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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Pune accident: Porsche car's registration was pending since March due to non-payment of Rs 1,758 fee
Mumbai, May 21: The permanent registration of the luxury Porsche car involved in the accident in which two IT professionals were fatally knocked down by in Pune city was pending since March due to non-payment of Rs 1,758 fees by the owner, top officials of the Maharashtra transport department said on Tuesday.
The electric luxury sports sedan - Porsche Taycan - was being driven allegedly by a prominent builder's 17-year-old son, who the police claim was drunk at the time of the accident that took place in Kalyani Nagar area in the early hours of Sunday.
Maharashtra Transport Commissioner Vivek Bhimanwar told PTI that the Porsche car was imported in March by a dealer in Bengaluru and from there it was sent to Maharashtra on a temporary registration.
"When it was produced at the Pune Regional Transport Office (RTO), it was found that a certain registration fee was not paid and the owner was asked to pay the amount for completion of the procedure. However, the vehicle was not brought to the RTO for the completion of the registration process after that," he said.
According to officials, road tax is exempted for electric vehicles registered in Maharashtra, and hence for the registration of this Porsche Taycan model, the registration fees that were applicable were only Rs 1,758 with the break-up of Rs 1,500 hypothecation fees, Rs 200 smart card RC fees and Rs 58 postal charges.
Interestingly, as per Porsche India's website, the ex-showroom price of the vehicle manufacturer's various cars starts at Rs 96 lakh and goes over Rs 1.86 crore. Though the price of the Porsche Taycan model is not given on the website, transport department sources said that it could be in crores.
The officials said that as per their records, the vehicle had a valid temporary registration certificate issued by Karnataka with a validity of six months from March to September 2024.
They said that the Porsche dealer in Bengaluru was not at fault as he had handed over the car after doing the temporary registration. Hence, it was the responsibility of the owner to get it registered at the RTO before plying it on the roads. During the temporary registration period, the vehicles can only be used to drive to and from the RTO.
Bhimanwar said that the teenage boy, who was said to be driving the car, will be barred from getting a driving licence until he turns 25 years of age, and the luxury car will also not be allowed to register at any RTO office for 12 months as its existing temporary registration will be cancelled as per the provisions in the Motor Vehicles (MV) Act.
Under the sub-sections of Section 199A (offenses by juveniles) of the MV Act, the transport authorities can take this action.
Bhimanwar said that their department is going to take stringent action in this case and the Pune RTO has been asked to register the police complaint for violation of provisions in the MV Act
"Whatever violations related to the Motor Vehicles Act happened in the issue, those will be registered in the FIR," Bhimanwar said, adding that they will also invoke the procedure for cancellation of the temporary registration of the vehicle as per the provisions in the act.
"The vehicle will be impounded for 12 months," another top official of the transport department said, adding that there is gross negligence in this case as the vehicle was driven at a speed over 160 kmph, allegedly in an inebriated state as per media reports.
The official said that there are several violations in this case, including driving the vehicle without a driving licence and without its registration, among others.
Meanwhile, Maharashtra Deputy Chief Minister and Home Minister Devendra Fadnavis said in a press conference in Pune this evening that the car was purchased in Bengaluru and was brought here.
"As per the primary information, the RTI had carried out its inspection but the tax which was required to be paid was not paid. If there is any violation regarding that, a separate FIR will be registered," he said.
