Are Kid's Flu Vaccines Properly Tested?

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]


Comments

    Read Ben Goldacre's Bad Pharma for more examples of how badly such drugs are regulated, and in particular how they are extended for use in children. Regulators and university ethics committees need to get with the program: http://www.alltrials.net/

    "According to the authors, new immunisation drugs are not tested with enough diligence"
    ... Thats what the kids are for ;D

    Pertussis at Birth is being properly tested

    right now,

    on my son.

    Get it when it comes out. Until then (and after then) get any adult who comes in contact with your child to have a whooping cough vaccine.

    My son has taken part in 2 vaccine trials now.

    But the big thing about these flu-vaccines is timeline. They need to weigh up the seriousness of if a baby gets infected with the flu vs the side-effects of the vaccine.

    In many cases, the vaccines are similar (And in a few cases, identical) to previous vaccines. They will then make the judgement call of "are the effects of the illness likely to be worse than the side-effects"? If yes, then they will likely cut things short. They will look at the results of trials (Which typically will have gone for months before hand on adults), determine that the reactions and side-effects are similar/same as previous similar incarnations of the vaccine and short-cut it.

    You can argue that it's bad, but would you still say that if they did the proper tests but children died because the vaccine was still testing?

    It truly is a case of 'lesser of the evils'.

    Sadly the anti vaccers will jump all over this? Seriously? You think vaccines should be released without adequate testing? That scientific protocol should not be followed where vaccines are concerned? And they say anti vaccers are unscientific...............

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