Australian public health experts have hit out at the way influenza vaccines for children are evaluated and licensed. According to the authors, new immunisation drugs are not tested with enough diligence.
Vaccine picture from Shutterstock
Researchers from the Western Australia Department of Health and the Australian National University in Canberra have released a new paper detailing the regulatory history of CSL’ Fluvax trivalent influenza vaccine TIV. (CSL TIV is no longer registered for children less than 5 years of age following a risk of high fevers and convulsions).
The report found that CSL TIV was approved in Australia for use in people aged 6 months and older despite a complete absence of controlled clinical studies of the vaccine’s effect on children.
The first paediatric study of CSL TIV in Australia eventually kicked off 2005, but this study failed to recognise the significantly higher risk of fever caused by subsequent booster doses of the vaccine in children under three.
“Among children less than 3 years of age, the proportion experiencing fever was 22.5% after vaccination with the CSL 2005 TIV formulation and 39.5% after vaccination with the 2006 formulation,” the paper notes.
The report concludes that CSL TIV was licensed for use in children without the benefit of data from controlled paediatric clinical trials.
Ideally, adequately powered, controlled paediatric studies should be conducted before a vaccine is licensed for children..
The report concludes that comprehensive postmarketing surveillance for adverse events is essential to maintain public trust and ensure the long-term success of paediatric influenza vaccination programs.
Professor Anton Middelberg, deputy director of The Australian Institute for Bioengineering and Nanotechnology at The University of Queensland released a statement supporting the paper’s views.
The study reminds us of the critical importance of strictly controlling vaccine manufacture processes, and the need to understand the fundamental behaviour of the components in complex vaccines made using historical egg-based processes…There is a clear need for new, quicker and better-understood vaccine manufacture technology.
Challenges in regulating influenza vaccines for children [The Medical Journal of Australia]