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.

Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.



New Delhi (PTI): Congress leader Rahul Gandhi on Monday said the Opposition is protesting for the right to vote for every Indian and demanded a "clean and pure" voter list, asserting that the issue of alleged irregularities pointed out by him will "explode" soon as it is not related to a single constituency but the whole country.

Indicating that he would not submit a signed affidavit as sought by the Election Commission, Gandhi asserted that the data analysed by the Congress to provide "proof" of "vote theft" is taken from the EC website.

"This is their data. It is not my data that I should sign. It is their data only and has been taken from their website. This is only a move to distract," he told reporters.

The Leader of Opposition in Lok Sabha, who participated in a protest march by the opposition on the "vote theft" issue, said the Election Commission is "silent" as the truth is before the entire nation after his charge that over one lakh votes in an assembly constituency in Karnataka were found to be fake in a research conducted by his party.

"Another thing I want to tell is that this has not just happened in Bangalore, but in different constituencies across the country, and the Election Commission knows this. The EC knows that this data will explode. What it is trying to control and hide, we will bring it out, and it will explode. The EC knows this," he told reporters.

Gandhi was briefly detained along with others as police stopped the protest march by opposition MPs from Parliament House to the EC office.

"They (EC) cannot talk as the truth is before the entire nation," the Congress leader said as he was being taken away in a bus by the police.

"This fight is not political, but for saving the Constitution," he asserted.

This fight is for 'one man, one vote' and we want a clean, pure voter list," the Leader of Opposition in the Lok Sabha added.

He said all the MPs of the INDIA alliance were stopped and taken into custody when they were going to meet the Election Commission.

"The truth of 'vote theft' is now before the country. This fight is not political; it is a fight to protect democracy, the Constitution, and the right to ‘one person, one vote’.

"The united opposition and every voter in the country demand a clean and transparent voter list. And, we will secure this right at all costs," Gandhi claimed in a post on X later.

Gandhi had on Thursday cited data from the 2024 Lok Sabha polls to claim that over 1 lakh votes were "stolen" through five types of manipulation in Mahadevapura assembly segment in Karnataka. He alleged there were 11,965 duplicate voters, 40,009 with fake and invalid addresses, 10,452 bulk voters or single-address voters, 4,132 voters with invalid photos and 33,692 voters misusing Form 6 of new voters.