AstraZeneca has admitted for the first time in court papers that its Covid vaccine may cause a rare side effect, in an apparent reversal that could pave the way for a multi-million pound regulatory payout.
The pharmaceutical giant is being sued in a class action over claims that its vaccine, developed with the University of Oxford, has caused death and serious injury in dozens of cases.
Lawyers claim the vaccine caused a side effect that has had a devastating effect on a small number of families.
The first case was filed last year by father-of-two Jamie Scott, who suffered a permanent brain injury after suffering a blood clot and brain haemorrhage that left him unable to work after receiving the vaccine in April 2021. The hospital called his wife three times to tell her that her husband was dying.
AstraZeneca disputes the claims but has accepted in a legal document filed with the High Court in February that its Covid vaccine “may cause TTS in very rare cases”.
TTS – which stands for Thrombosis with Thrombocytopenia Syndrome – causes people to develop blood clots and low platelet counts.
Fifty-one cases have been filed in the High Court, with victims and grieving relatives seeking damages estimated at up to £100 million.
AstraZeneca’s admission – made in a legal defense against Mr Scott’s High Court claim – follows intense legal wrangling. It could lead to payouts if the drug company accepts that the vaccine caused serious illness and death in specific lawsuits. The government has promised to endorse AstraZeneca’s legal bills.
In a May 2023 response letter, AstraZeneca told Scott’s lawyers that “we do not accept that TTS is caused by the vaccine at a generic level.”
But in the legal document submitted to the High Court in February, AstraZeneca said: “It is admitted that the AZ vaccine can cause TTS in very rare cases. The causal mechanism is not known.
“Furthermore, TTS can also occur without the AZ vaccine (or any vaccine for that matter). In each individual case, the causal link will be a matter for expert investigation.”
Lawyers claim the AstraZeneca-Oxford vaccine is “defective” and its efficacy has been “vastly exaggerated” – claims AstraZeneca strongly denies.
Scientists first identified a link between the vaccine and a new disease, vaccine-induced immune thrombocytopenia and thrombosis (VITT), in March 2021, shortly after the Covid-19 vaccine rollout began.
Lawyers for the plaintiffs argue that VITT is a subset of TTS, although AstraZeneca does not appear to recognize the term.
The government has shielded AstraZeneca from any legal action but has so far refused to intervene.
Kate Scott, Mr Scott’s wife, told the Telegraph: “The medical community has long recognized that VITT was caused by the vaccine. Only AstraZeneca has questioned whether Jamie’s condition was caused by the jab.
‘It took three years before this recognition came. It’s progress, but we’d like to see more from them and the government. It’s time for things to move faster.
“I hope their admission means we can resolve this sooner rather than later. We need an apology and fair compensation for our family and other families who have been affected. We have the truth on our side and we will not give up.”
‘Patient safety is our highest priority’
Sarah Moore, a partner at law firm Leigh Day, which is bringing the legal claims, said: “It has taken AstraZeneca a year to formally admit that their vaccine can cause the devastating blood clots, while this fact has been widely accepted by clinical practice. community since the end of 2021.
“In that context, it unfortunately appears that AZ, the government and their lawyers would rather play strategic games and drive up legal costs than seriously address the devastating impact their AZ vaccine has had on the lives of our clients.”
In a statement, AstraZeneca said: “Our condolences go out to everyone who has lost loved ones or reported health concerns. Patient safety is our top priority, and regulators have clear and strict standards to ensure the safe use of all medicines, including vaccines.
“The body of evidence from clinical trials and real-world data consistently shows that the AstraZeneca-Oxford vaccine has 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. Effects.”
The company notes that the product information relating to the vaccine was updated in April 2021, with UK regulator approval, to “include the possibility that the AstraZeneca-Oxford vaccine may in very rare cases be a trigger for ‘TTS .
The company does not acknowledge in court documents that it has made an about-face by acknowledging that the vaccine can cause TTS.
Independent studies show the AstraZeneca vaccine was incredibly effective in fighting the pandemic, saving more than six million lives worldwide in the first year of its rollout.
The World Health Organization has said the vaccine was “safe and effective for all persons aged 18 years and over” and that the adverse effect that led to the legal action was “very rare”.
The vaccine – heralded by Boris Johnson at its launch as a ‘triumph for British science’ – is no longer used in Britain.
In the months after the rollout, the potentially serious side effect of the jab was identified by scientists. It was then recommended that under-40s be offered an alternative jab because the risk from the AstraZeneca vaccine outweighed the harm from Covid.
Lawyers representing families suing the drug company claim the vaccine was not as safe as individuals had a right to expect. They are suing the Cambridge-based company under the Consumer Protection Act 1987.
Mr Scott’s lawyers have argued that he “suffered personal injury and consequential damages as a result of contracting vaccine-induced immune thrombosis with thrombocytopenia (VITT) as a result of his vaccination on April 23, 2021 with the AstraZeneca Covid-19 vaccination” .
Official figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show that at least 81 deaths in Britain are believed to be linked to the side effect that caused clotting in people who also had low platelets.
Overall, almost one in five people suffering from the condition died as a result, MHRA figures show.
The government is running its own vaccination compensation programme, but alleged victims claim the £120,000 one-off payment is inadequate.
Figures obtained under a freedom of information request show that of the 163 payouts made by the government in February this year, at least 158 went to recipients of the AstraZeneca vaccine.
The Vaccine Damage Payment Scheme provides compensation to those injured by vaccines or to surviving relatives. Fewer than five people covered by the scheme received vaccines other than AstraZeneca.
AstraZeneca has previously argued in lawsuits that claims against the company are “confusing” and “illegal.” In the defense filing, AstraZeneca said the benefit-risk profile of the vaccine was and remains positive.
AstraZeneca is the second largest listed company in Britain, with a market capitalization of more than £170 billion. Its CEO, Sir Pascal Soriot, is the highest paid boss among FTSE 100 companies, with profits of almost £19m.