The issue of adverse events associated with vaccination has been in the news recently following the release of the Horvath report, An investigation into the management of adverse effects associated with influenza vaccination of children (with the Panvax and Fluvax products).

Meanwhile, a rapid online publication by The Medical Journal of Australia has called for a no-fault compensation scheme for serious adverse events attributed to vaccination.

One of the authors, Associate Professor Heath Kelly, explains some of the context below.


It’s a matter of ethics and fairness

Heath Kelly writes:

In the last 50 years vaccines have served Australians well. Recognising this, we now spend more than $400 million annually on our National Immunisation Program. We fund vaccines against 12 diseases including common diseases, such as influenza, and rare diseases, such as polio.

If a disease is rare, we want the vaccine that prevents it to be incredibly safe. This is why Australia moved from the live attenuated oral polio vaccine – which can cause a disease that is indistinguishable from polio in about 1 in 2.5 million doses distributed – to inactivated polio vaccine, a much safer option.

For common diseases, we can accept a vaccine that may have a few untoward side effects, because the consequences of the disease should always exceed the unwanted consequences of the vaccine – and we don’t expect the vaccine to have serious unwanted consequences. Unfortunately this is not always true.

It wasn’t true in 2010 when an unexpectedly large number of febrile convulsions (fits that occur in young children because of high temperatures) occurred following receipt of the CSL trivalent seasonal influenza vaccine. Fortunately most of the convulsions did not result in any lasting problem, but for one family the consequences will be life-long.

Last year the CSL influenza vaccine for young children was withdrawn from the market in Australia and New Zealand and is no longer recommended for children under 5 years of age in either country. In the United States, where the vaccine is available under a different trade name, it is not licensed for children under 9 years of age.

As yet, there is no explanation for the increase in febrile convulsions associated with the CSL vaccine. When all the investigations into the vaccine have been completed, it may well turn out that no fault can be found with the manufacturing process, the regulatory process or the administration of the vaccine.

Because Australia does not have a no fault compensation scheme for serious adverse events attributed to vaccination, adults or parents of children who believe they have suffered a serious adverse event from a vaccine are required to prove this through the court system. This process is expensive, timing consuming and stressful – just at a time when more stress is the last thing a family needs.

More often than not fault is difficult – or impossible – to prove, even though it may be accepted that the vaccine was very likely the cause of the serious adverse event. Certain small risks are accepted to occur with vaccines.

If Australia had a no fault compensation scheme, as do 19 other countries around the world (Bull World Health Org 2011; 89:371-81), there would be no requirement to prove fault. It would still be necessary to adjudicate on a causal relationship between the vaccine and the adverse event, but all countries in which these schemes operate have established mechanisms for this.

Vaccination offers a benefit to both the individual and the community. The ethical principle of redistributive justice says that a person inadvertently injured while helping the community should in turn be helped by the community. No fault compensation is an expression of this ethical principle.

Now is a good time to ask again why Australia does not have a mechanism for compensating people when things go unexpectedly and seriously wrong after receipt of a vaccine.

• Heath Kelly is Head of the Epidemiology Unit at the Victorian Infectious Diseases Reference Laboratory and Associate Professor/Adjunct Associate Professor at School of Population Health, University of Melbourne; School of Computer Science, University of Western Australia; National Centre for Epidemiology & Population Health, Australian National University.

Update: more on this issue at New Matilda