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.
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.
Adani touts financial strength, shows can grow without external debt
New Delhi (PTI): Billionaire Gautam Adani's conglomerate on Monday touted its financial and credit details of its portfolio companies to investors, showcasing its robust profits and cash flows that can sustain growth without reliance on external debt.
The ports-to-energy conglomerate, which has been hit by an indictment in a US court against its founder chairman Gautam Adani and two other executives for allegedly bribing Indian official to secure solar power contracts, in a presentation to the investors highlighted its consistently expanding profits and cash flows, which over a period have led to lowering dependence on debt for its growth ambitions.
Equity now accounts for almost two third of its total asset creation, a stark contrast to five years ago. In the last six months, the group has invested close to Rs 75,227 crore, against a total debt increase of only Rs 16,882 crore.
A note was also shared with the investors, along with presentations.
Outlining the group's liquidity position, the note said, "Adani Portfolio companies have sufficient liquidity to cover all debt servicing requirements for at least 12 months. As of September 30, 2024, Adani Portfolio companies had a cash of Rs 53,024 crore, which was close to 21 per cent of its total gross debt outstanding".
This amount, it said, was sufficient to cover the next 28 months of debt servicing requirement.
GROWTH WITHOUT DEBT
In the past, the group has announced plans to invest over Rs 8 lakh crore (USD 100 billion) across portfolio companies in the next ten years.
The Fund Flows from Operations (FFO) or cash profits stood at Rs 58,908 crore for the last twelve months and is growing over 30 per cent for the past five years. On the basis of this, even after assuming no growth, the group will be able to invest Rs 5.9 lakh crore only from its internal cash accruals over the next ten years, leaving very little dependency on external debt.
Further, at the portfolio level, there is very low debt gearing of 2.46x -- which means it has massive headroom for debt, according to the presentation.
Other highlights from the presentation included EBITDA (earnings before interest tax and depreciation) for the last twelve months, which it said is highly stable and hence predictable due to its infrastructure projects, which grew by 17 per cent to Rs 83,440 crore.
Also, existing annual cash flows alone can pay the entire debt in 3 years.
Gross assets/investments increased by Rs 75,227 crore, against total debt increase of only Rs 16,882 crore. Asset base has now increased to Rs 5.5 lakh crore.
Average cost of borrowing at 8.2 per cent, lowest in the last 5 years, due to upgrade in ratings across group companies, it said.
Adani Group's long-term debt from domestic banks was Rs 94,400 crore. This stood against a cash balance of Rs 53,024 crore, most of which was parked with Indian banks.
Borrowings from global banks were 27 per cent of total debt.
