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Institute for Vaccine Safety

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IVS Position on Hepatitis B Vaccines

In response to news reports about hepatitis B vaccine, multiple sclerosis and other disorders, the following statement has been prepared by Neal A. Halsey, Chair, Committee on Infectious Diseases, American Academy of Pediatrics, and Director, Institute for Vaccine Safety. (August 30, 1999)

 

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 vaccinated individuals.

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:

  1. 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 transverse myelitis.
  2. 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 States.
  3. 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.

References:

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 1991;40(RR-13):1-20.

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. 1996;45(RR-12):7-8.

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 1996;276;1802-1803.

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; 1994.

Kaplanski G, Retornaz F, Durand J, Soubeyrand J. Central nervous system demyelination after vaccination against hepatitis B and HLA haplotype [letter]. J Neurol Neurosurg Psychiatry 1995;58(6):758-9.

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.

This page was last updated on February 12, 2014

Institute for Vaccine Safety