AstraZeneca admits ‘very rare’ side effect of COVID vaccine in UK court
London, Apr 30: UK-headquartered pharmaceutical giant AstraZeneca (AZ) has admitted that in "very rare cases" its COVID vaccine can cause a blood clot related side effect but the causal link is unknown, according to court papers being quoted in the UK media.
‘The Daily Telegraph’ reports that in a legal document submitted to the High Court in London in February for a group action being brought by 51 claimants, AZ admitted that the vaccine developed with the University of Oxford to protect against COVID-19 may cause Thrombosis with Thrombocytopenia Syndrome (TTS) in “very rare cases”. The AZ Vaxzevria vaccine, also manufactured by the Serum Institute of India (SII), was known in India as Covishield.
“It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence,” the newspaper quotes the legal document as stating.
Lawyers acting on behalf of the claimants say they, or their loved ones, who received the AZ vaccine suffered TTS – a rare syndrome characterised by the concurrence of thrombosis or blood clotting and thrombocytopenia or insufficiency of platelets.
The consequences of TTS are potentially life-threatening including strokes, brain damage, heart attacks, pulmonary embolism and amputation. Of the 51 claimants in the group action being represented by the law firm Leigh Day for damages under Section 2 of the UK’s Consumer Protection Act 1987 against AstraZeneca UK Ltd in respect of injuries sustained as a result of the vaccine, 12 are acting on behalf of a loved one who died.
“All of those within the group have death certificates or medical evidence confirming that the vaccine caused the deaths and injuries suffered,” said Sarah Moore, partner at Leigh Day.
“It has taken AstraZeneca a year to formally admit that their vaccine has caused this harm, when this was a fact widely accepted by the clinical community since the end of 2021. In that context, regrettably it seems that AZ, the government and their lawyers are more keen to play strategic games and run up legal fees than to engage seriously with the devastating impact that the vaccine has had upon our clients’ lives,” she said.
It is the claimants’ case that the safety of the AZ vaccine fell below the level of safety that persons were generally entitled to expect. AZ has strongly denied the claims.
“Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” AstraZeneca said in a statement.
“From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine 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 noted.
The British-Swedish multinational points out that product information relating to the vaccine was updated in April 2021, with the approval of the UK regulator, to include “the possibility that the AstraZeneca-Oxford vaccine is capable, in very rare cases, of being a trigger for” TTS, indicating that the court documents reference this aspect rather than something new.
“It’s absolutely appalling that only now AstraZeneca are acknowledging serious harm from their COVID vaccine. Surely, they would have known this from the outset and therefore there would have been serious question marks around whether it should have been administered to a single human being in the first place,” said British Indian cardiologist Dr Aseem Malhotra, who has been a vocal campaigner over the issue.
The World Health Organisation (WHO) has described the vaccine as “safe and effective for all individuals aged 18 and above”, with the adverse effect that has prompted the legal action being “very rare”.
The claimants in the UK have served “Particulars of Claim” in regard to two cases and AZ has provided its defence disputing liability. The parties have requested that the cases are managed together, and a case management hearing is expected later in the year in the London High Court.
SII has been approached for a comment.
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SC upholds inclusion of ‘secular, socialist’ in Preamble of Constitution
New Delhi: The Supreme Court on Monday upheld the inclusion of the words ‘socialist’ and ‘secular’ in the Preamble of the Constitution, confirming their retrospective application from November 26, 1949. The court ruled that the power to amend the Constitution under Article 368 extends to the Preamble, which is an integral part of the document.
A Bench led by Chief Justice of India Sanjiv Khanna stated, “The power under Article 368 cannot be curtailed. It will equally apply to the Preamble.” The 42nd Constitutional Amendment, which introduced these terms in 1976 during the Emergency, was challenged on grounds of its retrospective application and the lack of states’ ratification.
The petitioners, including BJP leader Subramanian Swamy, argued that the amendment forced a particular economic theory on the nation and violated the original intent of the Constitution. Advocate Ashwini Kumar Upadhyay contended that the Preamble reflects the will of the people at the time of adoption in 1949 and is therefore unalterable.
The court dismissed these objections, affirming that both socialism and secularism are part of the Constitution's Basic Structure. The Bench clarified that socialism refers to a welfare state ensuring equality of opportunity without negating private sector participation or individualism. It emphasised that secularism is embedded in the Constitution, particularly in the principles of equality and fraternity.
Chief Justice Khanna remarked, “Secularism has always been a core feature of the Constitution.” He added that the amendment did not impose socialism as dogma but aligned with the welfare goals enshrined in various constitutional provisions.
