Important reminder: bioCSL Fluvax must NOT be given to children under five

14 May 2015

Following confirmation of nine cases of the administration of bioCSL Fluvax to children under five years of age since the start of the 2015 Seasonal Influenza Vaccine Program last month, the Department of Health is urging all GPs to remember that bioCSL Fluvax is not registered for use in children less than five years of age and must not be given in this age group.

Since late 2010, bioCSL Fluvax® has not been registered for use in children aged less than five years because it causes unacceptably high rates of adverse events, specifically fevers and febrile convulsions, in children of this age. If bioCSL Fluvax is administered to a child under five years of age, this constitutes “off-label” use which exposes providers to legal risk.

Furthermore, the Australian Technical Advisory Group on Immunisation does not recommend the use of bioCSL Fluvax in children aged five to nine years due to an increased risk of fever in this age group. Alternative seasonal influenza vaccines, which are less likely to induce fever, are usually readily available.

GPs are advised to ensure that the warning labels that come with the vaccine are placed in a highly visible place, such as the fridge door. It is also suggested that practices ensure all staff who administer flu vaccines understand the restrictions and warnings for bioCSL Fluvax.

Further information on the Seasonal Influenza vaccine is available on the Department of Health website.