AstraZeneca claims allegations Covid jab is defective are ‘confused’ and ‘wrong in law’
AstraZeneca has denied its Covid-19 vaccine is “defective” in response to a multi-million pound legal case over claims the jab caused blood clots.
The drugs firm is being sued in the High Court by a father-of-two who suffered a significant permanent brain injury after receiving the vaccine in April 2021.
At least 40 further claims for damages are expected to be lodged in the court within weeks.
Lawyers estimate the claims are worth about £80 million.
In its defence filed in the High Court, AstraZeneca, which is based in Cambridge, has argued that the claim is “confused” and “wrong in law”.
In the defence filing, AstraZeneca said that the benefit/risk profile of the vaccine was, and remained, positive.
It said the vaccine developed in conjunction with Oxford University was approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
The company – one of the biggest in the UK – is being sued by Jamie Scott, who suffered a serious adverse reaction after receiving the jab.
The Telegraph has previously reported that his wife was called to his bedside three times by doctors who thought he was going to die.
Mr Scott, who worked in IT, survived but can no longer work after suffering a serious brain injury caused by a blood clot.
In the legal claim being brought under the Consumer Protection Act, lawyers for Mr Scott said he had “been left with very serious injuries including speech difficulties, reduced cognition, memory and processing”.
MHRA reports of adverse reactions to the AstraZeneca jab suggest at least 81 people died in the UK from a vaccine-induced reaction that led to blood clots and low blood platelets.
The new condition – known as Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT) – is also suspected of causing serious harm in hundreds more people.
VITT is very rare and affects about one in 50,000 people under the age of 50.
In its defence, AstraZeneca said Mr Scott’s claim was “unclear, lacking in detail and imprecise about the Claimant’s case in general and the nature of the defect alleged in particular”.
The firm’s lawyers said the vaccine’s development “was a significant scientific achievement which contributed substantially to bringing the Covid-19 pandemic under control in the UK”.
It said three billion doses of vaccine had been supplied to 180 countries and saved “6.3 million lives worldwide”.
AstraZeneca said that the vaccine “was granted, and retains, regulatory authorisations in the UK” and added: “The benefit/risk profile of the AZ vaccine was (and remains) positive.”
AstraZeneca said it recognised that VITT “refers to a ‘new diagnosis’”, but the company did not accept the use of the term in its defence.
“The term assumes a causal connection with the AZ vaccine and defines a condition by reference not to its symptoms but to its cause, when that may be disputed,” lawyers for AstraZeneca said.
‘Relative risk reduction’
The drugs company denied it had overstated the safety of the vaccine in press releases issued when the vaccine was first approved for use.
“Taken overall, the original wording of the press release did not exaggerate the safety of the AZ vaccine based on the clinical trial data,” said AstraZeneca in its defence.
Lawyers for Mr Scott had also argued the vaccine’s “efficacy” had been “vastly overstated” because the drugs firm had concentrated on a relative risk reduction of 70 per cent and not an absolute risk reduction of 1.2 per cent. But AstraZeneca “denied that the omission of ‘absolute’ risk reduction data was misleading”.
It added: “The absolute risk reduction was not included in the press release because this information varies depending on the underlying risk level at the time of the trial and in the context of individuals with different risk levels. Absolute risk reduction data are difficult to interpret, potentially confusing and (taken in isolation) not a good indicator of efficacy.”
Concerns about the rare but serious blood clotting side effect had emerged as the vaccine began its rollout. In the filing, AstraZeneca said there was a “reasonable possibility” that the vaccine was capable in “very rare cases” of triggering the side effect, but it was not known how this happens.
The UK changed its guidance to advise against giving the vaccine to under-30s in early April 2021 and to the under-40s in May 2021. But AstraZeneca pointed out that because Mr Scott was aged 44 at the time of receiving the vaccine, he was in the age category where the vaccine continued to be recommended in the UK.
