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Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality
Two large uncontrolled population-based studies provide relevant information on hepatitis B vaccination and arthritis. The largest is the summary of results of a vaccination program involving 166,757 children in New Zealand; each child received at least one injection of plasma-derived hepatitis B vaccine prepared by a U.S. pharmaceutical firm (Morris and Butler, 1992). In this large group of vaccinees, arthralgias or arthritis occurred on 12 occasions in 10 individuals, giving an incidence of less than 1 episode of arthralgia or arthritis in 10,000 vaccinees. Of these 12 episodes, five were reported after receipt of the first vaccine injection, six after the second, and one after the third. One of these patients was hospitalized for 1 day. In none of these individuals were there any chronic sequelae of the arthralgia or arthritis.
The second large observational study described the frequency of adverse reactions to hepatitis B vaccine in 43,618 Alaskan natives who received 101,360 doses of hepatitis B vaccine (McMahon et al., 1989). In that study myalgias or arthralgias lasting for more than 3 days occurred in 12 individuals, an incidence of less than 1 episode in 3,000 vaccinees. The authors felt that the arthralgias were coincidental to the hepatitis B vaccines. since 5 of the 12 patients had negative skin tests to the vaccine. These five patients as well as four others who did not undergo skin testing received additional doses of hepatitis B vaccine without an adverse event. One of the 12 patients did have an Arthus-type reaction, with transient polyarthritis and a positive skin test to the hepatitis B vaccine.
Controlled Observational Studies
Controlled Clinical Trials
No controlled clinical trials reviewed by the committee contained information regarding hepatitis B vaccine and arthritis.
On the basis of the two largest available observational studies, arthropathy appears to be unusual following vaccination against hepatitis B virus. On the basis of VAERS reports, the possibility exists that a hypersensitivity arthritis occurred in the 17 individuals who developed acute arthritis associated with fever with or without an associated rash. In the absence of a denominator, however, it is not clear that these episodes represented more than coincidental occurrences.
The 1988 National Health Survey indicated that approximately 13 percent of adults surveyed reported having ''arthritis or any kind of rheuma-