A report into what went wrong with this year’s seasonal flu vaccine for kids deserves our attention. The West Australian Health Department’s Ministerial Review into the Public Health Response into the Adverse Events to the Seasonal Influenza Vaccine sought to uncover the reason for “an alarming rise in adverse events following immunisation” that included vomiting, diarrhoea and febrile convulsions. Four weeks after the vaccination program began, Australia’s chief medical officer advised doctors across the country to stop giving the shot to children under five.
We still do not know what caused the estimated 800 per cent increase in the number of febrile convulsions experienced by children who got the jab this year. But the review does shed light on other aspects of the health scare.
First, it reveals an adverse event reporting system that is cumbersome and grossly unequal to its task of early detection of problems. There is no single agency responsible for monitoring and neither of those involved – including the Therapeutic Goods Administration – make it easy for parents and GPs to log adverse events. Existing methods of compiling and analysing various floaty bits of paper are slow and inefficient.
Add to this the inability to ascertain the total number of injections given – the all important denominator figure essential to knowing whether the reported number of adverse events is higher than expected – and you have a system the report describes as neither “robust or timely”.
It also fails to conform to World Health Organisation recommendations on mass immunisation programs. Each year Australia has only a short period to develop and test the seasonal influenza vaccine before it must be approved and manufactured. This means clinical trials are limited and that – to quote the WHO – “further testing of safety and effectiveness will need to take place after administration of the vaccine has begun”.
To achieve this, countries must implement post-vaccine surveillance systems that monitor the product for safety and efficacy. However, Australia’s doesn’t. Not only are our usual monitoring systems plagued by structural deficiencies but we also failed to keep in place the monitoring the WHO recommended for the swine flu pandemic shots.
This was particularly unfortunate, the review notes, given that the 2010 immunisation was “significantly different” to previous seasonal flu vaccinations and the program involved very young children.
Needless to say, parents knew none of this. They thought their government wouldn’t give vaccines to young children that had not been adequately tested. When their children were injured, some began researching the vaccine and discovered their faith was misplaced. The experience not only damaged trust in vaccination programs but the public health system more generally.
So where to now? For a start, every one of the review’s recommendations should be implemented. If time constraints associated with getting flu immunisations to market mean safety and efficacy tests must continue after vaccine administration starts, it is imperative our post-vaccine surveillance systems provide rigorous, efficient, online and real-time monitoring of the number and type of adverse events in relation to the overall number of doses given. It is also vital for parents to be adequately informed about the testing and safety of flu immunisation.
What happened this year was not good enough. Not at all.
System let parents and kids down in flu jab debacle The Sun Herald