COVID vaccines safety concerns need a no-fault compensation scheme
Zahra Nanji argues that a no-fault compensation scheme would be the best solution to difficulties arising about vaccine safety.
Posted on 18 March 2021
Despite The World Health Organisation (WHO) stating this week that benefits of the AstraZeneca vaccine outweigh its risks and recommending that vaccinations continue, countries including Germany, France, Italy, Denmark, Norway and Spain have suspended the use of the Oxford-AstraZeneca coronavirus vaccine as a precautionary measure amid concerns that it is causing blood clots. The WHO Global Advisory Committee on Vaccine Safety is assessing the latest available safety data for the AstraZeneca vaccine and have confirmed that they will communicate their findings to the public.
The WHO have highlighted that other countries in the EU, having considered the same information as those countries who have suspended the use of Oxford-AstraZeneca, have decided to continue using the vaccine in their immunisation programmes.
It is routine for adverse events to be reported following immunisation, it demonstrates that the surveillance systems in place to monitor potential adverse outcomes works and that effective controls are in place.
Therefore it is important to note that reports of adverse events do not necessarily mean that the events are linked to vaccination itself. The European Medicines Agency (EMA) has said that the number of thromboembolic events (formation of blood clots) reported in vaccinated people, as at 10 March 2021, is 30 cases among close to five million people vaccinated. The figure is no higher than the number of blood clot events seen in the general population.
The speed at which the vaccines for Covid-19 have been developed and licensed may have caused concerns about their safety, resulting in the Government having to launch a social media campaign to tackle false vaccine information with the launch of a ‘Check Before you share Toolkit’.
The UK’s process for approving Covid Vaccines was made via amendments to the Human Medicine Regulations (HMR) 2012 after the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (SI 2020/1125) (HMCIR) came into force on 16 October 2020. The amendments were introduced following a three-week Government consultation.
Amendments to the HMR have allowed a speedier licensing process, and have also extended immunity from civil liability not only to manufacturers and healthcare professionals if things go wrong but also to the companies placing an unlicensed medicine such as a vaccine on the market with the approval of the licensing authority.
The Government response to the consultation on changes to the HMR noted that many respondents to the consultation expressed concerns about the potential lack of accountability of pharmaceutical companies under the amended HMCIR where it is shown there has been negligence regarding safety and testing.
The Government clarified that extended immunity will be forfeited following any sufficiently serious breaches. What those ‘sufficiently serious breaches’ are is not set out in the new regulation 174A. Therefore, what constitutes a sufficiently serious breach will no doubt have to be subject to testing via the courts.
The spread of misinformation and reports of adverse events coupled with limited recourse to civil compensation should things go wrong, may lead to increased resistance to uptake of a vaccine.
A person injured by a vaccine (including the COVID-19 vaccines) could apply for a payment under the Vaccine Damages Act (VDA) – via the Vaccine Damage Payments Scheme (VDPS). The VDPS limits awards to a maximum payment of £120,000 if someone suffers a very serious consequence resulting in a 60 per cent disablement after receiving a vaccine. Each application under the VDPS will be assessed on its own facts to determine the level of disablement.
A claim can be made on behalf of a child once they reach the age of two years and by an adult by whichever is the latest of the following dates:
- On or before their 21st birthday (or if they’ve died, the date they would have reached 21)
- Within six years of the vaccination
Victims of vaccine damage may be deterred from making claims due to the difficulty in succeeding in a claim. Since the mid-1980s, the award approval rate has declined in the UK, and it is claimed that failure to prove causation is the main reason for this decline. In total, there were 6,196 claims between 1979 and May 2017. Since the schemes inception to May 2017, 79 per cent of claims were rejected based of the claimants’ inability to prove causation and the overall approval rate from the same period was just over six per cent.
For many years there have been calls for reform of the VDPS to a no-fault scheme which provides payment commensurate with the injury caused. It is of note that if a similar civil law claim were to be brought for 60 per cent disablement, claimants would be potentially entitled to much more significant sums.
An adverse reaction and inadequate compensation scheme currently means that an individual who suffers long-term harm from a vaccine will be left to rely upon their family, the NHS and the public purse to pick up the pieces if things go wrong for them.
It is unfair and unjust to expect an individual to take almost unmitigated responsibility for the potentially serious effects of a vaccine where taking it is encouraged not only to protect the individual receiving it, but the community at large.
There will be very significant profits made as a result of the roll-out of the Covid vaccines, the companies developing and producing the vaccines are not charities but businesses. With significant profits being made, and with immunity from prosecution in all but ‘sufficiently serious breaches’, and with confidence being eroded due to adverse reactions being reported, consideration should be given to a no-fault compensation scheme funded via a levy on profits of those producing the vaccine.
A no-fault scheme would allow companies to profit, whilst financially protecting individuals who may suffer adverse effects from vaccines thereby increasing confidence in mass vaccination programme.