Thrombocytopenia: A Possible Complication of Recombinant Hepatitis B Vaccine?
ABSTRACT & COMMENTARY
Synopsis: Three infants younger than 6 months of age developed thrombocytopenia 1-4 weeks after their first dose of ecombinant hepatitis B vaccine. In one child, rHpB vaccine was given alone. All children were treated with oral corticosteroids and recovered.
Source: Ronchi F, et al. Thrombocytopenic purpura as adverse reaction to recombinant hepatitis B vaccine. Arch Dis Child 1998;78:273-274.
Three infants, younger than 6 months of age, developed thrombocytopenia following immunization with recombinant hepatitis B (rHpB) vaccine. Petechia were present in all three infants; splenomegaly was present in two. In one case, only rHpB vaccine had been administered; in two cases, rHpB in combination with DtaP were given. Purpura was noted one, three, and four weeks after immunization. Platelet counts were 15,000, 32,000, and 20,000/ mm3, respectively. Serologic tests for adenovirus, mycoplasma rickettsia, chlamydia, toxoplasma, rubella, cytomegalovirus, and herpes simplex were negative in all children. Tests for platelet antibodies were positive in two cases, and bone marrow aspiration showed normal megakaryocytes. All children were treated with oral corticosteroids, and platelet count returned to normal without recurrence. Two children subsequently received DtaP, but none were given rHpB vaccine.
COMMENT BY HOWARD A. PEARSON, MD, FAAP
The recombinant hepatitis vaccine that is widely used throughout the world is usually well-tolerated with few serious side effects. Thrombocytopenia has not been listed as a complication. The Committee on Infectious Disease of the AAP (Red Book) currently recommends immunization with rHpB for all infants as part of the routine childhood immunization schedule, and that immunization be initiated shortly after birth.1 This article by Ronchi and colleagues from Italy cites two previous reports of an apparent association between thrombocytopenia and rHpB immunization.2,3 The three new cases from Italy where rHpB vaccine is universally administered at 3, 5, and 12 months of age add to this experience.
The rare association of vaccines and thrombocytopenia is well-accepted for measles vaccine, but neither the Red Book nor the package insert of rHpB vaccine list this as a possible adverse reaction. If the association is real, it is probably rare. However, it is possible that these children's cases represent the tip of an iceberg, and mild thrombocytopenia could be more frequent. The only reason that these infants were diagnosed is because they demonstrated cutaneous petechia. Spontaneous petechia and purpura do not usually occur if the platelet count is greater than 40,000 mm3. We obviously do not do platelet counts regularly after immunizations. Given the number of children receiving rHpB vaccine, if the association is a real one, we will hear more about this issue as time goes by. The thrombocytopenia is clinically mild and self limited. Whether treatment is necessary for such a mild condition is debatable.
References
1. Committee on Infectious Diseases. 1997 Red Book. 24th ed. American Academy of Pediatrics, 1997; 18.
2. Poullin P, Gabriel B. Thrombocytopenic purpura after recombinant Hepatitis B vaccine. Lancet 1994;344: 1293.
3. Meyboom RHB, et al. Thrombocytopenia reported in association with hepatitis B and A vaccines. Lancet 1995;345:1683.
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