreted the existence of these reports as evidence
of a causal relationship.
Unfortunately, allegations of adverse events
associated with universally recommended preventive interventions capture
the attention of the public and are considered newsworthy because of
their human interest appeal. Pediatricians and the Academy need to work
with news media to encourage responsible reporting of alleged
associations between vaccines and disorders of all types. Often
reporters do not realize that the stories that boost their ratings have
a negative impact on public health; these stories often lead parents not
to immunize their children against life-threatening diseases.
Hepatitis B vaccine is recommended for all children
because the risk of hepatitis B infection and chronic disease is very
real. Prior to routine immunization, every year in the United States
more than 300,000 people developed hepatitis B infections and 5,000 died
from chronic hepatitis or cancer of the liver caused by chronic
hepatitis B infection. Hepatitis B vaccines provide 95% protection
against chronic hepatitis B infection. Therefore, the World Health
Organization, the American Academy of Pediatrics, the American Academy
of Family Physicians and the Advisory Committee on Immunization
Practices of the Centers for Disease Control and Prevention all
recommend that all children should receive the vaccine. Parents should
not be mislead by the occasional inflammatory reports in the press.
Hepatitis B vaccines are very safe and effective and should continue to
be given to all children as part of their routine vaccination schedule.
American Academy of Pediatrics.
1997 Red Book: Report of the Committee on Infectious Diseases. 24th ed.
Elk Grove Village, IL: American Academy of Pediatrics; 1997.
Centers for Disease Control.
Hepatitis B virus: A comprehensive strategy for elimination of
transmission through universal childhood vaccination: recommendations
of the Immunization Practices Advisory Committee (ACIP). MMWR
Centers for Disease Control and
Prevention. Update, vaccine side effects, adverse events,
contraindications, and precautions: recommendations of the Advisory
Committee on Immunization Practices. MMWR CDC Survell Summ.
Douglas RG Jr. The heritage of
hepatitis B vaccine. JAMA 1996;276:1796-8.
Durand AM, Sabino H Jr, Mahoney
F. Success of mass vaccination of infants against hepatitis B. JAMA
Expanded programme on
immunization (EPI). Lack of evidence that hepatitis B vaccine causes
multiple sclerosis. Wkly Epidemiol Rec 1997;72(21):149-52.
Gardner P, Schaffner W.
Immunization of adults. N Engl J Med 1993;238:1252-8.
Institute of Medicine, Vaccine
Safety Committee. Adverse Events Associated with Childhood Vaccines:
Evidence Bearing on Causality. Washington, CD:National Academy Press;
Kaplanski G, Retornaz F, Durand
J, Soubeyrand J. Central nervous system demyelination after vaccination
against hepatitis B and HLA haplotype [letter]. J Neurol Neurosurg
McMahon BJ, Helminiak C,
Wainwright RB, Bulkow L, Trimble BA. Frequency of adverse reactions to
hepatitis B vaccine in 43,618 persons. Am J Med 1992;92:254-256.
Niu MT, Davis DM, Ellenberg S.
Recombinant hepatitis B vaccination of neonates and infants: emerging
safety data from the Vaccine Adverse Event Reporting System. Pediatr
Infect Dis J 1996;15:71-76.
Shaw FE, Graham JK, Guess HA,
et al. Post-marketing surveillance for neurologic adverse events
reported after hepatitis B vaccination. Experience of the first three
years. Am J Epidemiol 1988;127:337-52.
Stratton KR, Howe CJ, Johnston
RB, eds. Adverse Events Associated With Childhood Vaccines: Evidence
Bearing on Causality. Washington, DC: National Academy Press; 1994.
Originally posted on August 30, 1999.
was last updated on
June 09, 2016
© 2016 Institute for Vaccine Safety