By Julie Leask and Ian Kerridge
Vaccines against COVID-19 will prevent millions of deaths and hospitalisations, as early signs from Britain and Israel indicate. The savings for economies are likely to be in the trillions. The benefits are undeniable but vaccines also bring risks. Some are well described, such as feeling unwell in the day or so after receiving a COVID-19 vaccine, or the rare but treatable severe allergic reaction called anaphylaxis.
It appears increasingly likely that the AstraZeneca vaccine may cause a new rare clotting condition called “Suspected Vaccine Induced Prothrombotic Immune Thrombocytopenia”. VIPIT is a serious condition that presents as blood clots with low blood platelets (thrombocytopenia). The condition develops between four and 20 days after receiving the AstraZeneca vaccine, with a headache that won’t go away, other neurological symptoms, abdominal pain, shortness of breath or chest pain.
This is different to the regular side effect headache and feeling unwell, which usually starts on the day of vaccination and lasts for one to two days. It’s estimated that this more serious condition occurs at a rate of between 1 and 8 per million doses of vaccine given. These estimates will change as we learn more. It’s too early to tell if the condition is age- or gender-related and investigators are only now starting to work out if there is any way of identifying people who may be more at risk.
After about 400,000 doses of AstraZeneca vaccine were given in Australia, we had a probable case here presenting to a Victorian hospital – a 44-year-old man with clotting. The Australian regulator and vaccine experts are investigating.
The AstraZeneca vaccine is the main offer for Australia, with the government securing 53.8 million doses, 50 million of them to be made locally. If the risk is confirmed, a small number of people will develop this clotting condition from the vaccine. International experts in blood disorders are already working together to describe how VIPIT may be diagnosed and treated, to improve the outcomes of people who develop this probable rare side effect of the AstraZeneca vaccine. Our vaccination experts and regulator are now considering the evidence in full. Decisions will need to be made about how Australia should act on this potential new risk. People will need to be well informed.
For now, this event shows that global and local safety systems are working to detect, investigate and act on rare events. Australia has world-leading vaccine safety scientists advising our regulator, the Therapeutic Goods Administration, and sitting on our Technical Advisory Group on Immunisation.
Australia already compensates participants in COVID-19 vaccine trials and has indemnified two companies supplying vaccines against specific potential liabilities resulting from their vaccines. But the emergence of a new vaccine risk also shows up a big gap in our vaccination program – the lack of a no-fault vaccine injury compensation scheme for rare serious adverse events caused by a vaccine. This system, seen in 25 other countries, provides financial compensation for those who are injured by a vaccine, to cover expenses and lost income.
It could be funded by a small vaccine levy on pharmaceutical companies, like in the United States; or through insurance payments from industry (Sweden); or through general taxation or levies (New Zealand). Such a scheme would need to be planned and structured to enable formal assessment by vaccine safety experts.
Not all instances of vaccine injury are covered by the National Disability Insurance Scheme; death, short-term disability and medical bills are not eligible. People can seek compensation through the legal system but this is costly, complex and privileges people who are legally literate. And there is no guarantee a plaintiff will be awarded damages; legal evidence will consider medical evidence but the two are not the same.
The man in Victoria will undoubtedly have time off work and it is fair to financially compensate him. Vaccination experts have been calling on the government to provide a scheme that could do this since at least 2004 and as recently as last August. Some of the resistance to such a scheme is in the implied admission that vaccines carry risk – that somehow we will energise opponents of vaccination. But we cannot run programs out of fear about how a small band of activists will respond and the misinformation they could propagate from it.
Furthermore, some parents who don’t vaccinate, who are mostly not radical activists, see a lack of compensation as compounding their mistrust. They point out the inconsistency with a system that expects people to vaccinate for population immunity while individuals bear responsibility for any potential negative outcomes.
We don’t know if the scheme will increase confidence, but creating a no-fault compensation scheme will promote public health and increase the sustainability of population-based vaccination programs. It will be important not only during a pandemic but at all times in control of infectious disease.
Such a scheme is an expression of community solidarity and a manifestation of justice, fairness, equity and care. It recognises that if the community (via the government) promotes vaccination as a collective good for the public benefit, then it must accept both the moral obligation and financial burden to provide care to the very small number who might be harmed. It may promote trust in government and in vaccination programs more generally.
COVID-19 provides an urgent reminder that we need such a scheme, that we can afford it and that it should be part of our public health and social welfare systems, as its benefits will extend far beyond this pandemic.
Julie Leask is a professor at the Susan Wakil school of nursing and midwifery at the University of Sydney. Ian Kerridge is a professor of medicine and bioethics at the University of Sydney and a haematologist at the Royal North Shore Hospital.
Julie Leask is a professor at the Susan Wakil school of nursing and midwifery at the University of Sydney. She is an adviser to the World Health Organisation on improving vaccination uptake.