Benefits of COVID vaccine outweigh risks: AstraZeneca amid row over side effects

In the wake of the admission by pharmaceutical major AstraZeneca that its COVID-19 vaccine could cause blood clot-related side effects in rare cases, the company in a statement on Tuesday (April 30) reasserted its commitment to patient safety.

“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,” the British-Swedish pharmaceutical company said in a statement.

The company’s statement came on a day it came to light that it has admitted before the London High Court that its COVID-19 vaccine – known as Covishield in India – could cause Thrombosis with Thrombocytopenia Syndrome (TTS) in “very rare cases”, but the causal link is unknown.

Patient safety our highest priority: AstraZeneca

“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,” the company said in the statement.

The multinational said 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.

What AstraZeneca told the court?

The Daily Telegraph reported that in a legal document submitted to the High Court in London in February for a group action being brought by 51 claimants, the company 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 Vaxzevria vaccine, is manufactured by the Serum Institute of India (SII), in India.

“It is admitted that the AstraZeneca vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. Further, TTS can also occur in the absence of the AstraZeneca 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 AstraZeneca vaccine suffered TTS – a rare syndrome characterised by the concurrence of thrombosis or blood clotting and thrombocytopenia or insufficiency of platelets.

‘Life threatening consequences’

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 AstraZeneca, 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. AstraZeneca has strongly denied the claims.

‘Serious question marks’

“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 AstraZeneca 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.

(With inputs from agencies)