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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Bomb threats to Delhi Secretariat, Assembly, Red Fort and two schools declared hoax
New Delhi (PTI): Multiple institutions, including the Delhi Secretariat, Delhi Assembly, Red Fort and two schools in the national capital, received bomb threats via email on Monday, which were later declared hoax, officials said.
An official of the Delhi Fire Services confirmed that Delhi Secretariat, Delhi Army Public School in Dhaula Kuan and Air Force Bal Bharti School on Lodhi Road received bomb threats.
The threat emails were also received on the official ID of the Delhi Assembly and its Speaker at 8 am, reportedly from the Khalistan National Army, sources said.
Delhi Assembly Speaker Vijender Gupta asked the Delhi Police for immediate appropriate action on the bomb threat received on his personal email id.
"The Speaker, Delhi Legislative Assembly has desired that immediate necessary appropriate action be taken in the matter and an investigation be carried out to trace the source of these emails keeping in view the serious warnings about the bomb blast threats to Delhi Legislative Assembly Secretariat and Speaker in person," the Speaker office in a letter to Delhi Police Commissioner said.
The threatening emails mention “Delhi banega Khalistan” (Delhi will become Khalistan) and read that there will be blasts in Delhi Army School, Red Fort and Metros in the next three days.
The emails claimed a blast at the Delhi Army school at 1.11 pm, Vidhan Sabha at 3.11 pm and Red Fort at 9.11 am today, they said.
After receiving the threatening emails, the administrations of both schools informed authorities in the morning, a senior police officer said.
As a precautionary measure, the premises were evacuated, and thorough search operations were carried out, the officer said.
"After nothing suspicious was found, it was declared a hoax," the officer added.
An Aam Aadmi Party leader and former MLA, Dilip K Pandey, in a post on X said, "Today, I received a bomb threat on my personal email ID, and since the matter was related to public safety, I have immediately forwarded the email to Delhi Police."
Upon receiving the information, teams from the Delhi Police, the bomb disposal squad, dog squad and Delhi Fire Services rushed to the spots and cordoned off the areas around the schools and other locations.
"We are verifying the source of the emails and further investigation is underway," the officer added.
The cyber cell has been roped in to trace the origin of the emails and identify the sender. Search operations are continuing.
