Study provides confidence in timeliness and sensitivity of AusVaxSafety

A new simulation study on Australia’s leading active vaccine safety surveillance system, AusVaxSafety, has been released that shows that the system is robust and would have detected a vaccine safety signal had it been operating in 2010 when there was an unprecedented number of febrile seizures in young children associated with one specific influenza vaccine brand, Fluvax (CSL Biotherapies). Fluvax was subsequently prohibited for use in children.

The study simulated solicited responses from caregivers who would have received an SMS survey about adverse events experienced following seasonal influenza vaccination of their children aged 6 months to <5 years. The simulations provide confidence in the timeliness and sensitivity of the AusVaxSafety active vaccine safety surveillance system. The study has predicted that AusVaxSafety signal detection as it currently operates would have, in all likelihood, detected a safety signal during March 2010, the first month of vaccine deployment.

The authors conclude that active vaccine safety surveillance leading to rapid detection of a safety signal may have resulted in earlier suspension of Fluvax from the childhood vaccination program, potentially preventing many febrile convulsions and maintaining public confidence in influenza vaccination for young children.

Read the full study here