AstraZeneca told British court its COVID vaccine may cause rare side effects

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Vaccination benefits outweigh risks of potential side effects, global regulators say

The AstraZeneca laboratory admitted in legal documents that its COVID-19 vaccine could induce a rare side effect, British media reported. This statement occurred in the context of a class action lawsuit that was initiated in the United Kingdom, where it is alleged that the drug, a product of collaboration between that pharmaceutical company and the University of Oxford, would be the cause of serious injuries in a limited number of cases.

The pharma company had already pointed out in a paper published in 2021 the possibility of this adverse effect in very rare cases and does not now recognize the claims that it has made a turn in court documents.

The lawsuit argues that the inoculant caused a serious adverse reaction in some people, devastatingly affecting several families. This recognition by AstraZeneca could set the stage for a compensation agreement of up to £100 million (about $125 million) for the plaintiffs, The Telegraph reported.

Vaccination was and continues to be a crucial tool in the fight against COVID-19. There are multiple manufacturers, including AstraZeneca, which distributed doses globally within the framework of the health emergency and was an important player in preventing hospitalizations and deaths.

Claimants in the United Kingdom seek compensation for serious injuries after vaccination with AstraZeneca (REUTERS/Dado Ruvic/Illustration)

The aforementioned newspaper indicated that at first the laboratory rejected the claims, but then, last February, it accepted, in a legal document that it presented to the Superior Court that its formulation “can, in very rare cases, cause TTS,” that is That is, thrombosis syndrome with thrombocytopenia, which causes people to have blood clots and a low blood platelet count.

The High Court of the United Kingdom received 51 cases from people who claim to have suffered from these conditions or their relatives.

As described by The Telegraph, the laboratory admitted the presence of these rare cases in the framework of a legal defense against the lawsuit of Jamie Scott, who was the first to appear before Justice in 2023. The man suffered an irreversible brain injury after developing a blood clot and a brain hemorrhage after being vaccinated in April 2021. The case involves moral damage considering that the hospital notified his wife — both are parents of two children — that I would die.

As described by the newspaper, in May last year in a letter to Scott’s lawyers, AstraZeneca said: “we do not accept that TTS is caused by the vaccine at the generic level.” But in the legal document submitted to the High Court in February the laboratory said: “It is accepted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is unknown.” He also highlighted: “In addition, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter of expert evidence.”

Studies revealed in 2021 and 2022 a link between the AstraZeneca vaccine and thrombosis syndrome with thrombocytopenia (EFE / Carlos Barba)

A study published in the BMJ scientific journal in October 2022, based on research conducted between December 2020 and mid-2021 in health databases from France, Germany, the Netherlands, Spain, the United Kingdom, and the United States. a link between the aforementioned vaccine and the disease that was then called vaccine-induced immune thrombocytopenia and thrombosis (VITT).

On July 27, 2021, the The Lancet magazine published a study titled “Very rare thrombosis with thrombocytopenia after the second dose of AZD1222: an analysis of the global safety database,” by scientists from the laboratory itself. There, they point out that “since the launch of the COVID-19 vaccine, very rare cases of thrombosis with thrombocytopenia syndrome (TTS), which is known as vaccine-induced immune thrombotic thrombocytopenia, have been reported.”

The Oxford/AstraZeneca vaccine showed, as reported in May 2021 by Public Health England (PHE), that two doses are between 85% and 90% effective against symptomatic disease and cited an analysis of actual data obtained in the vaccine rollout.

The World Health Organization recognizes the risk of rare adverse events after the administration of the AstraZeneca vaccine (EFE/Eugene Hoshiko)

Regarding the vaccine in question, in a World Health Organization publication titled “Everything you need to know about the Oxford/AstraZeneca ChAdOx1-S (recombinant) vaccine against COVID-19,” the above was reported. by the Global Advisory Committee on Vaccine Safety, “a group of experts that provides independent and well-informed guidance to WHO on the safe use of vaccines, receives and evaluates reports of suspicious safety events that may have international consequences” , as described by the multilateral organization.

That Committee said: “A new type of very rare adverse event, known as thrombosis syndrome with thrombocytopenia, has been reported after administration of this vaccine. This syndrome involves rare and serious blood coagulation disorders associated with low platelet counts. In countries where SARS-CoV-2 transmission is currently recorded, the benefits of getting vaccinated far outweigh the risks, given the protection conferred by the vaccine against COVID-19.

The AstraZeneca-Oxford vaccine demonstrated to be effective in preventing COVID-19 with an acceptable safety profile (AP Photo/Carlos Giusti, File)

Attorney Sarah Moore, a partner in the Leigh Day study, who is part of the lawsuit, lamented that “it has taken AstraZeneca a year to formally admit that its vaccine can cause devastating blood clots, when this fact has been widely accepted by the clinical sector.” ” from the end of 2021.

For its part, in a statement from AstraZeneca it said: “Our solidarity is with anyone who has lost loved ones or reported health problems. “Patient safety is our top priority and regulatory authorities have clear and strict standards to ensure the safe use of all medicines, including vaccines.”

“Based on the body of evidence from clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continually been shown to have an acceptable safety profile and regulators around the world consistently claim that the benefits of vaccination outweigh the benefits.” risks of possible extremely rare side effects.”

The company noted that product information related to the vaccine was updated in April 2021, with approval from the UK regulator, to include “the possibility that the AstraZeneca-Oxford vaccine may be capable, in very rare cases, of being a TST trigger.”

The pharmaceutical company updated information about the vaccine in April 2021 to include possible rare side effects (EFE/EPA/RUNGROJ YONGRIT/File)

Independent studies show the AstraZeneca vaccine was incredibly effective in tackling the pandemic, saving more than six million lives worldwide in the first year of its rollout.