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Sudden infant death after hexavalent vaccine

Hexavalent vaccines, designed to improve vaccine acceptance by decreasing the number of injections, have been available in Europe as Hexavac and Infanrix Hexa since October 2000. They contain antigens for diphtheria, pertussis, tetanus, influenza, poliomyelitis, and hepatitis B immunization.

Six children who died unexpectedly one to two days after immunization with this product were autopsied at the Munich Institute of Legal Medicine. Findings included cerebral edema, a defective blood-brain barrier, and lymphocytic infiltration.

The rate of sudden unexplained infant death during the one-day period post vaccination was calculated to be 500 percent of the expected rate.

No cause-effect relationship could be proved. However, authors of the report concluded that: “If broad use of hexavalent vaccine continues, extensive studies are most likely required to assess or exclude a relationship between vaccination and death in infants” (Zinka B et al., preprint from Vaccine, available at www.sciencedirect.com).

Additional information:

AAPS resolution opposing mandatory vaccination

Costs vs. Risks vs. Benefits: the vaccine approval process

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