Although
anaphylaxis is an extremely rare
vaccine-associated adverse event, it occurred in young children following administration of the 2011/12 seasonal split
influenza vaccine, which contained
2-phenoxyethanol as the preservative. These children had high levels of
IgE antibodies against
influenza vaccine components. We herein investigated why these children were sensitized. One hundred and seventeen series of serum samples were obtained immediately before, and one month after the first and second immunizations with the HA split
vaccine of 2011/12. Forty-two sequential serum samples were collected in the acute and convalescent phases (2 and 4 weeks) after natural
infection with H1N1 Pdm in 2009.
IgE antibodies developed following the vaccination of young children with seasonal split
vaccines, whereas no significant
IgE response was observed following natural
infection with H1N1 Pdm 2009. The prevalence of
IgE antibodies was not influenced by outbreaks of H1N1 Pdm. Repeated immunization with the HA split
vaccine induced
IgE sensitization against the
influenza vaccine irrespective of the H1N1, H3N2, or B
influenza subtypes. The reasons why
anaphylaxis only occurred in recipients of the
influenza vaccine containing
2-phenoxyethanol are still being investigated, and the size distribution of
antigen particles may have shifted to a slightly larger size. Since the fundamental reason was
IgE sensitization, current split formulation for the seasonal
influenza vaccine needs to be reconsidered to prevent the induction of
IgE sensitization.