Last week the Australian Government announced two new agreements securing potential COVID-19 vaccine doses. The new agreements are with Novavax and with Pfizer together with German company BioNTech. These agreements are in addition to the ones already secured with AstraZenaca and the University of Queensland together with Australian manufacturer CSL. All these agreements are dependent on successful trials and the vaccines being declared safe and effective by the Therapeutic Goods Administration.
All these agreements also include indemnity for the suppliers against prosecution for side effects.
The Government initially stated the vaccine will be mandatory. After public complaint the Government shifted to a stance of “encouraging” all Australians to have the vaccine. This was reiterated by Health Minister Hunt on Thursday 5 November. Examples of “encouragement” for vaccinations already exist in Australia, through legislative requirements such as ‘No Jab No Pay’, and in some States ‘No Jab No Play’.
In order to establish herd immunity, the Government appears to be aiming for 95% vaccination of the Australian community. Once phase three trials have been deemed successful, the Government plans to distribute the vaccine quickly. Minister Hunt said they hope to be doing this by mid-2021.
The speed with which this is being carried out means that the full safety picture and efficacy will not be known. This is clearly a deterrent to people being “encouraged” to have the vaccine. There is already concern in the community regarding the urgency placed on the development of a vaccine, leaving many people wary of its safety.
Australia does not have a vaccine injury compensation scheme. Currently the Government has agreed to, instead of setting up a compensation scheme, pick up the bill for any compensation payout if someone takes legal action against any of the suppliers. But a no-fault compensation scheme would possibly assist the Government’s aim of vaccinating 95% of the community; it would also be fair and just.
Many countries have vaccine injury compensation programs. They compensate individuals who have a vaccine injury following administration of properly manufactured vaccines. These kinds of schemes mean people who experience adverse reactions can access compensation without having to convince a court that the vaccine was the cause of the injury.
The alternative is for an individual to commence litigation in order to seek compensation from either the company who made the vaccine or the medical professional who administered it. In tort litigation a direct link must be established between the particular action of the defendant and the adverse outcome. But the method by which causation is determined in tort law is quite different to the accepted method of establishing causation in science and epidemiology. Because of this most of the schemes which exist around the world offer a more liberal approach to the standard of proof than the legal standard.
The president of the Australian Medical Association, Dr Omar Korshid, has said that ‘with a new vaccine, it’s going to be really hard to tell what is a vaccine injury and what is a rare medical condition that someone would have had anyway’.
Due to the use of new technologies, limited sample size and the limited duration of follow up after phase three clinical trials, rare and serious vaccine related adverse effects will not be known prior to widespread population use of any vaccine.
It is considered that any small risks from vaccinations are balanced by the benefits that widespread population immunisation brings. But this means there are individuals who will be harmed for the benefit provided to the rest of the population. It is unfair that in a vaccination program some people have to ‘pay’ more for the social good of herd immunity. Sometimes this harm is due to negligence but often there is no clear attributable fault. So, what do people do if there is no evidence of negligence and therefore no one from whom to obtain compensation? What do people do who cannot afford to take legal action?
Australia sees great benefit from population wide vaccination programs. There is a strong ethical argument and public health justification to introduce a no-fault vaccine injury compensation scheme in Australia. It should be implemented before the use of any COVID-19 vaccines.