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The Safety of Hepatitis B Virus Vaccine

Since its licensure in 1981 and its general availability in July 1982, hepatitis B virus (HBV) vaccine has been administered to over 200,000 individuals, mostly health care workers. In a collaborative effort, the Centers for Disease Control, the Food and Drug Administration, and Merck, Sharp, and Dohme have collected information on illnesses that developed after receipt of HBV vaccine. All illnesses reported to any of these three groups have been recorded. Serious illnesses have been followed up by telephone or personal interviews. Some illnesses, especially minor ones, probably have not been reported, and many reported illnesses have not been causally related to the vaccine.

As of March 1, 1983, illness had been reported in 118 vaccinees (most illnesses began within 4 weeks of the first vaccine dose). Of the 118 cases, 56 (47.5%) were considered not likely to be attributable to vaccine use because: 1) another specific cause was identified, 2) onset of illness occurred before receipt of vaccine, or 3) the reported event was unrelated to the vaccine (e.g., deltoid pain after gluteal injection). Many of the remaining 62 illnesses may represent "background" disease rather than adverse reactions to the vaccine. Of these 62 persons, 57 (91.9%) had mild or moderate illness that included: six neurologic conditions (five persons with tremors and one with recurrent Bell's palsy); 11 skin or mucous membrane lesions (hives, herpes zoster, psoriasis, and nonspecific lesions); 10 musculo-skeletal ailments (including generalized aches, joint pain, and joint inflammation); five hepatitis-like illnesses (with increased liver enzyme levels and no other identified cause); and 25 miscellaneous complaints (14 persons with a flu-like syndrome, four with injection-site reactions, four with diarrhea, one with headache, one with vomiting, and one with self-limited chest pain with a normal cardiac evaluation).

Six persons had serious illness; illness was defined as serious when it caused hospitalization or other intensive medical care, lasted 14 days or more, caused permanent disability, or was life-threatening. Five of these serious illnesses included one case each of erythema multiforme, aseptic meningitis, grand mal seizure, possible transverse myelitis, and Guillain-Barre syndrome (GBS). A second case of GBS was also reported in a person with antecedent febrile illness, presumptively caused by cytomegalovirus; febrile illness began 11 days after receipt of HBV vaccine, and GBS began 10 days after onset of febrile illness. This case was thus counted among the 56 illnesses not likely to be attributable to the vaccine. Although the numbers of vaccinees and GBS cases are too few on which to base firm conclusions, two cases of GBS do not exceed the number expected by chance alone within 6 weeks of vaccinating 200,000 people (23 GBS cases per million adults per year).

Whether acquired immune deficiency syndrome (AIDS) could be associated with HBV vaccine has been questioned, since the vaccine is made from human plasma. Since 1979, homosexual men, including those from cities with reported AIDS cases, have been the source for much of this plasma. Vaccine produced from these sources has been used in various investigative studies since 1980 and has been commercially available since 1982. To date, no AIDS in vaccine recipients has been reported outside groups with high AIDS incidence. Specifically, no cases have occurred among the several thousand individuals, other than male homosexuals (primarily health care workers), who participated in vaccine studies from 1980 to date. In addition, no cases have been reported from the over 200,000 individuals who have received HBV vaccine since its general availability in July 1982. (The latent period for AIDS, if an infectious agent is involved, appears to be between 8 and 18 months.) Two homosexual men who participated in the original HBV vaccine field trials have developed AIDS. This occurrence is not significantly different from that observed among men who were screened for participation in these trials but who were ultimately not vaccinated. Furthermore, the manufacturing process for HBV vaccine includes several procedures that inactivate representative viruses of all known types (1). Thus, both current microbiologic and empiric data provide no support for the suggestion that HBV vaccine might carry an etiologic risk for AIDS.

Surveillance for reactions that may be caused by HBV vaccine is ongoing. The vaccine is recommended for groups at risk of HBV infection (2). Health care providers are encouraged to report illness following receipt of HBV vaccine through their local or state health departments to the Hepatitis Division, Center for Infectious Diseases, CDC. Reported by Div of Hepatitis and Viral Enteritis, Center for Infectious Diseases, CDC; Immunization Practices Advisory Committee.

References

  1. CDC. Hepatitis B virus vaccine safety: report of an inter-agency group. MMWR 1982;31:465-7.

  2. ACIP. Inactivated hepatitis B virus vaccine. MMWR 1982;31:317-22, 327-8.

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