The Annals of Pharmacotherapy: Vol. 36, No. 12, pp. 1970–1971.
David A Geier
President, MedCon, Silver Spring, Maryland
Mark R Geier MD PhD
President, The Genetic Centers of America, 14 Redgate Ct., Silver Spring, Maryland 20905-5726, FAX 301/989-1543, E-mail: email@example.com
Ann Pharmacother 2002;36:1970–1971.
TO THE EDITOR:Return to Top
We analyzed1 adult hepatitis B vaccine (HBV) serious reactions, showing statistical increases in arthritic, neurologic, immunologic, and gastrointestinal reactions. However, some reactions analyzed may have been acute self-limited reactions that did not lead to chronic problems. In order to study this problem, the purpose of this analysis was to examine chronic adverse reactions reported to the Vaccine Adverse Events Reporting System (VAERS) database following adult HBV from 1997 through 2000. We hypothesized that chronic conditions occurred similarly following adult HBV and adult vaccine control group. The scientific literature contains few studies briefly examining chronic reactions following adult HBV.2, 3
The VAERS is an epidemiologic database maintained by the Centers for Disease Control and Prevention (CDC) since 1990. All vaccine reactions are to be reported to this database as mandated by US law. The CDC requires written and telephonic confirmation of serious reactions and follows up serious reactions 1 year after they occur to determine whether the patient recovered. The VAERS Working Group of the CDC analyzes and publishes epidemiologic studies based on examination of the VAERS.4
Methods.Return to Top
We retrospectively examined adult HBV reactions reported to VAERS from 1997 through 2000 using Microsoft Access (Redmond, WA). We examined neuropathy, neuritis, myelitis, vasculitis, thrombocytopenia, gastrointestinal disease, multiple sclerosis, and arthritis reactions, where patients, based on a 1-year follow-up, were considered not to have recovered from their reaction. These terms for reactions were based on descriptions by those reporting them. We have examined each of these reactions in previous studies, enabling us to extend and expand our previous findings.
Incidence rates were based on the estimates of the Biological Surveillance Summaries that we obtained from the CDC for the number of doses administered during the study periods examined. The CDC estimates that 20 516 508 adult HBVs were administered from 1997 through 2000. Additionally, as a control, tetanus–diphtheria (Td) vaccine chronic reactions reported to VAERS from 1991 through 2000 in adults were analyzed. The CDC estimates that 141 832 679 adult Td vaccinations were administered from 1991 through 2000. The incidence rates of adult adverse reactions in the Td vaccine recipients provided a background rate to compare against the incidence rates of adverse reactions in adult HBV recipients. We chose our temporal period following adult Td vaccine so as to allow our search of the VAERS to yield as many reactions following our adult Td vaccine control group as possible; this would allow for an increased power in our statistical analyses. Relative risk was determined by dividing the incidence rate of the reaction following adult HBV by the incidence rate of the reaction following adult Td vaccine control group. Attributable risk was determined by subtracting 1 from the relative risk. Percent association was calculated by dividing the relative risk by the relative risk plus 1 and multiplying this computed value by 100. In our statistical analysis, a 2 2 × 2 contingency table was employed. We used the statistical package contained in Corel's Quattro Pro and accepted a p value of 0.05 as statistically significant.
Results.Return to Top
Table 1 summarizes chronic reactions reported following adult HBV in comparison with those reported following adult Td vaccination. The results show even more significant increases in chronic conditions following adult HBV than acute conditions in comparison with adult Td vaccination.
Discussion.Return to Top
In conclusion, our study demonstrates that adult HBV is statistically associated not only with acute neuropathy, neuritis, myelitis, vasculitis, thrombocytopenia, gastrointestinal disease, multiple sclerosis, and arthritis, but some of these patients go on to develop chronic adverse reactions that persist for at least 1 year following HBV. These types of chronic adverse reactions following adult HBV should be discussed with patients contemplating being immunized with HBV and should be included in the differential diagnosis of those who develop them following adult HBV.
1. Geier MR, Geier DA. Hepatitis B
vaccination safety. Ann Pharmacother 2002;36:370–4. [ABSTRACT]
2. Pope JE, Stevens A, Howson W, Bell DA. The development of rheumatoid arthritis after recombinant hepatitis B vaccination. J Rheumatol 1998;25:1687–93. [PubMed Citation]
3. Grotto I, Mandel Y, Ephros M, Ashkenazi I, Shemer J. Major adverse reactions to yeast-derived hepatitis B vaccines — a review. Vaccine 1998;16:329–34. [PubMed Citation]
4. Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT, the VAERS Working Group. An overview of the Vaccine Adverse Events Reporting System (VAERS) as a surveillance system. Vaccine 1999;17:2908–17. [PubMed Citation]
Mark R Geier and David A Geier have done consulting work before the no-fault Vaccine Compensation Act administered by the US Court of Claims, involving adverse reactions to hepatitis B vaccine. David A Geier is president of MedCon, a medical–legal consulting firm that assists vaccine injury patients in obtaining funds from both the National Vaccine Injury Compensation Program and through civil litigation.