B. Zinka, E. Rauch, A. Buettner, F. Ruëff, R. Penning
Received 9 March 2009; accepted 9 March 2009
Vaccinations are considered to be the most effective and safe method preventing infectious diseases. Although hexavalent vaccines like Hexavac® and Infanrix Hexa® are assumed to be well tolerated and safe regarding the rate of immunity [Liese JG, Stojanov S, Berut F, Minini P, Harzer E, Jow S, et al. Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP-T-HBs) administered at 2, 4, 6, and 12-14 months of age. Vaccine 2002;20:448-54; Mallet E, Fabre P, Pines E, Salomon H, Staub T, Schödel F, et al. Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants. Pediatr Infect Dis J 2000;19:1119-27], it was noticed that several cases of death occurred shortly after the vaccination.
We report six cases of sudden infant death that occurred within 48 h after hexavalent vaccination. At post-mortal examination, those cases showed unusual findings, especially in the brain and in laboratory tests.
Crude calculations of local epidemiology are compatible with an association between hexavalent vaccination and unusual cases of sudden infant death. If confirmed in systemic studies, our findings would have potentially serious clinical implications.