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
CDC. Hepatitis B virus vaccine safety: report of an
inter-agency
group. MMWR 1982;31:465-7.
ACIP. Inactivated hepatitis B virus vaccine. MMWR
1982;31:317-22, 327-8.
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