Disease News: << Alopecia>>
linked to HepB immunizations, in rare cases << Alopecia>>
linked to HepB immunizations, in rare cases ACIP voted to add this adverse
event to the hepatitis B recommendation statement.
ATLANTA - A statement about << alopecia>>
will soon be added to the Advisory Committee on Immunization Practices'
(ACIP) hepatitis B recommendation statement, based on a unanimous vote by the
Centers for Disease Control and Prevention (CDC) committee.
This decision follows a report that appeared in October 1997 which reviewed
the Vaccine Adverse Events Reporting System (VAERS) reports of hair loss
after immunizations. This report indicated that of 60 patients with reported << alopecia>> ,
46 received hepatitis B vaccines. The cases ranged in age from 17 days to 56
years; 70% were adults and 83% were female.
Of the 60 reports, 16 had positive rechallenges for hair loss (recurrence
following readministration of a suspect product), with nearly all (15)
occurring after hepatitis B immunization.
"Although the association has not been proven, the VAERS rechallenge
data are noteworthy and they raise some vaccine safety concerns," said
Geoffrey S. Evans, MD, Division of Vaccine Injury Compensation, Health
Resources and Services Administration. "It seems to me that we are
obligated to provide some clarity."
Although the advisory committee voted to include a comment regarding << alopecia>>
following hepatitis B vaccination, they unanimously voted not to indicate
"I think it's very important that we differentiate causality from
association," said Samuel L. Katz, MD, Wilburt C. Davison professor and
chairman emeritus of pediatrics, Duke University Medical School.
Robert T. Chen, MD, chief of Vaccine Safety and Development Activity,
National Immunization Program, explained that when << alopecia>>
began appearing in VAERS, the CDC and the Food and Drug Administration (FDA)
decided to search for the same adverse event in reports to the Vaccine Safety
Data Link (VSD), a similar surveillance system.
Steven B. Black, MD, Northern California Kaiser Permanente, together with
Henry Shinefield, MD, and Robert L. Davis, MD, headed the VSD analysis and
used data from the VSD Center at Group Health Cooperative in Puget Sound
(GHC) and Northern California Kaiser Permanente (NCKP).
Incidence of << alopecia>>
Using automated data and linking it with outpatient diagnostic codes, the
initial results identified several hundred cases of << alopecia>>
from automated data and did not show a significant association with receipt
of hepatitis B vaccine, Black explained.
He then completed a retrospective matched case-control study. Patients with
visits for hair loss were identified and five controls were assigned for each
case. A total of 392 cases, ages 0-7 years, were identified in NCKP and 130
cases, ages 7-17 years, were identified in GHC.
"The majority of cases in each group were in females, and the
predominant age group was 10-17 years," Black said.
During 1995, within the 10-17 year age group, 81,876 doses of hepatitis B
were administered and two cases of << alopecia>>
occurred; all within 14 days of vaccination.
"Based on this information, we're 95% sure that if there is an excess
risk associated with hepatitis B vaccine, that it is 8.2 per 100,000 or
fewer. I want to emphasize that it could be a lot less. It could be
zero," Black said.
"We conclude at this point that this study did not demonstrate a
statistically significant elevated risk of << alopecia>>
following hepatitis B vaccination in children," he said.
Recovery occurred in all cases in which outcome is known. All FDA-approved
hepatitis B vaccines and the plasma-driven products were represented in both
studies of VAERS and VSDL reports.
"The bottom line is that we've got a clear signal from safety
surveillance indicating that vaccines probably can cause hair loss, but maybe
only rarely," said Robert P. Wise, MD, MPH, FDA Center for Biologics
Evaluation and Research, lead author on the study of the VAERS reports.
For your information:
Wise RP, Kiminyo KP, Salive ME, et al. Hair loss after routine immunization.