The Oxford-AstraZeneca Covid-19 vaccine was 'defective', according to a multi-million pound landmark legal action. Photograph: The Telegraph
Victims of VITT – a new condition identified by specialists – question the Government’s monitoring of the vaccine’s rollout and its efficacy
The Oxford-AstraZeneca Covid-19 vaccine has been branded “defective” in a multi-million pound landmark legal action that will suggest claims over its efficacy were “vastly overstated”.
The pharmaceutical giant is being sued in the High Court in a test case by Jamie Scott, a father-of-two who suffered a significant permanent brain injury that has left him unable to work as a result of a blood clot after receiving the jab in April 2021. A second claim is being brought by the widower and two young children of 35-year-old Alpa Tailor, who died after having the jab made by AstraZeneca, the UK-based pharmaceutical giant.
The test cases could pave the way for as many as 80 damages claims worth an estimated £80 million over a new condition known as Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT) that was identified by specialists in the wake of the AstraZeneca Covid-19 vaccine rollout.
Independent studies show the AstraZeneca vaccine was incredibly effective in tackling the pandemic, saving more than six million lives globally in the first year of the rollout. Last year, the World Health Organisation said the vaccine was “safe and effective for all individuals aged 18 and above” and that the adverse effect that has prompted the legal action was “very rare”.
The vaccine, which was heralded at its launch by Boris Johnson as a “triumph for British science”, is no longer used in the UK. The Government recommends three other vaccines for its autumn booster programme.
In the months following the rollout, the potential serious side effect of the AstraZeneca jab was identified by scientists. Following this, it was recommend it no longer be given to the under-40s in the UK because the risk of receiving the jab outweighed the harm posed by Covid.
AstraZeneca last night told the Telegraph that patient safety was its “highest priority”, that its vaccine, called Vaxzevria, had “continuously been shown to have an acceptable safety profile”, and that regulators around the world “consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects”.
It is understood AstraZeneca, in its legal response, denies causing Mr Scott’s injuries.
Official figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show at least 81 deaths in the UK are suspected to have been linked to the adverse reaction that caused clotting in people who also had low blood platelets. In total, almost one in five people who suffered from the condition died as a result, according to the MHRA’s own figures.
Families complain over payment scheme
Victims and their lawyers question the Government’s monitoring of the rollout and point out that while Germany suspended the vaccine’s use for the under 60s at the end of March 2021 over the risk of rare blood clots. In the UK, the joint committee on immunisation and vaccination – which advises the government – said on April 7 that adults under 30 should be offered an alternative to the AstraZeneca jab. The following month this was amended to adults under 40.
Official figures obtained under a Freedom of Information request show that out of 148 payouts made by the Government under the Vaccine Damage Payment Scheme, which provides compensation to those injured by vaccines or to bereaved next-of-kin, at least 144 went to recipients of the AstraZeneca vaccine. Fewer than five people under the scheme received vaccines other than AstraZeneca.
Families complain the amount paid out under the scheme – a fixed tax-free sum of £120,000 – is insufficient, prompting them to bring the legal cases in the High Court against AstraZeneca.
The claim is being brought by Mr Scott under the Consumer Protection Act 1987 and argues that the AstraZeneca vaccine was “defective” in that it was not as safe as individuals were entitled to expect.
WhatsApp messages suggest concerns raised
The case will raise questions about what the UK authorities knew about concerns over the vaccine and how they were handled.
An examination of WhatsApp messages sent by or to Matt Hancock, the then health secretary, obtained by The Telegraph UK as part of the Lockdown Files and which have been passed to the Covid public inquiry, suggest concerns were aired by US authorities. AstraZeneca never in the end applied for a licence in the US.
At the time, a number of European countries were pausing the vaccine’s rollout over fears it caused clotting in some people.
Legal case to hold AstraZeneca to account
The test case was lodged by Mr Scott after he almost died after receiving the vaccine.
Mr Scott suffered a catastrophic bleed on the brain and doctors called his wife, Kate, three times to tell her to come to the hospital to say goodbye to him.
Mrs Scott said the couple were being forced to sue AstraZeneca because the Government’s compensation scheme, and the £120,000 paid out to her husband, was inadequate.
Mr Scott, who was 44 when he had the jab, has had to give up his job as an IT software developer. Mrs Scott said: “We are private people but we cannot stand the injustice of it. We have been lobbying the Government for 18 months for fair compensation for the injury caused by the vaccine.
“We were told by the Government the vaccine was safe and effective but what’s happened to Jamie has been life changing and their [AstraZeneca] vaccine caused that.”
Mrs Scott is seeking to raise funds to pay for the legal cases. “AstraZeneca cannot continue to ignore the circumstances in which their vaccine has caused devastating injury and loss,” Mrs Scott has written in an open letter. “Our legal case will seek to hold AstraZeneca to account but we need to build a significant fighting fund to get justice.”
Vaccine efficacy to be challenged
As many as 80 claimants could lodge legal cases with the High Court by the end of the year in a class action that threatens to undermine faith in the rollout of the AstraZeneca vaccine that was developed jointly with Oxford University.
In Mr Scott’s claim, his lawyers argue that he suffered “personal injuries and consequential losses arising out of his sustaining Vaccine Induced Immune Thrombosis with Thrombocytopenia (VITT) as a result of his vaccination on 23 April 2021, with the AstraZeneca Covid-19 vaccination”, which the legal claim alleges was “defective”. They also argue that no warning of the risk of VITT was included in the product information on the date of supply of the vaccine.
AstraZeneca issued press releases following clinical trials saying the vaccine – known as Vaxzevria – was between 62 per cent and 90 per cent effective at preventing symptomatic Covid-19 depending on dosages, with an average of 70 per cent. The legal claim states: “In fact, the absolute risk reduction concerning Covid-19 prevention was only 1.2 per cent.”
An absolute risk reduction measures how much the vaccine reduces an individual’s baseline risk of getting ill from Covid at a particular time. If Covid levels are low, the absolute risk reduction rate will be much lower too.
This is different from a relative risk reduction, which compares the numbers of vaccinated people getting ill with those getting ill who did not receive the jab. In the case of AstraZeneca, a peer-review study showed the relative risk was reduced by an average of about 70 per cent.
AstraZeneca has said it emphasised the higher figure – denoting the relative reduction in risk – because that did not alter regardless of the prevalence of Covid at the time.
Lawyers argued that information in the AstraZeneca press release on its efficacy was “misleading because members of the public… assume that the published efficacy rate was an absolute risk rate (in which case the published efficacy rate vastly overstated the efficacy of the vaccine)”.
The Court documents state: “The Claimant claims damages and interest… as a result of personal injuries and consequential losses arising out of his sustaining Vaccine Induced Immune Thrombosis with Thrombocytopenia (VITT) as a result of his vaccination on 23 April 2021, with the AstraZeneca COVID19 vaccination (ChAdOx1-S [recombinant]) manufactured and/or supplied by the Defendant which was defective within the meaning of the Consumer Protection Act 1987.”
On the complex issue of the vaccine’s efficacy, the court documents draw on a ruling by the Prescription Medicines Code of Practice Authority (PMCPA), which said in July last year that AstraZeneca had breached its code in using the repeated use of the word “safe” in a press release in December 2020. The PMCPA also ruled it had breached its code of practice in failing to disclose the absolute risk reduction of having the vaccine.
The particulars of claim state: “In fact, the absolute risk reduction concerning COVID-19 prevention was only 1.2 per cent, and the PMCPA concluded in response to the complaint… that the information provided in the press release as to the efficacy of the vaccine was misleading because members of the public reading the press release might assume that the published efficacy rate was an absolute risk rate (in which case the published efficacy rate vastly overstated the efficacy of the vaccine).”
Lawyers to examine government reassurance
The legal action will also examine the role of the Government in reassuring the public after Mr Hancock authorised an indemnity for AstraZeneca in the “very unexpected event of any adverse reactions that could not have been foreseen through the robust checks and procedures that have been put in place”.
Lawyers point out in the legal claim that Mr Hancock, in an accompanying departmental minute, said: “The data so far on this vaccine suggests that there will be no adverse reactions, and so no liability.”
The particulars of claim state: “Public statements by the Government as to the safety of the vaccine are relevant circumstances to be taken into account in considering the level of safety that persons generally were entitled to expect from the AZ vaccine.”
Writing for The Telegraph UK, Sarah Moore, partner at Hausfeld, the law firm bringing the claim, says: “The group of individuals whom we represent have always been clear: they do not dabble in anti-vaccine conspiracy theories. However, it is plainly factually inaccurate to claim that vaccines do no harm given the experience of our client group – the vaccine injured and bereaved.
“By beginning a legal battle against AstraZeneca, the vaccine injured and bereaved will use the law to seek accountability and compensation for the deaths of their loved ones and the life-changing injuries that many in the group have sustained.”
Government urged to settle cases
Sir Jeremy Wright KC, the former attorney general, urged the Government to step in and settle the legal claims before they came to court – given that ministers had indemnified AstraZeneca.
Sir Jeremy, who has raised the case of Mr Scott, who is one of his constituents, with Rishi Sunak, said: “It is very, very strange the Government has not come up with a way to settle these cases where the cause is clear. I don’t get it from a professional point of view, or from the political point of view, because of the damage done if these cases are not settled quickly.”
Sir Jeremy added: “There is no sense of urgency on this. There is no realisation in the Government this is an impending problem. The PM told me he would find out more about it and come back to me. But that was some time ago – long enough that I would expect to see progress. Given indemnification is a fact, this is a government problem. The Government should not be washing its hands of this. None of us can be confident we won’t have to go through all this again one day, and if we do, then confidence in mass vaccination needs to be in place.”
‘Patient safety is our highest priority’
The second claim is being brought by Anish Tailor, whose wife died in April 2021, just under a month after having the vaccine. An inquest in September 2021 determined she died from blood clots and bleeding on the brain caused by “vaccine-induced immune thrombosis and thrombocytopenia”. According to the claim lodged in the High Court, Mrs Tailor’s family are seeking damages of up to £5 million.
In a statement AstraZeneca said: “We do not comment on ongoing litigation matters,” but it added: “Patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines. Our sympathy goes out to anyone who has lost loved ones or reported health problems.
“From the body of evidence in clinical trials and real-world data, Vaxzevria has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”
It pointed out the MHRA had granted the vaccine “full marketing approval… for the UK based on the safety profile and efficacy of the vaccine”.
AstraZeneca also pointed out that it supplied three billion doses of the vaccine to more than 180 countries and that an independent study had found it had been responsible for saving six million lives.
Sir John Bell, who was chief adviser to the Government on life sciences and an adviser to the Joint Committee on Vaccination and Immunisation, said: “It is an asteroid-like risk from the AstraZeneca vaccine. There is a risk of getting hit by an asteroid but it isn’t very big.”